Silicon Investor - Unquoted Biotechs

[nigel bates] WATERTOWN, Mass., Aug. 8, 2018 /PRNewswire/ -- SQZ Biotechnologies (SQZ), a cell...

nigel bates — 11/1/2018 8:21:06 AM

WATERTOWN, Mass., Aug. 8, 2018 /PRNewswire/ -- SQZ Biotechnologies (SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, announced the completion of an oversubscribed $72 million Series C financing. New investors include Everblue, Illumina Ventures, Invus, Orient Life, and Viva Ventures Biotech Group. Existing investors also participated and include Bridger Healthcare Partners, Global Health Science Fund, GV, JDRF T1D Fund, NanoDimension, and Polaris.

"We are deeply appreciative of the excitement and support investors have expressed for the SQZ vision," said Armon Sharei, PhD, SQZ's co-founder and CEO. "Our cell therapy platform has transformative potential and with this funding, we have the financial strength to drive our programs in solid tumors and autoimmune diseases to the clinic, taking us closer to our goal of bringing high impact cell therapies to patients in need."

The SQZ platform directly engineers complex cell functions without affecting cell health, with a simple and scalable process. The therapeutic platform can bring cell therapies into indications where new and innovative treatments are needed the most.

Proceeds from the financing support SQZ's most advanced programs in solid tumors and auto-immunity. These first applications focus on SQZ's unique potential to generate target-specific immune responses in patients through natural mechanisms. The Company's lead program in antigen presenting cells (APCs) for oncology will have its first application in multiple HPV+ tumor indications; future applications will address solid tumors across cancer types. SQZ's APCs are engineered to deliver tumor-associated antigens that aim to prime and activate a patient's endogenous killer T cells against the target of choice in order to infiltrate tumors and destroy them. The Company's immune tolerance programs aim to leverage similar mechanisms to shut down target-specific immune responses. SQZ is currently pursuing type 1 diabetes and other autoimmune indications.

In association with the financing, Marc Elia, Partner at Bridger Healthcare, and Zafi Avnur, PhD, Chief Scientific Officer at Quark Venture (Global Health Science Fund) have joined SQZ's board of Directors. Mr. Elia, having been an investor in SQZ since 2016, has been an advisor to the company and now formally brings his 20 years of industry experience to the board. Dr. Avnur's relationship with SQZ began during her time at Roche when she played a key role in establishing the partnership with SQZ. She has since been a valuable supporter and advisor to the team and now has converted her role from a board observer to a board member.

"SQZ has broad patient applicability," commented Amy Schulman, SQZ's Executive Chair and Partner at Polaris. "This is a company and a team that delivers on its commitments. We welcome the new investors and board members and look forward to seeing the clinical results."

Interesting, possibly:
medicalxpress.com

[tuck] Aptinyx just did a 70 million B round financing. It was spun out from Naurex/Al...

tuck — 12/18/2017 8:02:06 PM

Aptinyx just did a 70 million B round financing. It was spun out from Naurex/Allergan as a consequence of AGN's munch of Naurex. It focuses on carefully modulating - rather than completely agonizing or antagonizing - NMDA to treat neurological problems.

Aptinyx Science

Having recently developed a touch of peripheral neuropathy, I'm especially interested in that program.

Aptinyx Pipe

I'm not diagnosed yet, and it's cramping my lifestyle only a bit. But if biofreaks reading this know of other other promising programs in this indication, I'd be curious.

Cheers, Tuck

[nigel bates] CAMBRIDGE, Mass., September 14, 2017 — Moderna Therapeutics, a clinical stage bi...

nigel bates — 9/14/2017 8:42:00 AM

CAMBRIDGE, Mass., September 14, 2017 — Moderna Therapeutics, a clinical stage biotechnology company that is pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, provided an update today, noting continued progress of clinical programs and the introduction of several new development candidates (DCs) across its broad, diverse development pipeline. Moderna announced the update in conjunction with an Investor R&D Day hosted by its management team this morning in New York.

A Phase 1 study of mRNA AZD-8601, the first-ever mRNA therapeutic to be evaluated in a clinical study, has been successfully completed. mRNA AZD-8601 is anticipated to move into Phase 2 development. mRNA AZD-8601 is being developed by Moderna’s partner AstraZeneca to express a local and transient surge of vascular endothelial growth factor-A (VEGF-A) as a potential treatment for cardiovascular diseases. The Phase 1 randomized, double-blind, placebo-controlled, single ascending dose study, which assessed the safety, tolerability and pharmacokinetics (PK) of mRNA-AZD-8601 after single dose administration in male patients with Type 2 diabetes mellitus was successfully completed. The study met its primary endpoint of safety and tolerability and also demonstrated proof of mechanism as measured by expression of VEGF-A protein in the skin (protein PK).

AstraZeneca has submitted a Clinical Trial Application (CTA) in Europe to initiate a Phase 2a study of mRNA AZD-8601 in heart failure patients undergoing coronary artery bypass grafting (CABG) surgery.

Moderna initiated a Phase 1 study of mRNA-2416, an intratumoral (iTu) immuno-oncology (I-O) therapeutic that encodes for the membrane expression of the co-stimulatory protein OX40 Ligand, or OX40L, to potentially enhance T-cell attack against tumors. This is Moderna’s first I-O therapeutic to enter clinical study.

Moderna also unveiled its first clinical development candidate (DC) that utilizes a novel modality, liver expression of therapeutic proteins. Utilizing this modality, the company will advance toward the clinic an mRNA DC, mRNA-3704, for methylmalonic acidemia (MMA), a serious and often life-threatening rare liver disease for which there are no approved therapies.

In total, Moderna announced the addition of four new DCs to its development pipeline today. The company also announced that it has replaced its preclinical stage Zika vaccine DC, mRNA-1706, with mRNA-1893, a Zika vaccine with an enhanced mRNA construct anticipated to augment immunogenicity. Moderna’s development pipeline now comprises 16 mRNA therapeutics and vaccines spanning infectious diseases, cancer (I-O), cardiovascular diseases and rare liver diseases. Approximately 460 subjects have been dosed to date across clinical studies for seven mRNA vaccines and therapeutics.

“2017 is a major inflection point for Moderna, as we’ve made significant progress advancing mRNA therapeutics for unmet needs across several disease areas,” said Stéphane Bancel, Chief Executive Officer of Moderna. “In the cardiovascular space, our partner AstraZeneca successfully completed a Phase 1 study for mRNA-AZD-8601, a VEGF-A therapeutic, and planning is underway for a Phase 2a study. In addition, we have initiated first-in-human dosing in a Phase 1 study of mRNA-2416, our first immuno-oncology candidate, encoding OX40 ligand. We also have progressed the expression of therapeutic proteins in the liver as a development stage modality. As such, we are now able to advance chronically dosed mRNA therapeutics to development for rare liver diseases. I’m very thankful to the Moderna team for their commitment, dedication and continued progress to deliver on our mission.”

[nigel bates] Seems worthy of note, with 5 compounds in PIII, and raising a billion plus... B...

nigel bates — 8/9/2017 12:47:03 PM

Seems worthy of note, with 5 compounds in PIII, and raising a billion plus...

Basel, Switzerland and London, United Kingdom, August 9, 2017 /PRNewswire/ Roivant Sciences today announced a $1.1 billion equity investment led by the SoftBank Vision Fund. This investment, which includes existing shareholder participation, is intended to accelerate the launch of new subsidiaries within and beyond the biopharmaceutical industry.

Roivant focuses on developing and commercializing novel therapies through subsidiary ‘Vants’. These include Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology).

Datavant, a new technology-focused subsidiary, will be the first company in the Roivant family to operate outside of traditional biopharmaceutical development. Datavant aims to dissolve barriers between siloed healthcare datasets in order to unlock novel insights and reduce the time and cost of delivering innovative medicines to patients.
“We are pleased to welcome the SoftBank Vision Fund as a new investor in Roivant, and we are grateful for the continued support of our existing shareholders,” said Vivek Ramaswamy, Founder and CEO of Roivant. “I admire SoftBank’s long-term vision and I believe they will add significant strategic value to Roivant in the next phase of our growth.”

“Roivant has attracted world-class talent in its pursuit of developing and commercializing drugs that target large unmet medical needs,” said Akshay Naheta, Managing Director of SoftBank Group International. “We are impressed with the ambition and track record of the Roivant team and look forward to supporting them in the next step of their journey, as they look to effectively harness technology and leverage big data across all aspects of their business.”

“Roivant has come a very long way in a relatively short period of time,” said Dan Oren, President and CEO of Dexcel Pharma, a member of the Dexxon investor group which is both an initial investor in Roivant and a participant in this financing. “Since 2014 they have formed a diverse array of companies with many promising therapies in development. We supported Roivant at the very beginning and we continue to support them as they scale their operations and pursue new opportunities.”

About Roivant Sciences

Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. We partner with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients.

We advance our drug pipelines through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant also plans to launch new companies operating outside of traditional biopharmaceutical development. Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. For more information, please visit roivant.com.

[nigel bates] CAMBRIDGE, Mass., January 13, 2015 — Moderna Therapeutics today announced a lice...

nigel bates — 1/13/2015 9:22:22 AM

CAMBRIDGE, Mass., January 13, 2015 — Moderna Therapeutics today announced a license and collaboration agreement with Merck, known as MSD outside the United States and Canada, through a subsidiary, for the discovery and development of vaccines and passive immunity treatments against viral diseases using modified messenger RNA (mRNA). Moderna is a pioneer in the development of mRNA Therapeutics™ across a range of therapeutic applications. Moderna’s work in the collaboration will be led by Valera, its venture focused on the development of mRNA vaccines and therapeutics to fight infectious disease.

The vaccines work of Valera builds on a body of preclinical research at Moderna showing the ability of modified mRNA to express viral antigens in vivo and to induce robust immune responses. Valera’s therapeutic passive immunity programs will expand on Moderna’s research using mRNA to express antibodies that bind to viral and other targets. The robust data in these programs across a range of preclinical infectious disease models, together with the inherent, rapid turn-around time in creating novel mRNA constructs, provide Valera with a potentially powerful and versatile new platform for the creation of a broad array of vaccines and passive immunity therapies.

“Given the tremendous potential for messenger RNA Therapeutics across a wide range of therapeutic applications, establishing long-term strategic relationships with world leaders in their fields will accelerate our ability to bring mRNA products to patients in need,” said Stéphane Bancel, president and CEO of Moderna. “Merck’s worldwide leadership in vaccines and anti-infective treatments make them an ideal collaborator for us, particularly given their strong commitment to innovation and new approaches to prevent and treat serious viral diseases. We are excited to work in collaboration to move these promising programs forward for patients.”

"By combining Merck’s strength in vaccine and antiviral therapeutic development with Moderna’s mRNA Therapeutics technology we are well positioned to develop differentiated candidates with the potential to provide meaningful benefit to patients,” said Dr. Roger M. Perlmutter, president of Merck Research Laboratories. “We look forward to working with the scientific and technical teams at Moderna.”

The three-year research collaboration (with the possibility of a one-year extension) is focused on the development of new mRNA-based treatments and vaccines against four undisclosed viruses. Under the terms of the agreement, Merck will make an upfront cash payment to Moderna of $50 million to give Merck the ability to utilize the granted licenses to commercialize five product candidates, and will make a $50 million equity investment in Moderna. This is in addition to the $450 million financing from other investors previously announced on January 5, 2015. Moderna will be eligible for undisclosed per-product development and commercial milestones under the license as well as tiered royalties on commercial sales. Merck will lead the discovery and development of candidates and commercialization of any products resulting from this license and collaboration agreement, while Moderna will design and synthesize the messenger RNA product candidates directed against selected targets.

Moderna’s mRNA Therapeutics™ platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs with therapeutic activity inside and outside of cells. In addition to the license and collaboration announced today with Merck, Moderna has ongoing strategic agreements with Alexion Pharmaceuticals in the area of rare diseases, AstraZeneca in cardiovascular disease and some areas of oncology, and DARPA (the Defense Advanced Research Projects Agency) in biodefense.

[nigel bates] (Oxford, UK and Philadelphia, PA, 2 June 2014). Adaptimmune Limited, a leading b...

nigel bates — 6/2/2014 3:19:19 AM

(Oxford, UK and Philadelphia, PA, 2 June 2014). Adaptimmune Limited, a leading biotechnology company developing TCR engineered T-cells to treat cancer, today announced that it has entered into a strategic collaboration and licensing agreement with GlaxoSmithKline (GSK) for the development and commercialisation of its lead clinical cancer programme.

Using its unique T-cell receptor (TCR) engineering technology, Adaptimmune has created TCRs which are deployed to target the cancer testis antigen, NY-ESO-1, and other targets. The company’s trials in the NY-ESO-1 programme in multiple myeloma, melanoma, sarcoma and ovarian cancer in the US are generating encouraging results, with European trials set to commence shortly, and it has a pipeline of follow-on programmes.

Under the terms of the agreement, Adaptimmune will co-develop its NY-ESO-1 clinical programme and associated manufacturing optimisation work together with GSK. GSK will have an option on the NY-ESO-1 programme through clinical proof of concept, anticipated during 2016, and, on exercise, will assume full responsibility for the programme. The companies will also co-develop other TCR target programmes and collaborate on further optimization of engineered TCR products.

According to the agreed development plan, the deal could yield payments in excess of $350 million to Adaptimmune over the next seven years, with significant additional development and commercialisation payments becoming due in subsequent years if GSK exercises all its options and milestones continue to be met. In addition, Adaptimmune would also receive tiered royalties ranging from single to double digits on net sales.

As part of its strategic commitment to the collaboration, Adaptimmune will immediately commence work on further TCR programmes with GSK.

James Noble, Chief Executive Officer of Adaptimmune, commented: “We are delighted to collaborate with GSK, a leading pharmaceutical company which has made a strategic commitment to immuno-oncology. Its substantial development and manufacturing expertise in key areas will be invaluable as we work together to accelerate the development of our programmes and bring potentially breakthrough cancer therapies to patients.”

Axel Hoos, Vice President of Oncology R&D and Head of Immuno-Oncology of GSK, said: “We are very pleased to be working with Adaptimmune to co-develop new treatments in cancer immunotherapy, an exciting area of core strategic focus for GSK Oncology R&D. We believe that Adaptimmune’s T-cell receptor engineering technology will be synergistic with the growing immuno-oncology portfolio of GSK and leverage our existing expertise in autologous cell gene therapy. Together this combination of capabilities offers an opportunity for significant progress in the use of the body’s immune system to fight cancer.”

[nigel bates] (Oxford, UK, 8 January 2014) Immunocore Limited, the Oxford-based biotechnology ...

nigel bates — 1/8/2014 4:11:08 AM

(Oxford, UK, 8 January 2014) Immunocore Limited, the Oxford-based biotechnology company developing novel biological drugs to treat cancer and viral disease, today announced that it has entered into an oncology research collaboration and licensing agreement with MedImmune, the global biologics research and development arm of AstraZeneca. Both companies will research and develop novel cancer therapies using Immunocore’s Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology.

This platform of biological medicines, or ImmTACs, exploits the power of the body’s own immune system to find and kill diseased cells. ImmTACs direct a patient’s T cells to specifically destroy only the cancerous cells, avoiding damage to healthy cells.

Under the terms of the agreement, Immunocore and MedImmune will work together to generate ImmTACs against selected cancer targets. AstraZeneca and MedImmune will have the right to further develop and commercialise ImmTAC products to add to their immune-mediated cancer therapy portfolio. Immunocore will receive an upfront payment of $20 million per programme and the company is then eligible to receive up to $300 million in development and commercial milestone payments for each target programme and significant tiered royalties if the programmes are successful.

[nigel bates] (Oxford, UK, 9 July 2013) Immunocore Limited, the Oxford-based biotechnology com...

nigel bates — 7/15/2013 4:08:37 AM

(Oxford, UK, 9 July 2013) Immunocore Limited, the Oxford-based biotechnology company

developing novel biological drugs called ImmTACs to treat cancer and viral disease, today

announced it has entered into a partnership with GlaxoSmithKline (GSK) for multiple novel targets

not addressable using antibody-based technologies. This is Immunocore’s second major partnership

this year.

Under the terms of the agreement, Immunocore will receive up to a total of £142 million in pre-

clinical milestone payments across the targets. In addition, for each product that reaches the market,

up to £200 million is due to Immunocore in development and commercial milestone payments, plus

up to double digit royalties. Immunocore will be responsible for all of the pre-clinical development

and for the initial clinical trials in patients and GSK will be responsible for the remaining

development and commercialisation of the products.

Immunocore has created a world-leading platform of bi-specific biological drugs, called ImmTACs

(Immune mobilising mTCR Against Cancer), which exploit the power of T Cell Receptors (TCRs) to

recognise intracellular changes that occur during cancer or viral infection. This unique recognition

ability of TCRs sets them apart from traditional antibody-based therapies that can only recognise

changes on the surface of cells, and provides, for the first time, the ability to develop extremely

potent targeted therapies for cancers that are currently poorly served. The most advanced ImmTAC

drug, IMCgp100 for the treatment of melanoma, is currently in Phase I/II clinical trials in the UK and

USA.

James Noble, Chief Executive Officer of Immunocore, commented: “We are delighted to collaborate

with GSK, our second major partnership signed this year. GSK is a leading pharmaceutical company

with a proven track record in the development of biotherapeutics and this is an important

partnership for Immunocore.”

Laurent Jespers, VP and Head of Innovation BDU, Biopharm R&D of GSK, said: “We are very excited

about the opportunity to work together with Immunocore to develop ImmTACs. We believe

ImmTACs offer a tremendous opportunity in treating cancer and in other areas where there is a

large unmet medical need.”

(Oxford, UK, 27 June 2013) Immunocore Limited, the Oxford-based biotechnology

company developing novel biological drugs known as ImmTACs to treat cancer and viral

disease, today announced that it has entered into a research collaboration and licensing

agreement with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:

RHHBY) for the discovery and development of multiple novel cancer targets using

Immunocore’s ImmTAC technology.

Under the terms of the agreement, Immunocore will receive an initiation fee of

between $10 and $20 million per programme and is eligible to receive in excess of $300

million in development and commercial milestone payments for each target programme

and significant tiered royalties.

Immunocore has created a world-leading platform of bi-specific biological drugs, called

ImmTACs, which exploit the power of T Cell Receptors (TCRs) to recognise intracellular

changes that occur during cancer or viral infection. This unique recognition ability of

TCRs sets them apart from traditional antibody-based therapies that can only recognise

changes on the surface of cells, and provides, for the first time, the ability to develop

extremely potent targeted therapies for cancers that are currently poorly served. A

particular feature is that the ImmTACs can be directed to target and destroy only the

cancerous cells, avoiding damage to healthy cells.

James Noble, Chief Executive Officer of Immunocore, commented: “We are very pleased

to have Genentech, a recognized leader in oncology, on board as our first major partner

to discover, develop and commercialise ImmTAC therapies against multiple cancer

targets.”

James Sabry, Senior Vice President of Genentech Partnering, said: “We believe

Immunocore is the leading company in T Cell receptor biology and drug development

and an excellent partner for Genentech in this area. We are delighted to have initiated

this significant partnership with them. We hope this collaboration will lead to

breakthrough therapies for cancer patients with unmet medical needs.”

Bent Jakobsen, Chief Scientific Officer and founder of Immunocore, added: “Our

collaboration with Genentech generating ImmTACs against these novel targets allows us

jointly to explore the true potential of the technology. We have established a robust and

reproducible platform and we look forward to see ImmTACs addressing some of the

major challenges in cancer therapy.”

[DewDiligence_on_SI] Sounds too good to be true. Looking forward to the phase-1 trial in a couple of ...

DewDiligence_on_SI — 6/17/2013 2:51:54 PM

Sounds too good to be true. Looking forward to the phase-1 trial in a couple of years. Regards, Dew

[nigel bates] LONDON, June 17 (Reuters) - British scientists have won early financial backing ...

nigel bates — 6/17/2013 4:36:51 AM

LONDON, June 17 (Reuters) - British scientists have won early financial backing for a new kind of anticoagulant drug they believe may prevent dangerous blood clots without causing bleeding - a previously unachievable goal.

Index Ventures, working with GlaxoSmithKline and Johnson & Johnson via an early-stage biotech fund, said on Monday it was investing $11 million in XO1, a new company set up to develop the experimental medicine.

Called ichorcumab, the new drug is still miles from reaching the market - clinical trials are only slated to start within the next two years - but the product may create a stir in a commercially important field, given its unusual properties.

It was created by scientists at the University of Cambridge and Addenbrooke's Hospital following the observation of a patient in her 50s whose blood appeared unable to clot but who had no major bleeding problems after a head injury in 2008.

The researchers pinpointed her unusual response to a unique antibody, which they went on to synthesise.

Currently, anticoagulants are used to reduce the risk of heart attacks and strokes, but doctors have to weigh up carefully their benefits against the danger of triggering uncontrolled bleeding.

"This antibody can deliver a high degree of anticoagulation without increased bleeding; we've never seen that before," said Jim Huntingdon, a professor at the Cambridge Institute of Medical and one of the scientists behind the project.

Warfarin has been a mainstay of anticoagulation therapy for many years. More recently new drugs have been launched, including Boehringer Ingelheim's Pradaxa, Bayer and J&J's Xarelto, and Pfizer and Bristol-Myers Squibb's Eliquis.

The $11 million start-up cash for XO1 comes from a $200 million life sciences fund launched last year by Index in an unusual collaboration with GSK and J&J. The fund aims to invest in companies with just one or two projects - a so-called "asset-centric" approach.

Under the three-way deal, the venture capital firm controls all investment decisions and the two drugmakers have no preferential rights to acquire any new drugs, although they do get a useful inside view should they wish to compete for assets...

[nigel bates] Possibly interesting. They have existing collaborations with Pfizer & Amgen. Ca...

nigel bates — 4/23/2013 9:45:04 AM

Possibly interesting.
They have existing collaborations with Pfizer & Amgen.

Cambridge, MA and Wilmington, DE, April 22, 2013 — BIND Therapeutics and AstraZeneca announced today that they have entered into a strategic collaboration to develop and commercialize an Accurin™, a targeted and programmable cancer nanomedicine from BIND’s Medicinal Nanoengineering platform, based on a molecularly targeted kinase inhibitor developed and owned by AstraZeneca.

The collaboration is based on emerging data suggesting that nanomedicines like Accurins selectively accumulate in diseased tissues and cells, leading to higher drug concentrations at the site of the tumor and reduced exposure to healthy tissues.

Under the terms of the agreement, the companies will work together to complete Investigational New Drug (IND)-enabling studies of the lead Accurin identified from a previously-completed feasibility program. AstraZeneca will then have the exclusive right to lead development and commercialization and BIND will lead manufacturing during the development phase. BIND could receive upfront and pre-approval milestone payments totaling $69 million, and more than $130 million in regulatory and sales milestones and other payments as well as tiered single to double-digit royalties on future sales.

“We are excited to grow this collaboration with AstraZeneca, a leading global biopharmaceutical company committed to developing innovative medicines for patients,” said Scott Minick, President and CEO of BIND. “One year ago, BIND started several feasibility projects with major pharmaceutical companies. Our collaboration with AstraZeneca is the first one completed and had very successful results. Due to the advanced nature of this program, we now plan to move an Accurin with optimized therapeutic properties quickly into product development.”

“AstraZeneca believes that targeted therapies which specifically address the underlying mechanisms of disease are the future of personalized cancer treatment,” said Susan Galbraith, Head of AstraZeneca’s Oncology Innovative Medicines Unit. “Our oncology teams are actively exploring a range of platforms to deliver targeted therapies, with a strategic focus on unlocking the significant potential of nanoparticles as an approach to cancer treatment. We view BIND’s targeted nanomedicines as a leading technology in this field."

About Accurins™
BIND Therapeutics is discovering and developing Accurins, proprietary new best-in-class therapeutics with superior target selectivity and the potential to improve patient outcomes in the areas of oncology, inflammatory diseases and cardiovascular disorders. Leveraging its proprietary Medicinal Nanoengineering® platform, BIND develops Accurins that outperform conventional drugs by selectively accumulating in diseased tissues and cells. The result is higher drug concentrations at the site of action with minimal off-target exposure, leading to markedly better efficacy and safety.

About BIND Therapeutics
BIND Therapeutics is a clinical-stage biopharmaceutical company developing a new class of highly selective targeted and programmable therapeutics called Accurins. BIND’s Medicinal Nanoengineering® platform enables the design, engineering and manufacturing of Accurins with unprecedented control over drug properties to maximize trafficking to disease sites, dramatically enhancing efficacy while minimizing toxicities.

BIND is developing a pipeline of novel Accurins that hold extraordinary potential to become best-in-class drugs and improve patient outcomes in the areas of oncology, inflammatory diseases and cardiovascular disorders. BIND's lead product candidate, BIND-014, is currently entering Phase 2 clinical testing in cancer patients and is designed to selectively target PSMA, a surface protein upregulated in a broad range of solid tumors. BIND also develops Accurins in collaboration with pharmaceutical and biotechnology partners to enable promising pipeline candidates to achieve their full potential and to utilize selective targeting to transform the performance of important existing drug products.

BIND is backed by leading investors Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners, NanoDimension, DHK Investments, EndeavourVision and Rusnano. BIND was founded on proprietary technology from the laboratories of two leaders in the field of nanomedicine, Professors Robert Langer, David H. Koch Institute Professor of the Massachusetts Institute of Technology (MIT) and Omid Farokhzad, Associate Professor of Harvard Medical School. For more information, please visit the company's web site at www.bindtherapeutics.com.

[pgo-neil] Soon to be quoted... Quintiles. The company gets no cash from this IPO, so it ...

pgo-neil — 2/15/2013 5:05:25 PM

Soon to be quoted... Quintiles.

The company gets no cash from this IPO, so it is the current holders getting some cash out.

sec.gov

A few excerpts...

We are the world’s largest provider of biopharmaceutical development services and commercial outsourcing services. We are positioned at the intersection of business services and healthcare and generated $3.7 billion of service revenues in 2012, conduct business in approximately 100 countries and have more than 27,000 employees. We use the breadth and depth of our service offerings, our global footprint and our therapeutic, scientific and analytics expertise to help our biopharmaceutical customers, as well as other healthcare customers, navigate the increasingly complex healthcare environment to improve efficiency and to deliver better healthcare outcomes.

Since our founding over 30 years ago, we have grown to become a leader in the development and commercialization of new pharmaceutical therapies. Our Product Development segment is the world’s largest contract research organization, or CRO, as ranked by 2011 reported service revenues, and is focused primarily on Phase II-IV clinical trials and associated laboratory and analytical activities. Our Integrated Healthcare Services segment includes one of the leading global commercial pharmaceutical sales and service organizations. Integrated Healthcare Services provides a broad array of services, including commercial services, such as providing contract pharmaceutical sales forces in key geographic markets, as well as a growing number of healthcare business services for the broader healthcare sector, such as outcome-based and payer and provider services. Product Development contributed approximately 74% and Integrated Healthcare Services contributed approximately 26% to our 2012 service revenues. Additional information regarding our segments is presented in Note 23 to our audited consolidated financial statements included elsewhere in this prospectus.

Our global scale and capabilities enable us to work with the leading companies in the biopharmaceutical sector that perform trials and market their products all around the world. During each of the last 10 years, we have worked with the 20 largest biopharmaceutical companies ranked by 2011 reported revenues. We have provided services in connection with the development or commercialization of the top 50 best-selling biopharmaceutical products and the top 20 best-selling biologic products, as measured by 2011 reported sales. Of the new molecular entities, or NMEs, and new biologic applications, or BLAs, approved from 2004 through 2011, we helped develop or commercialize 85% of the central nervous system drugs, 76% of the oncology drugs and 72% of the cardiovascular drugs.

We have extensive scientific and therapeutic expertise, including more than 800 employees globally who are medical doctors with experience across a number of fields. We also have substantial statistical, quantitative, analytical and applied technology skills, with more than 850 employees possessing a Ph.D. or equivalent. Our experts enable us to add sophisticated statistical, process development and advanced technology applications into our clinical development services to meet the needs of the broader healthcare industry for appropriate endpoints, adaptive trials, drug therapy analysis, outcome and real-world research and evidence-based medicine. Our scientific and medical expertise allows us to conduct biomarker discovery, perform gene sequencing and expression analysis, create assays that can be duplicated on a global scale and support the evolving fields of translational science and personalized medicine. Moreover, our flexible business solutions and commitment to our customers’ objectives enable us to provide our customers with customized operational delivery models to meet their particular needs.

...

In 2012, our service revenues were $3.7 billion, our net income was $177.5 million, our non-GAAP adjusted net income was $208.9 million, and our non-GAAP adjusted EBITDA was $543.7 million. In addition, our 2012 net new business was $4.5 billion, and we ended the year with $8.7 billion in backlog. From 2008 to 2012, our non-GAAP adjusted service revenues grew at a 7.3% compound annual growth rate, or CAGR, and our non-GAAP adjusted EBITDA grew at a 13.9% CAGR. During this period, our service revenues experienced year-over-year increases each year and our annual book-to-bill ratio was between 1.19x and 1.27x. During the last five years, we have had at least eight customers in each year from whom we earned more than $100 million in service revenues. No single customer represents more than 10% of our 2012 revenues. For additional information regarding these financial measures, including a reconciliation of our non-GAAP measures to the most directly comparable measure presented in accordance with United States generally accepted accounting principles, or GAAP, see “Selected and Pro Forma Consolidated Financial Data” included elsewhere in this prospectus.

[nigel bates] This looks a very interesting project (& they subsequently completed a $38m fina...

nigel bates — 1/21/2013 6:30:38 AM

This looks a very interesting project (& they subsequently completed a $38m financing on Dec 17th)

HOLLYWOOD, FL and EVANSTON, IL, December 6, 2012 -- Naurex Inc., a clinical-stage company developing innovative treatments to address unmet needs in psychiatry and neurology, today reported positive results from a Phase IIa clinical trial of its lead antidepressant compound, GLYX-13. GLYX-13 is a novel partial agonist of the NMDA receptor. The Phase Ila results are being presented this week at the 51st Annual Meeting of the American College of Neuropsychopharmacology (ACNP).

The Phase IIa results show that a single administration of GLYX-13 produced statistically significant reductions in depression scores in subjects who had failed treatment with one or more antidepressant agents. The reductions were evident within 24 hours and persisted for an average of seven days.

Importantly, the effect size, a measure of the magnitude of the drug’s antidepressant efficacy, observed at 24 hours and at seven days after a single administration of GLYX-13, was nearly double the effect size seen with most other antidepressant drugs after 4-6 weeks of repeated dosing.

In the Phase IIa trial, GLYX-13 was well tolerated. Reported side effects were mild to moderate and were consistent with those observed in subjects receiving placebo. Consistent with previous studies, GLYX-13 did not produce any of the schizophrenia-like psychotomimetic effects associated with other drugs that modulate the NMDA receptor.

“These data are an important step in validating Naurex’s mission of developing breakthrough therapies for depression and other CNS disorders,” said Derek Small, CEO of Naurex. “Our founder discovered a new class of drugs that appeared to have the remarkable antidepressant efficacy of ketamine-like compounds, but without their limiting side effects. These Phase II results suggest that this discovery may translate into measurable health improvements for individuals with depression, which bodes well for the future success of GLYX-13 and the other promising compounds we have generated from this platform.”

Other NMDA receptor-modulating agents, such as ketamine, have been shown in several human clinical trials to act very rapidly to alleviate the symptoms of depression and bipolar disorder, but their clinical utility has been hampered by their potential for abuse and behavioral impairment, including schizophrenia-like effects at therapeutic doses.

“We are encouraged by these promising data,” noted Ronald M. Burch, MD, PhD, Chief Medical Officer of Naurex. “We have recently begun dosing patients in a GLYX-13 Phase Ilb repeated dose trial, and we are on track to advance our second-generation oral compound, NRX-1074, into clinical trials next year.

Preclinical studies show that our novel NMDA modulators may be applicable to a number of CNS disorders, and we look forward to assessing their potential to address major unmet needs in psychiatry and neurology.”

The Phase Ila trial was a randomized, double blind, placebo-controlled study of the efficacy and safety of a single dose of intravenous GLYX-13 in subjects who had failed at least one other antidepressant during the current depressive episode. It was conducted at 12 clinical centers in the U.S. Outcome measures included ratings of signs, symptoms and changes in depression scores on standard rating scales for mood and psychiatric disorders. Independent raters from MedAvante, who were blinded to the protocol, administered certain psychiatric assessments for the trial to ensure the quality and objectivity of the screening and rating data. Safety was also assessed.

Naurex’s CNS programs are based on the work of company founder, Joseph R. Moskal, PhD, and his colleagues at the Falk Center for Molecular Therapeutics at Northwestern University.

About Naurex

Naurex Inc. is a clinical-stage private company developing novel therapies to address unmet needs in psychiatry and neurology based on a new mechanism of action for modulating the NMDA receptor in a safe way. Naurex’s lead product, GLYX-13, has shown promising antidepressant activity with excellent safety in a Phase II trial, confirming the efficacy signals and safety observed in Phase I and preclinical studies. In a Phase II trial in subjects who had failed treatment with one or more antidepressant agents, a single administration of GLYX-13 produced statistically significant reductions in depression scores within 24 hours, which persisted for an average of seven days. Naurex’s second-generation programs include a number of molecules with preclinical proof of concept. The company’s patented novel chemistry classes represent a platform for the development of new therapies for a variety of CNS disorders. For more information about Naurex, visit www.naurex.com.

[nigel bates] AstraZeneca and Ardelyx today announced a worldwide exclusive licensing agreemen...

nigel bates — 10/8/2012 4:31:24 AM

AstraZeneca and Ardelyx today announced a worldwide exclusive licensing agreement for Ardelyx’s NHE3 inhibitor programme, including the Phase 2-ready lead compound RDX5791, for the treatment of complications associated with end-stage renal disease (ESRD) and chronic kidney disease (CKD). NHE3 is the sodium–hydrogen antiporter 3, a protein essential in the absorption of sodium in the intestines.

Ardelyx has evaluated RDX5791 in a Phase 2a clinical trial in constipation-predominant irritable bowel syndrome (IBS-C) and in two Phase 1 clinical studies in healthy subjects for its ability to divert sodium absorption in the gastrointestinal tract. Through its unique mechanism of action, RDX5791 is believed to decrease the absorption of dietary sodium and thus divert sodium excretion from the kidney (urine) to the faeces, sparing the kidney and the cardiovascular system from unhealthy exposure of both sodium and fluid accumulation. On this basis, the companies plan to develop RDX5791 for use in ESRD and CKD in addition to IBS-C, and intend to evaluate possible development in other diseases that are a consequence of sodium and fluid overload.

Under the terms of the agreement, AstraZeneca will pay $35 million up front, with development milestones of $237.5 million and milestones related to launch and commercialisation, as well as tiered, double-digit royalties. AstraZeneca will assume the subsequent development costs and Ardelyx will conduct clinical trials in Phase 2. As part of the transaction, Ardelyx has secured an option to co-promote the product in the US, subject to agreed limitations. Additional financial details were not disclosed.

“This licensing agreement accelerates our strong commitment to developing new medicines for people with renal complications, including those resulting from diabetes,” said Gunnar Olsson, Vice President and Head of CVGI Innovative Medicines, AstraZeneca. “There is a significant unmet medical need to address the challenges caused by sodium and excess fluid in people with renal impairment. With a novel mechanism of action, RDX5791 has the potential to have a major impact on how doctors treat these patients. We are tremendously excited to join forces with the Ardelyx team and draw on their depth of knowledge and insight.”

“We’ve been impressed with our interactions with AstraZeneca throughout this process and are confident with their commitment to develop this molecule successfully. AstraZeneca has been aggressive about pursuing novel medicines, making them among the best possible worldwide partners for validating Ardelyx’s unique approach to drug development,” commented Mike Raab, CEO of Ardelyx. “RDX5791 is our first clinical example of how our technology can be used to develop non-absorbed, small molecule therapeutics. We are delighted that AstraZeneca recognizes the potential of this compound.”

[nigel bates] Interesting analysis of VC returns on the biggest private financings in 2007: li...

nigel bates — 8/30/2012 12:00:50 PM

Interesting analysis of VC returns on the biggest private financings in 2007:
lifescivc.com

[tnsaf] 4s3 Bioscience, Inc. Secures $20M in Series A Financing Medford, MA, USA, Mar...

tnsaf — 3/5/2012 11:41:42 PM

4s3 Bioscience, Inc. Secures $20M in Series A Financing

Medford, MA, USA, March 5, 2012 -- 4s3 Bioscience, Inc. (4s3), a privately-held biotherapeutics company focused on developing genetic disease therapies for orphan neuromuscular disorders announced today the closing of a $20 million Series A financing with KLP Enterprises, LLC (KLP). KLP's subsidiary, Alopexx Enterprises, LLC (Alopexx), will work with 4s3 to build and manage the company. The funding will be used to support the continued development of a proprietary antibody technology that provides targeted and active intracellular delivery of active proteins, enzymes and other macromolecules to skeletal muscle.

"We are excited to be working with 4s3," said Dr. Daniel Vlock, CEO and Founder of Alopexx. "We are very impressed with the broad applicability of 4s3's antibody technology and the company's robust intellectual property portfolio. The in vivo preclinical data validates the potential for this approach."

Application of the 4s3 technology enables the replacement of deficient proteins to skeletal muscle and holds promise for treating the underlying causes of muscular dystrophies, myopathies, motor neuron diseases, diseases of the neuromuscular junction and various enzyme deficiency disorders.

"A major obstacle to the treatment of genetic neuromuscular diseases is the challenge of delivering functional macromolecules to skeletal muscle tissue," said Dustin Armstrong, Ph.D., Vice-President of Research at 4s3. "Our approach represents a novel therapeutic strategy to address numerous indications with no currently approved therapies."
"We are extremely pleased to have received this financing," said Timothy Harris, President and CEO of 4s3. "This funding will greatly enhance our ability to expand our platform and accelerate therapeutic advancements for unmet medical needs, including diseases such as Myotubular Myopathy and Myotonic Dystrophy." Financial details of the transaction are not being disclosed.

About 4s3 Bioscience, Inc.

4s3 Bioscience is an emerging Boston-area biotechnology company, focused on developing genetic disease therapies for orphan neuromuscular disorders. The company's platform is an antibody-based system capable of enhanced intracellular delivery of active proteins, enzymes and other macromolecules to skeletal muscle. 4s3 was founded in 2007 by Vice President of Research, Dustin Armstrong, Ph.D. and President and CEO, Timothy Harris and received seed funding from Genzyme Ventures in 2008. The company has strong intellectual property protecting its platform, including a licensed portfolio from UCLA. In addition to the Series A financing, the company has received prior funding from the following organizations: Massachusetts Life Science Center, the Muscular Dystrophy Association, National Institute of Health, and the HHS Therapeutic Discovery Project. 4s3 occupies laboratory space at the UMass Boston Venture Development Center. For more information please go to www.4s3bioscience.com

About KLP Enterprises, LLC

KLP is a trust formed by the Pritzker/Vlock family office. The Pritzker/Vlock family office is managed by Karen Pritzker and Michael Vlock. This enterprise owns and manages a broad portfolio of public equities, consumer, biotech, industrial, medical equipment and technology businesses, several seed capital and venture funds, real estate, and has substantial private equity ownership of Global Hyatt Corporation, TransUnion LLC, Triton Container International Corporation and the Marmon Group.

About Alopexx Enterprises, LLC

Alopexx Enterprises, LLC is a healthcare company focused on investing and developing preclinical and early clinical compounds, with an emphasis on infectious diseases, oncology, CNS and orphan diseases. It was founded in 2011 by highly-experienced pharmaceutical executives and leverages the unique insights and experiences of its founders and world-class scientific advisors. Beyond the financial investment, the group is able to offer hands-on expertise in preclinical development, manufacturing, regulatory affairs, logistics, clinical development and partnering. For more information please go to www.alopexx.com

Contact:

Timothy Harris
President & CEO
4s3 Bioscience, Inc.
43 Riverside Ave. #4,
Medford, MA
02155
info@4s3bioscience.com
www.4s3bioscience.com

Read more: 4s3 Bioscience, Inc. Secures $20M in Series A Financing - FierceBiotech fiercebiotech.com

[nigel bates] IP Group plc – Portfolio company Oxford Nanopore to commercialise technology in ...

nigel bates — 2/1/2012 1:46:50 PM

IP Group plc – Portfolio company Oxford Nanopore to commercialise technology in 201201 Feb 2012IP Group plc – Portfolio company Oxford Nanopore to present DNA 'strand sequencing' technology at AGBT conference. Oxford Nanopore intends to commercialise independently in 2012

IP Group plc (LSE: IPO) (“IP Group” or “the Company” or “the Group”), the developer of intellectual property based businesses, is pleased to note that Oxford Nanopore Technologies Ltd ("Oxford Nanopore"), a spin-out company from the University of Oxford, has today announced it intends to commercialise DNA strand sequencing products directly to customers within 2012.

IP Group has a 21.5% beneficial stake in Oxford Nanopore, which is developing a novel technology for direct, electronic detection and analysis of single molecules using nanopores.

The full text of the Oxford Nanopore announcement follows:

“Oxford Nanopore to present DNA 'strand sequencing' technology at AGBT conference
-Company intends to commercialise independently in 2012-

1 February 2012, Oxford, UK. Oxford Nanopore Technologies Ltd. announces that Clive G Brown, Chief Technology Officer, will present at the Advances in Genome Biology and Technology (AGBT) conference in Marco Island, Florida, on 17th February 2012 at 11.40am (EST) / 4.40pm (GMT). The talk is titled: “Single Molecule ‘Strand’ Sequencing Using Protein Nanopores and Scalable Electronic Devices”.

Oxford Nanopore intends to commercialise DNA strand sequencing products, directly to customers within 2012. At the AGBT presentation, Oxford Nanopore will show DNA strand sequencing data and other disruptive features of the Company's proprietary electronics-based sensing devices.

Further information will be provided at the time of the Company's presentation at the AGBT conference.”

For more information, please contact:

IP Group plc www.ipgroupplc.comAlan Aubrey, Chief Executive Officer+44 (0) 20 7444 0050Liz Vaughan-Adams, Communications+44 (0) 20 7444 0062 / +44 (0) 7979 853 802
liz.vadams@ipgroupplc.comFTI Consulting Ben Atwell, John Dineen+44 (0) 20 7831 3113 Oxford Nanopore Technologies Ltd www.nanoporetech.comZoe McDougall, Communications+44 (0) 845 034 7900 x2013 media@nanoporetech.com