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here's a report on IMMU I did for the Motley Fool on AOL:
Immunomedics (IMMU)
Address : 300 American Road, Morris Plains, NJ 07950
Phone : 201-605-8200
CEO: Dr, David M. Goldenberg, Sc.D., M.D.
Investor Relations: Paul Herron, Director, Finance
email: immunomd@planet.net
web site: None
Analysts reports: None
Price (7-26-96): 7
52 wk range: 2 7/8-13
Shares outstanding: 34 mil
Market Cap: $239 mil
Insitutional Holdings: 10%
Ave trading vol: 113,475
Book Val: $24.6 mil
Price/Book: 9.7
EPS 1995: -0.38
EPS 1996 (est): ?
DRUGS AND THEIR APPROVAL STATUS:
1. CEA-Scan:
a. Colorectal Cancer: Approved by FDA for colorectal cancer, awaiting
final approval in Europe sometime in 1996
b. Lung Cancer Imaging: Phase III
c. Breast Cancer Imaging: Phase II Completed, Phase III to begin soon
d. Ovarian Cancer Treatment: Limited studies (2) with advanced cases
completed.
e. Medullay Thyroid and colorectal cancer treatment: unknown clinical
trial status, multiple studies completed.
2. LeukoScan:
a. Under review in Europe for osteomyelitis and diabetic foot ulcers,
awaiting final marketing approval
b. Phase III Completed; FDA submission being prepared
3. LymphoScan:
a. Phase III trials underway for the diagnostic imaging agent
b. Orphan drug designation
c. Therapeutic counterpart: unknown clinical trial status, multiple
studies completed.
4. AFP-Scan:
a. Phase II Clinical Trials in progress
b. Orphan drug designation
5. Antibody for Pneumocystis carinii pneumonia in AIDS
a. Preclinical stage, results of studies reported
6. RS7, LL1 and Biotin/Avidin
a. Study results reported, clinical stage unknown
I. INTRODUCTION AND OVERVIEW
Immunomedics is a biotechnology company involved in
radioimmunoscintigraphy - fancy medical lingo meaning labeling
monoclonal antibodies (mAb's) with radioactive chemicals with the goal of
imaging diseases such as cancer or infection. If anyone wants a
beginner's guide to mAb's, it is available at this URL:
esg-www.mit.edu:8001/bio/imm/monoclonal.html
They are also developing products for antibody-directed drug delivery for
treatment of disease, primarily cancer.
II. CEA-SCAN
A. Colorectal Cancer: CEA-Scan vs. OncoScint
CEA-Scan has been shown to be sensitive and specific for metastatic and
recurrent colorectal cancer of which over 90% express CEA. Currently,
OncoScint (Cytogen Corp, CYTO) is approved for colorectal cancer imaging,
but CEA-Scan is a superior product. Dr. Yehuda Patt (MD Anderson
Cancer Center) has a web page comparing colorectal cancer monoclonal
antibody imaging pharmaceuticals. (CEA-Scan is referred to as "Immu-
RAID-CEA(tm)" in this document.)
The address is
oncolink.upenn.edu
Major advantages of CEA-Scan over OncoScint include:
(1) OncoScint causes human anti-mouse antibody (HAMA) production in
>30% of patients following one dose compared to <1% for CEA-Scan. This
means that about a third of patients cannot get more than one dose of
OncoScint because of allergic reactions.
(2) The radioisotope for OncoScint costs $400-450 vs. <$20 for CEA-Scan.
(3) Liver metastases (that's where colorectal cancer likes to spread) don't
light up with OncoScint but they do for CEA-Scan. The sensitivity for liver
lesions is 63% for CEA-Scan vs. 41% for OncoScint.
(4) CEA-Scan is twice as likely (57% vs. 26%) to affect management of the
patient compared to OncoScint.
Disadvantages of CEA-Scan are minor compared to its advantages - look
at the table on the web page. CEA-Scan will eat OncoScint's lunch. It
should be noted that this comparison was with colorectal cancer patients,
but all of the advantages of CEA-Scan vs. OncoScint would apply to other
types of cancer as well.
B. CEA-Scan's Future: Other Cancers
i. Lung Cancer:
In Cancer 73(3 Suppl):890-5, 1994 Feb 1, patients with CEA positive non-
small cell lung cancer were imaged with CEA-Scan. "The tumor detection
rate was high, but the persistent blood pool at < 8 hours complicated image
interpretation. An intermediate imaging time point (12-16 hours) might be
preferable. SPECT is an important adjunct to imaging with this
radioimmunoconjugate. The acceptable dosimetry estimated for 30 mCi
Technetium 99m IMMU-4 Fab' and the lack of human anti-mouse antibo
Supposedly, according to a recent (April 10, 1996) IMMU press release,
Phase III trials with lung cancer are underway. Results are not available
yet.
ii. Breast Cancer:
Results from a Phase I/II trial of CEA-Scan in the initial evaluation of
breast cancer patients were reported on Sept. 11, 1995 in Cancer
Biotechnology Weekly: "In 49 women with operable, primary breast cancer,
CEA-Scan showed superior sensitivity, specificity and accuracy compared
to mammography (97 percent vs. 91 percent, 100 percent vs. 25 percent, and
97 percent vs. 85 percent, respectively).
"'CEA-Scan is complementary to mammography in that it was accurate
in six of seven cases where mammography gave inaccurate results,"
according to Hani A. Nabi, M.D., with the department of Nuclear Medicine
at the State University of New York in Buffalo, who presented the data.
"These results clearly demonstrate that the agent provides a safe and
efficient modality for the evaluation and staging of patients with primary
breast cancer.'"
Dr. Goldenberg stated, "We are also developing a radiolabeled-antibody
therapy for metastatic breast cancer, based upon the excellent disease
targeting capabilities of the antibody technology currently used in CEA-
Scan."
Another Phase II trial's results were reported on April 1, 1996 in Cancer
Biotechnology Weekly: "CEA-Scan promises to be a sensitive, noninvasive
means for breast cancer diagnosis and that radioimmunostaging could
make selective, rather than routine, use of axillary lymph node dissection
feasible in patients with early breast cancer, thereby minimizing surgical
morbidity." It was reported that, "CEA-Scan demonstrated an accuracy of
81 percent and a sensitivity of 89 percent for revealing
Further results were made public in a PR Newswire on May 20, 1996: "In
a study of 42 patients with inconclusive mammography findings requiring
surgical biopsies, CEA-Scan was able to predict those breast lesions which
were not cancerous, showing a specificity (true-negative rate) of 92%. The
overall accuracy of CEA-Scan was 92%. In patients with breast cancer that
may have spread to their arm pit nodes, CEA-Scan showed an accuracy of
85%, mainly by being true-negative.
"Dr. Rosner said, "CEA-Scan provides a new area of research by
discriminating indeterminate mammography lesions, and could reduce
the number of surgical biopsies in two-thirds of patients with benign breast
disease, resulting in substantial financial savings and sparing patients
emotional trauma."
Dr. Goldenberg stated: "We are very pleased about the prospects of using
CEA-Scan in patients with breast cancer, and although we do not believe it
can replace the sensitivity of mammography, future studies may show that
it can be used with mammography to determine those breast lesions that
must be biopsied and which may have a lower risk of cancer ... The test
may also aid in the better assessment of the presence and extent of disease
before or after therapy."
Remember, CEA-Scan has thus far only been approved by the FDA for
colorectal cancer, and the Phase III trials with breast cancer results are
not yet available. Approximately 70-90% of breast cancers are CEA-positive,
but these studies included all patients, not just ones with elevated CEA. If
CEA-Scan becomes a standard method of screening patients for the need to
do LND, this would be huge.
iii. Breast Cancer Treatment:
If an immune-mediated breast cancer treatment can be worked out
using this antibody - that would be huge as well.
iv. Medullary Thryoid Cancer (MTC) Imaging AND Treatment:
Similar results were also reported in Cancer Research. 55(23
Suppl):5946s-5951s, 1995 Dec 1.
v. Ovarian Cancer Treatment:
More results from this combination of MN-14 and radioactive iodine were
reported on June 17, 1996: "Eight patients withadvanced ovarian cancer
were given escalating doses of MN-14. Of the eight patients studied, one
patient had a complete clinical remission for five months, as measured by
CAT and CA-125, a blood assay. A second patient had 40 percent and 50
percent reduction in the size of two tumor masses. DThe results of this
Phase I study suggest that MN-14 may be a potential agent f
III. LeukoScan
LeukoScan is a monoclonal antibody fragment specific for granulocytes,
the white blood cells which aggregate at sites of infection or inflammation.
Like CEA-Scan, LeukoScan is labeled with Tc-99m making it simple and
cost effective to use. Every nuclear medicine department in even the
smallest hospital will have the equipment necessary to utilize it.
LeukoScan has been submitted in Europe for approval for imaging
osteomyelitis. FDA submission in the U.S. is expected before the end o
The potential market for LeukoScan is huge. I don't have solid numbers,
but there are many hundreds of thousands of bone scans performed in the
U.S. alone for diabetics with foot ulcers. Also, as discussed below,
LeukoScan has many advantages over current technology for diagnosing
appendicitis and other infections. Again, this is a huge market, and I
would expect FDA approval considering LeukoScan has no reported
adverse effects and has demonstrated superiority over current diagnostic
mo
A. Osteomyelitis:
Infection of the bone is one of the most frequent indications for bone
scans. Diabetics foot ulcers are probably the most common indication.
LeukoScan is useful for differentiating bone infections from infections of the
soft tissues around the bone. This is extremely important to patient care as
infection of the bone must be treated much more aggressively. Bone
infections often require 6 weeks of intravenous antibiotics and possibly
amputation whereas soft tissue infections are much
Results of a Phase II trial were published in Journal of Nuclear
Medicine. 35(9):1436-43, 1994 Sep: "Sensitivity, specificity and diagnostic
accuracy to detect infection [with LeukoScan] was 88%, 75% and 80%,
respectively. All lesions could be detected as early as 1 hr after injection of
the antibody fragment. In comparison, WBC scanning had values of 86%,
78% and 81%, respectively. Some lesions could only be detected 24 hr
following the injection of labeled WBC's. LeukoScan had three
Compared to 3-phase bone scans, LeukoScan has been found to be more
sensitive and more specific for osteomyelitis. Bone scans are often false
positive because, unlike LeukoScan and WBC scans, bone scans will show
increased activity at any arthritic joint and at sites of previous trauma.
This becomes problematic because you don't know if the scan is positive
because of infection in the bone or because of some other process.
B. Appendicitis:
One of the most common surgeries performed is appendectomy.
Unfortunately, because of limitations in current diagnostic tests, 15% of the
appendices removed are "pink" or healthy. LeukoScan has been shown to
be highly sensitive and specific for appendicitis and other abdominal
infections which necessitate surgery.
C. Other Infections, and Summary:
II. LymphoScan
1. Non-Hodgkin's Lymphoma (NHL):
Currently, Gallium is the most commonly used radioisotope for imaging
of Lymphoma. Nuclear medicine plays a key role in following lymphoma
patients because standard imaging like CT scans cannot differentiate active
lymphoma from the scar tissue which results from treatment.
Unfortunately, not all lymphomas are "Gallium-avid" and therefore
Gallium scanning is not helpful. LymphoScan is a safe, effective
alternative to Gallium scanning with one key advantage as described below.
Dr. Goldenberg's article in Eur J Nucl Med 1992;19(6):385-6 elaborated on
an important advantage of LymphoScan over Gallium scanning.
Specifically, LymphoScan resulted in "excellent targeting of gallium-
negative sites in the liver and bone." This is extremely important because
often the only clue that a soft tissue lesion is active lymphoma as opposed to
treated, scarred lymphoma is its uptake of Gallium. LymphoScan
therefore offers a unique advantage. Treated lymphoma (scar) and active
Promising results for imaging with LymphoScan are also reported in
Cancer Research. 55(23 Suppl):5764s-5770s, 1995 Dec 1.
2. TREATMENT of Non-Hodgkin's Lymphoma:
When the same antibody used in LymphoScan ("LL2") is attached to a
more potent radioactive chemical, highly efficient and specific therapy of
non-Hodgkin's Lymphoma may be possible. Very promising results have
been reported. In the July 24, 1996 Press Release, Dr. Goldenberg stated,
"Clinical trials with the lymphoma therapeutic are progressing well, with
encouraging clinical responses being noted. Thus, we plan to develop both
an imaging/staging agent and its therapeutic partner."
III. Antibody for Pneumocystis Carinii Pneumonia (PCP)
IV. Drug Delivery
V. OTHER DRUGS NOT DISCUSSED
A. AFP-Scan
B. LL1:
LL1 is another antibody which can be used to find bone marrow spread of
cancer. Studies have shown that it is better (gives better images) than the
currently used compound, sulfur colloid.
C. Biotin and Avidin
These are drugs which can be linked to antibodies which can be used to
increase the dose of a chemotherapy drug that goes to a specific type of
tumor. The hope is that by using these compounds, it will be possible to
deliver a larger dose of toxic drugs and kill off the cancer cells without
increasing the side effects of the chemotherapy. IMMU has patent
protection for this process, but I'm not sure if they've done any clinical
work yet. |
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