From GS: Stock rating: In-Line
Coverage view: Neutral
Small-Cap Growth
Price: US$10.64
June 2, 2003
ABGX (IL/N): Encouraging interim PII
ABX-EGF data in colorectal cancer
52-Week Range US$13-5
YTD Price Change 44.37%
Market Cap US$933.7mn
Interim data from a Phase II study with ABX-EGF, in development with Amgen, were
reported at the American Society of Clinical Oncology meeting in Chicago on 5/31/03.
Although a relatively small study, we regard the data as encouraging so far, with an
approximate 10% response rate with ABX-EGF as monotherapy in advanced patients who
had failed other regimens. This study is continuing to enroll as are four other studies. We
expect additional data will help map the course for potential pivotal studies. ABX-EGF is
the company's lead candidate. With the recent approval of Astra Zeneca's Iressa and
encouraging data on Bristol/ImClone/Merck KGA's Erbitux, we think that there is strong
interest in the EGF class. Further, we believe that ABX-EGF may have potential side
effect advantages relative to other antibodies. We maintain In-Line rating and Neutral
coverage view. Key risks include potential clinical failures, long development timeframes
and volatility in the biotech sector.
INVESTMENT OUTLOOK: We believe that Abgenix represents an attractive
opportunity for long term oriented investors with a high risk tolerance. Abgenix is
distinguished by its ability to make fully human antibodies to a broad range of targets, a
platform technology that can fuel an expansive, diversified pipeline. Abgenix has
established a blue chip partner list and has the potential to develop a growing roster of
proprietary therapeutic antibodies. Over the next several years, we expect a range of new
antibodies to enter the clinic on a proprietary and partnered basis. The main clinical data
to be presented over the course of 2003 and 2004 will be Phase II results with cancer antibody
ABX-EGF.
I. Encouraging interim Phase II data in colorectal cancer
ABX-EGF is a fully human antibody to the EGF receptor, which is over- expressed in a range of
cancers. Abgenix and partner Amgen, are developing ABX-EGF in a number of different oncology
applications. A series of Phase II studies are underway in renal, colorectal, prostate cancer and
non-small cell lung cancer.
** Interim colorectal cancer data presented at ASCO **
Data were reported from an interim analysis of one of two open-label trials with ABX-EGF ongoing
in colorectal cancer. This study includes patients who are refractory to chemotherapy, including the
Saltz regimen. Some patients were also refractory to oxaliplatin. Data were reported on 40 patients
evaluable for efficacy (having had at least 5 EGF doses) and on 44 patients on an intent to treat
basis. The study will include 150 patients (expanded from 100 to get more data on oxaliplatin
treated patients) who will receive monotherapy intravenous infusions of 2.5 mg/kg of ABX-EGF
weekly over an 8- week treatment cycle, for up to 6 cycles. The endpoints of the trial are tumor
response rates and time to progression.
At 8 weeks, 4/40 patients had partial responses (RECIST criteria -greater or equal to 30% tumor
shrinkage) and 22 patients had stable disease. We regard a 10% response with ABX-EGF in such
advanced patients who had failed other therapies as an encouraging start. Similar response rates
have been observed with optimized chemotherapy in second line patients.
As expected, the most common adverse events were mild to moderate skin rash. Skin rash is a
common side effect of the class and may be correlated with response. No patients reported allergies
or experienced anaphylaxis or antibody formation. To date, diarrhea has not been observed as it has
with some of the oral agents. Lack of infusion reaction and anaphylaxis could potentially
differentiate ABX-EGF from some of the other antibodies.
II. Other EGF studies underway.
In the second trial in colorectal cancer, initiated in January 2002, up to 84 patients will receive
weekly intravenous infusions of 2.5 mg/kg of ABX- EGF in combination with standard doses of
irinotecan, leucovorin, and 5- fluorouracil (Saltz regiment) over a 6-week treatment cycle, for up to
eight cycles.
** prostate cancer **
In January 2002, Abgenix initiated a 50-patient, multi-center, open-label Phase II study of
ABX-EGF in prostate cancer patients who are failing hormone replacement therapy. In this trial,
patients will receive intravenous infusions of 2.5 mg/kg of ABX-EGF weekly over an 8-week
treatment cycle, for up to 5 cycles. The primary efficacy endpoint of the study will be measured by
prostate specific antigen (PSA) response rates (decrease of PSA level by >50% compared to
baseline). This study is intended to be a proof of principle study as PSA levels are not an accepted
primary endpoint.
** renal cancer **
Positive initial Phase II data on ABX-EGF as monotherapy in 88 advanced kidney cancer patients
were reported at ASCO in May, 2002. At 8 weeks, stable disease was achieved in 50% of the
patients. We believe this is a strong start given the severity of the patients studied, and the fact that
ABX-EGF was studied as monotherapy. The second part of this study will assess less heavily
treated pretreated patients and has enrolled 115 new patients.
** Competition **
Several companies are pursuing anti-EGF approaches to cancer, some of which are further ahead
than Abgenix. However, we believe that the market is large enough to support multiple players.
Further, until the relative risk/benefit of each candidate is determined, it will be difficult to predict
the ultimate winners. Advanced programs include Astra Zeneca's Iressa, approved, Bristol Myers
Squibb/ImClone's Erbitux, (NDA application not accepted) and Genentech/Roche/OSI's Tarceva,
an oral EGFr inhibitor in Phase III studies.
Abgenix is also developing an antibody to epidermal growth factor receptor version 3 (EGFrvIII),
which could be a more selective target.
=== 2003 milestones ===
* Phase II data for ABX-EGF monotherapy in second and third line colon
cancer at ASCO
- Fremont manufacturing facility to come on line
=== 2003/2004 milestones ===
- Phase II ABX-EGF monotherapy time-to-progression data in renal cancer
- Phase II data for ABX-EGF monotherapy in prostate cancer
- Phase II data for ABX-EGF combination therapy in non-small cell lung
cancer
- Phase II data for ABX-EGF combination therapy in first-line colon cancer
- Phase I data for ABX-MAI in cancer
* Milestone attained
I, Meg Malloy, hereby certify .. |
