Antibody Clinical Development & Marketing

Venue: U.S. Grant- A Wyndham Historic Hotel

Location: San Diego, California, United States

Event Date/Time: Feb 24, 2003 End Date/Time: Feb 26, 2003
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8:30 - 8:45 - Chairs' Opening Remarks

Thomas Davis, Ph.D.
Director, Oncology

Gisela Schwab, M.D.
Vice President, Clinical Development

8:45 - 9:15 - Late Phase Clinical Development of Complement Inhibitors in Cardiovascular Disease and Rheumatoid Arthritis
Alexion Pharmaceuticals has developed antibodies that potently block the complement cascade and has two compounds in multiple Phase II trials and is currently conducting a pivotal phase III trial as well. The Phase III compound, pexulizamab, is also being developed for myocardial infarction while eculizamab is being explored in a Phase
IIb rheumatoid arthritis trial as well as several other autoimmune disease areas. An update on these clinical programs will be presented during this talk.

Stephen P. Squinto, Ph.D.
Executive Vice President and Head of Research

9:15 - 9:45 - Jamming Viral Reception with the HIV Entry Inhibitors PRO 542 and PRO 140
HIV entry comprises a series of receptor-mediated processes that provide rich targets for a new generation of antiretroviral therapies. PRO 542 blocks the initial attachment of virus to its primary receptor, CD4. PRO 140 is a humanized monoclonal antibody to the chemokine receptor CCR5, which serves as an obligate HIV co-receptor. PRO 542 is in Phase 2 clinical testing, while PRO 140 is entering Phase 1.This presentation describes the development and status of these agents as innovative treatment modalities for HIV infection.

William C. Olson, Ph.D.
Vice President,R &D

9:45 - 10:15 - Clinical Trials of Interstitial Administration of 131I-chTNT-1/B MAb (Cotara(tm)) to Patients with Malignant Glioma
A Phase I, open-label, dose-escalation study was conducted to determine the maximum tolerated dose of 131I-chTNT-1/B when administered interstitially to patients with recurrent glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA). Twelve patients (7 men and 5 women between the ages of 26 to 73 years) were enrolled, 9 with GBM and 3 with AA. A Phase II, open-label, non-randomized study of interstitial 131I-chTNT-1/B for the treatment of newly diagnosed or recurrent malignant glioma was then conducted to collect preliminary efficacy and additional safety data. Thirty-nine patients (25 men and 14 women between ages of 15 and 79 years) have been treated to date, 28 with recurrent GBM, 8 with newly diagnosed GBM, and 3 with recurrent AA. Updated results will be presented.

Joseph Shan, M.P.H.
Associate Director, Clinical Affairs
Peregrine Pharmaceuticals, Inc.

10:15 - 11:00 - Networking & Exhibits

11:00 - 11:30 - Zevalin( (90Y Ibritumomab tiuxetan) - Ten Years Later (or Past, Present and Future)
Zevalin( (90Y Ibritumomab tiuxetan) is the first radioimmunoconjugate (RIC) to be approved by the FDA for treatment of CD20-positive relapsed or refractory, low-grade, follicular or transformed, B-cell non-Hodgkin's lymphoma, including rituximab-refratory follicular NHL. A phase I trial of this agent initiated in 1993, first used ibritumomab, the murine parent of rituximab, as the pre-treatment unlabeled antibody followed by 111In ibritumomab tiuxetan for imaging and 90Y ibritumomab tiuxetan for therapy. Subsequent studies used rituximab to optimize biodistribution prior to the administration of 111In imaging and 90Y therapeutic Zevlin RICs. Three important trials were conducted between 1998-1999: 1) A phase III comparison of Zevlin( vs rituximab in rituximab-naïve patients, which showed a higher overall response rate (ORR) in the Zevalin( arm (80%) vs the rituximab arm 56% (p=0.002); 2) A phase II dose-reduced Zevalin( in rituimab-naïve NHL patients with mild thrombocytopenia demonstrated a high response rate in this group; and 3) A phase II trial of Zevalin( in rituximab-refractory patients also resulted in a high ORR of 74%. The open label study conducted between 1999-2002 treated an additional 571 patients prior to the commercial availability of Zevalin( in 2002. Toxicity was primarily hematologic, with nadir counts developing at 7-9 weeks and lasting approximately 1-4 weeks, depending on the method of calculation. About 20% of patients require transfusions of platelets and red cells. Grade 4 neutropenia, thrombocytopenia, and anemia occurs in about 30%, 10% and 3% of patients, respectively. Interestingly, long-term follow-up of these trials indicate that a subset of patients who achieve CR/CRu with Zelavin( go on to enjoy durable responses ranging from 3-4 years, confirming the efficacy of this RIC as an anti-lymphoma therapy. As experience with the use of Zevalin( expands, investigations of novel applications of this unique therapeutic RIC agent will focus on the use in other histologic subtypes such as mantle cell lymphoma, diffuse aggressive lymphoma and Waldenstom's macroglobulinemia, incorportation of Zevalin( with chemotherapy into myeloablative and non-myeloablative transplant regimens followed by autologous and allogeneic stem cell support, and combination of Zevalin( with standard upfront and salvage combination chemotherapy regimens.

Arturo Molina, MD, MS
Senior Director, Medical Affairs
IDEC Pharmaceuticals

11:30 - 12:00 - Clinical Development of Humanized Antibodies that Inhibit Lymphokines for Treatment of Immune-Mediated Diseases
Protein Design Labs has developed a number of humanized antibodies that potently inhibit various lymphokines involved in immunity and inflammation, including IL-2, IL-4, IL-12, and interferon gamma. This has been facilitated by use of our proprietary computer-modeling technology. The antibodies are being tested in clinical trials for autoimmune diseases such as psoriasis, and Crohn's Disease, as well as for asthma. Several of these antibodies in Phase II clinical trials will be discussed during the presentation.

Robert Kirkman, M.D.
VP, Business Development & Corporate Communications
Protein Design Labs, Inc.

12:05 - 1:40 - Luncheon

1:40 - 2:10 - Preliminary Results of a Phase I Evaluation of Intravenous 131I-chTNT-1/B MAb for the Treatment of Advanced Colorectal Cancer
CotaraTM is a 131I radiolabeled chimeric monoclonal antibody that targets Histone H1, an intracellular marker. Cotara is being studied in a Phase I trial at Stanford University administered intravenously to patients with advanced colorectal cancer. Patients must have failed standard therapy. Cohorts of 3 patients each are given increasing doses of Cotara until dose limiting toxicities are seen. Subsequent to identification of DLTs, additional patients will be treated at the maximum tolerated dose. Radiation dosimetry information is being analyzed. Preliminary clinical and dosimetry results will be discussed.

Nilofar Bassiri
Manager, Clinical Affairs
Peregrine Pharmaceuticals, Inc.

2:10 - 2:40 - ABX-EGF, A Fully Human Anti-Epidermal Growth Factor Receptor
(EGFr) Monoclonal Antibody (MAb) for the Treatment of Advanced Cancer ABX-EGF is a high-affinity,fully human IgG2 MAb generated in XenoMouse(r) mice that binds to EGFr and inhibits tumor growth in vitro and vivo, and is being developed as a cancer therapeutic. In Phase 1 and 2 studies evaluating ABX-EGF as a monotherapy in about 130 patients with advanced cancer, it has been observed that:
* ABX-EGF was generally well tolerated
* No infusion-related reactions, no HAHA and no allergies or anaphylaxis occurred
* Transient acneiform skin rash occurred in a dose dependent acneiform skin rash was seen with > 90% of patients exposed to weekly dosing at >2.0 mg/kg
* Single agent anti-tumor activity was observed at low doses that appear to result in complete receptor blockade in the surrogate organ skin as suggested by occurrence of skin rash in most patients
* ABX-EGF is being evaluated in multiple Phase 2 studies

Gisela Schwab, M.D.
Chief Medical Officer
Abgenix, Inc.

2:40 - 3:10 - MDX-010: An Immunostimulatory Antibody in Clinical Development for Cancer
This talk will address recent safety and activity data in Phase I/II trials of our compound in advanced melanoma and prostate cancer. The Antibody is an immunomodulatory agent that can prolong and augment induced immune responses, hence it has a very broad therapeutic potential including all malignancy, infectious disease, and disorders
associated with immune suppression. Initial studies have shown a good safety profile and clear evidence of both immunologic and anti-tumor activity. A broad Phase II/III development program in the arenas is planned.

Thomas A. Davis, M.D.
Senior Director for Clinical Sciences
Medarex, Inc.

3:10 - 3:50 - Networking, Exhibits & Posters

3:50 - 4:30 - How Are Monoclonal Antibodies Doing in Clinical Trials?
In this audience-interactive panel, today's speakers who so wish will have opportunity to discuss their respective clinical programs. Among the topics that may be discussed include clinical protocols and cost, regulatory issues, safety and efficacy, patient recruitment, commercialization, and overall prospects in the field.

4:30 - 4:35 - Conference Concludes

4:35 - 6:30 - Networking Reception

Wednesday, February 26, 2003

7:30 - 8:45 - Networking & Exhibits

8:45 - 9:00 - Chairs' Opening Remarks

David Palella
Bioscience Ventures, Inc.

Zhu Shen, Ph.D., MBA
Bioforesight Strategies

9:00 - 9:45 - Strategies For Building A Commercial Infrastructure and Key Ingredients To Successfully Marketing Novel Biotech Products
Most biotech companies aspire to retain commercial rights to sell their therapeutic product upon FDA approval, IDEC Pharmaceuticals has been fortunate to have two novel therapeutic products approved, which it sells. This presentation will review IDEC's strategy for building its commercial group as well as marketing these products. Specific topics to be discussed include: Co-marketing, product positioning, branding, lifecycle planning, physician advocacy and intellectual property strategy.

Mark Wiggins
Vice President, Marketing and Business Development
IDEC Pharmaceuticals Corporation

9:45 - 10:20 - How Commercial Planning Increases the Value of Drug Candidates
One of the most important yet overlooked success factors for a biotechnology or pharmaceutical company is the integration of commercial planning throughout all phases of the drug development process. Commercial planning extends beyond the conventional wisdom of selecting indications for use, target patient populations, and price points. It is an essential process for focusing research efforts and "blueprinting" a development pathway offering the greatest potential return. The expected net present value of a development candidate (cash flow forecast, risk adjustment, development time) and the influence of market dynamics (emerging competitors and drug classes, potential available treatment population) are but a few considerations in selecting an optimum path for value creation. Pharmacoeconomic data and payer acceptance are also critical components that determine the magnitude of success. This presentation will describe an iterative process of commercial assessment beginning with preclinical development and continuing through product launch. Methods, strategies, and tactics will be discussed and case examples reviewed.

Larry A. Risen
BioTrak Consulting Group

10:20 - 11:00 - Networking & Exhibits

11:00 - 11:35 - Optimizing Antibody Clinical Trial Costs

Clinical trials are the single largest investment for the development of an antibody product. The FDA evaluates safety and effectiveness of drugs, biologics and devices through evidence obtained in clinical trials. But FDA regulatory changes, poor development planning, rising expenses, as well as a diversity of other factors, have made success in clinical trials an increasingly costly moving target. This panel presents diverse viewpoints in maximizing the return on investment while minimizing the associated risks in today's turbulent regulatory climate.

Elliot Parks
Managing Director - Life Sciences
Ventana Global

Alan Donald
President and CEO
Matrix Medical Consulting, Inc.

11:35 - 12:10 - Scientific Information Exchange in Managing Medical Thought-Leader Relationships: Benefits And Relevant Regulations
The therapeutic use of antibodies is based on complex medical science. Leveraging MTL relationships can play a crucial role in the acceptance and use of new therapies by the broader medical community. This talk will concentrate on leveraging MTL relationships and the regulators environment surrounding scientific information exchange to optimize the appropriate use of products.

Bill W. Massey
Scientific Commercialization LLC
Scientific Commercialization LLC

12:10 - 1:30 - Luncheon

1:30 - 2:05 - Current Investigator Attitudes about Therapeutic Antibody Development/ Marketing and CROs Experience in Therapeutic Antibody Development
Several thousand U.S. clinical investigators from various specialties were surveyed regarding their current experience, opinions, attitudes and concerns about the state of Antibody clinical development and marketing. These investigators included experienced Antibody investigators, investigator-prescribers of therapeutic Antibodies and potential prescribers. Given recent developments in therapeutic Antibodies, the opinions of these influential investigator-physicians will benefit sponsors planning clinical trials and marketing therapeutic Antibodies. In addition, several hundred CROs were surveyed for experience managing therapeutic Antibody trials and the results will be presented to assist sponsors select appropriately experienced CROs.

Joe A. Bollert, Ph.D.
President & CEO
Investigator Location Services

2:05 - 2:40 - Optimizing the Design of Antibody Clinical Trial Protocols
The high costs and uncertainties of clinical trials have become increasing concerns for biotechnology companies, including those with antibody compounds. Fast Track has developed a suite of data-driven modeling products and services that reduce cost and risk of Phase 1-3 trials by assuring that trial designs are cost-efficient and free of protocol errors that can cause operational problems during execution. Fast Track will describe these methodologies and present case studies of how they have been used by antibody companies to improve the design and management of their clinical development programs.

Jim McCord
Chairman and CEO
Fast Track Systems, Inc.

2:40 - 3:00 - Refreshments

3:00 - 3:35 - Visualizing the Value Proposition: The Visualization of Bioscience.
It has become common knowledge that a product launch must be supported by a strong product and corporate brand. Research and strategic planning can help define the attributes of a differentiating brand, but then the most difficult part arrives: the execution and implementation of this brand. What does an effective brand look like? Guy Iannuzzi, the founder and CEO of one of the West Coast¹s most experienced life science marketing agencies, Mentus, will present case studies of branding for new products, technologies and markets.

Guy Iannuzzi
Mentus, Inc.

3:35 - 4:10 - Branding in Biotech
Success in the biotechnology and pharmaceutical industries today relies on staying ahead of the competition. Being first to market is not enough. Indeed, winning requires that product launch be supported by a strong brand identity - a brand name which is dynamic, hard-hitting, and differentiating. In the changing regulatory environment, successful branding is key and must be considered.

Karen J. Hyve, Ph.D.
Genactis, Inc.

4:10 - 4:15 - Discussion

4:15 - 4:20 - Conference Concludes