On December 1, 2015 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for the Company’s lead fully human antibody product HuMab 5B1 as a therapeutic agent (Filing, 8-K, Telik, DEC 1, 2015, View Source [SID:1234508380]). Subject to FDA acceptance, MabVax plans to initiate the Phase I clinical trial early in 2016.

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The planned Phase I trial will evaluate the safety, tolerability and pharmacokinetics of HuMab 5B1 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients to be enrolled in the planned clinical trial will be enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient cohort will establish the safety and optimized dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer.

David Hansen, MabVax’s President and Chief Executive Officer, said, "The filing of the first of two planned INDs for our novel HuMab 5B1 antibody is a significant achievement for MabVax. Pending FDA acceptance of the IND, we will begin the dose escalation portion of this Phase I trial as early in 2016 as possible and anticipate reporting on the early safety assessment and determination of a maximum tolerated dose in mid-year 2016. Achievement of this important interim milestone will enable us to move into the combination therapy and monotherapy portions of the trial where we could learn much more about the pharmacological effects of this new therapy. The milestone could also have a positive impact on our future commercial and corporate development activities. We currently anticipate having full enrollment of all three patient cohorts sometime before the end of 2016."

MabVax plans to file a second IND application this month for its HuMab 5B1-based PET imaging agent and, subject to FDA acceptance, will begin this Phase I trial as early as possible in 2016. When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab 5B1 product has demonstrated high image resolution of tumors in established xenograft animal models, making it attractive as a potential companion diagnostic for the HuMab 5B1 therapeutic product.

"We believe the data generated in the early portions of these two Phase I trials will help demonstrate the initial safety, targeting specificity, and utility of the HuMab 5B1 antibody in this devastating disease," added Mr. Hansen. "We are excited about the potential applicability of our dual-product development approach in other cancers with HuMab 5B1, as well as with follow-on antibodies under development at MabVax."

About HuMab 5B1:
MabVax’s HuMab 5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.

On December 1, 2015 Syndax Pharmaceuticals reported the initiation of the entinostat clinical program in Japan by its partner Kyowa Hakko Kirin, Co., Ltd (Press release, Syndax, DEC 1, 2015, View Source [SID:1234508552]). Entinostat, an oral, small molecule drug candidate that targets both cancer cells and immune regulatory cells, is being developed by Syndax as an immuno-oncology therapeutic and evaluated as a treatment for advanced hormone receptor positive (HR+) breast cancer in an ongoing Phase 3 clinical trial (designated E2112) in the United States. In September 2013, entinostat was granted breakthrough therapy designation by the U.S. Food and Drug Administration in advanced HR+ breast cancer following positive results from the Phase 2b clinical trial, ENCORE-301.

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"In addition to the entinostat immuno-oncology combination regimens entering clinical development in the U.S., we are pleased to see continued clinical progress for entinostat in advanced breast cancer both in the U.S. and Japan," said Briggs Morrison, M.D., Chief Executive Officer of Syndax. "We view this milestone as an important step towards potentially providing new treatment options to breast cancer patients globally and look forward to continuing our collaboration with our valued partner Kyowa Hakko Kirin."

In January 2015, Syndax announced completion of a license agreement with Kyowa Hakko Kirin for the exclusive rights to develop and commercialize entinostat in Japan and Korea. Kyowa Hakko Kirin has now dosed the first patient in Japan in a Phase 1 clinical trial investigating the safety of entinostat (designated KHK2375 by Kyowa Hakko Kirin) as a monotherapy and in combination with exemestane in advanced or metastatic HR+ breast cancer patients previously treated with a nonsteroidal aromatase inhibitor. Secondary endpoints include pharmacokinetic parameters and preliminary efficacy.

On December 1, 2015 Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) reported that data for VYXEOS (formerly CPX-351), its lead product candidate, will be presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, December 5-8, 2015 (Press release, Celator Pharmaceuticals, DEC 1, 2015, View Source [SID:1234508370]).

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Abstracts selected for poster presentation are:

Date: Sunday, December 6, 2015, 6:00 p.m. – 8:00 p.m.
Presentation Title: CPX-351 ((Cytarabine:Daunorubicin) Liposome Injection, (Vyxeos)) Does Not Prolong QTcF Intervals, Requires No Dose Adjustment for Impaired Renal Function and Induces High Rates of Complete Remission in Acute Myeloid Leukemia
Presenter: Dr. Tara Lin
Abstract Number: 2510
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster II
Location: Hall A (Orange County Convention Center)

Date: Monday, December 7, 2015, 6:00 p.m. – 8:00 p.m.
Presentation Title: CPX-351 Enables Administration of Consolidation Treatment in the Outpatient Setting and Increases the Time Spent out of the Hospital after Completion of AML Treatment Compared with 7+3
Presenter: Dr. Jeffrey Lancet
Abstract Number: 4507
Session: 902. Health Services and Outcomes Research – Malignant Diseases: Poster III
Location: Hall A (Orange County Convention Center)

On December 1, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that it has reached its enrollment target of 400 patients for the company’s pivotal global Phase 3 clinical trial of aldoxorubicin in patients with previously treated soft tissue sarcoma (STS) (Press release, CytRx, DEC 1, 2015, View Source;p=RssLanding&cat=news&id=2119175 [SID:1234508371]). Enrollment was originally estimated to be completed in Q1 2016. The Phase 3 trial is a randomized, comparative trial being conducted under a Special Protocol Assessment from the FDA at 79 sites in the United States, Canada, Israel, Australia, Western & Eastern Europe and Chile.

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"It is a true testament to the dedicated work of our clinical team, the enthusiasm of our participating physicians, and the willingness of patients to participate in our study that enrollment in our global pivotal Phase 3 clinical trial was completed ahead of schedule," said Steven A. Kriegsman, Chairman and CEO of CytRx. "We now expect to report the primary endpoint of top-line progression-free survival (PFS) in the first half of 2016, and pre-commercial launch activities are underway."

"As a member of the sarcoma research community, I am very excited to see the overwhelmingly positive response from my colleagues to this pivotal trial," said Sant P. Chawla, M.D., F.R.A.C.P., Principal Investigator and Director of the Sarcoma Oncology Center. This trial is the first to compare a single agent, aldoxorubicin, to five of the most commonly used treatment options for STS patients that have received prior chemotherapy. The rapid timeframe in which this Phase 3 trial reached its targeted enrollment reflects the desire of practitioners for more efficacious therapies."

Trial Design

This is a multicenter, randomized, open-label Phase 3 clinical trial designed to enroll approximately 400 late-stage patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to, or who have progressed following treatment with one or more systemic regimens of nonadjuvant chemotherapies. Trial patients are randomized 1:1 to be treated with aldoxorubicin or the investigator’s choice of an approved chemotherapeutic regimen, including doxorubicin, ifosfamide, dacarbazine, pazopanib (Votrient), or gemcitabine plus docetaxel. The primary endpoint of the study is PFS and will be calculated after 191 events occur. Secondary endpoints include overall survival, response rates and safety. In January 2014, CytRx announced that it received approval from the FDA to amend the Phase 3 protocol to continue dosing patients with aldoxorubicin until disease progression as defined by RECIST 1.1 criteria. The ability to dose until disease progression creates the potential for substantially improved Phase 3 efficacy results.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

On December 1, 2015 Genmab A/S (Nasdaq Copenhagen: GEN) reported it will hold its annual R&D Update focused on the company’s latest developments in antibody innovation on December 8, 2015 from 8:00 PM to 10:00 PM CET (Press release, Genmab, DEC 1, 2015, View Source [SID:1234508372]). The update will include presentations by key opinion leaders describing data from studies of daratumumab presented at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) as well as information on Genmab’s pipeline product HuMax-TF-ADC. Genmab will also discuss the company’s pre-clinical pipeline, the proprietary DuoBody and HexaBody technologies and will present its 2016 Key Goals.

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The following cancer experts and senior Genmab staff will attend the event:

Daratumumab Key Opinion Leaders:

Professor Thierry Facon, Professor of Hematology, Head of the Department of Hematology, Lille University Hospital, Lille, France
Professor Maria Victoria Mateos, Associate Professor of Medicine, University Hospital of Salamanca, Salamanca, Spain
Professor Torben Plesner, Department of Hematology, Vejle Hospital, Vejle, Denmark
Dr. Peter Voorhees, M.D., Associate Professor, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, US

HuMax-TF-ADC Key Opinion Leader:

Professor Johann de Bono, Director of the Drug Development Unit & Head of Prostate Cancer Targeted Therapy Group, Professor of Experimental Cancer Medicine & Honorary Consultant in Medical Oncology, The Institute of Cancer Research, Surrey, UK

Genmab:

Dr. Jan van de Winkel, President and CEO, Genmab
David Eatwell, Executive Vice President and CFO, Genmab

ASH abstracts to be discussed during the event include:

Management of Infusion-related Reactions Following Daratumumab Monotherapy in Patients with ≥3 Lines of Prior Therapy or Double Refractory Multiple Myeloma (MM): 54767414MMY2002 (Sirius)
Clinical Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma
Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma: Updated Results from a Phase 1/2 Study (GEN503)
Open-label, Multicenter Phase 1b Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Patients with ≥2 Lines of Prior Therapy and Relapsed or Relapsed and Refractory Multiple Myeloma (MM)

The R&D Update is taking place at the Hyatt Regency Orlando in Orlando, Florida. Those wishing to attend in person should email [email protected]

The event can be attended via webcast. To view this webcast visit: View Source Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player. An archive of the webcast will be available on Genmab’s website. The webcast will be conducted in English.
This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.