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MabVax Therapeutics’ Human Antibody Clinical Development Candidate HuMab 5B1 Successfully Clears Important Early Toxicology Testing

On May 5, 2015 MabVax reported it has received the final report on toxicology testing of its HuMab 5B1 antibody, which was completed by a leading independent contract research organization (Press release, MabVax, MAY 5, 2015, View Source [SID:1234503590]). The report detailed that the antibody, given in either a single dose or repeated doses, had no significant adverse findings even at the highest dosage levels tested. These results further validate the Company’s decision to advance HuMab 5B1 into Phase 1 clinical trials before the end of 2015.

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David Hansen, President and CEO of MabVax Therapeutics, explained, "We challenged the non-human primates in this acute dose range finding study with multiple dose levels to assess drug pharmacokinetics, as well as with repeated doses of the antibody to identify any adverse toxicology signals. These studies were conducted in the most relevant animal models with material produced by our GMP manufacturing partner. The antibody as tested is representative of the clinical supply material scheduled for delivery later this year. As the final report provided evidence that there were no significant adverse findings, we are moving forward with our plan to enter the clinic later this year. Because the HuMab 5B1 antibody is fully human recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center, we believe that these antibodies reduce the likelihood of unwanted immunogenicity and cross reactivity. These results continue to build the body of evidence that makes our HuMab 5B1 product a valuable asset."

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The clinical development plan calls for two Phase I clinical trials to begin late this year. One program will determine the safety and potential utility of HuMab 5B1 in subjects with metastatic pancreatic cancer as a single agent or in combination with the current standard of care. The second program will be aimed at demonstrating the utility of 89Zr-HuMab 5B1, our radiolabeled HuMab 5B1 antibody, as a next generation PET imaging agent for the diagnosis and management of pancreatic cancer.

Mr. Hansen continued, "We are excited about the potential of utilizing a therapeutic antibody in combination with a companion diagnostic agent. We believe this unique dual-product development approach is applicable to other cancers utilizing our HuMab 5B1 antibody as well as with follow-on antibodies already under development in our preclinical pipeline."

About HuMab 5B1:
In pre-clinical research MabVax’s HuMab 5B1 antibody has demonstrated high specificity, affinity, and lack of cross-reactivity with closely related antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancer. When combined with a radio-label as a novel PET imaging agent, 89Zr-HuMab 5B1 has demonstrated high image resolution of tumors in established xenograft animal models, making it attractive as a companion diagnostic for the therapeutic product.

Merrimack Pharmaceuticals Announces Initiation of a Phase 2 Front-line Clinical Trial of MM-141 in Biomarker-Selected Patients with Metastatic Pancreatic Cancer

On May 5, 2015 Merrimack reported the initiation of a randomized, double-blinded, placebo-controlled Phase 2 clinical trial of MM-141, a bispecific antibody targeting IGF-1R and ErbB3, in combination with nab-paclitaxel and gemcitabine, versus nab-paclitaxel and gemcitabine alone in patients with newly-diagnosed metastatic pancreatic cancer who have high serum levels of free IGF-1
(Press release, Merrimack, MAY 5, 2015, View Source [SID:1234503584]).

"Pancreatic cancer is the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2020. Merrimack is committed to advancing the standard of care for patients with inoperable, metastatic pancreatic cancer. We are taking steps to move our therapeutics forward based on matching them to the biology of individual tumors," said Chrystal Louis, M.D., Medical Director of MM-141 at Merrimack. "Data from our Phase 1 trial supports further clinical evaluation of MM-141 in patients with high serum levels of free IGF-1. Patients with this biomarker profile may have the greatest potential of benefit from the use of MM-141 combined with standard chemotherapies, and we look forward to further validating this in our Phase 2 trial."

As part of this trial, 146 front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1 will be randomized (1:1) to receive either MM-141 plus nab-paclitaxel/gemcitabine or nab-paclitaxel/gemcitabine alone. Eligible patients for the trial must have received no prior radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. The primary endpoint of the trial is progression free survival (PFS). Secondary endpoints include overall survival, objective response rate, safety and tolerability. Merrimack plans to conduct the trial at sites in the United States, Canada and Europe. Initial trial sites located at St. Jude Heritage in Fullerton, California and Northwestern University in Chicago, Illinois are now open to screen patients in the United States. For more information, please visit clinicaltrials.gov (Identifier: NCT02399137).

About MM-141

MM-141 is a tetravalent bispecific antibody designed to block tumor survival signals by targeting receptor complexes containing IGF-1R and ErbB3 (HER3). IGF-1R and ErbB3 complexes both activate a major signaling pathway that allows tumor cells to grow and develop resistance to chemotherapy. MM-141 has been tested in a Phase 1 dose-escalation clinical trial. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for MM-141 for the treatment of pancreatic cancer. This orphan drug designation could provide Merrimack with seven-year marketing exclusivity and other benefits for MM-141 when approved by the FDA

ArQule and Beryllium Announce Collaborative Research and Development Agreement

On May 5, 2015 ArQule and Beryllium Discovery reported a collaborative research and development agreement to identify and unlock the therapeutic potential of small molecule compounds by combining ArQule’s chemistry and drug development expertise with Beryllium’s discovery platforms (Press release, ArQule, MAY 5, 2015, View Source [SID:1234503580]). The Beryllium platforms integrate structure-guided drug discovery, biophysics and cell biology.

The therapeutic targets to be pursued by the parties include PD-1 (programmed cell death protein 1) and PDL-1 (programmed death ligand 1), two proteins believed to play major roles in suppressing or limiting the response of the immune system. Molecules that bind to and inhibit the effects of these targets may help direct the immune system to combat a variety of tumors.

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"We are excited by the potential synergy in combining complementary technologies and expertise to pursue cost-effective, shared-risk development pathways for the selection of compounds identified from ArQule’s small molecule library or rationally designed through Beryllium’s fragment-based research capabilities and ArQule chemistry technology," said Brian Schwartz, chief medical officer of ArQule. "We are prioritizing the scope of our collaboration based on the recognition that immuno-oncology represents a promising area of research with potential applications across a number of cancers."

"We welcome the opportunity to combine our functional and structural biology platforms with ArQule’s chemistry and drug development capabilities," said Dalia Cohen, Ph.D., chief scientific officer of Beryllium. "We believe that there are significant synergies between the two companies, and we are excited to work together. ArQule’s chemistry know-how and clinical development expertise are a perfect complement to Beryllium’s strengths in target-centric drug discovery."

10-Q – Quarterly report [Sections 13 or 15(d)]

Pharmacyclics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Pharmacyclics, MAY 4, 2015, View Source [SID1234503575]).

10-Q – Quarterly report [Sections 13 or 15(d)]

Vertex Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Vertex Pharmaceuticals, MAY 4, 2015, View Source [SID1234503573]).