On January 4, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported that it has received notice from the U.S. Food and Drug Administration (FDA) authorizing the initiation a Phase I clinical trial with HuMab-5B1 as a therapeutic treatment for pancreatic cancer (Press release, MabVax, JAN 4, 2016, View Source [SID:1234508656]).

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The Company filed an Investigational New Drug (IND) application for its lead fully human antibody product on November 30, 2015. Patient enrollment in the Phase I clinical trial is expected to begin at multiple investigational sites in early 2016.

The Phase I trial will evaluate the safety, tolerability and pharmacokinetics of HuMab-5B1 as a single agent or in combination with a standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients 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 a standard of care chemotherapy. Two additional patient cohorts will be administered the optimized dose of antibody as a single agent, or in combination with a standard of care chemotherapy regimen, for the treatment of patients with pancreatic cancer.

David Hansen, MabVax’s President and Chief Executive Officer, said, "We are delighted with the FDA’s expeditious response to our IND filing. We intend to begin the dose escalation portion of this trial as soon as possible and anticipate reporting early safety assessment and determination of a maximum tolerated dose by mid-year 2016. This significant interim milestone will enable us to move into the combination therapy and monotherapy portions of the trial that we expect will provide important pharmacological data. This milestone could also have a positive impact on our future commercial and corporate development activities."

MabVax plans to file a second IND application for a HuMab-5B1 PET imaging agent and, subject to FDA authorization, will begin this Phase I trial in patients with pancreatic cancer in early 2016. 89Zr-HuMab-5B1, which is the antibody combined with a radio-label as a novel PET imaging agent, 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.

"Data generated in the early portions of these two Phase I trials could demonstrate important initial safety, targeting specificity and utility of the HuMab-5B1 antibody in patients with 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 January 4, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it has entered into a $150 million credit agreement, secured by future royalties of ENHANZE products, received only from Halozyme’s collaborations with Roche and Baxalta (Press release, Halozyme, JAN 4, 2016, View Source [SID:1234508654]).

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"This transaction allows us to continue to execute our two pillar strategy supporting the initiation of our phase 3 study in pancreatic cancer, ongoing studies in non-small cell lung and gastric cancers, and start of our planned trial in breast cancer in collaboration with Eisai," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This opportunity for non-dilutive financing further demonstrates how our ENHANZE platform can drive value, and is additive to the $25 million upfront payment from the recently announced licensing and collaboration agreement with Eli Lilly."

The debt transaction is expected to close in January 2016. The financing will be facilitated through investment funds managed by Pharmakon Advisors and Athyrium Capital Management. "We are pleased to partner with Halozyme in this transaction," said Martin Friedman, managing member of Pharmakon Advisors. "We believe Halozyme’s ENHANZE technology adds tremendous value to biologic products as demonstrated by the strength of Halozyme’s collaborations with Roche and Baxalta." As part of the financing structure, Halozyme formed a wholly-owned subsidiary, Halozyme Royalty LLC ("Halozyme Royalty"), which, subject to satisfaction of certain closing conditions, will borrow $150 million at a per annum interest rate of 8.75 percent plus the three-month LIBOR rate. Under the terms of the loan, the three-month LIBOR rate is subject to a floor of 0.70 percent and a cap of 1.50 percent.

On the closing date, Halozyme will transfer to Halozyme Royalty the right to receive certain royalty payments from the commercial sales of Herceptin SC and MabThera SC under Halozyme’s collaboration agreement with Roche and from the commercial sales of Hyqvia under Halozyme’s collaboration agreement with Baxalta. Halozyme will continue to record and report royalty revenues over the term of the loan, using the payments from the collaboration agreements as the source of funds to repay the principal and interest on the loan. Milestone payments received under any current or future collaboration agreements are excluded from the transaction.

Under the terms of the credit agreement, Halozyme Royalty will not be required to apply any of the royalty payments to repay the loan during 2016. All interest accrued in 2016 will be capitalized and added to the outstanding balance of the loan. Halozyme Royalty will only be required to apply 50 percent of royalty payments received in 2017 to make principal and interest payments subject to quarterly caps set forth in the credit agreement. Thereafter, subject to quarterly caps set forth in the credit agreement, Halozyme Royalty will apply all of the royalty payments received to repay outstanding principal and interest on the loan. If royalty payments available to repay the loan are insufficient to pay accrued interest due on any quarterly payment date, the unpaid interest will be capitalized and added to the outstanding principal balance of the loan. Royalty payments received in excess of the quarterly caps will be retained by Halozyme Royalty and distributed to Halozyme. Loan-related expenses will be deducted from the royalty payments before such amounts are applied to the loan or distributed to Halozyme Royalty.

The final maturity date of the loan will be the earlier of (i) the date when the principal amount and accrued interest are paid in full, (ii) the termination of Halozyme Royalty’s right to receive royalties under the collaboration agreements with Roche and Baxalta and (iii) December 31, 2050. Repayment of the loan is the sole obligation of Halozyme Royalty and is intended to be non-recourse to Halozyme Therapeutics, Inc. and its other subsidiaries.

On January 4, 2016 Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and Symphogen, a private biopharmaceutical company developing recombinant antibodies and antibody mixtures, reported a broad strategic immuno-oncology collaboration (Press release, Baxalta, JAN 4, 2016, View Source [SID:1234508653]).

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Under the terms of the agreement, Baxalta and Symphogen will advance novel therapeutics against six checkpoint targets, with the first program to enter clinical studies in 2017. On a product-by-product basis, following successful completion of Phase 1 clinical trials, Baxalta will have exclusive option rights to complete late-stage development and worldwide commercialization. Symphogen will receive an upfront payment of $175 million (€160 million) from Baxalta in exchange for the exclusive option rights for six checkpoint therapies. Symphogen will be responsible for performing R&D through Phase 1 clinical trials at its own expense. The agreement holds a total potential value up to €1.4 billion ($1.6 billion) in option fees and milestones over the long-term, in addition to royalties on worldwide sales. Additional terms, including therapeutic targets, were not disclosed.

"This exciting partnership aligns well to Baxalta’s strategy to invest in immuno-oncology and build an innovative portfolio of immunotherapies," said David Meek, executive vice president and president, Oncology, Baxalta. "With the expertise Symphogen offers in this category and their broad portfolio of early-stage immuno-oncology programs, this collaboration allows us to actively advance one of the most innovative areas of this field. For Baxalta, this is just the beginning of our focus in building world-class capabilities in immuno-oncology."

"Baxalta’s dedication to delivering transformative therapies and its global commercial presence make it an ideal strategic partner for Symphogen, as we complement Baxalta with R&D competencies within the immuno-oncology area," said Kirsten Drejer, Ph.D., Chief Executive Officer, Symphogen. "We look forward to providing Baxalta with innovative immuno-oncology product candidates under this broad collaboration."

Dr. Göran Ando, Chairman of Symphogen’s Board of Directors added, "This collaboration also provides strong validation for Symphogen’s antibody approach and capabilities within the exciting field of immuno-oncology therapy."

Immuno-oncology, a field focusing on activating and directing a patient’s immune system against tumor growth and proliferation, is a highly attractive area of research that is generating promising new therapeutic advances. Recent research indicates that these immunotherapies, both as single agents and as combination therapies, are likely to significantly improve outcomes for a variety of cancers.