On December 20, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported the completion of enrollment and initial patient dosing in an expanded cohort of the Company’s Phase 1 trial evaluating MVT-5873 in combination with standard of care chemotherapy in newly diagnosed patients with pancreatic and other CA19-9 positive malignancies (Press release, MabVax, DEC 20, 2017, View Source [SID1234522728]).

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In October, the Company provided an update at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference highlighting encouraging preliminary tumor response data when MVT-5873 was given in combination with nab-paclitaxel and gemcitabine in newly diagnosed patients with CA19-9 positive pancreatic cancer. At this meeting the Company reported that this dose was generally well tolerated in all subjects and that two of three subjects receiving 0.125 mg/kg MVT-5873 in combination with gemcitabine plus nab-paclitaxel had a partial response ("PR"). The Company expanded this cohort to further explore safety and potential response and is now reporting that it has completed enrollment in the 0.125 mg/kg expansion cohort.

This portion of the Company’s Phase 1 clinical trial is an open-label, multi-center nonrandomized dose escalation study evaluating the safety and maximum tolerated dose ("MTD") and recommended Phase 2 dose of MVT-5873 in combination with a standard of care chemotherapy in subjects with pancreatic and other CA19-9 positive malignancies. Secondary objectives include evaluating tumor response rate by RECIST 1.1, duration of response, and to determine pharmacokinetics. Dr. Eileen O’Reilly, Associate Director of the David M. Rubenstein Center for Pancreatic Cancer Research, attending physician, member at Memorial Sloan Kettering Cancer Center and Professor of Medicine at Weill Cornell Medical College, is the lead investigator in the MVT-5873 Phase 1 clinical trial.

"We are pleased to have completed patient enrollment of the 0.125 mg/kg expansion cohort of our clinical development program evaluating MVT-5873 as a first line therapy with standard of care gemcitabine plus nab-paclitaxel. We plan to report interim safety and RECIST results from this study in the first quarter of 2018," commented David Hansen, MabVax’s President and Chief Executive Officer.

For additional information about the Phase 1 MVT-5873 clinical trial, please visit clinicaltrials.gov, and reference Identifier NCT02672917.

On 20 December 2017, Idorsia Ltd reported that it has entered into a research collaboration that provides Roche with an exclusive option right to develop and market first-in-class compounds for a promising new approach in the field of cancer immunotherapy (Press release, Hoffmann-La Roche, DEC 20, 2017, View Source [SID1234584171]).

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Martine Clozel, M.D. and Chief Scientific Officer of Idorsia, commented: "The preclinical data we have generated leads us to believe that our approach can translate into significant therapeutic benefits for patients. By joining forces, we are combining our advanced drug discovery program together with the cancer immunotherapy expertise of Roche. I am looking forward to the collaboration with our partner to leverage our research and bring compounds through clinical development as soon as possible."

About the terms of the agreement

The parties will collaborate on the discovery of products through the formation of a joint committee, chaired by Idorsia.

Roche will pay Idorsia an upfront payment of CHF 15 million and will have the option to exclusively license Idorsia compounds and compounds resulting from the collaboration, for a further payment of 35 million, after a pre-determined period. After the exercise of its option right, Roche would have the exclusive worldwide right to develop and commercialize the Idorsia and collaboration compounds.

Idorsia will be eligible to receive one-time development and regulatory milestones of up to CHF 410 million. Idorsia will also be entitled to one-time milestones based on sales thresholds, as well as tiered royalties on annual net sales of all products resulting from the collaboration.

On December 20, 2017 Samsung Bioepis Co., Ltd. reported that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptini (trastuzumab) (Press release, Samsung Bioepis, DEC 20, 2017, View Source [SID1234522734]). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the United States (US). If approved, SB3 will be commercialized in the US by Merck, which is known as MSD outside of the US and Canada.

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On December 20, 2017 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that Phil Hagerman, CEO and chairman, and Atul Kavthekar, CFO, will present at the upcoming 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Diplomat Speciality Pharmacy, DEC 20, 2017, View Source [SID1234522736]).

(Press release, Diplomat Speciality Pharmacy, DEC 20, 2017, View Source [SID1234522736])

Mr. Hagerman and Mr. Kavthekar are scheduled to present at the conference on Wednesday, Jan. 10, 2018, at 1:30 p.m. PT. A live audio-only webcast of the presentation and related presentation materials will be available on the investor relations section of the Company’s website at diplomat.is. The archived webcast and presentation materials will also be available for approximately 90 days at the same URL.

On December 20, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission (EC) has granted a marketing authorisation for Alecensa (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, DEC 20, 2017, View Source [SID1234522737]). The approval is based on results from the phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 53% (hazard ratio (HR)=0.47, 95% confidence interval (CI): 0.34-0.65, p<0.001) compared to crizotinib. The study also showed that Alecensa reduced the risk of tumours spreading to, or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10-0.28, p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to crizotinib.1

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"Many ALK-positive lung cancer patients see their disease progress within a year on current treatments," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The EU approval of Alecensa heralds a new era for these patients, who now have a treatment option available that halves the risk of disease progression compared with the previous standard of care, crizotinib and is also highly effective against brain metastases."

In addition to today’s first-line approval, the EC also converted the conditional marketing authorisation of Alecensa in crizotinib failure to a standard marketing authorisation. Alecensa has also recently (6 November 2017) been approved by the US FDA, as well as Japan and Turkey as an initial (first-line) ALK-positive NSCLC treatment, and is already approved in Japan as well as in 18 countries in the crizotinib-failure setting.

Results from the phase III ALEX study were simultaneously presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The New England Journal of Medicine. Subsequently, Alecensa was recommended in the US National Comprehensive Cancer Network (NCCN) guidelines as a treatment option for first-line ALK-positive metastatic NSCLC (Category 1, Preferred).2

ALK-positive NSCLC is a distinct form of lung cancer commonly affecting younger people (median age 52), and those with a light or non-smoking history.3 Around 75,000 people are diagnosed with ALK-positive NSCLC every year.4,5,6