On December 17, 2018 Bristol-Myers Squibb Company (NYSE:BMY), and Boston Medical Center, a private, not-for-profit, academic medical center, reported a multi-year joint research study to identify and analyze potential sensitivity and resistance markers in patients treated with standard-of-care checkpoint inhibitors (Press release, Bristol-Myers Squibb, DEC 17, 2018, View Source [SID1234532098]). The comprehensive, multi-dimensional study will place an emphasis on uncovering mechanisms associated with lack of response to Immuno-Oncology (I-O) therapies, with the ultimate goal of identifying prognostic and potentially predictive I-O biomarkers in a variety of cancers.

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"Our newly opened R&D site in Kendall Square is focused on better understanding, and ultimately overcoming, the challenge of I-O resistance. We are thrilled to establish our first partnership since the site opened with our new neighbor, Boston Medical Center, with the goal of uncovering new insights into the biology of cancer and how it evolves with exposure to I-O intervention," said Saurabh Saha, M.D., Ph.D., senior vice president and global head of translational medicine, Bristol-Myers Squibb. "The information we glean from this collaboration will ultimately inform the development of novel therapeutic strategies to improve response rates and outcomes for patients."

Through the study, researchers will explore the role of tissue and circulating biomarkers on treatment sensitivity and resistance. In addition, scientists will investigate the role of the microbiome as a potential predictive biomarker in patients receiving treatment with immune checkpoint inhibitors.

"Boston Medical Center serves a diverse patient population, with 70 percent of our patients coming from underserved communities," said Matthew Kulke, M.D., chief of hematology/oncology at Boston Medical Center. "These patients are sorely underrepresented in current research studies. We look forward to partnering with Bristol-Myers Squibb on this study to identify and assess biomarkers across a diverse patient population, providing us with a deeper and more comprehensive understanding of I-O resistance."

The two organizations will jointly conduct the research throughout the duration of the study, after which Bristol-Myers Squibb and Boston Medical Center may collaborate to publish results.

Bristol-Myers Squibb opened its Cambridge R&D site, located in Kendall Square, on November 26, 2018.

On December 17, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported top line results from the Phase III NALA trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease (Press release, Puma Biotechnology, DEC 17, 2018, View Source [SID1234532097]). The Phase III NALA trial is a randomized controlled trial of neratinib plus capecitabine versus Tykerb (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer. The trial enrolled 621 patients who were randomized (1:1) to receive either neratinib plus capecitabine or lapatinib plus capecitabine. The trial was conducted globally at sites in North America, Europe, Asia-Pacific and South America. The co-primary endpoints of the trial are centrally confirmed progression free survival (PFS) and overall survival (OS). An alpha level of 1% was allocated to the PFS and 4% allocated to OS. The study was to be considered positive if either of the co-primary endpoints was positive. Puma reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of the Phase III clinical trial and the European Medicines Agency (EMA) also provided follow-on scientific advice (SA) consistent with that of the FDA regarding the Company’s Phase III trial design and endpoints used in the trial.

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For the primary analysis of centrally confirmed PFS, treatment with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS (p=0.0059) compared to treatment with lapatinib plus capecitabine. For the primary analyses of OS, neratinib plus capecitabine resulted in an improvement in OS that did not achieve statistical significance but trended positively in favor of the neratinib plus capecitabine arm of the study (p=0.21). For the secondary endpoint of time to intervention for symptomatic central nervous system disease (also referred to as brain metastases), the results of the trial showed that treatment with neratinib plus capecitabine led to an improvement over the combination of lapatinib plus capecitabine (p=0.043).

The safety profile of neratinib in the Phase III NALA study was consistent with previous clinical trials of neratinib.

Full results of the trial will be submitted to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency. Results of the trial will be submitted for presentation at a major medical conference in 2019.

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are highly encouraged by these results from the NALA trial with the combination of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments. We look forward to working with the regulatory authorities in the hope of bringing another potential treatment option to patients with HER2-positive metastatic breast cancer as soon as possible."

Conference Call

Puma Biotechnology will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Monday, December 17, 2018, to discuss the results of its NALA trial. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 30 days.

On December 17, 2018 Gossamer Bio, Inc., a privately held, clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it has appointed Jakob Dupont, M.D. as Chief Medical Officer (Press release, Gossamer Bio, DEC 17, 2018, View Source [SID1234532096]). Dr. Dupont has nearly 20 years of academic, biotechnology and pharmaceutical drug development experience, from early clinical phase through post-commercialization.

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"Gossamer has grown rapidly during the past year and has a meaningful pipeline of exciting clinical and preclinical drug candidates," said Sheila Gujrathi, M.D., Gossamer Bio’s Co-Founder and Chief Executive Officer. "Jakob’s extensive clinical development and regulatory expertise comes at a critical time for the company as we accelerate our development and look ahead to multiple significant clinical milestones. Jakob’s deep experience across the spectrum of therapeutic clinical development is an ideal fit, and we are thrilled to welcome him to the Gossamer team."

"Gossamer’s program pipeline addresses a number of significant disease areas that continue to be underserved by currently available therapies," said Dr. Dupont. "I am excited to be joining the team to advance these important potential new treatments in an environment that combines a rare blend of the nimbleness of an early-stage biotech company with the resources, expertise and rigor of a much more mature company."

Dr. Dupont most recently served as Vice President and Global Head of Breast and Gynecologic Cancer Development and was a member of the Oncology Leadership Team for Genentech/Roche. He was responsible for global development of Herceptin, Perjeta, Kadcyla, ipatasetib, taselisib, and Tecentriq, among others, and co-led the Genentech/Roche Breast Cancer Disease Area Strategy Team. Prior to his recent role at Genentech/Roche, Dr. Dupont was Chief Medical Officer and Senior Vice President of OncoMed Pharmaceuticals, Inc. where he oversaw clinical development and regulatory activities in oncology and other therapeutic areas. These activities included investigational new drug applications (INDs), clinical trials initiation, conduct and analysis. Dr. Dupont also participated in the execution of corporate initiatives, including OncoMed’s initial public offering and a partnership agreement with Celgene. Dr. Dupont began his career in the biotechnology industry with Genentech/Roche where he served as Global Medical Director of Avastin and was Group Director and Medical Director overseeing the angiogenesis pipeline, playing a key role in the development and approval of Avastin in ovarian, cervical and breast cancers as well as IND filings of novel anti-angiogenic agents. Prior to first joining Genentech/Roche in 2006, Dr. Dupont was a faculty member and laboratory researcher at Memorial Sloan-Kettering (MSK) Cancer Center and oversaw a solid tumor and GYN oncology clinic and a tumor immunology laboratory. He also served as adjunct clinical faculty in medical oncology at Stanford University, overseeing a GYN Oncology clinic.

Dr. Dupont received his undergraduate degree in philosophy from Vassar College and an M.A. in philosophy from New York University. He studied pre-medical science at Columbia University and received his M.D. from the Joan & Sanford I. Weill Medical College of Cornell University. He also served as Assistant Chief Resident at MSK and completed his Medical Oncology Fellowship at MSK Cancer Center, his Internal Medicine Residency at the New-York Presbyterian Hospital—Cornell Campus, and his Internal Medicine Internship at The University of Michigan Medical Center in Ann Arbor.

On December 17, 2018 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, reported that it has initiated the rolling submission with the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) for UGN-101 (mitomycin gel) for instillation as a treatment for patients with low-grade upper tract urothelial cancer (LG UTUC) (Press release, UroGen Pharma, DEC 17, 2018, View Source [SID1234532095]). The company expects to complete its NDA submission by mid-2019, with potential approval in 2019.

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"This is an important milestone in our mission to bring innovative, non-surgical treatment options to patients with urothelial cancers and potentially eliminate the need for repetitive surgical intervention and kidney removal," said Ron Bentsur, Chief Executive Officer of UroGen. "UGN-101 has the potential to be the first non-surgical therapy for LG UTUC, and the first drug ever approved in this indication. We are grateful to our UroGen team and clinical investigators who have worked diligently to advance this potentially paradigm-shifting program."

The NDA submission is supported by clinical data from the Phase 3 OLYMPUS clinical trial of UGN-101 for the non-surgical treatment of LG UTUC. Results from an interim analysis were presented at the American Urologic Association Annual Meeting in May 2018. UroGen plans to present topline data from the OLYMPUS study in January 2019.

The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.

About UGN-101
UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade upper tract urothelial cancer (LG UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of mitomycin to urinary tract tissue, thereby enabling the treatment of tumors by non-surgical means. UGN-101 is delivered to patients using standard ureteral catheters.

On December 17, 2018 Selexis SA and Teneobio, Inc. reported that they have entered into a second services agreement to expand Teneobio’s oncology pipeline of Human Heavy-Chain Antibodies (UniAbs), a new class of multi-specific biologics (Press release, TeneoBio, DEC 17, 2018, View Source [SID1234532094]). Under the agreement, Teneobio will utilize Selexis’ proprietary SUREtechnology Platform to develop research cell banks (RCBs) for three additional preclinical candidates for the potential treatments of B-cell malignancies and prostate cancer. Selexis and Teneobio announced their first services agreement in June 2017 to develop RCBs for multi-specific UniAb candidates for multiple myeloma.

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"Selexis’ cell line development technology was very effective in the advancement of Teneobio’s initial bispecific therapeutic lead," said Yemi Onakunle, PhD, MBA, Selexis vice president, licensing and business development. "We’re excited to continue our work with the Teneobio team as it seeks to bring a new class of oncology biologics to patients. Our partners choose Selexis because we deliver stable and high-performing manufacturing cell lines, while reducing the time, effort and costs associated with their development. The expansion of this relationship with Teneobio is a testament to our expertise and the competitive edge we’re able to deliver to our partners."

Selexis’ modular SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the biologics development continuum, spanning discovery to commercialization.

"Beyond TNB-383B, our lead anti-BCMAxCD3 bispecific for the treatment of multiple myeloma, Teneobio is rapidly advancing a pipeline of differentiated multispecific candidates in immuno-oncology. The productivity and effectiveness of our initial work with Selexis made it an easy decision to apply the company’s protein expression platform to additional Teneobio preclinical candidates," said Omid Vafa, PhD, MBA, chief business officer at Teneobio, Inc. "We look forward to continuing to work with Selexis as we bring our programs into the clinic."