On February 13, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported the closing of a $60 million senior secured loan facility with Oxford Finance LLC, a specialty finance firm providing senior debt to life sciences and healthcare service companies (Press release, Syros Pharmaceuticals, FEB 13, 2020, View Source [SID1234554295]).

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"The initial $20 million tranche of this financing extends our expected cash runway into 2022, beyond key planned clinical data readouts for SY-1425 and SY-5609 in multiple cancer patient populations," said Joseph Ferra, Syros’ Chief Financial Officer. "By providing access to additional capital, this facility also increases our financial flexibility as we continue to advance our clinical programs and earlier-stage pipeline with the aim of bringing small-molecule medicines to market that provide a profound benefit for patients with cancer and monogenic diseases."

Syros plans to use the proceeds of the financing to advance its lead product candidates SY-1425 and SY-5609, for which expected clinical readouts include potential proof-of-concept data for SY-1425 in RARA-positive relapsed or refractory acute myeloid leukemia patients in the fourth quarter of 2020, initial dose-escalation data for SY-5609 in select solid tumors in the fourth quarter of 2020, and additional dose-escalation data, including clinical activity data, for SY-5609 in mid-2021. Syros also expects to use proceeds from the financing to advance its preclinical programs toward the potential nomination of its next development candidate by the end of 2021, as well as for general corporate purposes.

The non-dilutive financing agreement provides Syros with up to $60 million in borrowing capacity in three tranches, with the initial tranche of $20 million available immediately. Syros is required to make monthly interest-only payments on each tranche prior to the amortization date of March 1, 2023. The debt facility will mature on February 1, 2025.

On February 13, 2020 SOPHiA GENETICS, leader in Data-Driven Medicine, reported the appointment of Philippe Menu, MD-PhD, MBA, as Chief Medical Officer (Press release, Sophia Genetics, FEB 13, 2020, View Source [SID1234554311]).

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Dr. Philippe Menu brings a unique blend of medical expertise across multiple areas including clinical medicine, fundamental research in molecular biology, and management consulting. He spent the last eight years at McKinsey & Company where he co-led the McKinsey Cancer Center and served dozens of clients in the biopharma sector. Dr. Menu advised global pharmaceutical companies, mid-size players and biotech alike across the entire value chain, with a major focus on innovative therapies and diagnostics in oncology and rare diseases.

"The potential linked to new-generation health data is limitless and it is our goal to continue expanding the scope of new clinical applications for our community of more than 1,000 hospitals across 82 countries," affirmed Jurgi Camblong, CEO and Co-founder of SOPHiA GENETICS. "Philippe’s background and track record across different sectors of life sciences, including biopharma, will help the execution of new clinical-grade applications. In turn, this will allow the longitudinal monitoring of patients through multi-modal data approaches and the optimization of drug development."

"It is a privilege to be joining SOPHiA GENETICS as Chief Medical Officer," said Dr. Menu. "I am incredibly inspired by what the SOPHiA team has already achieved by analyzing half a million patients’ genomic profiles across the world through its unique and growing global network of hospital partners. Looking ahead, I am most impressed by the full potential to positively impact patients’ lives that still lies ahead of us through the application of SOPHiA’s multi-modal data approach. SOPHiA is uniquely positioned to help deliver transformative progress for patients around the world: we can help discover new biomarkers to develop new therapies, match the right treatment to the right patients in clinical trials as well as in routine clinical care, and follow patients longitudinally through a multi-omics approach to help predict who will most benefit from which therapies and why. I look forward to working closely with our hospital, biopharma and other healthcare ecosystem partners to help accelerate the adoption of Data-Driven Medicine."

On February 13, 2020 Theravance Biopharma, Inc. (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, reported that it will report its fourth quarter and full year 2019 financial and operating results and provide a business update after market close on Monday, February 24, 2020 (Press release, Theravance, FEB 13, 2020, View Source [SID1234554327]). An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/10:00 p.m. GMT) that day.

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Conference Call Information

To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 5775588. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through March 25, 2020. An audio replay will also be available through 8:00 p.m. ET on March 2, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 5775588.

On February 13, 2020 Foundation Medicine, Inc. and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that they have entered into an agreement with the National Cancer Center (NCC) for the use of FoundationOne Liquid, Foundation Medicine’s laboratory-developed liquid biopsy test, in the third stage of SCRUM-Japan, the largest cancer genomic screening consortium in Japan (Press release, Chugai, FEB 13, 2020, View Source [SID1234554251]). The multinational program provides genomic screening in collaboration with hospitals on a regional scale in Japan and other countries in Asia, and aims to accelerate the development of innovative biomarker-driven precision medicine cancer therapies.

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The third stage of SCRUM-Japan is structured in two programs – LC-SCRUM-Asia and MONSTAR-SCREEN. LC-SCRUM-Asia is investigating genomic changes with the aim of delivering precision medicine to lung cancer patients. MONSTAR-SCREEN is investigating genomic changes across all types of advanced solid tumors, expanding beyond gastrointestinal cancer which was the focus of the second stage.

"The SCRUM-Japan program is a model of how collaboration between industry and academia is making precision medicine a reality for people in need of new treatment approaches," said Brian Alexander, chief medical officer of Foundation Medicine. "Utilization of FoundationOne Liquid in this program underscores its value in informing potential therapy selection for advanced-stage cancer patients. We look forward to continuing to expand access to comprehensive genomic profiling through this collaboration."

"SCRUM-Japan is a groundbreaking program to find therapies for patients with advanced cancer. There is an increasing need for blood-based genomic testing in patients who cannot give tissue samples including those who are unable to undergo invasive tumor biopsy," said Dr. Minoru Watanabe, Vice President, head of Chugai’s Foundation Medicine Unit. "We believe that this collaboration with the NCC, which has led a genome screening in Japan will pave the way to realize true precision medicine across the country."

"With the aim of delivering optimal treatments to patients, SCRUM-Japan was started with a view to detect cancer genomic alterations. The important achievements we saw from the first two stages include registration of over 10,000 patients’ clinical and genomic data, and approval of five therapeutic drugs and six in vitro diagnostics products based on clinical studies conducted by utilizing the data," said Atsushi Ohtsu, M.D., Ph.D. Director of National Cancer Center Hospital East and Representative of SCRUM-Japan. "Cancers remain leading causes of deaths in Japan and lung cancer has been ranked as the first leading cause of death among all cancer types. By incorporating FoundationOne Liquid into LC-SCRUM-Asia and MONSTAR-SCREEN, we believe the third stage of SCRUM-Japan will further prove the benefit of comprehensive genomic profiling tests such as FoundationOne Liquid."

Lung and gastrointestinal cancers are among the leading causes of cancer-related deaths in Japan, accounting for over 72 percent of cancer deaths in 2018 according to the World Health Organization. Through this collaboration, Foundation Medicine and Chugai will provide FoundationOne Liquid to academic centers participating in LC-SCRUM-Asia and MONSTAR-SCREEN.

In April 2018, Foundation Medicine received Breakthrough Device Designation from the U.S. Food and Drug Administration (U.S. FDA) on a forthcoming version of Foundation Medicine’s liquid biopsy test, which is currently under U.S. FDA review. Chugai and Foundation Medicine are preparing for the regulatory filing of this version of the test in Japan with the intention that the product will be approved for use under the National Health Insurance coverage in Japan. The parties intend that both LC-SCRUM-Asia and MONSTAR-SCREEN will transition from the existing FoundationOne Liquid test to the forthcoming version of Foundation Medicine’s liquid biopsy test following its anticipated approval by the U.S. FDA and subject to the terms of the agreement.

About SCRUM-Japan
SCRUM-Japan is the largest cancer genomic screening consortium in Japan and aims to accelerate the development of innovative biomarker-driven precision medicine cancer therapies. Since its launch in 2015, more than 10,000 patients with advanced cancers have participated in SCRUM-Japan. The third stage of SCRUM-Japan started in June 2019, and includes two programs – LC-SCRUM-Asia and MONSTAR-SCREEN. LC-SCRUM-Asia is investigating genomic changes with the aim of delivering precision medicine to lung cancer patients. More than 200 hospitals in Japan and Taiwan have joined the program and its scope area is expanding across Asia. MONSTAR-SCREEN is investigating genomic changes across all types of advanced solid tumors including gastrointestinal cancer. 28 hospitals have registered in Japan, and it aims for patients with various types of cancer to participate in the program.

On February 13, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported updated results from the combination arm of KEYNOTE-46 (Part B), the Company’s ongoing Phase 1/2 study investigating ADXS-PSA with KEYTRUDA (pembrolizumab) in patients with metastatic, castrate-resistant prostate cancer (mCRPC) at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in San Francisco, California (Press release, Advaxis, FEB 13, 2020, View Source [SID1234554279]). The KEYNOTE-46 trial was conducted in conjunction with Merck (known as MSD outside the U.S. and Canada) and evaluated ADXS-PSA, one of Advaxis’ Listeria monocytogenes (Lm)-based immunotherapies, alone and in combination with KEYTRUDA, Merck’s anti-PD-1 therapy.

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"The presented survival data in patients with visceral metastases strengthens our confidence that ADXS-PSA in combination with KEYTRUDA has the potential to provide meaningful increases in median overall survival in patients with advanced, metastatic, castration-resistant prostate cancer," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Importantly, these demonstrated impacts on survival have not been previously observed with immunotherapy in this advanced patient population leading us to actively assess next steps for the program with the hope of providing a much-needed new treatment for these patients with limited options."

Key findings presented by Mark N. Stein M.D., FACS, Associate Professor of Medical Oncology at Columbia University Medical Center and lead study investigator, titled, "KEYNOTE-046 (Part B): Effects of ADXS-PSA in combination with pembrolizumab on survival in metastatic, castration-resistant prostate cancer patients with or without prior exposure to docetaxel" include:

●Median overall survival (95% CI) of 33.7 months (15.4-NR) for patients treated with ADXS-PSA in combination with KEYTRUDA (n=37)
●Median overall survival (95% CI) of 16.0 months (6.4-34.6) for patients with prior docetaxel (n=20)
●Median overall survival (95% CI) of 16.4 months (4.0-NR) for patients with prior visceral metastasis (n=11; 10 of who had prior docetaxel)
72.4% (21/29) of evaluable patients showed stable disease
●38% of patients had PSA declines and 27% had >= 30% PSA decline from baseline
●The combination of ADXS-PSA and pembrolizumab appeared safe and tolerable in this heavily pretreated, unselected population of patients with MSI-High-negative mCRPC
●Treatment-related adverse events were mostly Grade 1-2, with no additive toxicity observed with combination therapy

Mark N. Stein M.D., FACS said, "These data are encouraging given the advanced nature of the patient population which includes those who have failed next generation hormonal agents and/or docetaxel, and now those with visceral metastasis." He added, "I am particularly enthusiastic to see increases in median overall survival to 16.4 months as compared to standard of care, which tends to be closer to 11 months in patients with measurable disease/visceral metastasis. This improvement, delivered with a generally safe and well-tolerated treatment regimen, warrants additional evaluation in larger studies and I look forward seeing the potential of a continued evaluation of ADXS-PSA in combination with KEYTRUDA."

KEYNOTE-046 was an open-label, multicenter, dose-determining safety and tolerability Phase 1/2 trial of 50 heavily pretreated patients conducted in two parts (Part A and Part B), with a Phase 2 expansion cohort. The objective of the study was to evaluate ADXS-PSA alone (Part A) and in combination with KEYTRUDA (Part B) for primary endpoints that include safety, tolerability and dosing. Secondary endpoints included anti-tumor activity, progression-free survival and overall survival, and exploratory endpoints that include associations between biomarkers of immunologic response (serum PSA) with clinical outcomes. Enrollment in the study has been completed and the database lock occurred on January 28, 2020. The majority of treatment-related adverse events consisted of transient and reversible Grade 1-2 chills/rigors, fever, hypotension, nausea and fatigue. The combination of ADXS-PSA and KEYTRUDA has appeared to be well-tolerated, to date, with no additive toxicity observed.

About KEYNOTE-046

KEYNOTE-046 (NCT02325557) was a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA (Part B; n= 37) in heavily pretreated patients with progressive and refractory mCRPC.