On September 10, 2019 Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, reported that the first patient was dosed in a Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in China for the treatment of cancer patients with peritoneal carcinomatosis (Press release, Clover Biopharmaceuticals, SEP 10, 2019, View Source [SID1234539418]).

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"Peritoneal carcinomatosis has historically posed significant challenges for both patients and clinicians, and with no efficacious therapies currently available, it remains a high unmet medical need for many cancer patients worldwide. My team and I look forward to evaluating SCB-313 as a potential new therapy for the treatment of cancer patients with peritoneal carcinomatosis." said Dr. Yan Li, Director of Department of Peritoneal Surgical Oncology at Beijing Shijitan Hospital and Principal Investigator of the trial.

The Phase I, open-label, dose escalation trial in China is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of intraperitoneally administered SCB-313 as a single-agent for the treatment of peritoneal carcinomatosis.

"Since China has the largest global incidence of gastrointestinal cancers, which often cause peritoneal carcinomatosis, we are extremely excited about the initiation of the SCB-313 study in China. Now that SCB-313 has successfully initiated clinical studies evaluating SCB-313 in multiple countries, Clover hopes to bring this novel and potentially first-in-class therapy to patients worldwide," said Dr. Min Dong, Executive Vice President, Global Clinical Development at Clover.

"TRAIL has long been considered a tantalizing target for cancer therapy because it can induce apoptosis in a tumor-specific manner across many different tumor types. SCB-313, which utilizes our proprietary Trimer-Tag© technology, is able to potently and uniquely target this trimerization-dependent pathway," said Dr. Peng Liang, co-founder, Chairman and President of Clover. "We believe that SCB-313 has the potential to be a best-in-class TRAIL-based therapy based on our R&D results to date, and in the months ahead, we look forward to initiating multiple new clinical studies for the treatment of intracavitary cancers."

On September 10, 2019 The Multiple Myeloma Research Foundation (MMRF) reported that Hearn Jay Cho, MD, PhD, will serve as the organization’s Chief Medical Officer (CMO) (Press release, Multiple Myeloma Research Foundation, SEP 10, 2019, View Source [SID1234539417]). As CMO, Dr. Cho will be an integral part of the MMRF Executive Leadership team and will be responsible for developing a clinical research strategy and accelerating drug development programs for the MMRF.

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Dr. Cho will maintain his clinical responsibilities as Associate Professor of Medicine at the Icahn School of Medicine at Mt. Sinai and Attending Physician with the Multiple Myeloma Service at the Mt. Sinai Tisch Cancer Institute. Additionally, he will continue to manage his laboratory at Mt. Sinai which is focused on developing novel therapies for multiple myeloma. At the MMRF, he will also lead the Multiple Myeloma Research Consortium (MMRC), a group of 25 leading research centers dedicated to researching and advancing treatment options for multiple myeloma patients.

"The MMRF continues to drive our strategic plan forward to accelerate major breakthroughs for cancer patients," said Paul Giusti, President and Chief Executive Officer of the MMRF. "Having a world-class leadership team is critical to executing our thoughtful, innovative, plan. We are excited to have Dr. Cho, with his talent, expertise and experience as a leading physician in the myeloma field, join the MMRF. Dr. Cho will contribute to the MMRF’s mission to find a cure for each and every multiple myeloma patient."

The MMRF strategic plan is built on three pillars: accelerating standardization and precision in immuno-oncology, investing in and partnering with innovative biotech companies with promising myeloma therapies, and generating, aggregating and analyzing critical data to identify new targets and care pathways. Focusing the MMRF efforts in these three broad areas will transform how multiple myeloma is treated and ultimately cured. To learn more about the MMRF Strategic Plan visit: themmrf.org/we-are-curing-multiple-myeloma/strategic-plan-2019.

Dr. Cho joins the MMRF Executive Leadership Team of: Paul Giusti, President and CEO; Michael Andreini, Chief Operating Officer; Daniel Auclair, PhD, Chief Scientific Officer; Stephen Labkoff, MD, FACP, FACMI, Chief Data Officer; Rob Miani, Chief Financial Officer; Anne Quinn Young, MPH, Chief Marketing and Development Officer; and Peter Kosa, Managing Director of the Myeloma Investment Fund.

Kathy Giusti, MMRF Founder and Chief Mission Officer, will continue to set the vision for the organization, which includes oversight of the MMRF’s strategic plan, with a focus on developing partnerships across research, drug development, and health care delivery, to align incentives that drive precision medicine and cures for patients.

"It is a great honor and privilege to join the MMRF," said Dr. Cho. "The MMRF has been instrumental in the FDA approval of new treatments that have revolutionized the care of multiple myeloma. We will keep the MMRF at the forefront of clinical and translational research, expanding our footprint in data and immunotherapy in our relentless pursuit of a cure for every patient."

On September 10, 2019 SEngine Precision Medicine and Atomwise, Inc. reported a joint venture to accelerate novel oncology drug discovery utilizing the unique platform technologies each company has validated through years of development (Press release, SEngine Precision Medicine, SEP 10, 2019, View Source [SID1234539416]).

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SEngine Precision Medicine will provide the joint venture with validated gene targets that are essential for the growth of mutant cancer cells. Atomwise will use its AI technology to discover and develop inhibitor compounds against these targets. SEngine will evaluate and validate these novel compounds using its proprietary PARIS Test to perform "in vitro clinical trials" which can screen hundreds of candidate drugs and drug combinations simultaneously against living tumors in the form of patient-derived organoids. Atomwise will use its AI technology to optimize possible drug candidates based upon data from SEngine’s "in vitro clinical trials." This unique approach is expected to rapidly advance the development of clinical candidates and greatly reduce time and costs.

"The combined capabilities of this collaboration create a model for the next generation of drug discovery to decrease time to market and lower the cost of clinical trials," said Dr. Carla Grandori, SEngine Precision Medicine Founder and CEO. She continued, "The process from discovering a promising small molecule to validation for a clinical trial candidate may now be accomplished at a fraction of the cost and time required of current efforts which may take up to ten years."

"Precision medicine for oncology requires technology that can provide a deep understanding of the biology of individual cancers and technology that can identify and evaluate potential drugs for individual cancers," said Dr. Abraham Heifets, CEO and Co-Founder of Atomwise. "This joint venture creates a path toward the development of small molecule therapies that are personalized for each cancer patient."

On September 10, 2019 Atomwise, Inc. the leader in artificial intelligence (AI) for drug discovery, reported the launch of a joint venture with OncoStatyx, LLC, an oncology focused preclinical stage biotechnology company based in Ohio (Press release, Atom Bioscience, SEP 10, 2019, View Source [SID1234539415]). The joint venture will discover and develop small molecule compounds that inhibit KDM5B, lysine-specific demethylase 5B, a key epigenetic modulator protein, as an anti-cancer agent, especially for triple negative breast cancer (TNBC).

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Atomwise will use its proprietary AI technology to iteratively model interactions between the KDM5B pharmaceutical target and putative inhibitor compounds. Inhibition of KDM5B will reactivate expression of the tumor suppressor protein HEXIM1, which plays an important role in turning off the cancerous state in multiple types of solid tumor cancers, including TNBC. OncoStatyx will provide proprietary information concerning interactions between the target and current lead compounds that inhibit KDM5B at nanomolar concentrations in cancer cells – a potency significantly better than published compounds. By combining the capabilities of both companies, the joint venture will be able to rapidly expand successful chemotypes and also optimize OncoStatyx’s current lead compounds to create clinical candidates. OncoStatyx will perform biochemical and biological testing and evaluation of the most promising compounds produced at each step of the collaboration.

"We’re extremely pleased to be launching a joint venture with Atomwise and see it as a significant validation of our approach," says Matt Lawes, PhD MBA, CEO and Co-Founder of OncoStatyx. "Our collaboration will be transformative for a scrappy Midwestern upstart like OncoStatyx and levels the playing field for us in very significant ways. It allows us to stay both ultra-lean and fast and pursue a novel approach to treating solid tumor cancers by switching off multiple cancerous properties. Disrupting cancer: faster, better, cheaper. Why not?!"

"Entrepreneurial biotech companies and academic spin-outs, such as OncoStatyx, are engines of innovation and discovery," says Abraham Heifets, PhD, CEO and Co-Founder of Atomwise. "We are excited to partner with the OncoStatyx team who are committed to novel treatments that will have meaningful impact on patient health."

"As an academic researcher it’s very gratifying to see the translation of my lab’s work on tumor suppressor HEXIM1 into potential clinical medicines," says Monica Montano PhD, Professor of Pharmacology at Case Western School of Medicine, and CSO and Co-Founder of OncoStatyx. "We are planning to develop the first medicine to induce the expression of a tumor suppressor as the primary therapeutic approach to treat solid tumor cancers. I’m very interested to see what emerges from the collaboration between Atomwise and OncoStatyx, certainly things will move a lot more quickly now with access to Atomwise’s expertise."

On September 10, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported that it will host an Investor Day on September 24, 2019 in New York where the Company will share updates on its clinical programs and launch readiness plans for UGN-101 (mitomycin gel) for instillation, its lead product candidate for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC) (Press release, UroGen Pharma, SEP 10, 2019, View Source [SID1234539414]). The program will also highlight the Company’s vision and strategy and include a panel discussion with key opinion leaders on the treatment of LG UTUC and low-grade non-muscle invasive bladder cancer.

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The live audio webcast and accompanying slide presentation will begin at 10:00AM Eastern Time. The live audio webcast can be accessed through the Events and Presentations section under the Investors tab of UroGen’s website at www.urogen.com. Following the live audio webcast, a replay will be available on UroGen’s website for approximately 30 days.

Management will also present at two investor conferences in September:

H.C. Wainwright 21st Annual Global Investment Conference

Tuesday, September 10th
10:50AM Eastern Time
New York, NY

Ladenburg Thalmann Healthcare Conference

Tuesday, September 24th
3:00PM Eastern Time
New York, NY
A live audio webcast of each event will be available on the Investors section of UroGen’s website, www.urogen.com. A replay of each webcast will be available on the website for approximately two weeks.