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.

On September 10, 2019 AVEO Oncology (NASDAQ: AVEO) reported results from the second prespecified analysis of overall survival (OS) in the TIVO-3 trial (Press release, AVEO, SEP 10, 2019, View Source [SID1234539413]). TIVO-3 is the Company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib (FOTIVDA) to sorafenib in 350 subjects with highly refractory metastatic renal cell carcinoma (RCC). These results include an OS hazard ratio (HR) below 1.00, favoring tivozanib (HR=0.99; 95% CI: 0.76-1.29; p=0.95). An OS hazard ratio assesses the relative risk of death for the entirety of the data set. TIVO-3 is the first and only positive Phase 3 study in 3rd and 4th line RCC, and the first Phase 3 study in RCC to investigate a predefined subpopulation of patients who received prior immunotherapy, an emerging standard of care for earlier lines of therapy.

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The data cutoff date for the second prespecified analysis was August 15, 2019, two years from the last patient enrolled and approximately ten months from the data cut-off date for the first prespecified analysis. Between the two data cut-off dates, 16 additional OS events were reported on the tivozanib arm and 28 on the sorafenib arm, resulting in a total of 114 OS events on the tivozanib arm and 113 on the sorafenib arm. Median OS, a point in time value separating the earlier half of events from the latter half within each arm, was 16.4 months for tivozanib (95% CI: 13.4-22.2) and 19.7 months for sorafenib (95% CI: 15.0-24.2). Twenty patients remain progression free on the tivozanib arm and two on the sorafenib arm, with a median duration on study of 32.5 months.

In November 2018, the Company announced positive final results for the primary endpoint of progression-free survival (PFS) and the secondary endpoint of overall response rate (ORR). Statistically significant improvements favoring tivozanib were reported for PFS (HR=0.73; p=0.0165) and ORR (18% vs. 8%; p=0.02). The Company also announced that tivozanib was found to be generally well-tolerated, with grade 3 or higher adverse events consistent with those observed in previous tivozanib trials. Infrequent but severe adverse events reported in greater number in the tivozanib arm were thrombotic events similar to those observed in previous tivozanib studies. The most common adverse event in patients receiving tivozanib was hypertension, an adverse event known to reflect effective VEGF pathway inhibition.

The Company plans to discuss the updated OS results with the U.S. Food and Drug Administration to identify the appropriate path forward for tivozanib in RCC in the fourth quarter, and to provide an update regarding the potential submission of a New Drug Application for tivozanib in RCC following these discussions.

"These are the first data to demonstrate durable improvements in this highly refractory advanced kidney cancer population, including the post-immunotherapy setting, a predefined subset of the TIVO-3 trial," said Brian Rini, MD, Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Director, Cleveland Clinic Genitourinary Cancer Program, and principal investigator of the TIVO-3 trial. "The TIVO-3 study suggests the potential for tivozanib to serve as an important new treatment option for patients with advanced RCC. I look forward to seeing tivozanib studied further in the immunotherapy combination setting, and to continuing to explore its full potential in the evolving RCC treatment landscape."

"We are pleased to see that the positive PFS and ORR outcomes from TIVO-3 have translated into an improved OS hazard ratio," said Michael Bailey, president and chief executive officer of AVEO. "On behalf of the entire AVEO team, we once again offer our sincerest thanks to the patients, caregivers and investigators for participating in this study. AVEO remains committed to improving outcomes for patients with RCC, and we look forward to discussing these results with the FDA."

Conference Call and Webcast

In connection with this announcement, AVEO will host a conference call and audio webcast today, September 10, 2019, at 8:00 am Eastern Time. The call can be accessed by dialing (844) 882-7841 (U.S. and Canada) or (574) 990-9828 (international). The passcode for the conference call is 3275406. To access the live audio webcast, or the subsequent archived recording, please visit the Investors section of the AVEO website at www.aveooncology.com. The webcast will be recorded and available for replay on AVEO’s website for two weeks.

About TIVO-3

The TIVO-3 trial was designed to enroll patients with RCC who have failed at least two prior regimens, including VEGFR-TKI therapy. Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients were randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival (PFS). Secondary endpoints include overall survival (OS), overall response rate (ORR), and safety and tolerability. TIVO-3, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a regulatory submission of tivozanib in the U.S. as a treatment for RCC in multiple lines of therapy. TIVO-3 patients were exclusively enrolled in North America, Western Europe, and Central Europe.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.