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MetVital, Inc. Announces FDA Clearance of Investigational New Drug (IND) Application for AEO for Phase 2 testing for Glioblastoma Multiforme

On June 11, 2019 MetVital, Inc., a biopharmaceutical company developing small molecule modulators of glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, reported that the U.S. Food and Drug Administration (FDA) has notified MetVital that it may proceed with its clinical investigation of "Anhydrous Enol-Oxaloacetate" (AEO) as a potential treatment for patients with Glioblastoma Multiforme (Press release, MetVital, JUN 11, 2019, View Source [SID1234537004]). The notice to proceed was received following MetVital’s submission of an investigational new drug (IND) application for this program. FDA has approved a Phase 2A "Proof of Concept" trial to advance.

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AEO, a patented metabolite, is MetVital’s lead clinical development candidate for Glioblastoma Multiforme, a malicious type of brain cancer. Measured endpoints in the trial include Overall Survival (OS), Progression Free Survival at 6 months (PFS-6) and Seizure amelioration.

"The FDA’s acceptance of this commercial IND application is an important milestone for MetVital, as it allows us to immediately go into Phase 2A testing," said Alan Cash, president and chief executive officer of MetVital, Inc. "We are excited about the potential of modulating the excess glutamate levels in the central nervous system for patients with brain cancer, and the potential of the drug for a wide variety of other diseases." AEO is also being examined in Investigator lead clinical trials for the treatment of Amyotrophic Lateral Sclerosis (ALS) and Alzheimer’s disease.

Anhydrous Enol-Oxaloacetate is a metabolite that has demonstrated efficacy in animal models with human Glioblastoma Multiforme tissue implants, in animal models of ALS, and in animal models of Alzheimer’s disease. US FDA Orphan Drug Designations for oxaloacetate have been received for Gliomas, ALS and Hepatocellular Carcinoma.

Glioblastoma Multiforme is the most aggressive of the gliomas. It is often referred to as a grade IV astrocytoma, and is the most common type of brain cancer.

Arcus Biosciences to Provide a Mid-Year Update on Clinical and Preclinical Programs

On June 11, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer therapies, reported that the Company will host a conference call and live webcast on Tuesday, June 25, 2019, at 1:30 p.m. Pacific Time/4:30 p.m. Eastern Time to provide a mid-year update on its clinical and preclinical programs (Press release, Arcus Biosciences, JUN 11, 2019, View Source [SID1234537003]).

Investors interested in listening to the conference call may do so by dialing (866) 211-3164 in the U.S. or (647) 689-6573 internationally, using Conference ID: 7163128.

To access the live webcast and accompanying slide presentation, please visit the "Investors" section of the Arcus website at www.arcusbio.com. Following the live webcast, a replay will be available on the Company’s website for approximately 30 days.

Celsius Therapeutics Appoints Tariq Kassum, M.D., as Chief Executive Officer

On June 11, 2019 Celsius Therapeutics, a company translating single-cell genomic insights into precision therapeutics for patients with autoimmune diseases and cancer, reported the appointment of Tariq Kassum, M.D., as president and chief executive officer (Press release, Celsius Therapeutics, JUN 11, 2019, View Source [SID1234537002]). Dr. Kassum brings nearly 20 years of experience in the biopharmaceutical industry to Celsius. He succeeds interim CEO Alexis Borisy, who will remain chairman of the company’s board of directors.

"Since its launch just over a year ago, Celsius has been making tremendous progress, and we are very excited to welcome Tariq as CEO to lead the company through its next phase of development," said Alexis Borisy, chairman of Celsius. "Tariq brings a highly diverse skill set incorporating corporate development, strategy and business leadership. His extensive experience in multiple settings in the biotechnology industry will be instrumental in helping guide the company going forward."

Dr. Kassum joins the company from Obsidian Therapeutics, where he was a co-founder and served as chief operating officer and head of corporate development. During this time, Dr. Kassum helped build Obsidian into a leading platform technology company and played a central role in the company’s strategic partnership with Celgene. Prior to Obsidian, Dr. Kassum spent seven years with Millennium Pharmaceuticals and Takeda, most recently as vice president, business development and strategy for Takeda Oncology, responsible for transactions, collaborations, alliance management and strategic planning. He also led Takeda’s global corporate development efforts, where he managed multiple acquisitions and divestitures. Prior to Takeda, Dr. Kassum was an analyst covering healthcare equities for institutional investment firms, where he led diligence and investment decisions on numerous companies and pharmaceutical compounds. He began his career as an investment banker with CIBC World Markets serving clients in the biotechnology and specialty pharmaceuticals industries. He holds an M.D. from University of Toronto and an A.B. from Cornell University.

"Celsius has integrated a unique combination of technologies, including single-cell genomics, machine learning, deep biology and drug discovery, all in the service of patients with serious conditions including autoimmune diseases and cancer," said Dr. Kassum. "I am thrilled to be joining the company at this stage as we establish the power of this multifaceted approach to drive a portfolio of transformative therapies for patients."

Tarveda Therapeutics to Present at Raymond James Life Sciences and MedTech Conference

On June 11, 2019 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing a new class of potent and selective precision oncology medicines for the treatment of patients with a wide range of solid tumor malignancies, reported that Drew Fromkin, President and Chief Executive Officer, will present at the Raymond James Life Sciences and MedTech Conference occurring June 18-19, 2019 in New York City (Press release, Tarveda Therapeutics, JUN 11, 2019, View Source [SID1234537001]). Tarveda presentation details:

Date: Tuesday, June 18, 2019
Time: 8:00am Eastern Time
Location: Lotte New York Palace, New York, NY

Boehringer Ingelheim and University of Dundee Highlight Successful PROTAC Drug Discovery Program and Extend Their Ongoing Anti-Cancer Alliance

On June 11, 2019 Following the success of their ongoing alliance, Boehringer Ingelheim and the University of Dundee reported that they extend their collaboration to develop new medicines that target and destroy key cancer causing proteins (Press release, Boehringer Ingelheim, JUN 11, 2019, View Source [SID1234537000]). This brings together the expertise of Professor Alessio Ciulli, one of the pioneers in the field of Proteolysis targeting chimeras (PROTACs), based in the School of Life Sciences at Dundee, with Boehringer Ingelheim’s pharmaceutical expertise and commitment to bring innovative medicines to patients with cancer.

PROTACs represent a new class of drug candidates with the potential to tackle compelling cancer targets which have failed traditional medicinal chemistry approaches. They work by harnessing the cell’s natural disposal system (the ubiquitin-proteasome). Candidate disease-causing proteins are labelled as "expired" proteins which the proteasome then shreds.

"PROTACs are a disruptive therapeutic modality which are bringing previously deemed undruggable targets within reach. Our collaboration will continue to work to bring this new class of medicines to patients," said Darryl B. McConnell, Ph.D., Senior Vice President and Research Site Head, Boehringer Ingelheim, Vienna, Austria. "The joint team is making rapid progress and have successfully reached the first collaboration milestone setting a solid basis for achieving our goals."

Since the initiation of the collaboration in 2016 and a significant expansion in 2018, the application of PROTACs has grown dramatically. However, designing PROTACs remains challenging and largely empirical in nature, hindering faster progress in the field. The partners have thus developed a structure-based design approach as a solid basis to accelerate further development. In addition, to boost PROTAC research around the world, Boehringer Ingelheim has made the protein degrader compound MZ-1, developed at the University of Dundee, freely available through its opnMe portal in 2018. Further PROTAC molecules are considered for release on opnMe based on the success of this initiative.

The joint team has reported recent progress in a number of scientific publications, including most recently in the journal Nature Chemical Biology. This publication highlights their approach to use 3-dimensional pictures at atomic resolution to design highly potent and selective drug candidates. The new approach has yielded the first PROTAC which shreds SMARCA2, a protein that drives the tumors of more than 20,000 new patients with cancer each year and for which drug discovery approaches have otherwise been unsuccessful to date.

"Our joint publication is a leading example of translating the detailed understanding we are developing of how PROTACs work, to craft degrader molecules that effectively tackle previously ‘undruggable’ targets", said Alessio Ciulli, Ph.D., Chair of Chemical and Structural Biology at the University of Dundee, and winner of the 2016 RSC Capps Green Zomaya Award for medicinal chemistry. "The expansion marks an important milestone in the development of our alliance. It enables the joint team to drive the next phase of degrading highly-prized cancer targets previously intractable via other approaches"

Boehringer Ingelheim is focusing on developing innovative new treatment approaches providing outstanding value for patients. To achieve this, the company is increasing its commitment to external innovation, and is working with top partners from academia and industry worldwide. A growing network of academic collaborations reflects the company’s focus on emerging science that could open new avenues leading to the breakthrough medications of the future.