Forbius Nominated for “Best New Drug Developer” Award at the 2018 World ADC Awards

On October 11, 2018 Forbius (Formation Biologics) reported that it was nominated in the "Best New Drug Developer" category at the 5thAnnual World ADC Awards (Press release, Forbius, OCT 11, 2018, View Source [SID1234531671]). This competitive nomination process involved over 2,545 casted votes to recognize leaders and innovators in the antibody-drug conjugate (ADC) research field.

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Forbius’ lead program, AVID100, is an ADC targeting EGFR. AVID100 is undergoing Phase 2 clinical trials in patients with confirmed EGFR overexpression in squamous cell carcinoma of the head and neck, squamous non-small cell lung cancer, and triple negative breast cancer. Phase 2a development of AVID100 is supported by the recently announced $18.75M peer-reviewed grant from the Cancer Prevention Research Institute of Texas (CPRIT).

Oncolytics Biotech® Announces Publication of Positive Clinical Results for
Pelareorep in Abstract for ESMO 2018 Congress

On October 11, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported publication of an abstract on pelareorep (formerly known as REOLYSIN) for the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place October 19-23 in Munich (Press release, Oncolytics Biotech, OCT 11, 2018, View Source [SID1234530639]).

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The abstract, authored by Sanjay Goel, Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, et al., "Dose finding and safety study of Reovirus (Reo) with irinotecan/ fluorouracil/ leucovorin/ bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC): Final results", outlines positive clinical trial results for pelareorep in the treatment of patients with KRAS mutant metastatic colorectal cancer. Thirty-six patients received treatment with FOLFIRI/B and pelareorep, and the results demonstrated that the combination is not only safe and well tolerated, but that progression free survival (PFS) and overall survival (OS) are significantly superior to historical data.

The patients receiving the recommended phase 2 dose had a 50 percent response rate (3 of 6 patients) and the median PFS and OS were 65.6 weeks and greater than 98.3 weeks (as of May 9, 2018), respectively.

"The noted improvement in both PFS and OS compared to historical results are meaningful for Oncolytics and for the patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "The favorable results reported from this clinical trial demonstrate the potential of pelareorep to be a compelling treatment choice for a patient population that otherwise has limited therapeutic options after they have progressed on current standard-of-care chemotherapy."

The complete Abstract can be found online at View Source Full details from the poster presentation will be announced after it is presented.

Presentation Number:
565P
Date:
October 21, 2018
Lecture Time:
1:05 pm CEST
Location:
Hall A3 – Poster Area Networking Hub, ICM München, Munich, Germany
Speakers:
Sanjay Goel
Session Name:
Basic science, Endocrine tumours, Gastrointestinal tumours – colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The

compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

MEI Pharma and BeiGene Announce Clinical Collaboration to Evaluate ME-401 in Combination with Zanubrutinib in Patients with B-Cell Malignancies

On October 11, 2018 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational BTK inhibitor, for the treatment of patients with B-cell malignancies (Press release, MEI Pharma, OCT 11, 2018, View Source;p=irol-newsArticle&ID=2371323 [SID1234529862]).

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"We are excited to be working with BeiGene to explore the potential of ME-401 in combination with zanubrutinib," said Robert Mass, M.D., chief medical officer of MEI Pharma. "Combinatorial approaches to fighting difficult to treat cancers historically have proven to be important in the delivery of better treatments to patients, and we believe that the data observed to date for ME-401, with its unique pharmaceutical properties, and for zanubrutinib support the evaluation of the combination for the treatment of patients with various B-cell malignancies."

"Zanubrutinib is a potentially differentiated BTK inhibitor that is being globally developed in a number of B-cell malignancies both as a monotherapy and in combination. We look forward to exploring this interesting combination in patients with B-cell malignancies," commented Jane Huang, M.D., chief medical officer, hematology, at BeiGene.

Under the terms of the clinical collaboration agreement, MEI will amend its ongoing Phase 1b trial to include evaluation of ME-401 in combination with zanubrutinib in patients with B-cell malignancies.

Study costs will be shared equally by the parties, and MEI will supply ME-401 and BeiGene will supply zanubrutinib. MEI will retain full commercial rights for ME-401 and BeiGene will retain full commercial rights for zanubrutinib.

About ME-401
ME-401 is an investigational oral phosphatidylinositol 3-kinase ("PI3K") delta inhibitor; PI3K delta is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancer cells. ME-401 displays high selectivity for the PI3K delta isoform and has distinct pharmaceutical properties from other PI3K delta inhibitors. It is being clinically evaluated in patients with various B-cell malignancies. MEI is initiating a Phase 2 study to evaluate the efficacy, safety, and tolerability of ME-401as a single agent in patients with follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. The Phase 2 study is intended to support an accelerated approval marketing application with the U.S Food and Drug Administration.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B cell malignancies.

Incyte to Report Third Quarter Financial Results

On October 11, 2018 Incyte Corporation (Nasdaq:INCY) reported that it has scheduled its third quarter 2018 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, October 30, 2018 (Press release, Incyte, OCT 11, 2018, View Source [SID1234529863]).

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The schedule for the press release and conference call/webcast is as follows:

Q3 2018 Press Release: October 30, 2018 at 7:00 a.m. ET

Q3 2018 Conference Call: October 30, 2018 at 8:00 a.m. ET

Domestic Dial-In Number: 877-407-3042

International Dial-In Number: 201-389-0864

Conference ID Number: 13683637

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13683637.

The live webcast with slides can be accessed at www.incyte.com under For Investors, Events and Presentations and will be available for replay for 30 days.

Spherix to Merge with CBM BioPharma Pharmaceutical Company

On October 11, 2018 Spherix Incorporated (Nasdaq: SPEX) reported that it has entered into a merger agreement with CBM BioPharma, Inc. ("CBM") that will transform Spherix into an innovative pharmaceutical company with pioneering drugs and treatments focused on the multibillion dollar oncology therapeutics market.

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CBM is a privately held pharmaceutical company with exclusive drug development rights from world-renowned partners including Wake Forest Innovations and the University of Texas at Austin. CBM has a team of leading drug development scientists who will be joining Spherix as advisors to advance the technology. The CBM platform focuses on the treatment of numerous cancers, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and pancreatic cancer.

Two specific proprietary drugs that are currently being researched are:

KPC34 (Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia)

Developed at Wake Forest School of Medicine, AML and ALL drug, KPC34, is a next generation treatment designed to overcome multiple resistance challenges observed with the current standard of care. KPC34 has also been shown to be more effective in AML relapse cases, notably increasing the lifespan of mice treated with the drug.

One competitive benefit of KPC34 includes its ability to be orally administered. This is critical for patients that are unable to tolerate repeated cycles of chemotherapy. In addition, it has served to double the mean survival time versus the current standard of care treatments in a mouse model of leukemia.
DHA-dFdC (Pancreatic Cancer Drug)

Developed at the University of Texas at Austin, DHA-dFdC has shown positive results in preclinical studies, inhibiting pancreatic tumor growth in clinically relevant transgenic mouse models. DHA-dFdC also overcomes tumor cell resistance to current chemotherapeutic drugs. Pancreatic cancer is a deadly disease that affects millions of people around the world.

The following doctors will be supporting the efforts of Spherix, after the completion of the merger:

Dr. Timothy S. Pardee, MD, PhD, an Associate Professor of Internal Medicine, Section on Hematology and Oncology and Cancer Biology and Director of Leukemia Translational Research at Wake Forest School of Medicine. Dr. Pardee stated, "I am very excited at the possibility of bringing KPC34 to the clinic in early phase clinical trials. As a physician scientist who treats acute leukemia patients, I know firsthand the clear unmet medical need for relapsed patients."

Dr. Gregory Kucera, a Professor of Internal Medicine at the Wake Forest University School of Medicine with over 28 years of research experience on novel therapeutics for cancer treatment. His laboratory has expertise in synthesizing therapeutics, lipid biochemistry, and in vitro drug testing. Dr. Kucera stated, "As a research scientist, the satisfaction of seeing a compound like KPC34 go from the laboratory to an early stage clinical trial is immense. I have a great sense of pride in knowing that the work done by our research team has produced a drug that may benefit cancer patients in the very near future."

Joining Spherix as Chief Science Officer to oversee clinical advancement of these drugs is Dr. Tom Wilkie who is an Associate Professor of Pharmacology at the University of Texas Southwestern Medical Center in Dallas. He earned both his BA at the University of California Berkeley and his PhD with Richard Palmiter at UW Seattle, in biochemistry. Wilkie has published 74 primary research papers and reviews, serves on NIH, CIRM, and AACR (Free AACR Whitepaper) grant review study sections. He reviews manuscripts for multiple journals, and is Director of the first-year graduate student core course at UT Southwestern.

Dr. Wilkie stated, "I’m delighted to join Spherix as Chief Science Officer. The agreement between Spherix Incorporated and CBM BioPharma will advance the exciting potential for improving the lives of patients, family, friends, and ultimately, all of us. Proposals for the next phase of testing are underway."

Dr. Robert J. Vander Zanden, Spherix’s Chairman of the Board, stated, "Spherix is extremely pleased to announce this merger with CBM, as we believe it serves as a necessary step in our transition to a diversified biopharmaceutical company. This deal builds upon our investment in Hoth Therapeutics, which owns several exciting assets in various stages of development."

Anthony Hayes, CEO of Spherix stated, "We are very excited to welcome CBM BioPharma and its team to Spherix. It is an exciting and transformational time for the Company. Spherix will pay $16.5 million in stock for 100% of CBM by issuing 15 million Spherix shares to CBM at a fixed price of $1.10 per share. I look forward to sharing more information with our shareholders about the merger in the upcoming weeks, via investor outreach and our upcoming SEC filings."