Oncoceutics and the National Cancer Institute Collaborate to Develop ONC206

On February 2019, Oncoceutics, Inc., reported the expansion of its diverse collaborations across the National Institutes of Health (NIH) involving its imipridone family of anti-cancer compounds (Press release, Oncoceutics, FEB 22, 2019, View Source [SID1234553818]).

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ONC206 has been studied extensively for several years in models of central nervous system cancers, including high grade gliomas as evaluated by the laboratory of Mark Gilbert, MD, Chief of the Neuro-Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI). These studies convincingly demonstrate that ONC206 exerts significant therapeutic effects on preclinical models of brain cancers that are commonly recognized as incurable. The properties of ONC206 that include penetrance of the blood brain barrier, feasibility of oral administration, demonstration of a benign safety profile in preclinical studies, and selective antagonization of dopamine receptor D2 (DRD2) further demonstrate the potential therapeutic value of the new class of imipridone compounds. While DRD2 is targeted by ONC206, as well as the first clinical-stage imipridone ONC201, the receptor pharmacology of ONC206 is unique, offering therapeutic options beyond ONC201.

Based upon NCI’s positive data from preclinical studies of ONC206, Dr. Mark Gilbert and his team in the Neuro-Oncology Branch, CCR, NCI in Bethesda, MD, are interested in conducting the first-in-human trial of ONC206 following Oncoceutics’ completion of IND-enabling studies and the execution of an appropriate agreement. This clinical trial will incorporate biomarker information derived from the molecular mechanism of ONC206 to select patients and to profile its activity in patients with central nervous system malignancies.

"I am excited to see ONC206, as the second imipridone, on the verge of entering the clinic," Minesh Mehta, MD, Deputy Director And Chief Of Radiation Oncology, Miami Cancer Institute and member of the board of directors of Oncoceutics. "This translational effort will introduce ONC206 as an impactful new therapy for patients with untreatable brain tumors and broadens the clinical utility of imipridones beyond its founding member, ONC201, which is already helping patients."

AcelRx to announce fourth quarter 2018 results and provide a corporate update on Thursday, March 7th, 2019

On February 22, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company, reported that it will release fourth quarter and annual financial results after market close on Thursday, March 7th, 2019 (Press release, AcelRx Pharmaceuticals, FEB 22, 2019, View Source [SID1234533592]). AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on March 7, 2019 to discuss the financial results and provide a corporate update.

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Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the company’s website at www.acelrx.com and clicking on the webcast link on the Investors home page.

A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company’s website at www.acelrx.com.

Elpiscience Announces Clinical Trial Approval of ES101 in China

On February 22, 2019 Elpiscience Biopharma, Ltd. reported that the bispecific antibody ES101 has been approved by the Center for Drug Evaluation (CDE) for clinical trials in China (Press release, Elpiscience, FEB 22, 2019, View Source;id=1311 [SID1234536920]). ES101 is a first-in-class, bispecific antibody targeting both PD-L1 and 4-1BB, where 4-1BB-induced T cell activation is dependent on the binding to PD-L1 in the tumor microenvironment. The combination of "de-brake" and "add-gas" ideas not only greatly improved the efficacy of the drug, but also avoided the toxicity that 4-1BB single agent may have. This would solve the problem that 4-1BB monoclonal antibodies have encountered in clinical development. In the mean time, on February 19th, Inhibrx, Elpiscience’s US partner of ES101, announced the dosing of first patient of ES101 in the US. With ES101 being tested in clinical trials both in China and the US, it is expected to benefit cancer patients worldwide.

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Dr. Darren Ji, CEO of Elpiscience, said: "ES101 represents the arrival of the next generation of cancer immunotherapy beyond PD-1/PD-L1. As a first-in-class bispecific antibody, ES101 is expected to bring a transformative treatment to cancer patients on top of the existing therapies. We are delighted to witness this historical moment, which would have marked a small step for Elpiscience and its partner, and a giant leap for patients."

About ES101

ES101 is a tetravalent bispecific antibody that contains four binding domains, two targeting PD-L1 and two targeting 4-1BB, with a molecular weight being only two-thirds of that of an conventional antibody. Based on the high expression of PD-L1 in the tumor microenvironment and an unique antibody engineering, ES101 can conditionally activate 4-1BB upon binding to PD-L1. This would allow for a more efficient tumor killing by immune cells.

First-in-Human Trial Using BXQ-350 for the Treatment of Cancer

On February 22, 2019 Bexion Pharmaceuticals, Inc. (Bexion) reported the opening of Part 3 of their Phase I First-In-Human Trial using BXQ-350 for the treatment of cancer (Press release, Bexion, FEB 22, 2019, View Source [SID1234533802]). This trial was designed to determine the maximum tolerated dose of BXQ-350 and to characterize its safety and pharmacokinetics.

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The Phase I Part 1 study showed that BXQ-350 was well tolerated at all five doses tested with no dose limiting toxicities observed and with no serious adverse events attributed to the therapy. Part 2 tested the highest dose in an additional 36 solid tumor patients. Preliminary data support a safe and tolerable drug profile. The purpose of Part 3 will be to explore safety, and additional indications in rare and gastrointestinal tumors.

"By enrolling patients in Part 3, we hope to gain a better understanding of the potential of BXQ-350 in treating cancer," stated Dr. Ray Takigiku, Founder and CEO of Bexion.

Iovance Biotherapeutics to Host Fourth Quarter and Year-End 2018 Financial Results Conference Call and Webcast on Wednesday, February 27, 2019

On February 22, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it will report its fourth quarter and year-end 2018 financial results on Wednesday, February 27, 2019 (Press release, Iovance Biotherapeutics, FEB 22, 2019, View Source;p=RssLanding&cat=news&id=2388560 [SID1234533577]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. EST.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7055329. The live webcast can be accessed under "News & Events" in the Investors section of the Company’s website at www.iovance.com or at the link: View Source

A replay of the call will be available from February 27, 2019 to March 7, 2019. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 7055329. The archived webcast will be available for thirty days in the Investors section at www.iovance.com.