1stOncology™: Cancer Intelligence Service – Page 14595 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BioTime Announces Closing of Acquisition of Asterias Biotherapeutics Creating Leading Cell Therapy Company

On March 11, 2019 BioTime, Inc. (NYSE American and TASE: BTX), reported the closing of its previously reported acquisition of Asterias Biotherapeutics, Inc. (Asterias), whereby BioTime has acquired through a merger, all of the remaining outstanding common stock of Asterias which was not previously owned by BioTime (Press release, BioTime, MAR 11, 2019, View Source;p=RssLanding&cat=news&id=2390816 [SID1234534224]). As a result of the acquisition, Asterias became a wholly-owned subsidiary of BioTime and the operations of BioTime and Asterias have combined. Notably, 98% of BioTime votes cast and 96% of Asterias votes cast were in favor of the merger. BioTime is now advancing three clinical stage product candidates for degenerative retinal diseases, neurological conditions associated with demyelination, and aiding the body in detecting and combating cancer. In connection with the closing, two members of the Asterias Board of Directors, Don Bailey, the former Chairman of Asterias’ Board and Michael Mulroy, the former Chief Executive Officer of Asterias will be serving on the BioTime Board of Directors. BioTime will continue to be led by the Company’s current management team.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"This acquisition is a key step in our plan to turn BioTime into a pioneering and leading cell therapy company, with an innovative and diversified pipeline which we believe can significantly impact disease areas with groundbreaking therapeutic approaches," stated Brian M. Culley, Chief Executive Officer of BioTime. "Importantly, we expect to enjoy significant financial synergies from this merger as we already have a cGMP manufacturing facility in Jerusalem, Israel, which has successfully produced our projected needs for the next clinical trial of OpRegen and which now can turn to process development and scale-up activities for the former Asterias assets. We also look forward to continuing our partnerships with notable institutions such as CIRM, the California Institute for Regenerative Medicine, and Cancer Research UK, to support the clinical development of the OPC1 and VAC2 programs we added to our pipeline. We further believe that greater involvement with patient and advocacy groups will be helpful toward increasing our value and visibility in the disease communities we aim to serve."

BioTime’s Pipeline

OpRegen – a retinal pigment epithelium cell replacement therapy currently being tested in a Phase I/IIa multicenter clinical trial for the treatment of advanced dry-age-related macular degeneration (dry-AMD) with geographic atrophy. OpRegen has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA).
OPC1 – an oligodendrocyte progenitor cell therapy currently being tested in a Phase I/IIa multicenter clinical trial (the "SciStar Study") for the treatment of acute spinal cord injuries (SCI). The clinical development of OPC1 has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of acute SCI and has been granted Orphan Drug Designation by the FDA.
VAC2 – an allogeneic (non-patient-specific or "off-the-shelf") cancer immunotherapy of antigen-presenting dendritic cells currently being tested in a Phase I clinical trial in non-small cell lung cancer (NSCLC) fully funded and conducted by Cancer Research UK, the world’s largest independent cancer research charity.
Following the closing of the merger, BioTime has 151,579,482 million shares of common stock issued and outstanding with prior BioTime stockholders collectively owning approximately 84% of the combined company, and prior Asterias stockholders collectively owning approximately 16% of the combined company.

BioTime’s financial advisor in the transaction was Maxim Group LLC. Raymond James acted as financial advisor to Asterias. Cooley LLP served as legal counsel to BioTime and Dentons LLP served as legal counsel to Asterias.

Advaxis Announces Presentations of ADXS-NEO and ADXS-PSA Data at Upcoming American Association for Cancer Research Annual Meeting

On March 11, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported two poster presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held March 29 – April 3, 2019 in Atlanta, Georgia (Press release, Advaxis, MAR 11, 2019, View Source [SID1234534226]).

Poster Presentation 1
Title: Safety and immunogenicity of a personalized neoantigen-Listeria vaccine in cancer patients
Presenter: J. Randolph Hecht M.D., UCLA
Session: Phase I Clinical Trials: Part 1
Abstract Number: CT007
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16
Date and Time: Sunday, March 31, 2019 1:00 p.m. – 5:00 p.m. ET

Poster Presentation 2
Title: KEYNOTE-046: Effects of ADXS-PSA with or without pembrolizumab on survival and antigen spreading in metastatic, castration-resistant prostate cancer patients
Presenter: Mark N. Stein M.D., FACS, Columbia University, NYC
Session: Phase I Clinical Trials: Part 3
Abstract Number: CT098
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16
Date and Time: Monday, April 1, 2019 1:00 p.m. – 5:00 p.m. ET

All accepted abstracts will be published in the 2019 Proceedings of the AACR (Free AACR Whitepaper). Session information is available online via the Annual Meeting Itinerary Planner through the AACR (Free AACR Whitepaper) website at www.aacr.org.

Stemline In-Licenses Worldwide Rights to Novel Selective RET Inhibitor (SL-1001); Expands Oncology Pipeline

On March 11, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that it has exclusively licensed worldwide rights to develop and commercialize a novel, oral, selective small molecule RET (rearranged during transfection) kinase inhibitor from the CRT Pioneer Fund LP, a £70 million specialist oncology investment fund managed by Sixth Element Capital, a UK based fund manager (Press release, Stemline Therapeutics, MAR 11, 2019, View Source [SID1234534227]). The RET inhibitor was rationally designed by scientists at Cancer Research UK Manchester Institute at the University of Manchester (United Kingdom). The preclinical compound has been designated SL-1001 and is expected to enter the clinic in 2020.

RET kinase genetic alterations have been found in a diverse range of cancers and, we believe, is a clinically validated target in multiple indications. SL-1001 is an oral RET kinase inhibitor that has demonstrated potent, selective, preclinical anti-cancer activity, both in vitro and in vivo, in RET-driven tumor models.

"SL-1001 is an ideal strategic fit for us, given its targeted mechanism of action and potential for streamlined development," commented Stemline’s CEO, Ivan Bergstein. He continued, "Building upon our team’s proven track record of success, culminating with the recent ELZONRIS approval, we intend to advance SL-1001 swiftly through the clinical and regulatory process with an eye towards achieving our goal of helping more patients succeed in their fight against cancer."

Robert James, Managing Partner at Sixth Element Capital said, "We are delighted to have partnered SL-1001 with Stemline. We are confident that Stemline’s skills and resources will take the project forward rapidly and offer an alternative treatment option to patients with cancer driven by RET kinase".

ArQule to Participate in the 31st Annual ROTH Conference on March 17-19, 2019

On March 11, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, Chief Executive Officer, and Marc Schegerin, Senior Vice President and Head of Strategy, Finance and Communication, will participate in the 31st Annual ROTH Conference on March 17-19, 2019 in Dana Point, California (Press release, ArQule, MAR 11, 2019, View Source [SID1234534212]).

BioXcel Therapeutics Announces Late Breaking Data Presentation at AACR 2019 Annual Meeting

On March 11, 2019 BioXcel Therapeutics, Inc. ("BTI") (BTAI) reported that it will present a late breaking poster featuring data from a preclinical study of the Company’s BXCL701 and an OX40-agonist antibody as a potential combination therapy for treatment of certain solid tumors at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 being held from March 29 to April 3, 2019 in Atlanta, Georgia (Press release, BioXcel Therapeutics, MAR 11, 2019, View Source [SID1234534213]).

Details of the accepted poster are below:

Abstract #077 / Poster #22: Dipeptidyl Peptidase Inhibitor BXCL701 synergizes with an OX40-agonist antibody resulting in synergistic anti-tumor response and survival in an animal model of colorectal cancer by bridging the innate and adaptive arms of the immune system

Date:

Monday, April 01, 2019

Time:

8:00 AM-12:00 PM ET

Session:

Late Breaking Research – Immunotherapy 1

Location:

Georgia World Congress Center, Exhibit Hall B, Section 41

Dr. Vince O’Neill, Chief Medical Officer of BTI commented, "The encouraging results from this preclinical study of BXCL701 and an OX40 agonist, an investigational monoclonal antibody immunotherapy, represent a potentially valuable therapeutic option for cancer patients. We believe that this immunotherapy combination can effectively activate both the innate and adaptive immune system to fight cancer. We are excited to showcase this compelling data set and its potential at the AACR (Free AACR Whitepaper) annual meeting."

About BXCL701

BXCL701 is an orally-available systemic innate-immune activator with dual mechanisms of action. It has demonstrated single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients. Designed to stimulate both the innate and acquired immune systems, BXCL701 works by inhibiting dipeptidyl peptidase (DPP) 8/9 and blocking immune evasion by targeting Fibroblast Activation Protein (FAP). Preclinical combination data evaluating BXCL701, a checkpoint inhibitor and other immuno-oncology agents has demonstrated encouraging anti-tumor activity in multiple tumor types and formation of functional immunological memory. BXCL701’s primary mechanism of action has recently been highlighted in multiple peer reviewed journals, providing an important validation of the scientific rationale behind BXCL701.