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BioXcel Therapeutics Files Clinical Trial Application for the Development of BXCL701 and Pembrolizumab in Neuroendocrine Prostate Cancer (tNEPC)

On March 25, 2019 BioXcel Therapeutics, Inc. ("BTI") (BTAI) reported that it has filed a Clinical Trial Application (CTA) with the U.K. health authorities for its lead immuno-oncology asset, BXCL701, an orally-available small molecule immune-modulator with dual mechanisms of action, in combination with pembrolizumab (Keytruda), a checkpoint inhibitor, in tNEPC (Press release, BioXcel Therapeutics, MAR 25, 2019, View Source [SID1234534627]). BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology.

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Following approval of the CTA, BTI plans to expand the Phase 1b/2 US study of BXCL701 and pembrolizumab in tNEPC to the U.K. Professor Johann de Bono, M.D., Ph.D., of The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, will serve as Principal Investigator for the European study of BXCL701 in tNEPC. Data from the open-label trial will support the ongoing global clinical development of BXCL701.

Additionally, BioXcel Therapeutics is preparing to file an Investigational New Drug (IND) application with the FDA for a clinical trial evaluating the triple combination of BXCL701, NKTR-214 and avelumab in the treatment of advanced pancreatic cancer.

Dr. Chetan D. Lathia, SVP & Head of Translational Medicine, Clinical Pharmacology and Regulatory Affairs of BTI said, "The filing of the CTA in the U.K., for the BXCL701 combination trial is an important regulatory milestone for BTI. It marks the beginning of our plans for the global development of our lead programs."

Dr. Vimal Mehta, Chief Executive Officer of BTI added, "We remain committed to translating the potential of BXCL701’s novel mechanism of action into therapies that can fundamentally change the lives of cancer patients. The filing of this CTA is the first milestone in the expansion of our footprint into major markets outside the US. We believe that our pancreatic cancer clinical development partnership with Nektar, Pfizer and Merck KGaA, Darmstadt, Germany will also benefit the broader BXCL701 program."

The Company also announced that Professor de Bono has joined its Immuno-oncology Clinical Advisory Board. Professor De Bono is the Regius Professor of Cancer Research and a Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust. He is also the Director of the Drug Development Unit, overseeing the Phase I trials, with a particular interest in innovative trial designs, circulating biomarkers and prostate cancer. Additionally, he leads the Prostate Cancer Targeted Therapy Group and the Cancer Biomarkers laboratory team. He has served as chief investigator on trials for multiple approved drugs, including ZYTIGA, JEVTANA and XTANDI.

Professor de Bono is a clinical investigator in the KEYNOTE- 199 trial, a study evaluating Pembrolizumab in docetaxel pre-treated castrate-resistant metastatic prostate cancer patients. He graduated with a medical degree and a postdoctoral degree from University of Glasgow. He also trained in medical oncology and was awarded a master’s degree in cancer sciences from the University of Glasgow. Professor de Bono has received multiple awards including one of the "World’s Most Influential Scientific Minds," the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) award and the Royal Society of Chemistry award.

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.

NeuroVive Pharmaceutical AB Publishes 2018 Annual Report

On March 25, 2019 NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF) reported that the English version of the Annual report for 2018 is now available on the company’s website www.neurovive.com (Press release, NeuroVive Pharmaceutical, MAR 25, 2019, View Source [SID1234534616]).

This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, at 10:00 a.m. CET on 25 March 2019.

Aprea Therapeutics Appoints Dr. Eyal C. Attar as Chief Medical Officer

On March 25, 2019 Aprea Therapeutics, a clinical-stage biotechnology company developing novel anticancer therapies targeting the p53 tumor suppressor protein, reported the appointment of Dr. Eyal C. Attar as Senior Vice President and Chief Medical Officer (Press release, Aprea, MAR 25, 2019, View Source [SID1234534615]). A trained physician in medical hematology and oncology, Dr. Attar brings nearly 20 years of medical research and clinical development experience to Aprea.

"Dr. Attar’s deep medical and biotech industry experiences will strengthen our clinical development efforts as we continue to advance our first-in-class p53 reactivating agents in late-stage clinical studies," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "His proven leadership and focus on improving outcomes for patients with limited therapeutic alternatives is an excellent fit with Aprea’s determined strategy to advance novel oncology therapies."

"I am thrilled to join the Aprea team at this exciting time in the company’s evolution," said Dr. Attar. "I believe Aprea’s leading scientific approach in reactivating the mutated tumor suppression gene, p53, represents a new paradigm in anti-cancer treatment and a promising novel therapeutic approach for patients for whom there is tremendous need."

Dr. Attar joins Aprea from Agios Pharmaceuticals, where he was Senior Medical Director and IDH Hematology Medical Lead. Having served at Agios since 2014, Dr. Attar played a leadership role in the clinical development and approval of IDHIFA and TIBSOVO for patients with relapsed/refractory AML. Prior to Agios, he served on the clinical staff at the Massachusetts General Hospital Cancer Center, where Dr. Attar was a member of the Center for Leukemia and Assistant Professor of Medicine at Harvard Medical School. He completed his residency in Internal Medicine at Brigham and Women’s Hospital and held fellowships in hematology and oncology in the Dana-Farber Partners Cancer Care Hematology/Oncology Fellowship Program. Dr. Attar received his medical degree from the University of North Carolina School of Medicine.

Epic Sciences Appoints Lloyd Sanders as Chief Executive Officer

On March 25, 2019 Epic Sciences, Inc. (Epic) reported that Lloyd Sanders has joined the company as president and chief executive officer (Press release, Epic Sciences, MAR 25, 2019, View Source [SID1234534614]). After serving nearly six years in the role, Murali Prahalad, Ph.D., has stepped down to pursue new opportunities and has been appointed to Epic’s board of directors.

"Under Murali’s leadership, the Epic team has made substantial progress in advancing our proprietary Functional Cell Profiling platform and successfully launching and obtaining Medicare coverage for the world’s first predictive test for metastatic prostate cancer," said Gregory T. Lucier, chairman of Epic Sciences. "As Murali continues to advise the company in his role as a director, we welcome Lloyd to the team to capitalize on our solid foundation. The trajectory has been set for significant commercial growth through Epic’s portfolio of high-value liquid biopsy tests and expansion into breast cancer, immuno-oncology and global markets. Lloyd and the leadership team, board, investors and Epic employees are highly motivated to take Epic to the next level."

Mr. Sanders joins Epic with 20 years of diagnostics and pharmaceutical industry experience, much of it focused on oncology. Prior to Epic, he served as president of the oncology segment of the molecular diagnostics company Myriad Genetics, overseeing the oncology, urology and dermatology commercial organizations. While at Myriad, he was responsible for the sales, marketing and laboratory operations of numerous commercial products. Previously, Mr. Sanders served as chief operating officer at Dey Pharma, a division of Mylan, overseeing sales, marketing and medical affairs, including the EpiPen flagship brand. Prior to Dey Pharma, he ascended from vice president of marketing to chief operating officer of oncology biotech Genta. He also held several leadership positions and was responsible for the commercial success of several oncology products at Sanofi-Synthelabo, subsequently Sanofi-Aventis, and Pharmacia (now Pfizer).

"Epic has established an impressive position in the prostate cancer liquid biopsy market and I am eager to work with the team to advance the mission of providing very powerful predictive, actionable information to physicians and patients that can extend lives," said Mr. Sanders. "By expanding the breadth and depth of Epic’s portfolio of reimbursed products, and building our thriving biopharma solutions business that supports our pharmaceutical partners’ development of next-generation immunotherapies and targeted cancer agents, we can play an important role in changing cancer from a lethal to a chronic, manageable disease."

EpiVax Oncology To Present Latest Research On The Importance Of Identifying And Removing, Using Machine-Learning Based Advanced Computational Tools, Inhibitory Neoantigens From Therapeutic Cancer Vaccines, At AACR Annual Meeting 2019

On March 25, 2019 EpiVax Oncology, Inc., a precision cancer immunotherapy company, reported that its abstract has been selected for an oral presentation, at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, taking place on March 29th – April 3rd in Atlanta, Georgia (Press release, EpiVax, MAR 25, 2019, View Source [SID1234534613]). It will present data highlighting how inhibitory neoepitopes uncovered using advanced computational tools affect immune responses to therapeutic cancer vaccines.

Ancer is a Superior Neoantigen Prediction Platform, Powered by Machine Learning Based Algorithms.

Self-like Treg Cancer Neoepitopes Uncovered Using Ancer.

"While it is extremely important to select both Class I and Class II neoantigens in order to induce an effective anti-tumor response, we have shown that including computationally predicted inhibitory Class II T cell neoepitopes in neoantigen-based vaccines, can significantly suppress the immune response," said EpiVax Oncology CEO, Gad Berdugo, MSc Eng., MBA. "Current neoantigen selection methods are non-validated and may select neoantigens that are non-immunogenic, that potentially trigger immune-related adverse events, or that lead to immunosuppression via the induction of regulatory T cells. Our neoantigen discovery platform, Ancer, is powered by machine-learning based algorithms that have been used commercially for 20 years and have shown superior accuracy at predicting not only CD8 T cell neoepitopes, but also the much more challenging CD4 T cell neoepitopes. Furthermore, we are thrilled to bring to the immuno-oncology field advanced algorithms that have been able to predict inhibitory T cell epitopes since 2013. We will show at AACR (Free AACR Whitepaper) that it is critical to identify and filter out these inhibitory Class II neoepitopes in order to improve the immune response generated by cancer vaccines."

ORAL PRESENTATION:
Abstract: 943
Presenter: Guilhem Richard, PhD, Lead Computational Immunologist, EpiVax Oncology Inc.
Title: "Filtering out self-like neoantigens improves immune response to cancer vaccines"
Date: Sunday, March 31, 2019
Session: MS.IM02.03 – Cancer Vaccines and Intratumoral Immunomodulation
Time: 3:00 PM – 5:00 PM Eastern Time
Location: Georgia Ballroom 3 – Building C – GWCC
Session Link: View Source!/6812/session/830