On September 16, 2019 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that Robert Wasserman, MD, has joined the Rgenix management team as its new Chief Medical Officer (Press release, Rgenix, SEP 16, 2019, View Source [SID1234539567]). Dr. Wasserman takes on his new role after a 20-year career that includes senior positions at large pharma companies including Roche, Novartis and Merck.

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In his new role, Dr. Wasserman will have oversight of clinical development for Rgenix’s two lead clinical programs, RGX-104 and RGX-202. In particular, he will oversee the imminent launch of a Phase 1b/2 trial of Rgenix’s lead therapy, RGX-104, a first-in-class oral LXR agonist that has demonstrated anti-tumor activity as a single agent and in combination with other therapies – including chemotherapy and checkpoint blockade – in patients with refractory cancers.

For the Phase 1b/2 trial, RGX-104 will be tested in combination with the standard-of-care regimen consisting of chemotherapy (carboplatin/pemetrexed) plus the checkpoint inhibitor immunotherapy pembrolizumab as a first-line treatment in non-small cell lung cancer (NSCLC) patients whose tumors lack expression of the PD-L1 protein (<1% expression). NSCLC patients whose tumors lack PD-L1 expression have significantly lower response rates to standard-of-care in the first line setting, and thus represent a patient population of high unmet need. Resistance to standard-of-care immunotherapy has been associated with the presence of high levels of immunosuppressive myeloid cells known as MDSCs. RGX-104 has demonstrated broad-spectrum depletion of MDSCs in refractory cancer patients – including NSCLC patients – and therefore represents a novel approach to overcome drug resistance. As part of the Phase 1b/2 trial, RGX-104 will also be tested in patients with small cell lung cancer (SCLC/HG-NET) in combination with docetaxel chemotherapy as a second line treatment.

"Bob’s vast experience in oncology and clinical research is a perfect fit for Rgenix given our expanding clinical programs and pending milestones," said Masoud Tavazoie, MD, PhD, Chief Executive Officer and co-founder of Rgenix. "As we prepare to launch Phase 1b/2 studies for our first-in-class compounds RGX-104 and RGX-202, we are eager to leverage his knowledge and expertise to help expand our efforts for patients with cancers considered to have high unmet need."

"I look forward to working with the team at Rgenix to develop novel treatments for these patients by applying the company’s unique platform technology and methodology to discover drivers of cancer growth. With its roots in strong science and its dedication to a novel approach, Rgenix’s reputation as a premier innovator in the oncology space is growing and I’m excited to be a part of such a dynamic effort at this key stage for the company," said Dr. Wasserman.

Dr. Wasserman started his career in the industry working with major pharmaceutical companies. His last large pharma appointment was at Roche, where he ended a six-year period at the company as the Chairman of the Clinical Biomarker Leadership Team and where he also served for a time as the Global Head of Oncology Translational Medicine (Early Clinical Development) for Roche Pharma Research/Early Development. Prior to Roche, he was the Deputy Global Head of Oncology Biomarkers at Novartis and, before that at Merck.

His most recent biotech role was as the Chief Medical Officer at Northern Biologics, a Canadian company developing first-in-class immuno-oncology products. He currently maintains a position as an Advisory Board Member of Sectoral Asset Management out of Montreal.

Dr. Wasserman earned his B.A. from the University of Pennsylvania and his MD from the Johns Hopkins University School of Medicine. He completed his pediatric residency and pediatric hematology-oncology fellowship training at The Children’s Hospital of Philadelphia, at the University of Pennsylvania and then was on faculty as an Assistant Professor

On September 16, 2019 PPF reported the acquisition of a 19.2% stake in Autolus Therapeutics plc, a leader in next-generation T cell programming technologies (Press release, PPF , SEP 16, 2019, View Source [SID1234539566]). The shares were acquired in the market through NASDAQ.

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Autolus Therapeutics plc ("Autolus") is a leader in T cell programming technologies and is developing a pipeline of next generation T cell therapies targeting both hematological cancers and solid tumors. Focused on the development of precisely targeted, controlled and highly active CAR-T cell products, Autolus aims to provide T cell therapies with very favorable safety profile and enhanced clinical efficacy to better recognize cancer cells, break down their defense mechanisms, and attack and kill these cells. The lead program AUTO1 is expected to enter a pivotal phase II study in patients with adult relapsed or refractory acute B lymphocytic leukemia ("adult ALL") later this year with an anticipated filing for marketing authorization in 2021.

With the investment into Autolus, PPF Group N.V. ("PPF") significantly increased its commitment to the healthcare sector. Next to Autolus, PPF’s majority-owned biotechnology company SOTIO a.s. ("SOTIO") is aiming to become a fully-integrated oncology specialty pharma company. Together with SOTIO, PPF have built a biotechnology portfolio through in-house research and development, investments, acquisitions and in licensing of products with companies like NBE-Therapeutics, Cellestia Biotech, Cytune Pharma or Lead Discovery Center. SOTIO is developing its proprietary dendritic cell-based cell therapy platform DCVAC and has a significant manufacturing and regulatory expertise in the domain of cellular therapies. SOTIO also recently initiated a Phase I/Ib clinical trial with its interleukin-15 superagonist SO-C101.

"We are very excited by our investment into Autolus. The data published by Autolus on their CAR-T programs is very promising and their long-term ambitions are a perfect match with PPF’s strategy in healthcare," said Ladislav Bartonicek, shareholder of PPF responsible for the biotechnology sector. "Our investment in Autolus confirms the long term commitment of PPF and SOTIO to build a strong biotechnology portfolio developing a broad range of its own oncology products and investing in various biotech companies with promising new therapies."

On September 16, 2019 EdiGene, Inc., which develops genome editing technologies into novel therapeutics for a broad range of diseases and into creative solutions to advance drug discovery, reported the successful completion of raising approximately $11 Million in a Series pre-B2 financing (Press release, EdiGene, SEP 16, 2019, View Source [SID1234539565]). EdiGene’s Series A lead investor IDG Capital and Series pre-B lead investor Lilly Asia Ventures (LAV) invested in this round.

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Separately, EdiGene has formed research collaboration with a clinical stage biopharmaceutical company developing novel T-cell therapies to explore new allogeneic T-cell therapeutic approaches for cancer. Company name and deal terms are not disclosed.

"Allogeneic T-cell therapeutics has tremendous potential in China and beyond, by offering innovative T-cell therapies "off the shelf" with more effective quality control and lower cost. We have been building the Allogeneic CAR-T Platform and this new research collaboration further demonstrates our commitment to develop such therapeutics to help the cancer patients in need," said Dong Wei, Ph.D., MBA, CEO of EdiGene. "We are pleased to complete the new round of financing by our lead investors IDG and LAV. We look forward to working with them and other current investors to advance our exciting portfolio into the next stage."

On September 16, 2019 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, reported it has received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with two Phase 1 clinical trials of its lead myvac candidate TG4050 (Press release, Transgene, SEP 16, 2019, View Source [SID1234539553]). TG4050 is a novel individualized immunotherapeutic designed to elicit an immune response directed specifically against the patient’s own tumor.

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Two international clinical studies due to start in 2019

One trial is evaluating TG4050 as a potential treatment for patients with newly diagnosed, locoregionally advanced, HPV negative, squamous cell carcinoma of the head and neck (SCCHN), that have received an adjuvant (first line) therapy. This multicenter, two-arm trial will include patients in the UK and in France. In France, it will be conducted at Institut Curie (Paris – Pr. Le Tourneau) and Toulouse-Oncopole (Pr. Delord); its principal investigator is Pr. Ottensmeier from Southampton University (United Kingdom). In July 2019, Transgene received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with this Phase 1 clinical trial.

In the second trial, TG4050 will be assessed in patients with ovarian cancer after first-line surgery and chemotherapy. This multicenter, one-arm trial will recruit patients in the United States and in France. In France, the trial will be conducted at Institut Curie (Pr. Le Tourneau). Transgene was granted an Investigational New Drug (IND) clearance from the US FDA for this trial in May 2019.

Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene commented, "This clearance from the ANSM, following the approval from the UK MHRA and the US FDA, will allow us to start both our Phase 1 studies with TG4050 later this year. These studies, which are co-funded by NEC and benefit from their artificial intelligence (AI) capabilities, will provide us with data that will be key to further develop novel individualized immunotherapeutics."

myvac, an individualized immunotherapy that integrates leading AI capabilities

TG4050 is an individualized MVA-based immunotherapy derived from the myvac platform. It has been designed to stimulate and educate the patient’s immune system to recognize and destroy tumor cells. Tumor cells accumulate mutations and each patient has a set of mutations that are unique to their tumor. TG4050 has been designed to target a panel of these patient specific mutations, which have been selected using NEC’s Neoantigen Prediction System.

Transgene’s partner NEC will apply its advanced AI technology and capabilities, "NEC the WISE", in the frame of these studies. The AI engine will be used to analyze patient specific mutational patterns and to select relevant target mutation for the design of the vaccine. NEC and Transgene are co-funding these studies.

The NEOVIVA collaborative project will also support the industrial development of the myvac platform which combines bioengineering, bioIT and a recognized know-how in viral vectorization. Transgene in conjunction with NEOVIVA will use these Phase 1 studies to progress the development and validation of a manufacturing approach that would provide the solutions needed for the future development of TG4050 (see press release dated March 13, 2019).

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About TG4050

TG4050 is an immunotherapy designed to stimulate the immune system of patients in order to induce a response that is able to recognize and destroy tumor cells in a specific manner.

This personalized immunotherapy is developed for each patient, on the basis of mutations identified through sequencing of tumor tissue, prioritized using NEC’s Neoantigen Prediction System and delivered using the myvac technological platform which allows development and manufacture of a product that is specific to each patient and that is within time frames compatible with clinical management.

About myvac

myvac is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded an "Investments for the Future" funding from Bpifrance for the development of its platform myvac.

About NEC’s Neoantigen Prediction System

NEC’s neoantigen prediction utilizes its proprietary artificial intelligence (AI), such as graph-based relational learning, which is combined with other sources of data to discover candidate neoantigen targets. NEC comprehensively evaluates the candidate neoantigens with a primary focus placed on its in-house MHC-binding affinity prediction trained on public and proprietary datasets. These allow NEC to effectively prioritize the numerous candidate neoantigens identified in a single patient.

On September 16, 2019 Varian (NYSE: VAR) has named Francis R. Facchini, M.D., FSIR, as the new chief medical officer, Interventional Oncology, reporting to Dee Khuntia, Varian chief medical officer (Press release, Varian Medical Systems, SEP 16, 2019, View Source [SID1234539552]). Effective September 3, 2019, Dr. Facchini has global responsibility for overseeing all aspects of this area including ongoing development of Varian’s innovative IO treatment offerings, clinical strategy, and helping advance the field of interventional oncology as an important pillar of patient care.

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Dr. Facchini was most recently chief medical officer and head of medical affairs for BTG Plc. where he had responsibility for developing and commercializing products targeting critical care, cancer, vascular and other disorders. Facchini previously had served as global director of Medical and Clinical Affairs for Angiodynamics, Inc. and was chief medical officer of Navilyst Medical, Inc.

"Frank will be a great addition to the Varian Medical Affairs team," said Khuntia. "He is a strategic thinker with strong business acumen and a deep understanding of this ever-changing industry. As a key opinion leader in the field of Interventional Oncology, Frank has a proven track record delivering highly creative, impactful solutions that will benefit Varian in our fight against cancer."

"Varian is known for keeping patients at the center of its thinking and developing the most advanced technologies to fight cancer," said Facchini. "Varian excels at bringing together the greatest scientists, clinicians and researchers to do great things to advance oncology treatment. This is the most ideal time in my career path to be joining this team."

Among his many academic achievements, Dr. Facchini received a Doctor of Medicine from Loyola University, Stritch School of Medicine and a BA in Philosophy from DePauw University.