On October 18, 2021 TAE Life Sciences (TLS), a biological-targeted radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported the sponsorship of an Industry-Expert Theater session focused on advancements in BNCT at the American Society for Radiation Oncology (ASTRO) Annual Meeting, occurring October 24-27, 2021 (Press release, TAE Life Sciences, OCT 18, 2021, View Source [SID1234591468]).

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The session, "New Era in Biologically-Targeted Radiation Therapy: Clinical Application and Technical Advancement in Boron Neutron Capture Therapy" will feature presentations by Timothy Malouff, M.D., Mayo Clinic, Ester Orlandi, M.D., National Center of Oncological Hadrontherapy (CNAO) and Kendall Morrison, Ph.D., Chief Scientific Officer, TAE Life Sciences. They will discuss the clinical application and technical advancements in BNCT for the treatment of invasive, recurrent and difficult to treat cancers.

"Our deep commitment to innovation in clinical practice is underscored by our research in BNCT as an emerging treatment modality for traditionally difficult to treat tumors," said Dr. Timothy Malouff, Mayo Clinic. "With clinical studies in a variety of disease sites including head and neck cancers, lung cancers, and breast cancers, BNCT holds the promise of transforming the cancer treatment landscape. We look forward to sharing an update on the current clinical research at ASTRO."

"We announced a partnership with TAE Life Sciences last year to provide BNCT for the treatment of invasive, recurrent and difficult to treat cancers," said Dr. Ester Orlandi, Medical Director at CNAO. "Taking part in this session enables us to provide an update on how we are providing a new pillar in cancer therapy."

Session Title: New Era in Biologically-Targeted Radiation Therapy: Clinical Application and Technical Advancement in Boron Neutron Capture Therapy
Location: Theater 1, Innovation Hub, McCormick Place West
Date: Monday, Oct 25 2:45 PM

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

On October 18, 2021 NFlection Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing novel drug candidates for rare RASopathies, reported that it has appointed William Hodder as CEO (Press release, NFlection Therapeutics, OCT 18, 2021, View Source [SID1234591467]). The company also named Gerd Kochendoerfer, Ph.D., as Chief Operating Officer, Libbie Mansell, Ph.D., MBA, as SVP of Global Regulatory Affairs & Quality Assurance, and Patrice Horwath as VP of Clinical Operations.

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Mr. Hodder brings over 30 years of broad biopharmaceutical industry experience including fundraising, business development, corporate strategy, product marketing, sales, and product development to NFlection, most recently serving as Chief Business Officer at Escient Pharmaceuticals where he was responsible for all financing, licensing and M&A activity, and overseeing corporate operations and administrative functions while developing and implementing infrastructure to support the growth of the organization.

At NFlection, Mr. Hodder will lead efforts to discover and develop effective, targeted therapies for rare disorders driven by aberrant activation of the RAS pathway (RASopathies), initially focusing on cutaneous neurofibromas in neurofibromatosis type 1, disfiguring congenital birthmarks (including keratinocytic epidermal nevi and nevus sebaceous), and immunosuppressant-mediated squamous cell carcinoma.

"NFlection has achieved several significant milestones in 2021, under the leadership of Chris Powala, including the FDA granting orphan drug designation for NFX-179 for the treatment of cutaneous neurofibromatosis type 1," said Mr. Hodder. "It is an exhilarating time to join NFlection as the company progresses NFX-179 Gel to Phase 2b, as we believe it is an important novel therapy for the treatment of RASopathies, such as cutaneous neurofibromatosis, and other unmet medical needs."

Further strengthening the leadership team, NFlection has appointed three key executives, including:

Gerd Kochendoerfer, Ph.D., has been named COO overseeing R&D operations. Dr. Kochendoerfer has over 20 years of experience in drug development, operations, and program management in the biotech and specialty pharma industry. Before NFlection, he was SVP and Head of Operations at PellePharm, a BridgeBio company, where he was responsible for oversight of R&D and built quality and business systems/infrastructure from the ground up for the development of an orphan cancer drug candidate with Breakthrough Designation status addressing a rare genetic disease.

Libbie Mansell, Ph.D., MBA, RAC, will serve as SVP of Global Regulatory Affairs & Quality Assurance. Dr. Mansell has over 30 years of experience in Product Registration and Development Strategy who has demonstrated success in translating innovative science and technology into high-quality, commercially attractive medicines for serious and/or rare diseases. Prior to joining NFlection, she served as SVP, Regulatory Affairs, for AskBio (acquired by Bayer in December 2020).

Patrice Horwath has been appointed VP of Clinical Operations, overseeing the day-to-day operation of all clinical development. Ms. Horwath has over 20 years of experience directing global pharmaceutical, medical device and combination product development and successfully led multiple clinical programs through Phase I-IV studies, global regulatory approvals, product launch and clinical affairs management including medical education and scientific communications. She joined NFlection from Kalika Biosciences/Ralexar Therapeutics.

On October 18, 2021 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapies, reported sponsored research to evaluate AB-329, an AXL inhibitor in metastatic breast cancer (Press release, AnHeart Therapeutics, OCT 18, 2021, View Source [SID1234591466]). The coprimary investigators of the study are Jangsoon Lee, Ph.D., and Naoto Ueno, M.D., both of The University of Texas MD Anderson Cancer Center.

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In breast cancer, AXL expression independently predicts poor overall patient survival. Activation of AXL kinase activity or overexpression of AXL is associated with drug resistance in multiple cancers.

"We are excited to launch this study to evaluate AXL inhibitor AB-329 in metastatic breast cancer, an area of significant unmet medical need," said Bing Yan, M.D., MBA​, Co-Founder & Chief Medical Officer, AnHeart. "Metastatic breast cancer (mBC) has limited therapeutic regimens. Although long-term survival rates for patients with mBC have improved, toxicity and resistance to conventional treatment remain major clinical problems for mBC."

"We look forward to this study as it will enable us to identify molecules and chemotherapy agents to enhance the anti-tumor and anti-metastatic efficacy of our investigational candidate AB-329 in AXL-positive metastatic triple-negative breast cancer," said Jerry Junyuan Wang, Ph.D., CEO and Co-Founder of AnHeart. "The results will allow us to propose new treatment options with AB-329 for future clinical trials. There is an urgent unmet medical need to advance new therapeutic strategies for patients with metastatic triple-negative breast cancer and inflammatory breast cancer."

On October 18, 2021 -Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that Lineage will be featured in the B. Riley Securities Fall 2021 "Growth Biotech Best Idea" Virtual Series, in a fireside chat hosted by Mayank Mamtani, Managing Director, Senior Biotech Research Analyst and Group Head of Healthcare Research at B. Riley Securities (Press release, Lineage Cell Therapeutics, OCT 18, 2021, View Source [SID1234591465]). The fireside chat will feature Lineage management, including, Brian M. Culley, Chief Executive Officer, Kevin Cook, Chief Financial Officer, and Gary Hogge, Senior Vice President of Clinical and Medical Affairs. The Lineage team will be joined by Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula, Director and Principal Investigator, Barcelona Macula Foundation: Research for Vision. Interested investors can register to join the live event today at 9:30am Pacific / 12:30pm Eastern here.

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Therapeutic Area Expert

Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula, Director and Principal Investigator, Barcelona Macula Foundation: Research for Vision.

Dr. Monés is an ophthalmologist, macula and vitreoretinal specialist, and macular and retinal degeneration researcher. Dr. Monés earned his medical degree at the University of Barcelona and subsequently specialized in ophthalmology at Barraquer Ophthalmology Centre. He completed his retinal specialist training at the Massachusetts Eye and Ear Infirmary at Harvard University, and at Hospital San José, Monterrey Institute of Technology and Higher Education. He earned his PhD degree in Medicine and Surgery at the University of Barcelona. Dr Monés is dedicated to fighting blindness by supporting and conducting research in retinal disease. For the last 15 years he has been one of the foremost researchers involved in clinical trials for the treatment of age-related macular degeneration. He is currently conducting Phase I, II and III clinical trials. His work has been widely published in scientific journals and he has given more than 200 presentations at international congresses. He is a member of 12 scientific societies.

Interested parties can register to view both the live event and replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

On October 18, 2021 Schrödinger (Nasdaq:SDGR) and Centessa Pharmaceuticals plc ("Centessa") (Nasdaq:CNTA), together with subsidiary Orexia Therapeutics ("Orexia"), reported an exclusive collaboration focused on the discovery of novel therapeutics targeting the orexin-2 receptor (OX2R), which is known to play a role in a broad spectrum of sleep disorders, including narcolepsy (Press release, Centessa Pharmaceuticals, OCT 18, 2021, View Source [SID1234591464]). The collaboration provides Orexia with substantial access to Schrödinger’s entire computational platform as well as Schrödinger’s extensive expertise in ultra-large-scale deployment of its technology.

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Orexia will leverage Schrödinger’s computational platform, including LiveDesign and Free Energy Perturbation (FEP+), which facilitates high-performance calculations for drug discovery to enable accurate prediction of potency at the target of interest. The collaboration will be enabled by Orexia’s structural biology capabilities, including the stabilized OX2R StaR protein exclusively licensed from Sosei Heptares, and high-resolution crystal structures in agonist conformation. The collaboration represents the first time Schrödinger’s technology will be applied in an orexin agonist setting at scale.

"While prevailing treatment approaches only address the symptoms associated with narcolepsy type 1 (NT1), we believe orexin agonists offer a disruptive approach, with the capacity to address the underlying pathology of the disorder. Orexia’s utilization of OX2R stabilized receptors (StaRtechnology) provides the foundation for R&D which could significantly benefit patients with NT1. We look forward to partnering with Schrödinger to complement the discovery and development work we are conducting at Orexia," said Saurabh Saha, M.D., Ph.D., chief executive officer of Centessa.

"Orexia’s asset-centric approach enables us to pick the best technology partners for discovery and development. While we expect to enter IND enabling studies with our lead molecule next year, we are also delighted to work with Schrödinger to enable the acceleration of our discovery efforts for molecules with potentially differentiated clinical profiles. Indeed, the therapeutic possibilities of orexin agonists extend well beyond NT1 into other rare primary hypersomnia disorders, such as narcolepsy type 2 and idiopathic hypersomnia, and into a broad range of additional indications characterized by excessive daytime sleepiness. We are committed to exploring the full potential of orexin agonists to help patients across a wide range of indications," said Mario Alberto Accardi, Ph.D., chief executive officer of Orexia.

"Our research collaboration with Orexia is illustrative of a new approach to help support discovery efforts at biotech companies, where we apply our technology at scale on behalf of our collaborator," stated Ramy Farid, Ph.D., president and chief executive officer of Schrödinger. "The Orexia team brings deep experience in orexin biology and structure-based drug design, and we’re excited to provide Orexia with large-scale access to our leading computational approaches and expertise to accelerate the discovery of novel therapeutics targeting orexin biology."

Under the terms of the agreement, Orexia will be responsible for preclinical research activities, clinical development and commercialization of future product candidates discovered under the collaboration. Schrödinger will receive an upfront software access payment and may become eligible to receive certain preclinical, development, regulatory and commercial milestone payments, as well as low single digit royalties on global net sales.