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.

On October 18, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that members of its senior management team will participate in a fireside chat at the H.C. Wainwright 2nd Annual Precision Oncology Conference on Wednesday, October 20, 2021 at 12:30 p.m. Eastern Time (Press release, Repare Therapeutics, OCT 18, 2021, View Source [SID1234591463]).

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A live webcast of the fireside chat can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days.

On October 18, 2021 Xilio Therapeutics, Inc. (Xilio) a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate XTX202, its tumor-selective IL-2 product candidate, as a potential treatment for patients with solid tumors (Press release, Xilio Therapeutics, OCT 18, 2021, View Source [SID1234591462]). XTX202 is designed to localize activity in the tumor microenvironment (TME), with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity.

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"We are excited to have received FDA clearance for our IND application for XTX202," said Martin Huber, M.D., president of research and development and chief medical officer of Xilio. "IL-2 has shown potential for long-term, durable complete responses in certain cancers, but life-threatening toxicity has limited its use to a small subset of patients. We have designed XTX202 with the goal of delivering enhanced anti-tumor activity while minimizing the known liabilities of existing IL-2 therapies. We look forward to beginning Phase 1/2 development to evaluate the potential that XTX202 may offer as both a monotherapy and combination agent for patients in need."

Leveraging its proprietary geographically precise solutions (GPS) platform, Xilio designed XTX202 to be activated selectively in the TME, resulting in localized clinical activity without dose-limiting toxicities. In preclinical studies, XTX202 exhibited tumor-selective biological activity and anti-tumor activity comparable to aldesleukin, a high-dose IL-2 therapy, at its maximum tolerated dose, while minimizing the severe toxicity observed with aldesleukin. XTX202 was well-tolerated in non-human primate models up to 10 mg/kg weekly.

Xilio expects to initiate a Phase 1/2 dose-escalation monotherapy trial for XTX202 in patients with solid tumors who have previously received an anti-PD(L)1 treatment regimen in the first quarter of 2022.

On October 18, 2021 ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company, and Canadian Nuclear Laboratories (CNL), Canada’s premier nuclear science and technology organization, reported that the companies have signed a Memorandum of Understanding (MoU) to explore the development and industrial-scale production of Actinium-225, an extremely rare alpha-emitting radioisotope with heightened potential in precision oncology (Press release, ITM Isotopen Technologien Munchen, OCT 18, 2021, View Source [SID1234591461]). Under the terms of the agreement, the organizations will collaborate on the development, manufacturing, and distribution pathways for the medical radioisotope. Further details of the agreement have not been disclosed.

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Targeted Alpha Therapy (TAT) has been rapidly gaining growing interest from the scientific and medical community. Alpha-emitters, particularly Actinium-225, are in high demand for their ability to cause irreparable damage to cancer cells. Notably, Actinium-225 emits powerful, high-energy alpha particles with a short penetration range, which enables highly precise treatment of tumor cells, including hard-to-target micro metastases, with minimal impact to surrounding healthy tissue. In preclinical studies, TAT has shown remarkable results, destroying cancer cells by effectively breaking the bonds in their DNA. Actinium-225 can be labelled to a variety of peptide ligands or antibodies to specifically target cancer cells in a wide range of tumor indications.

As the current annual global production of Actinium-225 is miniscule, one of the biggest challenges in harnessing the full potential of the alpha-emitter is ensuring its supply. CNL and ITM have the expertise and infrastructure in place to work to sufficiently bypass the supply hurdle to develop and produce this coveted radioisotope with huge therapeutic potential.

"CNL is very excited to enter into this agreement with ITM, an industry leader that shares our ambition of bringing the next-generation of medical radioisotopes to the global market," commented Joe McBrearty, CNL’s President and CEO. "It is also an exciting evolution of CNL’s work in the field of medical radioisotopes, and makes use of our capabilities in target development, radiochemistry, radioisotope analysis and by-product management. Working with ITM, we hope to leverage these capabilities to accelerate the development of this promising new isotope, and to establish a commercial pipeline for what we believe will be a ground-breaking new cancer treatment."

"It is always a pleasure to work alongside another radiotherapeutic industry leader like CNL in the development of a radioisotope with the potential to address a high unmet need. We look forward to sharing our expertise in the global production and supply of the highest quality radioisotopes in our shared mission of exploring the otherwise untapped potential of Actinium-225, commonly referred to as the ‘rarest drug on earth’. We are eager to unveil the therapeutic value of this radioisotope which we believe has the potential to unlock revolutionary TAT treatments," said Steffen Schuster, CEO of ITM.

ITM is a world leader in the development, production and global supply of radiotherapeutics and diagnostics, and maintains an evolving precision oncology pipeline. Coupled with CNL’s extensive scientific infrastructure and vast experience in developing and distributing medical radioisotopes, the companies are very well-positioned to produce and provide this highly sought-after radioisotope to the global industry.

Under the terms of the agreement, CNL will be responsible for the research and development as well as the production of Actinium-225. The company is already developing and producing Actinium-225 in research-scale quantities using Thorium-229 generators. ITM will be responsible for further processing Actinium-225 to Good Manufacturing Practices (GMP) standard and will subsequently have the primary responsibility for associated regulatory processes, marketing and sales of the product. CNL and ITM aim to leverage their capabilities towards establishing a continuous commercial supply of GMP-grade Actinium-225 for the global market. Both parties are working towards signing a more formal agreement in the form of a Collaborative Venture.