On October 18, 2021 Phase Genomics, Inc., a biotech company leading advancements in next-generation sequencing (NGS) solutions for genome assembly and analysis, reported the launch of the beta version of its new platform for next generation cytogenomic applications in the reproductive genetics and oncology spaces (Press release, Phase Genomics, OCT 18, 2021, View Source [SID1234591470]).

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The platform enables rapid, efficient sample processing and does not require culturing of live, dividing cells nor high-molecular-weight DNA extraction. "This is a fast and inexpensive platform that is capable of providing tremendous benefit towards answering complex genomic questions that existing methods are unable to fully resolve,” said Shawn Sullivan, Co-founder and CTO of Phase Genomics. "The flexibility of this method allows us to use a low starting volume of cells from fresh and frozen material and, most notably, paraffin-embedded tissue. We can deliver an invaluable compendium of genetic information from a single sample without having to wait for results from multiple tests. With our robust chemistry and the machine learning underpinnings of our analytic technology, our platform offers the potential to complement or replace incumbent technologies like cytogenetics, FISH, and CMA in both solid and liquid cancers and in reproductive health."

While the platform can be broadly applied to constitutional genetics, Phase Genomics sees the immediate utility that it can bring to the prenatal market. According to Sullivan, the platform can help provide answers to the study of patient populations faced with infertility or unexplained repeated pregnancy loss. "For example, our platform can detect cryptic rearrangements potentially causing a couple’s fertility issues, it can uncover novel structural and copy-number changes essential to fetal development in non-viable or paraffin-embedded POC tissue samples and, most importantly, help fuel the translation of these discoveries into clinical tools that will remove emotional, financial and other burdens borne by patients working through these heartbreaking conditions."

Many of the same challenges exist in oncology. Unlocking and maximizing the use of the genetic information contained in unculturable and paraffin-embedded cancer samples is a unique property of the Phase Genomics platform. Phase Genomics’ Co-founder and CEO Dr. Ivan Liachko stated, "The Phase Genomics ultra-long-range sequencing method and machine learning-enabled analytical platform arm clinical researchers, and eventually, healthcare providers, with a cost-effective, high-throughput, sequencing-based method that delivers actionable information. This information provides insights that can be used in the development of new diagnostic and treatment options for cancer and genetic disease, ultimately leading to improved patient care and outcomes."

Today’s announcement opens RUO platform access to early beta participants. Phase Genomics is engaged in a number of active partnerships with research and commercial entities and is presenting early results in a poster at the American Society of Human Genetics Conference. The Phase Genomics platform is for research use only and is not for use in diagnostic procedures. More information on the platform is available here.

Join Phase Genomics for a webinar on Tuesday, November 30th to learn more about this technology and follow Phase Genomics on Twitter for the latest news and information.

On October 18, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported that October 19, 2021 has been set as the record date for the dividend of shares of common stock of 2seventy to be distributed to bluebird stockholders in order to effect the separation of bluebird bio and 2seventy bio, Inc. into two independent, publicly traded companies (Press release, bluebird bio, OCT 18, 2021, View Source [SID1234591469]).

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Each bluebird bio stockholder of record as of the close of business on October 19, 2021 will receive, on the distribution date, one share of 2seventy common stock for every three shares of bluebird common stock held. The share dividend is expected to be distributed to bluebird stockholders on or about November 4, 2021. Following the separation, bluebird stockholders will also receive cash in lieu of any fractional shares of 2seventy common stock that those holders would have received after application of the 3:1 distribution ratio. No action is required by bluebird stockholders in order to receive the shares of 2seventy common stock in the dividend distribution.

Additionally, on October 18, 2021 the Securities and Exchange Commission declared 2seventy’s Registration Statement on Form 10 (the "Form 10") effective. This Form 10 contains further information regarding bluebird bio’s plans for a tax-free spin-off of its oncology programs and portfolio into 2seventy bio as a publicly traded company, including the conditions to completion of the separation.

"When-issued" trading for 2seventy common stock and "ex-distribution" trading for bluebird common stock is expected to commence on October 18, 2021 under the stock ticker symbols "TSVTV" and "BLUEV", respectively. A description of these expected trading markets is included in the Form 10. After the separation, 2seventy common stock is expected to trade on the Nasdaq Global Select Market under the stock ticker symbol "TSVT" and bluebird will continue to trade on Nasdaq Global Select Market under the stock ticker symbol "BLUE."

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."