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BridgeBio Pharma to Host Virtual R&D Day on October 12, 2021

On October 6, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, reported that it will host its second R&D Day on Tuesday, October 12, 2021, at 8:30 a.m. ET (Press release, BridgeBio, OCT 6, 2021, View Source [SID1234590858]).

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BridgeBio founder and CEO Neil Kumar, Ph.D., will present and be joined by Richard Scheller, Ph.D., chairman of R&D at BridgeBio; Charles Homcy, M.D., chairman of pharmaceuticals at BridgeBio; and Uma Sinha, Ph.D., chief scientific officer at BridgeBio, along with senior scientists and physicians leading BridgeBio’s drug discovery and development programs. BridgeBio has 14 programs that are being advanced in the clinic or commercial setting with 30+ programs total in its pipeline for patients living with genetic diseases and genetically-driven cancers.

BridgeBio will unveil new programs, share new information about its pipeline and discuss how it is broadening the scope of its R&D engine. It will also cover the company’s most significant near-term catalysts with a focus on the upcoming topline results for acoramidis, BridgeBio’s investigational therapy for transthyretin (TTR) amyloidosis (ATTR). ATTR is a rare heart condition with a progressive and debilitating impact on quality of life likely affecting more than 400,000 patients worldwide.

Topline results from Part A are expected in late 2021 and from Part B in 2023. The primary endpoint at Part A is the change from baseline in a 6-minute walk distance (6MWD) in trial participants receiving acoramidis or placebo after 12 months. If the change from baseline in 6MWD in Part A is highly statistically significant, BridgeBio expects to submit an application for regulatory approval of acoramidis in 2022 to the U.S. Food and Drug Administration.

The R&D Day program importantly and additionally will highlight BridgeBio’s broader efforts in cardiorenal, progress in its KRAS portfolio, and advancements in its previously disclosed early-stage Mendelian programs. The Company will also be unveiling new programs in gene therapy.

Agenda:

Welcome and introduction – Grace Rauh, vice president of marketing and communications, BridgeBio Pharma
Genetic basis of disease – Richard Scheller, Ph.D., chairman of R&D, BridgeBio Pharma
BridgeBio’s endless summer – Neil Kumar, Ph.D., founder and CEO, BridgeBio Pharma
Precision cardiorenal introduction – Cameron Turtle, D.Phil., chief strategy officer, BridgeBio Pharma
Acoramidis: TTR stabilizer for ATTR – Jonathan Fox, M.D., Ph.D., chief medical officer, BridgeBio Cardiorenal
Encaleret: Calcium sensing receptor (CaSR) inhibitor for autosomal dominant hypocalcemia type 1 (ADH1) – Mary Scott Roberts, M.D., senior director of clinical development, BridgeBio Cardiorenal
Gene therapy platform – Eric David, M.D., J.D., CEO, BridgeBio Gene Therapy
Mendelian programs: Primary hyperoxaluria type 1 (PH1), limb-girdle muscular dystrophy type 2i (LGMD2i), recessive dystrophic epidermolysis bullosa (rDEB) – Uma Sinha, Ph.D., chief scientific officer, BridgeBio Pharma
Precision oncology programs: KRAS, SHP2 – Eli Wallace, Ph.D., chief scientific officer, BridgeBio Oncology
BridgeBioX – Charles Homcy, M.D., chairman of pharmaceuticals, BridgeBio Pharma
Q&A
The event will be webcast, with a link available in the event calendar on BridgeBio’s investor website, View Source A replay of the webcast will be available for one year following the event.

To register for BridgeBio’s R&D Day, please sign up here. To view the agenda and speaker profiles visit our R&D Day webpage. Attendees must register and watch the webcast to participate in the Q&A sessions.

Anixa Biosciences Announces First Chinese Patent on its CAR-T Cancer Therapy Technology

On October 6, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the China National Intellectual Property Administration (CNIPA) has issued a Notification of Grant of Patent Right on Anixa’s novel Chimeric Antigen Receptor-T cell (CAR-T) cancer treatment technology, known as its Chimeric Endocrine Receptor T-cell, or CER-T approach, or more specifically, "Follicle Stimulating Hormone Receptor-Mediated CAR-T technology," which has been licensed from The Wistar Institute and is being developed in partnership with Moffitt Cancer Center (Press release, Anixa Biosciences, OCT 6, 2021, View Source [SID1234590857]).

The patent is titled, "Methods and Compositions for Treating Cancer," and the inventors are Drs. Jose Conejo-Garcia and Alfredo Perales-Puchalt, both formerly of The Wistar Institute. Dr. Conejo-Garcia is Chair of the Department of Immunology at Moffitt Cancer Center and Dr. Perales-Puchalt is Vice President of R&D at Geneos Therapeutics. The patent is assigned to The Wistar Institute and Anixa Biosciences’ majority-owned subsidiary, Certainty Therapeutics, Inc. is the exclusive, world-wide licensee.

Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "We are pleased to receive this notification from the CNIPA, and we are happy to see our CAR-T technology receive additional intellectual property protection in markets outside the U.S. This patent notification follows our announcement last week in which the U.S. Patent and Trademark Office issued a Notice of Allowance broadening protection of Anixa’s CER-T approach. Our novel CAR-T technology takes advantage of specific hormone-to-hormone receptor biology to address malignancies and holds promise to be the first successful CAR-T therapy against solid tumors. While our initial focus is the treatment of ovarian cancer—with clinical trials expected to begin before year-end—the technology covered by the patent is broad and may have applicability in treating other solid tumors by exploiting an anti-angiogenesis mechanism of action."

About Anixa’s CER-T approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s Chimeric Antigen Receptor-T cell (CAR-T) Technology approach, known as "Follicle Stimulating Hormone Receptor (FSHR)-mediated CAR-T technology," is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.
The therapy based on this technology was recently authorized by the U.S. Food and Drug Administration (FDA) for Phase 1 clinical testing.

Boston Scientific Announces Agreement to Acquire Baylis Medical Company Inc.

On October 6, 2021 Boston Scientific Corporation (NYSE: BSX) reported that it has entered into a definitive agreement to acquire Baylis Medical Company Inc. for an upfront payment of $1.75 billion, subject to closing adjustments (Press release, Boston Scientific, OCT 6, 2021, View Source [SID1234590856]). The acquisition will expand the Boston Scientific electrophysiology and structural heart product portfolios to include the radiofrequency (RF) NRG and VersaCross Transseptal Platforms as well as a family of guidewires, sheaths and dilators used to support left heart access. These platforms have advanced transseptal puncture and are clinically proven to enhance safety, efficacy and efficiency when crossing the atrial septum to deliver therapies in the left side of the heart, such as atrial fibrillation ablation, left atrial appendage closure (LAAC) and mitral valve interventions.i,ii,iii Baylis Medical Company is expected to generate net sales approaching $200 million in 2022, having achieved double-digit year-over-year sales growth during each of the past five years.

"The talented and innovative Baylis Medical Company team, combined with these transseptal platforms, will enhance our efforts to improve procedural efficiencies with physician tools designed to make left atrial access safer and more predictable, with a focus on patient outcomes," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "A leader in many of the fastest growing markets in our industry, we believe that Baylis Medical Company will add meaningful revenue, operating income, and new research and development capabilities across multiple Boston Scientific businesses, while complementing existing offerings within our electrophysiology and structural heart portfolios."

Physicians have traditionally relied on a mechanical needle to pass through the septum and access the left side of the heart, which can present safety concerns and placement challenges based on varying patient anatomy. Rather than relying solely on mechanical force, the Baylis Medical Company platforms facilitate predictable and safe transseptal access by using RF energy – a method shown to increase efficiency, and improve the safety and efficacy of transseptal puncture during left heart procedures.i,ii,iii The new VersaCross platform further streamlines transseptal crossing procedures and therapy delivery by offering the same benefits while eliminating potential wire and sheath exchanges, which may help mitigate risks during procedures.

"As a leading innovator in left heart access solutions, we develop advancements that help physicians deliver critical, high-precision therapies, which raise the standard of care for patients," said Kris Shah, president, Baylis Medical Company. "We look forward to making these life-changing technologies available to more patients across the globe through the significant commercial reach of Boston Scientific."

Baylis Medical Company received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NRG platform in 2008 and the technology has since been used in more than one million procedures. The company received FDA 510(k) clearance for the VersaCross platform in 2020. These platforms are complemented by the company’s family of guidewires, sheaths and dilators, which are designed for use in left-sided diagnostic, ablation, mitral and LAAC procedures.

The transaction is anticipated to close in the first quarter of 2022, subject to customary closing conditions, and is expected to be approximately one cent accretive to adjusted earnings per share in 2022 and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be less accretive, or dilutive as the case may be, in 2022 and less dilutive or increasingly accretive thereafter, as the case may be, due to amortization expense and acquisition-related net charges.

Additional information about this transaction is available on the Events and Presentations section of the Boston Scientific investor relations website.

BIO-Europe, 25-28 October 2021

On October 6, 2021 Sijme Zeilemaker, CEO of Immunetune, reported that it will be attending BIO-Europe, taking place October 25-28, 2021, in digital format (Press release, ImmuneTune, OCT 6, 2021, View Source [SID1234590854]). Feel free to reach out to us to set up a meeting and explore collaboration and investment opportunities.

IpiNovyx Bio Closes $10 Million Seed Financing to Advance Best-in-Class Immunoproteasome Inhibitors Toward First-in-Human Clinical Studies

On October 5, 2021 IpiNovyx Bio, a biopharmaceutical company developing a platform of best-in-class immunoproteasome modulating therapeutics to transform treatment of autoimmune and inflammatory diseases, reported the closing of a $10 million seed financing round (Press release, IpiNovyx Bio, OCT 5, 2021, View Source [SID1234656418]). The financing was led by Viva BioInnovator (a Viva Biotech division) and also included participation from Lilly, Opaleye Management, Orange Grove Bio and Alexandria Venture Investments. Proceeds from the financing will support the company’s continued advancement of its lead drug candidates toward first-in-human clinical studies, including submission of the company’s first investigational new drug (IND) application.

IpiNovyx Bio’s drug development candidates have emerged from the company’s proprietary technology platform, which enables the creation of novel, highly-selective and reversible immunoproteasome inhibitors. These innovative small molecule inhibitors are designed to selectively target the immunoproteasome and modulate specific immune cell types that are associated with autoimmune and inflammatory diseases. Importantly, preclinical research suggests the compounds may possess a favorable toxicity profile as compared to immunosuppressive therapies based on their ability to inhibit immune responses without killing immune cells. Additionally, the inhibitory activity of the company’s drug candidates is reversible, further reducing the potential for toxicity. This promising therapeutic profile positions the development candidates as potential steroid-sparing therapeutics for patients with a range of autoimmune diseases, as well as long-term therapies for autoimmune and inflammatory diseases, many of which are lacking effective therapeutic options.

IpiNovyx was founded by Orange Grove Bio, a preclinically-focused capital allocation and asset development biotech firm, alongside scientific founders Gang Lin, Ph.D. and Carl Nathan, M.D. of Weill Cornell Medicine, and Franck Barrat, Ph.D., of Hospital for Special Surgery (HSS) Research Institute.

"Patients suffering from autoimmune and inflammatory diseases are faced with limited treatment options and most therapies that are available are non-selective and carry significant toxicity concerns. This lack of appealing therapeutic options is largely due to the heterogeneity of these diseases, which makes addressing their fundamental pathophysiology challenging," said Dr. Nathan, chairman of the Department of Microbiology and Immunology and the R.A. Rees Pritchett Professor of Microbiology at Weill Cornell Medicine. "We believe that a strategy of specifically and selectively targeting the immunoproteasome offers the opportunity to overcome these challenges, allowing for the development of highly-selective, broad-acting and reversible immunoregulatory therapies that carry significantly reduced potential for toxicity. We are eager to continue our research in this area and work to advance these best-in-class immunoproteasome inhibitors into human clinical trials."

"Orange Grove Bio is dedicated to partnering with world-class researchers to advance the most promising drug development technologies emerging from leading academic institutions. We believe that IpiNovyx’s scientific founders and their unique approach to developing best-in-class immunoproteasome inhibitors are the ideal fit for this model," said Marc Appel, co-founder and chief executive officer of IpiNovyx and chief executive officer of Orange Grove Bio. "This seed funding will enable the company to rapidly progress through preclinical studies and into the clinic with the goal of delivering life changing therapies to patients suffering from autoimmune and inflammatory diseases."

The immunoproteasome possesses several key attributes that position it as a promising therapeutic target for complex inflammatory diseases. First, inflammatory disease relevant stimuli rapidly induce the immunoproteasome, which then supports the activity of immune cell functions including growth, differentiation, cytokine release and signaling. This induced activity is exacerbated by both the high prevalence of the immunoproteasome in multiple immune cell types that are linked to immunopathology and the fact that its abundance increases further in those cells undergoing activation. Supporting the value of this therapeutic target are preclinical study results in multiple in vivo and in vitro inflammatory disease models that have demonstrated efficacy for modestly selective inhibition of the immunoproteasome.

The fundamental technology being advanced by IpiNovyx is based on pioneering science conducted in the Nathan and Lin laboratories at Weill Cornell Medicine in collaboration with the Barrat lab at HSS, with prior support provided by Weill Cornell Medicine’s de-risking program, the Daedalus Fund for Innovation, which operates under the auspices of Weill Cornell Medicine Enterprise Innovation. An important component of this work was also developed through the efforts of the Tri-Institutional Therapeutics Discovery Institute, a unique program that provides a dedicated medicinal chemistry platform to generate novel chemical and molecular entities on behalf of its academic collaborators, with a view toward advancing early-stage therapeutic candidates into new treatments for patients. The technology is also in-licensed through an agreement with Cornell University’s Center for Technology Licensing (CTL).

"Weill Cornell Medicine’s robust innovation ecosystem works together to bring our faculty’s cutting-edge research to market for the benefit of patients by providing institutional support at critical junctures," said Dr. John Leonard, senior associate dean for innovation and initiatives at Weill Cornell Medicine. "IpiNovyx Bio, a company based on the fundamental work of Drs. Lin and Nathan, serves as an example of innovation meeting collaboration at the frontiers of science, and we look forward to the treatment advances this technology may one day offer for autoimmune and inflammatory diseases."

Weill Cornell Medicine Enterprise Innovation accelerates the best of biomedical innovation to market, translating groundbreaking research into transformational care. Enterprise Innovation provides a bridge between academic researchers and industry stakeholders, brokering engagements and alliances, engaging with and educating faculty about biotech commercialization and business development—which includes patenting and licensing, as well as designing dedicated research alliances —and providing a full suite of entrepreneurial programming, education, mentoring, and other resources.