On October 6, 2021 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that the first patient has been dosed with ELI-002, an investigational lymph node-targeted therapeutic vaccine, by Shubham Pant, M.D. at MD Anderson as part of a Phase 1/2 (AMPLIFY-201) study evaluating its safety and efficacy as a treatment for patients with KRAS-driven tumors who have minimal residual tumor cells following surgery to remove the tumor (Press release, Elicio Therapeutics, OCT 6, 2021, View Source [SID1234590860]). The trial is expected to enroll patients with mKRAS+ solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and other solid tumors. ELI-002 is an Amphiphile (AMP) KRAS investigational therapeutic vaccine containing AMP mKRAS peptides and a proprietary AMP CpG adjuvant, administered subcutaneously.

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"Our unique trial design will study the ability of ELI-002 to generate RAS-specific killer T cells that target the microscopic residual tumor cells that remain following surgery. With its design to target lymph nodes, the ’schoolhouse’ where T cells are educated, we believe ELI-002 holds promise to lengthen remission and could prevent future recurrence. We expect to share initial data by the first half of 2022," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer.

Cancers related to KRAS mutations are among the most prevalent, accounting in studies for as much as 27% of patients with lung adenocarcinomas, 49% of metastatic colorectal cancer, or CRC patients, and 93% of all PDAC. Approximately 74% of patients who undergo surgery with curative intent develop a recurrence of pancreatic cancer, despite adjuvant chemotherapy.[1]The Phase 1 trial for ELI-002 (AMPLIFY-201) employs an investigational in vitro diagnostic device, or IVD, that detects circulating tumor DNA, or ctDNA, to identify patients who show signs of minimal residual disease in their blood, but before relapse is detected in traditional radiographic scans.

Julian Adams, Ph.D., Elicio’s Chairman, added, "The AMPLIFY-201 trial is a great example of the use of liquid biopsies to identify patients with minimal residual disease (MRD) who test positive for circulating tumor DNA following surgery and chemotherapy. An estimated 25% of all cancer patients have RAS mutations present in their tumor. ELI-002 targets the seven most common KRAS mutations and has the potential to become a multi-targeted mKRAS therapy that can prevent disease recurrence in patients with KRAS-driven tumors."

About AMPLIFY-201

AMPLIFY-201 is a Phase 1/2 clinical trial of ELI-002 in patients with solid tumors, including colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The AMPLIFY-201 trial is being conducted at multiple sites, including U.S. cancer treatment institutions such as MD Anderson, Memorial Sloan Kettering, Massachusetts General Hospital, City of Hope, Washington University St. Louis, and Henry Ford Health System. Following an initial dose escalation phase, we intend to continue to evaluate the potential of ELI-002 as a treatment for a number of KRAS-mutated cancers. AMPLIFY-201 is strategically constructed to target patients with minimal residual disease, or MRD, a stage where tumor burden and immunosuppressive effects within the tumor are lower. The Phase 1/2 trial employs an investigational in vitro diagnostic device, or IVD, that is intended to detect circulating tumor DNA, or ctDNA, and identify patients who show signs of minimal residual disease in their blood before relapse is detected in traditional radiographic scans.

Endpoints including safety, determination of maximum tolerated dose, ctDNA change from baseline, relapse free survival and immunological responses including lymph node enlargement, cytokine activity and immune response will be assessed. We anticipate initial safety, dose escalation, and correlative biomarker data from the Phase 1 portion of the trial to be available by the first half of 2022.

The purpose of the Phase 1/2 multi-center, dose-escalation study is to evaluate the safety and preliminary efficacy of ELI-002 in patients with KRAS-driven cancers with minimal residual disease following surgery to remove the tumor. Each cohort will receive escalating doses of ELI-002 to determine safety and tolerability and to assess preliminary antitumor activity. The primary endpoints are, to define the maximum tolerable dose (MTD), recommended Phase 2 dose (RP2D), and incidence of adverse events (AE) for Phase 1 and relapse-free survival (RFS) for Phase 2. The secondary endpoints are ctDNA response rate for Phase 1, incidence of AEs, 1-year RFS, overall survival (OS) and the objective response rate (ORR) for Phase 2, among other endpoints. Please refer NCT04853017 on clinicaltrials.gov for additional clinical trial information.

About ELI-002

ELI-002 is a structurally novel investigational AMP therapeutic vaccine targeting KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide adjuvant. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they potentially enhance action on key immune cells.

About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform is thought to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.

On October 6, 2021 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, and a company it founded, Caelum Biosciences, Inc. ("Caelum"), a biotechnology company developing treatments for rare and life-threatening diseases with two ongoing Phase 3 clinical trials, reported the closing of AstraZeneca’s acquisition of Caelum, pursuant to the Development, Option and Stock Purchase Agreement in place between Fortress, Caelum, AstraZeneca’s Alexion and the other parties thereto (as amended, the "DOSPA") (Press release, Caelum Biosciences, OCT 6, 2021, View Source [SID1234590859]).

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AstraZeneca acquired Caelum for the agreed option exercise price of approximately $150 million. Distributions will be made to all existing Caelum stockholders. The agreement also provides for additional potential payments to Caelum stockholders totaling up to $350 million, payable upon the achievement of regulatory and commercial milestones.

Fortress is eligible to receive approximately 43 percent of all proceeds from the transaction.

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.

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]).

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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.

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.

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"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.