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.

On October 6, 2021 Dialectic Therapeutics, Inc. (Dialectic), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, reported the dosing of the first patient in a first-in-human, dose escalation Phase 1 trial evaluating DT2216, the first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD) technology, in patients with relapsed or refractory solid tumor and hematologic malignancies (Press release, Dialectic Therapeutics, OCT 6, 2021, View Source [SID1234590873]).

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"Advancing our first generation APTaD DT2216 into the clinic is the culmination of a tremendous amount foundational research conducted by our scientific team supported by extensive preclinical studies. This also marks the first time a protein degrader targeting the antiapoptotic BCL family of proteins has been administered in humans. We believe DT2216 has the potential to be a first-in-class anticancer agent targeting BCL-XL, the most commonly over-expressed antiapoptotic protein in cancer, as a single agent and in combination with chemotherapy regimens and other therapeutics. We look forward to learning more about the safety, tolerability and anti-tumor activity of DT2216 in this trial and presenting future data" said Dr. David Genecov, Dialectic’s President and Chief Executive Officer. "With DT2216 in the clinic, we look forward to leveraging our novel APTaD technology platform to advance the next generations of our degrader compounds."

The multicenter Phase 1 clinical trial is designed as an open-label, first-in-human, dose escalation study in patients with histologically or cytologically confirmed advanced or metastatic solid tumors and hematologic malignancies who are no longer responsive to approved or accepted standard-of-care interventions. The Phase 1 trial is anticipated to enroll between 20-40 patients that will receive a single intravenous (IV) infusion of DT2216 twice weekly for at least 4 weeks, with each cycle consisting of 28 days.

Renowned cancer centers participating in the trial include Mays Cancer Center at UT Health San Antonio, Mary Crowley Cancer Research in Dallas, Texas and The Lurie Cancer Center at Northwestern University in Chicago, Illinois. Additional information about the clinical trial is available at ClinicalTrials.gov (NCT04886622).

About DT2216 and the APTaD Technology Platform
In preclinical studies supported through a Seed Award from the Cancer Prevention & Research Institute of Texas (CPRIT), DT2216 selectively induces the degradation of B-cell lymphoma extra-large, or BCL-XL, in cancer cells and either stimulates the return of cellular apoptosis or sensitizes the cells to be more susceptible to chemotherapy, and thus cellular destruction. DT2216 has been shown to be effective in various hematologic and solid tumors as a single agent and in combination with chemotherapy. Further, these preclinical studies show cancer cells are less likely to develop resistance to DT2216 compared to other chemotherapy drugs. DT2216 accomplishes this with very little toxicity, particularly to platelets.

As with BCL-XL, there are many other significant proteins associated with cancer that cannot be targeted with current therapies. Our proprietary APTaD technology platform is a novel approach that can be applied to the broader BCL family and other protein targets. Our current research and preclinical efforts are focused on developing next generation APTaD candidates to address this high unmet need.

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 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders, reported that it will present three abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held in Washington D.C. and virtually November 10-14, 2021 (Press release, OncoResponse, OCT 6, 2021, View Source [SID1234590874]).

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"We are pleased to be highlighting several preclinical findings at the SITC (Free SITC Whitepaper) conference demonstrating the application of our propriety immunotherapy platform we are utilizing to discover and develop therapeutic antibodies that modulate the tumor microenvironment. This includes preclinical findings for our lead therapeutic candidate, OR2805, which has entered clinical development," said Clifford Stocks, Chief Executive Officer of OncoResponse.

Details of the poster presentations are as follows:

Title: Development of OR2805, an anti-CD163 antibody derived from an elite responder to checkpoint inhibitor therapy that relieves immunosuppression caused by M2c macrophages

Poster/Abstract Number: 271
Date/Time: Friday, November 12, 7:00 a.m. to 8:30 p.m. ET

Title: Preclinical characterization of humanized anti-Siglec-15 antibodies that rescue T cells from macrophage-mediated immune suppression

Poster/Abstract Number: 262
Date/Time: Saturday, November 13, 2021, 7:00 a.m. – 8:30 p.m. EST

Title: Discovery and preclinical characterization of anti-LILRB2 antibodies that rescue T cells from macrophage-mediated immune suppression

Poster/Abstract Number: 276
Date/Time: Saturday, November 13, 2021, 7:00 a.m. – 8:30 p.m. EST

Poster presentations will be accessible in person and virtually. Onsite posters will be displayed in the SITC (Free SITC Whitepaper) Poster Hall located in Hall E of the convention center. ePosters will be available for SITC (Free SITC Whitepaper) attendees on Nov. 12 at 7 am ET and can be accessed on the SITC (Free SITC Whitepaper) virtual meeting site.

About OR2805

OR2805 is a fully human antibody discovered using B cells derived from an elite responder to checkpoint inhibitor (CPI) therapy. This antibody binds to CD163 which is highly expressed on tumor associated macrophages (TAMs) that create an immunosuppressive tumor microenvironment and inhibit anti-tumor T-cell responses. High frequency of CD163-expressing TAMs generally predicts an unfavorable prognosis in solid tumors. OR2805 is designed to improve anti-tumor T-cell responses, by reversing the immunosuppression of TAMs, as a therapeutic strategy for monotherapy and in combination with CPI.

On October 6, 2021 Cothera Bioscience Inc. and Adastra Pharmaceuticals Inc., private biopharmaceutical companies focused on the development of first-in-class therapeutics for the treatment of cancer, reported a definitive agreement under which Cothera has acquired zotiraciclib (ZTR), an oral kinase inhibitor that readily crosses the blood brain barrier and possesses a unique mechanism of action of Myc depletion via the inhibition of cyclin-dependent kinase 9 (CDK9) (Press release, Cothera Bioscience, OCT 6, 2021, View Source [SID1234627381]). Financial terms of the asset purchase were not disclosed.

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In June 2021, the results of the zotiraciclib Phase 1b clinical trial were published in Clinical Cancer Research. The conclusion of the Phase 1b trial found that Zotiraciclib combined with temozolomide (TMZ) is safe in patients with recurrent high-grade astrocytomas.

After the conclusion of the trial a successful Type B meeting with the U.S. Food and Drug Administration Division of Oncology (D02) was held. The transition of ZTR from Adastra to Cothera enables the execution of clinical development plans built on input from the FDA meeting, as well as insight from global neuro-oncology thought-leaders and clinical investigators.

"The acquisition of zotiraciclib fits nicely into the Cothera portfolio of differentiated drug candidates synergistically aligning to our current research efforts to address cancers driven by the Myc oncogene," said Alex Wu, Ph.D., President and Chief Executive Officer and Founder of Cothera. "Importantly, zotiraciclib adds to the Cothera portfolio of therapeutics that hold promise for cancer patients around the world."

Scott Megaffin, Chief Executive Officer of Adastra, said, "I want to thank all the physicians and dedicated healthcare providers who have put forward relentless effort on behalf of their patients as the Adastra team transitions zotiraciclib into Cothera."

Vernon Jiang, Ph.D., Executive Vice President and Co-Founder of Cothera, added, "We are grateful to Adastra for its important work with physicians within neuro-oncology. Cothera is enthusiastic to build upon these relationships, as we believe highly in the promise of zotiraciclib in high-grade gliomas and pediatric mid-line gliomas such as Diffuse Intrinsic Pointe Glioma (DIPG).