On October 6, 2021 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, reported that it will present at two investor conferences during the month of October 2021 (Press release, Citius Pharmaceuticals, OCT 6, 2021, View Source [SID1234590872]).

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EVENT: Benzinga Rising Stars: Catalytic Small Cap Growth Conference
DATE: Thursday, October 7, 2021
Citius Executive Chairman Leonard Mazur will present at 9:05 a.m. ET. His presentation will be available for viewing on Benzinga’s live stream channel.

EVENT: Dawson James Securities 6th Annual Small Cap Growth Conference
DATE: Thursday, October 21, 2021
Citius Executive Chairman Leonard Mazur will present at 8:55 a.m. ET in Track 1 and will be available for 1-on-1 meetings with registered conference attendees. The conference will be held October 20-21 at the Wyndham Grand Jupiter at Harbourside Place in Jupiter, Florida. A webcast of the presentation will be available on the Events page of the Citius Investors website.

At the conferences, Mr. Mazur will discuss the Company’s growing pipeline of therapies targeting unmet medical needs consisting of two late-stage assets completing Phase 3 trials, three potential first-and-only prescription treatments in their indications, and a next-generation stem cell therapy program.

On October 6, 2021 Defence Therapeutics, a biotechnology company working on cancer therapeutics and infectious disease vaccines is finalizing all required steps in preparation to a pre-IND meeting to initiate a phase I trial against melanoma using its DC cancer vaccine candidate AccuVAC-D002 (Press release, Defence Therapeutics, OCT 6, 2021, View Source [SID1234626237]).

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Defence has successfully exploited the use of its AccumTM technology platform to develop a large pipeline of products in immune-oncology and infectious diseases. Amongst its lead products is AccuVAC-D002, a DC-based cancer vaccine engineered to treat melanoma. The AccumTM technology platform is very efficient at enhancing intracellular delivery of proteins of pharmacological interests such as ADCs or vaccine antigens. Defence’s scientific team recently identified a novel function for the use of "free" AccumTM and its recently developed variants as anti-cancer molecules.

"We have successfully moved our product pipeline forward and developed various cancer vaccines including AccuVAC-D002. With the synopsis in hand, we are actively working with a large established CRO in the USA to identify and set-up the site for our Phase I against melanoma in the first half of 2022", says Mr. Plouffe, CEO of Defence Therapeutics.

Defence Therapeutics has antibody-drug conjugates and vaccines in late-stage pre-clinical development and/or undergoing GLP studies. With two DC cancer vaccines (AccuVAC-D001 and D002) undergoing manufacturing in clean rooms, Defence is most likely to initiate its Phase I trials in Q1/Q2 of 2022.

Skin Cancer Treatment Market to reach USD 14.55 Billion with a 7.5% CAGR by 2027, according to a report by Fortune Business InsightsTM.

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.