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Anixa Biosciences Announces Issuance of Canadian Patent for its CAR-T Cancer Therapy Technology

On July 11, 2023 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Canadian Intellectual Property Office has issued Canadian Patent 2,989,807 covering Anixa’s novel Chimeric Antigen Receptor-T cell (CAR-T) cancer treatment technology, which has been licensed from The Wistar Institute and is being developed in partnership with Moffitt Cancer Center (Press release, Anixa Biosciences, JUL 11, 2023, View Source [SID1234633159]).

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The patent, entitled "Methods and Compositions for Treating Cancer," covers a nucleic acid that encodes a chimeric protein whose domains can be used to treat certain types of cancer by binding to specific hormone receptors and activating T cells. The patent was invented by Drs. Jose Conejo-Garcia and Alfredo Perales-Puchalt, both formerly of The Wistar Institute, to which the patent is assigned, along with Anixa’s majority-owned subsidiary, Certainty Therapeutics, Inc., which is the exclusive, world-wide licensee.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "We are pleased that our CAR-T technology has received additional intellectual property protection in a market outside the U.S. Our novel CAR-T technology takes advantage of specific hormone-to-hormone receptor biology to address malignancies and has the potential to be the first successful CAR-T therapy against solid tumors. While our initial focus is on the treatment of ovarian cancer — with a Phase 1 clinical trial currently ongoing — the technology covered by the patent has broad application and could potentially also be used to treat 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 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 known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.

Alligator Bioscience to Present its CD40 Program at the 3rd Annual Tumor Myeloid-Directed Therapies Summit in July 2023

On July 11, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that its Chief Science Officer Peter Ellmark will hold a presentation on the company’s CD40 program at the 3rd Annual Tumor Myeloid-Directed Therapies Summit, taking place July 18-20, 2023, in Boston, as well co-hosting the Industry Leaders’ Fireside Chat: "Reviewing the Current Landscape & Future Potential of the Myeloid" (Press release, Alligator Bioscience, JUL 11, 2023, View Source [SID1234633158]).

The presentation, entitled "Targeting CD40 on Myeloid Cells to Reverse the Suppressive Tumor Microenvironment & Enhance T Cell Priming", highlights the latest very promising interim results from the ongoing OPTIMIZE-1 Phase 2 study assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINIOX, in previously untreated (1st line) patients with metastatic pancreatic ductal adenocarcinoma.

Preclinical data on mitazalimab as well as clinical efficacy and pharmacodynamic biomarker data from the OPTIMIZE-1 interim readout will also feature in the presentation, along with preclinical in vivo and in vitro data on ATOR-4066, a 3rd generation bispecific antibody targeting CD40 and CEACAM5. ATOR-4066 was developed by Alligator’s proprietary Neo-X-Prime platform that generates bispecific conditional antibody agonists able to ignificantly boost dendritic cells and T-cell activation by efficiently connecting them to CEACAM5-expressing tumor debris.

In summary, the latest OPTIMIZE-1 interim results include the continued follow-up on the futility analysis cohort (23 patients), which showed a deepening of tumor responses and an increase in the Objective Response Rate (ORR) to 57% from 52%. The interim ORR of 44% in the full OPTIMIZE-1 cohort (57 patients) confirms the benefit of mitazalimab added to mFOLFIRINOX. The median Duration of Response (DoR) of 8.7 months compares favorably with the 5.9[1] months reported with FOLFIRINOX in a similar patient population.

This year, mitazalimab has been granted orphan drug designation (ODD) in the U.S. by the Food and Drug Administration. Orphan designation is granted to medicines that treat rare diseases and qualifies the sponsor to regulatory and financial benefits, including marketing exclusivity once the product has been approved.

Iovance Biotherapeutics, Inc. Announces Pricing of Its Public Offering of $150 Million of Common Stock

On July 10, 2023 Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) ("Iovance" or "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ("TIL") therapies for patients with cancer, reported the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $7.50 per share (Press release, Iovance Biotherapeutics, JUL 11, 2023, View Source [SID1234633136]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are expected to be approximately $150 million. In addition, Iovance has granted the underwriters a 30-day option to purchase up to 3,000,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about July 13, 2023, subject to customary closing conditions.

Iovance intends to use the proceeds from this offering to fund preparations for the commercial launch of lifileucel (if approved), including continuing to prepare the Iovance Cell Therapy Center, the Company’s manufacturing facility in Philadelphia, to support ongoing clinical programs including its NSCLC registration-directed study and its frontline advanced melanoma Phase 3 confirmatory trial, to expand the combination of TIL and immune checkpoint inhibitors ("ICIs") in ICI naïve patient cohorts, to support the continued development of our pipeline candidates, to support Proleukin integration activities and for other general corporate purposes.

Goldman Sachs & Co. LLC and Jefferies LLC are acting as joint lead book-running managers for the offering.

The shares of common stock described above are being offered by Iovance pursuant to its shelf registration statement on Form S-3 that became automatically effective upon filing with the Securities and Exchange Commission on June 16, 2023. The offering may be made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained by contacting Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected] or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York, 10022, by telephone at (877) 547-6340, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Elsie Biotechnologies Announces Collaboration with GSK to Accelerate Oligonucleotide Discovery Technologies

On July 10, 2023 Elsie Biotechnologies, Inc., a biopharmaceutical company unlocking the full potential of oligonucleotide therapeutics, reported a research collaboration agreement with GSK plc (LSE/NYSE: GSK) to advance the discovery and development of Elsie’s innovative oligonucleotide discovery platform with the aim of finding novel oligonucleotides optimized for safety, efficacy, and delivery (Press release, Elsie Biotechnologies, JUL 10, 2023, View Source [SID1234644227]). The collaboration combines GSK’s extensive expertise in DNA encoded library technologies with Elsie’s drug discovery platform. The companies will begin an initial research period where GSK and Elsie will explore the platform capabilities. Throughout the research term, GSK may exercise an option to a non-exclusive license from Elsie for the discovery platform and P(V) chemistry technologies to employ in GSK’s own oligonucleotide drug discovery research.

Kevin Green, Chief Operating Officer, Elsie Biotechnologies, said: "Our next generation oligonucleotide therapeutics, which include RNA medicines, enable new opportunities to treat intractable human diseases, including those with no current or limited therapeutic options. This collaboration combines GSK’s expertise as leaders in the field of DNA encoded library technologies with the unique capabilities of Elsie’s scientists and discovery platform with P(V) chemistry with the goal to discover new RNA medicines."

Elsie’s discovery platform is an unparalleled ultra-high throughput proprietary process that allows for the complete evaluation of oligonucleotide chemical space. By applying proprietary encoding technology to oligonucleotide therapeutic candidates, all possible sequences or chemical modification patterns can be evaluated to increase activity, reduce toxicity, and improve delivery. Elsie also applies proprietary P(V) chemistry technologies, encompassing a suite of novel reagents and processes, to synthesize diverse oligonucleotide therapeutics with complete synthetic control.

Phil Baran, Ph.D., Cofounder, Elsie Biotechnologies, said, "By leveraging all the tools across Elsie’s platform, we can explore the entire chemical oligonucleotide space and uniquely define inter-nucleotide linkages and stereo chemistry to tune safety, activity, and delivery of oligonucleotide therapeutics." Phil Dawson, Ph.D., Cofounder, Elsie Biotechnologies, concluded, "We believe this approach will overcome the historical drug development limitations of this space and expand the use case for oligonucleotide medicines to previously intractable diseases."

Under the terms of the agreement, Elsie will receive an upfront collaboration payment from GSK to conduct initial research activities. Upon exercising the option during the research term, GSK would be obligated to make further payments including licensing fees, development, and commercial milestones.

Pyrotech Therapeutics Announces Completion of 700 Million RMB Series A Financing

On July 10, 2023 Pyrotech Biotechnology, a company dedicated to developing revolutionary innovative drugs for the treatment of inflammation and cancer, reported that it has recently raised a RMB700 million ($97 million) Series A financing round (Press release, Pyrotech, JUL 10, 2023, View Source [SID1234643785]). The company has raised more than RMB1 billion since it was founded in 2020.

This round of financing was led by SDIC Venture Capital and China Venture Capital Innovation Investment Fund, with participation from Taiping Innovation Capital, China Life Investment, Lotus Lake Capital, and follow-on investments from seed round investors such as MSA Capital, LAV, FreeS Fund, LSV Capital, BioTrack Capital, Greenwaters Fund and CTID. Pyrotech Therapeutics’ research and development pipeline consists of multiple projects focusing on the fields of innate immune and pyroptosis, addressing indications including various inflammatory diseases and oncology. The funds raised in this round will be used to advance the clinical-stage pipeline, accelerate preclinical research for multiple projects, further expand the research and development pipeline, and enhance the already talented team.

Pyrotech Therapeutics was co-founded by Dr. Feng Shao and Dr. Tianjing Deng in October 2020, with the mission to become a leading global Chinese biopharmaceutical company driven by original innovations based on the scientific discoveries of Chinese scientists. The scientific foundation of Pyrotech Therapeutics is built upon Dr. Shao Feng’s globally leading biological discoveries in the fields of innate immune and pyroptosis. The company has chosen unaddressed medical key issues in inflammation and oncology for its primary research focus, establishing the "Molecular Switches of Pyroptosis and Innate Immune Regulation" technology platform. Through independent research and collaboration with leading medical translational institutions both domestically and internationally, the company is dedicated to developing revolutionary innovative drugs for the treatment of inflammation and tumors, aiming to benefit global patients suffering from these conditions based on innovations that originated in China.

Pyrotech Therapeutics has established research centers in Beijing, Shanghai, and the United States, and has built a top-notch international drug development team of over 100 employees. The company is engaged in multiple small molecule and gene regulation global first-in-class new drug development projects. Several projects have achieved breakthrough progress, including the development of pyroptosis inhibitors and innate immune modulators. Among them, the innate immune agonist is expected to begin a clinical study in early 2024, and the pyroptosis inhibitor is on track to select a drug candidate and enter clinical evaluation later in 2024.