On September 26, 2024 Epitopea, a transatlantic cancer immunotherapy company, and CQDM reported the launch of a collaborative research project between Epitopea and Université de Montréal (UdeM), a leading Canadian research institution renowned for scientific innovation and technology transfer (Press release, Epitopea, SEP 26, 2024, View Source [SID1234646875]). Together, they will examine the feasibility of developing new immunotherapies to effectively treat patients with lung and ovarian cancers. This collaborative program was made possible by a grant of Canadian $1,499,457 from the government of Quebec.

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CryptoMapTM is a platform resulting from the work of Professors Claude Perreault and Pierre Thibault at the Institute for Research in Immunology and Cancer (IRIC) of UdeM. This platform has already allowed identification of non-mutated tumor antigens, uniquely expressed by cancer cells present in patients with the same type of cancer, called Cryptigens. During this project, novel CryptigenTM sets will be identified from patients with diverse origins enabling the creation of universal RNA-coding cancer vaccines targeting this new class of antigens. Epitopea will validate this unique approach to stimulate the immune system to precisely recognize and destroy cancer cells more rapidly and effectively.

This project has the potential to ‘unveil’ an unprecedented collection of CryptigensTM, an approach that distinguishes Epitopea from other cancer vaccine companies. Based on these data, Epitopea will be positioned to develop new RNA-based immunotherapies from this vast collection of patients samples and advance these innovative products into clinical trials. Epitopea’s mission aligns perfectly with Quebec’s initiatives to develop expertise in the field of RNA vaccines, as was highlighted in the recent AReNA announcement, Quebec’s new RNA cluster, which aims to position Quebec as a leader in RNA-based therapies(1).

"Our government is pleased to support CQDM’s initiative to facilitate research into new RNA-targeting therapies for the treatment of various forms of cancer. Québec is a global centre for innovation in the life sciences, and we remain committed to pushing forward on behalf of all Quebecers who are affected by cancer in one way or another,"

said Christine Fréchette, Minister of the Economy, Innovation and Energy, Minister responsible for Regional Economic Development and Minister responsible for the Greater Montreal Area.

"We are very pleased to partner with CQDM, UdeM, and our scientific co-founders, Drs. Perreault and Thibault to further extend the patient population that could potentially benefit from Epitopea’s transformative approach to treating cancer,"

commented Epitopea’s CEO, Alan C. Rigby.

"Epitopea will initially deploy these CryptigensTM in an off-the-shelf cancer vaccine approach, which we believe offers significant competitive advantages over personalized cancer vaccines being developed by many other organizations in the RNA immunotherapy ecosystem. Thanks to its refined versatility, we believe that the CryptoMapTM platform developed at UdeM could be applied to a wide range of tumor types, positively impacting patient responses in Quebec and across the globe."

"CQDM is proud to support a project that could transform the lives of cancer patients by providing accessible and effective RNA therapeutic solutions for difficult-to-treat diseases. This innovative collaboration between the Université de Montréal and Epitopea illustrates Quebec’s dynamism as a world leader in immunotherapy research. Not only will this project strengthen our understanding of cancer treatments, it will also position Quebec as a key player in the global vaccine and RNA therapy industry,"

On September 26, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells, reported the pricing of an underwritten public offering of (i) 11,564,401 shares of its common stock and accompanying common stock warrants to purchase an aggregate of 2,891,100 shares of common stock and, (ii) to certain investors in lieu of common stock, pre-funded warrants to purchase 12,435,599 shares of common stock and accompanying common stock warrants to purchase an aggregate of 3,108,900 shares of common stock (Press release, Cue Biopharma, SEP 26, 2024, View Source [SID1234646893]). Each share of common stock and accompanying common stock warrant are being sold together at a combined public offering price of $0.50, and each pre-funded warrant and accompanying common stock warrant are being sold together at a combined public offering price of $0.499. The aggregate gross proceeds of the offering are expected to be approximately $12.0 million, before deducting underwriting discounts and commissions and other offering expenses. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately and will be exercisable until all of the pre-funded warrants are exercised in full. Each common stock warrant will have an exercise price of $0.50 per share, will be exercisable immediately and will expire five years from the date of issuance. The offering is expected to close on or about September 30, 2024, subject to satisfaction of customary closing conditions. All of the securities are being offered by Cue Biopharma.

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Oppenheimer & Co. Inc. is acting as sole book-running manager for the offering. Newbridge Securities Corporation is acting as co-manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-271786) relating to the securities to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") on May 9, 2023 and declared effective on May 26, 2023. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and final prospectus supplement relating to the offering may also be obtained by contacting: Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release does 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.

On September 26, 2024 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported that Dr. Jeffrey Miller, MD1, from the University of Minnesota Medical School and GT Biopharma’s Consulting Senior Medical Director, will participate in a panel discussion on innovative therapies for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) at the 3rd Annual ROTH Healthcare Opportunities Conference taking place October 9, 2024 in New York, NY (Press release, GT Biopharma, SEP 26, 2024, View Source [SID1234646876]). Company management will also be participating in 1×1 meetings during the event.

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3rd Annual ROTH Healthcare Opportunities Conference – October 9, 2024
Title: Panel 4 – Focus: Hematologic malignancies
Date: Wednesday, October 9, 2024
Time: 1:15-1:55 pm ET
Participant: Dr. Jeffrey Miller, MD, Deputy Director, Masonic Cancer Center, Co-Leader Immunology Program at the University of Minnesota Medical School & Consulting Senior Medical Director, GT Biopharma

If you are interested in arranging a 1×1 meeting request with management, please contact your ROTH representative.

On September 26, 2024 ImmunoPrecise Antibodies Ltd.(the "Company" or "IPA") (NASDAQ: IPA), ImmunoPrecise Antibodies Ltd. (the "Company" or "IPA") (NASDAQ: IPA), an AI-driven biotherapeutic research and technology company, reported the clinical progress achieved with rabbit monoclonal antibodies designed and developed using IPA’s proprietary B Cell Select platform for the clinical-stage company, OncoResponse Inc (Press release, ImmunoPrecise Antibodies, SEP 26, 2024, View Source [SID1234646877]). This achievement underscores IPA’s leadership as a Contract Research Organization creating high-quality therapeutic antibodies, while pioneering work in the field of rabbit monoclonal antibody development. These antibodies are rapidly gaining recognition as a unique tool in therapies due to their distinctive properties, advancing into clinical trials aimed at improving patient outcomes.

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OncoResponse’s Breakthrough in Cancer Treatment

In a live presentation at the recent PEGS 2024 conference, OncoResponse shared exciting updates on two novel antibodies, OR502 and OR641, both of which were discovered and refined using IPA’s innovative B Cell Select platform:

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OR502, a novel, humanized anti-leukocyte immunoglobulin like receptor B2 (LILRB2) antibody, has successfully entered Phase I/II clinical trials, showing excellent safety profile, and is being evaluated for efficacy in treating advanced solid tumors. Preclinical models have demonstrated that OR502 is a best-in-class anti-LILRB2 antibody that reverses immunosuppression caused by myeloid cells in the TME.
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OR641, a novel, humanized dual antagonist antibody targeting both LILRB1 and LILRB2, has completed Cell Line Development and is undergoing IND-enabling studies. Preclinical models have demonstrated its superior ability to reverse immunosuppression caused by myeloid and lymphoid cells compared to other anti-LILRB1/2 antibodies.

Driving Antibody Discovery and Design for Clinical Success

IPA’s proprietary B Cell Select platform has been instrumental in the rapid design and discovery of antibodies that have advanced to clinical stages for numerous clients. By preserving the natural structure of antibodies, IPA’s technology supports optimal functioning of the therapies in a clinical setting. Through comprehensive testing and validation, the process ensures that these antibodies maintain their efficacy and reliability from the lab to the clinic.

"At ImmunoPrecise Antibodies, our mission is not just to develop antibodies, but to redefine what’s possible in therapeutic interventions," said Dr. Jennifer Bath, President and CEO of IPA. "Our innovative platform, built on years of expertise, has consistently delivered antibodies with superior qualities, many of which are now advancing in clinical trials. This reflects our unwavering commitment to innovation and our strategic advantage in the market. We are proud to support our clients in bringing groundbreaking, life-changing treatments to patients around the world, reinforcing the long-term value of our technologies."

Harnessing Rabbit B Cell Technology for Breakthrough Antibody Discovery

The Rabbit B Cell platform, a rapidly advancing technology in therapeutic antibody development, played a pivotal role in the discovery process. This platform excels at generating high-affinity and highly specific rabbit monoclonal antibodies, a demand met with very limited providers in the market.

IPA has successfully utilized their B Cell Select platform in over 200 antibody programs, achieving remarkable success against a variety of targets, including small molecules, peptides, and proteins. The distinctive properties of rabbit antibodies, combined with IPA’s expertise, have consistently led to the development of promising therapeutic candidates. Building on this success, IPA is now offering more complex therapeutic rabbit antibody campaigns as a partnering model, providing companies with greater flexibility in structuring their more complicated programs.

Outlook

The field of rabbit monoclonal antibody (mAb) therapeutics is advancing rapidly, driven by innovations in antibody engineering and humanization techniques. These advancements are making rabbit mAbs increasingly popular for human therapeutic use. The unique properties of rabbit antibodies, combined with IPA’s full-service technologies, such as in silico humanization, indicate a strong potential for more rabbit-derived mAbs to enter clinical trials and achieve approval in the coming years. The distinctive advantages of rabbit antibodies make them a promising foundation for future therapeutic development. As this technology progresses, IPA remains at the forefront, harnessing these innovations to bring new, effective treatments to the clinic, reinforcing our growing leadership in the industry.

Dr. Kamal D. Puri, Chief Scientific Officer of OncoResponse, recognized IPA’s pivotal role in their success, praising the quality and reliability of IPA’s antibody discovery services. "We are thrilled to have worked with IPA to discover our lead therapeutic antibodies. The IPA team’s deep experience and know-how with a battery of customized, high-throughput discovery strategies has played a critical role in the successful discovery of our molecules with unsurpassed speed and efficiency," said Kamal D. Puri, Chief Scientific Officer of OncoResponse.

About OR502

LILRB2 is an immunoinhibitory receptor expressed on tumor-associated macrophages (TAMs) found in the tumor microenvironment (TME). TAMs inhibit the activity of checkpoint inhibitor (CPI) therapy and prevent T cells from killing tumors. Blocking the inhibitory activity of TAMs and promoting the activity of tumor-killing T cells reverses inhibition of CPI therapy, potentially leading to more and deeper responses to CPIs in patients. This is the mechanism of OR502, which modulates LILRB2 by blocking its engagement of HLA-G on tumor cells and prevents the suppression of the myeloid cells. Elevated expression of LILRB2 correlates with reduced patient survival in various tumor types. This humanized monoclonal antibody, OR502, targets LILRB2 and blocks the inhibitory activity of TAMs and promotes the activity of tumor-killing T cells, reversing inhibition of CPI therapy.

On September 26, 2024 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, reported to advance its Natural Killer (NK) cell therapy, INKmune, in a Phase I/II trial (the "CaRe PC" trial) for men with metastatic Castration-Resistant Prostate Cancer (mCRPC) (Press release, INmune Bio, SEP 26, 2024, View Source [SID1234646878]). The Company is pleased to announce initial results from the first patient cohort in the trial.

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Mark Lowdell, CSO and inventor of INKmune, said, "The enrollment of the first cohort ran entirely in-line with our predicted timelines and confirmed the excellent safety profile with all patients receiving treatment as out-patient without the need for pre-medication of any kind. Furthermore, even at this lowest dose of INKmune, there is clear evidence of persistent immunologic effects of INKmune treatment in these men with mCRPC.

Blinded analysis of the monitoring blood samples from the first three patients showed changes in the phenotype and function of the patient’s NK cells. Although this is the lowest dose cohort, 2 of 3 patients showed an increase in circulating activated NK cells and all three showed increased NK cell function sustained for more than 40 days after the final INKmune infusion. One patient showed a transient 21% decrease in PSA associated with the increase in NK cell activity and function.

The CaRe PC trial has recently completed dosing the last patients in the second of its three dose-escalation cohorts. The third cohort is expected to begin in approximately 30 days. The dose of INKmune in the second and third cohort is 3 and 5 times the dose of INKmune in the first cohort. All eight clinical sites are now open and additional results from the trial will be released from the higher dose cohorts as they become available.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins. INKmune is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer. INKmune is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the United States.