On October 7, 2024 HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company reported its participation in the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place November 6-10 in Houston, Texas (Press release, HiFiBiO Therapeutics, OCT 7, 2024, View Source [SID1234647055]).

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The company will present a pioneering clinical development strategy, showcasing the predictive power of its Drug Intelligence Science (DIS) platform to guide the Phase I development of two novel monoclonal antibodies: a first-in-class TNFR2 agonist HFB200301 (NCT05238883) and a best-in-class BTLA antagonist HFB200603 (NCT05789069). DIS provides a single cell and AI/ML-driven approach to selecting the most promising tumor types, dose regimen, and patient population for clinical success.

HiFiBiO’s unique DIS approach enables the translation of complex clinical data including patient history, imaging, PK/PD, and genomic sequencing into meaningful patient selection strategies for enhanced clinical benefit. This patient-data guided translational strategy demonstrates the company’s deep commitment to innovative research and impactful therapies to address the highest unmet medical needs.

Details on the poster presentations are as follows:

Title: Predictive and Generative AI to guide the clinical development of HFB200301, a first-in-class TNFR2 agonist: Drug Intelligence Science (DIS).​
Abstract Number: 1233
Session Date: Friday, 8 November 2024
Speaker: Spencer Huggett, PhD, HiFiBiO Inc.

Title: Utilizing Drug Intelligence Science (DIS) for tumor type selection and molecular characterization of HFB200603, a best-in-class B and T Lymphocyte Attenuator (BTLA) monoclonal antagonist.
Abstract Number: 1224
Session Date: Saturday, 9 November 2024
Speaker: Spencer Huggett, PhD, HiFiBiO Inc.

The initial data from these abstracts will be available on the SITC (Free SITC Whitepaper) website starting on November 5 at 9 am EST. Additionally, the posters will be accessible on the HiFiBiO Therapeutics website following the live presentation.

On October 7, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators at Meharry Medical College were selected to present at the upcoming 39thAnnual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting being held November 6-10, 2024 in Houston, Texas (Press release, Genprex, OCT 7, 2024, View Source [SID1234647054]). The collaborators will present a poster on positive preclinical data from a study of the Company’s lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid) evaluating TUSC2’s role in modulating immune responses in cancer.

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"The body of preclinical evidence supporting REQORSA’s potential in the treatment of a variety of cancers continues to grow as we bolster our robust research program for REQORSA with our collaborators at many academic institutions," said Ryan Confer, President and Chief Executive Officer at Genprex. "We are very pleased that our academic partners have been selected to present their findings on REQORSA at this prestigious cancer meeting, and we look forward to this presentation next month sharing more about TUSC2’s role in modulating immune responses in cancer."

The featured Genprex-supported poster to be presented at the 2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting:

Title: "TUSC2 Modulates Cancer Immune Responses"

Collaborator: Meharry Medical College

TUSC2 is the tumor suppressor gene used in REQORSA. REQORSA consists of a TUSC2 gene expressing plasmid encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

On October 7, 2024 Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, reported that, following an intensive strategic review process, Galecto has determined to focus on cancer and liver disease, leveraging its existing clinical stage asset GB1211, which has shown positive results in non-small cell lung cancer (NSCLC) and decompensated cirrhosis clinical studies (Press release, Galecto Biotech, OCT 7, 2024, View Source [SID1234647053]). Galecto further announced that it has bolstered its pipeline with the acquisition of the global rights to BRM-1420, a novel, first-in-class asset developed by Bridge Medicines, a company co-founded by Takeda.

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"Our strategic review process concluded that our best opportunity for building value and changing the lives for patients with severe diseases was to focus on our existing clinical stage compound GB1211 and increase our chance for success by acquiring complementary assets. The addition of BRM-1420 represents a significant advancement in our mission to develop and deliver breakthrough treatments for oncology and liver conditions," said Dr. Hans Schambye, CEO of Galecto. "We are particularly optimistic about BRM-1420’s potential to address challenging genetic subsets of AML and its observed synergistic effects with standard-of-care therapies and menin inhibitors."

"AML is the most common acute leukemia in adults, yet despite available treatments, patient prognosis remains poor with significant unmet needs," said Miles Gerson, Head of Takeda Ventures and Takeda’s Representative to Bridge Medicines. "Bridge Medicines has made considerable progress in recent years developing this new class of drugs and Galecto’s team is well positioned to continue advancing BRM-1420."

As consideration for the acquisition of the global rights of BRM-1420, Galecto issued 62,594 shares of common stock to Bridge Medicines, representing 4.99% of the outstanding shares of Galecto’s common stock as of the date of the asset purchase, and 160.562 shares of a newly-issued Series A preferred stock convertible into 160,562 shares of common stock, or approximately 12.8% of Galecto’s common stock, upon receipt of stockholder approval.

Matthew Kronmiller, Bridge Medicine’s Chief Executive Officer, will be joining Galecto’s management team as the Executive Vice President of Strategy and Chief Business Officer. The transaction was approved by the Boards of Directors of both companies.

Leerink Partners served as the exclusive financial advisor to Galecto and Lazard served as exclusive financial advisor to Bridge Medicines. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to Galecto. Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP is serving as legal counsel to Bridge Medicines.

About BRM-1420

BRM-1420 is a potent and selective ENL-YEATS and FLT3 inhibitor of multiple genetic subsets of AML. It disrupts key oncogenic pathways by inhibiting these domains, showing potent activity in MLLr and NPM1c cell lines. Promising preclinical and in vivo results highlight its efficacy in inhibiting leukemia cell growth and extending survival in AML models. In animal models, BRM-1420 exhibited superior efficacy to both FLT3 and menin inhibitors and was shown to inhibit cell proliferation in primary AML patient samples across multiple genotypes, including MLL-r, NPM1m, cKIT+, FLT3+, TET2+, and TP53+. These mutations are often seen in AML and, in total, could account for greater than 30% of the AML patient population. Many of these mutations have proven difficult to treat with currently available regimens and therefore represent a significant unmet medical need. The Company believes, based on preclinical data, that BRM-1420 could be additive or synergistic when used in combination with the current standard of care (azacitidine, venetoclax, cytarabine, gilteritinib), as well as current therapies under development, such as menin inhibitors.

Galecto plans to file an IND for BRM-1420 in the US in late 2025 or early 2026 and initiate clinical studies in patients with AML thereafter. Exclusive global rights to the program were assigned by Bridge Medicines to Galecto through a license with The Rockefeller University. The pioneering discoveries were a result of collaboration between the Rockefeller University and the Tri-Institutional Therapeutics Discovery Institute (Tri-I TDI), followed by licensing by Bridge Medicines.

On October 7, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that it has entered into a Clinical Manufacturing Agreement with SpectronRx for the production of the diagnostic 64Cu-SAR-bisPSMA product for its Phase III trials (Press release, Clarity Pharmaceuticals, OCT 7, 2024, View Source [SID1234647052]). This agreement builds on the earlier Master Services Agreement and Supply Agreement for the production of the 64Cu isotope, now allowing for a streamlined manufacturing process of both the isotope and the 64Cu-SAR-bisPSMA product at the same facility.

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SpectronRx’s facility enables on-demand 64Cu-SAR-bisPSMA manufacturing and distribution to all 50 states. This provides reliable, universal access of 64Cu-SAR-bisPSMA in the U.S. for Clarity’s Phase III trials, including the ongoing CLARIFY trial in the pre-prostatectomy setting, as well as the upcoming pivotal trial for prostate cancer patients with biochemical recurrence (BCR). The agreement with SpectronRx complements Clarity’s existing supply network, providing a layered and abundant supply approach, which is unique in the radiopharmaceutical space.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are excited to continue strengthening our supply network, ensuring vulnerable patients in need of novel diagnostic options can get access to what we believe is a best-in-class product, on time and at any treatment centre with a positron emission tomography (PET) camera.

"Current-generation radiopharmaceutical diagnostic products rely on isotopes with very short half-lives, specifically Ga-68 with a half-life of ~1 hour and F-18 with a half-life of ~2 hours, which translate into short shelf-lives of the diagnostic products. This limits the use of these products to large treatment centres and hospitals with radiopharmacy facilities nearby that can produce F-18 and/or Ga-68. Cu-64 has an ideal 12.7-hour half-life and can overcome the overwhelming supply restraints of other diagnostic isotopes through central manufacture and distribution across the U.S. from a single facility. At Clarity, we believe that this approach has the potential to reduce disparities in prostate cancer care, providing patients with access to next-generation imaging products, regardless of their geographic location."

SpectronRx has a proven track record in generating multi-curie activities, representative of hundreds of patient doses, in a short irradiation window. SpectronRx also has in-house target preparation and integrated recycling facilities for Ni-64, the starting material for Cu-64 production. As such, the leftover Ni-64 after the initial production cycle can be recycled at SpectronRx. This avoids the inefficiencies, low yields and costs associated with the use of third-party systems for Ni-64 target production and target recycling that are more suited to small-scale on-site cold kit labelling.

"We look forward to swiftly progressing our Phase III trials with the assurance of abundant product supply and seamless distribution across the U.S. as we are getting closer to our ultimate goal of improving treatment outcomes for people with cancer," Dr Taylor said.

The Clinical Manufacturing Agreement is effective as of 8 October 2024 and is for an initial period of 24 months. Cancellation and extension provisions are aligned with industry standard rates.

On October 7, 2024 Celyad Oncology (Euronext: CYAD) (the "Company"), reported two poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held in Houston, November 6-10, 2024 (Press release, Celyad, OCT 7, 2024, View Source [SID1234647051]).

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Poster Presentation Details

Abstract 262: PSMA/NKG2DL tandem CAR T-cells to overcome antigen heterogeneity and improve anti-tumor efficacy against prostate cancer. To be presented on Saturday, November 9 at the Poster session (Cellular Therapies)
Abstract 1133: Efficient, safe and customizable modulation of multiple target genes in CAR T-cells through a miRNA-based shRNA platform. To be presented on Friday November 8 at the Poster session (Immuno-Engineering)
Posters will be available in the poster hall and virtually to registrants of the SITC (Free SITC Whitepaper) Annual Meeting, beginning Nov. 7 at 10 a.m. ET. Posters will also be archived under "Scientific Publications" in the Science section of the Company’s website located at www.celyad.com.