On October 17, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported a clinical engagement update of its pivotal Phase 3 study of Bria-IMT in combination with immune check point inhibitor in metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, OCT 15, 2024, View Source [SID1234647245]). The study will enroll up to 354 patients randomized 1:1 to the BriaCell combination regimen or physician’s choice and will include a small number (n=50) of patients randomized to Bria-IMT monotherapy.

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"We are very pleased to report that patient enrollment is on track for expected completion by mid-2025. We anticipate the interim data analysis of the ongoing pivotal Phase 3 study will confirm the effectiveness of the Bria-IMT combination regimen in patients with metastatic breast cancer who failed approved therapies," stated Dr. William V. Williams, BriaCell’s President and CEO.

"Despite multiple approved drugs, breast cancer remains the second-leading cause of cancer death in American women," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We are determined to make our novel immunotherapy available to breast cancer patients whose medical needs remain unmet."

35 clinical sites (18 main and 17 satellite) are active and enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer. Additional sites are in various stages of start-up.

Interim data will be analyzed once 144 events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. Secondary analyses include comparison of the Bria-IMT combination regimen vs Bria-IMT monotherapy. BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient population. The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.

On October 15, 2024 Tolerance Bio, Inc., a biopharmaceutical company pioneering a novel approach to increasing healthspan by preserving, restoring, and manipulating the function of the thymus, the master regulator of immune tolerance, reported the closing of its oversubscribed $17.2 million seed financing round, led by Columbus Venture Partners, with participation from Criteria Bio Ventures, Sessa Capital, BioAdvance, Ben Franklin Technology Partners and individual biotechnology investors (Press release, Tolerance Bio, OCT 15, 2024, View Source [SID1234647220]).

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Tolerance Bio is developing an allogeneic, or "off the shelf," thymus induced pluripotent stem cell (iPSC)-based cell therapy platform as well as pharmacological thymus therapies to address immune-mediated diseases caused by abnormalities in immune tolerance, including cancer, autoimmunity, transplant rejection, infections, immune deficiencies, and allergies.

"Defeating immune diseases has been the lifelong quest of this exceptional team we have assembled, with patients and their families always front and center for us," said Francisco Leon, M.D., Ph.D., Co-Founder and Chief Executive Officer of Tolerance Bio. "We intend to rapidly advance and validate our pioneering concepts in a rare disease and then assess proof-of-concept in multiple major indications, advancing these novel therapeutics to target immune disease at its core."

The thymus, an organ in the chest, plays a crucial role in training T lymphocytes (T cells) to defend against threats such as infections and cancers while preventing autoimmunity. The T cell repertoire is developed in the first two years of life, and the thymus then declines with age, increasing the risk of immune diseases and mortality. Tolerance Bio’s technologies aim to delay and prevent thymic involution and restore thymic function if lost, ultimately addressing these immune diseases and potentially increasing longevity.

The iPSC technologies were initially developed at the University of Colorado and the University of Florida by Holger Russ, Ph.D., Scientific Co-Founder and Associate Professor, Department of Pharmacology and Therapeutics, Diabetes Institute at the University of Florida. The technologies were advanced alongside a proven team of drug and cell therapy developers, including Dr. Francisco Leon, former Co-Founder and Chief Scientific Officer of Provention Bio (acquired by Sanofi in 2023) and former Co-Founder, Chief Executive Officer, and Chief Medical Officer of Celimmune (acquired by Amgen in 2017).

"After pioneering the generation of bioengineered thymuses from iPSC in vitro and in vivo, I am very excited for the opportunity to advance this technology to benefit patients," said Dr. Holger Russ. "I couldn’t have found a more experienced and dynamic team to partner with than the cell and drug therapy experts at Tolerance Bio."

The Tolerance Bio team includes cell therapy experts such as Yeh-Chuin Poh, Ph.D., Vice President of Technical Operations, formerly with Semma Therapeutics (acquired by Vertex Pharmaceuticals in 2019) and Beam Therapeutics. The team also features experienced drug developers such as Justin Vogel, Chief Financial Officer; Phil Ball, Ph.D., Senior Vice President of Business Development and Operations; and Paul Dunford, Vice President of Translational Science. All three formerly worked at Provention Bio and each bring more than 20 years of biopharma experience from leading pharmaceutical companies such as Allergan, Janssen and Roche.

"The mission of Columbus Venture Partners is to support world-class teams to enable transformational technologies to become products and help people in need," said Damia Tormo, Managing Partner of Columbus Venture Partners. "With Tolerance Bio, we not only have the prospect of preventing and treating immune disease but also possibly extending longevity, a tremendously exciting opportunity."

Pablo Cironi, Ph.D., Director at Criteria Bio Ventures added, "We are excited to support Tolerance Bio in their mission to manipulate immune tolerance via thymus-based therapies, potentially transforming the landscape of immune-mediated diseases. The exceptional team at Tolerance Bio, with deep expertise across both cell and drug therapies, is uniquely positioned to bring these groundbreaking treatments to patients. Their combined experience from leading biopharmaceutical companies will be key in advancing these innovative therapies and addressing unmet medical needs in immune disease management."

On October 15, 2024 BPGbio, Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, reported its participation in the US Pharma Partnering Summit, scheduled for October 16, in Boston (Press release, BPGbio, OCT 15, 2024, View Source [SID1234647219]). BPGbio executive Vivek K. Vishnudas, Ph.D., Chief Technology Officer and R&D Site Head, will present a session titled, "A Novel and Differentiated Approach to Targeted Protein Degradation – Leveraging the Ubiquitin Conjugating Enzyme (E2) Family." The session will highlight latest developments in the company’s protein homeostasis program as BPGbio continues to advance the potential E2-based therapeutics in both oncology and neurology.

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"Our unique approach to protein degradation through the ubiquitin conjugating enzyme (E2) family represents a significant step forward in the field of targeted protein degradation (TPD), drugging the long considered ‘undruggable’ and distinguishing us from conventional E3 strategies, which are known to have high susceptibility to resistance mechanisms," said Dr. Vishnudas. "We are excited to share the progress we made with our E2 program in the neurology space such as Huntington’s disease and Alzheimer’s disease, as well as potential oncology indications."

In addition to utilizing E2s, the BPGbio’s protein homeostasis program features a proprietary library of more than 1,000 Ro3 fragments discovered by BPGbio that are potential ligands and seed compounds to a variety of E2 targets, proprietary ternary structures, a computational tool kit for E2 ligand design, and assays for rapidly attaining selectivity and specificity.

"Derived from BPGbio’s NAi Interrogative Biology platform, BPGbio’s E2 program has demonstrated strong and specific E2 binding, overcoming E2’s hard-to-bind challenge and advancing the potential for first-in-class drug design," added John Beeler, Ph.D., SVP of Business Development at BPGbio. "Our team is looking forward to meeting with potential partners in the biopharma industry who want to join us in bringing novel E2-based therapeutics to patients in need or in leveraging our AI capabilities to support their drug discovery and development activities."

BPGbio executives will also provide insights into the company’s growing portfolio of therapeutic targets and candidates, including several that are in late-stage clinical trials, which have been identified through BPGBio’s proprietary AI-powered NAi Interrogative Biology Platform. This platform identifies targets, biomarkers, and drugs and assists the development team through both the developmental and clinical trial stages. The NAi Platform is now commercially available to pharma, academic and government organizations. BPGbio’s therapeutic pipeline includes drug candidates for glioblastoma (orphan drug), pancreatic cancer (orphan drug), primary CoQ10 deficiency (rare pediatric disease designated), epidermolysis bullosa (EB, orphan drug), squamous cell carcinoma (SCC, orphan drug), sarcopenia, solid and liquid tumors, Huntington’s disease (orphan drug) and Parkinson’s disease. The company’s diagnostic pipeline includes its prostate diagnostic test pstateDx, as well as tests being developed and validated for the detection of Parkinson’s disease (ParkinsonDx), pancreatic cancer (PancDx), breast cancer, and liver disease.

On October 15, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that an abstract related to the company’s second generation of proprietary telomere-targeting THIO prodrugs has been accepted for poster presentation during the upcoming 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place October 23-25, 2024, in Barcelona, Spain (Press release, MAIA Biotechnology, OCT 15, 2024, View Source [SID1234647218]). The Symposium is hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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MAIA will present the results of preclinical studies for its new THIO-based prodrugs, designated as MAIA-2021-20 and MAIA-2022-12, which are lipid-conjugated compounds derived from THIO. These second-generation compounds belong to a new chemical class of molecules called telomere targeting divalent dinucleotides. These preclinical studies were designed to evaluate the efficacy of the new molecules alone and in combination with or without immune checkpoint-blocking antibodies (anti-PD-L1).

MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. commented, "Our presentation will demonstrate that treatment with each of the prodrugs studied was highly efficacious and was shown to overcome immunotherapy resistance. Our results have shown marked activity in advanced tumors and resulted in tumor growth inhibition in preclinical models of lung cancer, colorectal carcinoma, melanoma and hepatocellular carcinoma. We are actively working to advance these candidates toward clinical development."

Presentation details:

Title:

New Dual-Pharmacophore Dinucleotide Prodrugs as Potent Telomere Targeting Anticancer Molecules

Abstract number:

ENA24-0044

Session title:

New Drugs

Date and time:

Wednesday, October 23, 2024, at noon CEST

Presenting author:

Ilgen Mender, Ph.D., Director of Biology Research, MAIA Biotechnology

Poster access:

MAIA’s poster will be available at maiabiotech.com/publications on October 23, 2024

MAIA has designed and evaluated more than 80 THIO-like compounds to date and has submitted three U.S. patent applications for its second-generation telomere targeting agents.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On October 15, 2024 BostonGene, a leading provider of AI-driven, molecular and immune profiling solutions, and Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported a collaboration aimed at integrating innovative molecular testing and informatics platforms into clinical decision-making processes at SCRI phase 1 clinics (Press release, BostonGene, OCT 15, 2024, View Source [SID1234647217]). Additionally, the collaboration seeks to validate novel biomarkers using BostonGene’s AI-powered multiomics platform in real-world cancer populations.

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This collaboration will establish robust data connectivity between BostonGene and SCRI’s precision medicine platform Genospace. By integrating BostonGene’s advanced testing platform into clinical workflows at community oncology clinics, the effects of molecular profiling on clinical trial enrollment frequency will be examined, including the impact of human leukocyte antigens (HLA) genotyping on pre-screening patients.

"By integrating BostonGene’s advanced molecular profiling into our phase 1 clinical workflows, physicians are poised to significantly enhance our ability to make precise, data-driven treatment decisions. We look forward to the impact we can make in advancing personalized oncology care through our strategic collaboration," said Andrew McKenzie, PhD, Vice President of Personalized Medicine at SCRI and Scientific Director at Genospace.

BostonGene will provide its CLIA-certified, CAP-accredited Tumor PortraitTM tests to clinicians at SCRI’s phase 1 sites. Comprehensive data analyses by Genospace and SCRI will focus on HLA typing, microenvironment profiles, RNA expression levels, gene alterations, trial enrollment, treatment outcomes, therapy duration and other clinically relevant metrics.

"We are thrilled to collaborate with SCRI, integrating our AI-driven multi-omics platform into select community oncology practices. This collaboration will enable us to personalize cancer treatment more effectively and expedite biomarker discovery and validation, ultimately shifting the standard of care and improving patient outcomes," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.