On January 8, 2025 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage immunology company advancing RNA therapeutics to conquer cancer, reported its participation at the 43rd Annual JP Morgan Healthcare Conference, taking place January 13-16, 2025 (Press release, Myeloid Therapeutics, JAN 8, 2025, View Source [SID1234649521]).

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Daniel Getts, Ph.D., CEO of Myeloid, will present on Wednesday, January 15, 2025, at 8:30 am PT. Company management will also participate in one-on-one meetings with investors during the conference.

On January 8, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision T cell activation, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to invikafusp alfa (STAR0602), Marengo’s first-in-class selective dual T cell agonist being studied as a potential new treatment for advanced colorectal cancer with TMB-H (Press release, Marengo Therapeutics, JAN 8, 2025, View Source [SID1234649520]). Fast Track designation is designed to facilitate the development and expedite the review of therapies intended to treat serious or life-threatening conditions with unmet medical needs.

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"The FDA’s Fast Track designation is an important milestone for the STAR0602 program and further positions our unique selective dual T cell agonist platform as a promising solution to address key challenges that perpetuate significant unmet needs in oncology," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "This recognition specifically validates the promise of STAR0602 as a novel treatment option for patients with TMB-H metastatic colorectal cancer, which is insensitive to PD-1 treatment."

The FDA’s decision is informed by the encouraging results from Marengo’s first-in-human Phase 1 clinical study of invikafusp alfa in heavily pretreated cancer patients, which were recently presented during a plenary oral session at the 2024 SITC (Free SITC Whitepaper) Annual Meeting and an oral presentation at the 2024 ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress. The data reinforce invikafusp alfa’s anti-tumor activity and favorable safety profile.

"Marengo’s selective Vβ T cell activation approach targeting specific T cell subsets enriched in Tumor-infiltrating lymphocytes to enhance anti-tumor activity is unique and highly promising," said Bruce Chabner, M.D., Clinical Director Emeritus for the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School. "The Phase 2 clinical investigation of invikafusp alfa is ongoing and this novel treatment could lead to a new class of therapeutics for tumor types that are PD-1 insensitive or resistant, especially in colorectal cancer where current treatment options remain limited."

Marengo is committed to advancing STAR0602 – the asset entered Phase 2 clinical trials at the end of 2024, and the company expects to report additional efficacy results later this year.

On January 8, 2025 Taiho Oncology, Inc. reported presentations at the 2025 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), to be held Jan. 23-25, 2025, in San Francisco (Press release, Taiho, JAN 8, 2025, View Source [SID1234649519]). The poster presentations include a comparison of real-world clinical outcomes of patients with metastatic colorectal cancer (mCRC) who received trifluridine and tipiracil (FTD/TPI) monotherapy or FTD/TPI + bevacizumab (FTD/TPI+bev) combination therapy and an additional analysis of the same dataset on real-world clinical outcomes in 639 black patients with mCRC.

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"Access to real-world clinical outcomes of FTD/TPI monotherapy versus FTD/TPI+bev combination therapy among patients with mCRC, could provide valuable insights to ultimately help improve clinical development and treatment protocols, broadly and in underrepresented populations," said Tehseen Salimi, MD, MHA, Senior Vice President and Head of Medical Affairs, Taiho Oncology. "At Taiho Oncology, our understanding of patient experience is a driving force that allows us to bring innovative cancer therapies to patients."

Details for both studies and data to be presented can be found below:

Title: Real-World Clinical Outcomes of Patients (Pts) with Metastatic Colorectal Cancer (mCRC) Who Received Trifluridine-Tipiracil (FTD-TPI) Monotherapy or FTD-TPI + Bevacizumab (FTD-TPI+bev) Combination Therapy
Abstract Number: 79
Session Name: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date: Jan. 25, 2025
Session Time: 7 – 7:55 a.m. PST
Location: Level 1, West Hall | On Demand
Presenter: Maliha Nusrat, MD, MS

Title: Real-World Clinical Outcomes of Trifluridine-Tipiracil Monotherapy (FTD-TPI) and FTD-TPI + Bevacizumab Combination Therapy (FTD-TPI+bev) in 639 Black patients (pts) with Metastatic Colorectal Cancer (mCRC)
Abstract Number: 81
Session Name: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date: Jan. 25, 2025
Session Time: 7 – 7:55 a.m. PST
Location: Level 1, West Hall | On Demand
Presenter: Maliha Nusrat, MD, MS

On January 8, 2025 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel, first-in-class biologic therapy to treat solid tumors and chemotherapy-induced peripheral neuropathy (CIPN), reported a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), being held January 23-25, 2025, in San Francisco, CA. Poster details are included below (Press release, Bexion, JAN 8, 2025, View Source [SID1234649518]).

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Poster Details:

Session Title: Trials in Progress Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date: January 25, 2025
Abstract Number: TPS320
Abstract Title: "BXQ-350, a novel sphingolipid metabolism modulator, in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal cancer (mCRC) patients: A phase 1b/2 study."

More details on the conference can be found at the ASCO (Free ASCO Whitepaper) GI website at conferences.asco.org/gi/attend.

About BXQ-350

Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional sphingolipid activator protein, Saposin C, and a phospholipid. Multiple Phase 1 clinical trials in adult and pediatric patients have demonstrated a robust safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumor types. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy, an area of high unmet medical need in patients treated with oxaliplatin and other chemotoxic agents.

On January 8, 2025 Samsung Biologics (KRX: 207940.KS), a global contract development and manufacturing organization (CDMO), reported to extend collaboration with LigaChem Biosciences (KOSDAQ: 141080) to provide antibody-drug conjugate (ADC) services (Press release, Samsung BioLogics, JAN 8, 2025, View Source [SID1234649517]).

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Samsung Biologics will support a series of LigaChem Biosciences’ ADC programs at Samsung Biologics’ new dedicated ADC facility. The two companies have already been collaborating on ADC programs for the treatment of solid tumors. LigaChem Biosciences is a biotech pioneering research and development of ADC candidates.

"The latest collaboration will further strengthen Samsung Biologics’ capabilities across all stages of ADC development and manufacturing as part of our commitment to deliver safe and high-quality therapeutics to patients," said John Rim, CEO and President of Samsung Biologics. "We look forward to supporting our clients’ innovative ADC pipelines, ensuring the highest quality and timelines are met."

"This collaboration with Samsung Biologics will be an important step toward strengthening the supply chain of high-quality ADC drugs and enhancing the competitiveness of both companies in the global ADC market," said Yong-Zu Kim, LCB’s President and CEO. "By leveraging Samsung Biologics’ extensive experience as a CDMO, we will accelerate the development of our pipeline and quickly provide innovative ADC treatments to patients".

Samsung Biologics’ ADC facility is a segregated suite, equipped with a 500-liter reactor, supporting the development and manufacture of ADC therapies. Building on the company’s track record of expertise in large-scale antibody manufacturing and process engineering, Samsung Biologics’ ADC service scope spans late discovery to development and conjugation.

Samsung Biologics has also been making active investments through the Samsung Life Science Fund in biotech companies pioneering ADC linker technologies, toolbox, and protein engineering.