On February 10, 2025 BioRay Pharmaceutical Co., Ltd. ("BioRay") reported that the National Medical Products Administration (NMPA) has accepted the clinical trial application for its self-developed Class 1 innovative therapeutic biological product, BR111 for injection (Press release, BioRay Pharmaceutical, FEB 10, 2025, View Source [SID1234650146]). BR111 is an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, intended for the treatment of ROR1-positive hematological malignancies and solid tumors.

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ROR1 is a transmembrane receptor tyrosine kinase protein that is either not expressed or expressed at low levels in normal tissues, but is highly expressed in various hematological malignancies and solid tumors, such as lymphoma, breast cancer, ovarian cancer, and lung cancer. ROR1 is involved in the non-canonical Wnt signaling pathway mediated by Wnt5a, regulating the growth and invasion of tumor cells. It is closely associated with tumorigenesis and drug resistance, making it a potential target for oncology drug development. To date, no ROR1-targeting drugs have been marketed.

BR111 utilizes BioRay’s next-generation CysX irreversible site-specific conjugation technology platform to conjugate an antibody targeting dual epitopes of ROR1 with the small-molecule toxin eribulin. It is the world’s first anti-ROR1 Bi-paratopic ADC to enter clinical trials. BR111 can recognize two non-overlapping epitopes of ROR1 on the surface of tumor cells, and dual-epitope recognition brings stronger affinity and endocytosis. Once endocytosed into ROR1-positive tumor cells, BR111 releases the small-molecule toxin in the lysosome, effectively killing tumor cells. Developed using the CysX platform, BR111 has higher homogeneity and circulating stability, significantly reducing toxin release in circulation, which enhances safety and optimizes the therapeutic window.

In preclinical studies, BR111 demonstrated superior in vivo anti-tumor efficacy compared to its clinical counterparts in multiple animal models and exhibited better safety. Additionally, BR111 can induce a bystander effect and activate immune response in the tumor microenvironment, showing potential for combination therapy with various drugs, including targeted therapies and immunotherapies.

The acceptance of this project application is a testament to BioRay’s R&D capabilities and a validation of the CysX platform technology. Moving forward, BioRay will continue to focus on clinical needs, drive innovative research, and advance biopharmaceutical technology, with the goal of delivering more effective and safer treatment options to patients through innovative drugs.

On February 10, 2025 Foresee Pharmaceuticals (TPEx: 6576) ("Foresee") reported the acceptance of an abstract for presentation at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Genitourinary (ASCO-GU) Cancers Symposium conference, which will be held at the Moscone Convention Center West in San Francisco, CA, from February 13 to 15, 2025 (Press release, Foresee Pharmaceuticals, FEB 10, 2025, View Source [SID1234650145]).

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The abstract is titled: "Global, Phase 3, Open-Label, Single-Arm Studies to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg (Triptorelin Mesylate Injection, 11.25 mg) and FP-014, 22.5 mg (Triptorelin Mesylate Injection, 22.5 mg) in Patients with Advanced Prostate Cancer (KATANA studies).", and highlights our commitment to improve advanced prostate cancer treatment. Building on the success of CAMCEVI and our SIF-LAI technology, the KATANA studies will help evaluate the efficacy and safety of FP-014 11.25 mg every 3 months and 22.5 mg, every 6-months injections which have the potential to provide significant benefits for patients with advanced prostate cancer, with its unique and differentiated profile offer substantial benefits for an opportunity to become the only available ready-to-use triptorelin long-acting injectable ("LAI").

Poster Board Number: M3

Abstract Number: TPS284

Session Title: Trials in Progress Poster Session A: Prostate Cancer

Date and Time: Thursday, February 13, 2025, from 11:25 AM-12:45 PM PT

Location: Level 1, West Hall

(View Source)

"This prestigious event brings together leading urology, oncology, and cancer research experts to discuss the latest advancements and findings related to prostate cancer," said Dr. Yisheng Lee, Chief Medical Officer at Foresee. "The accepted abstract presents our differentiated FP-014 Phase 3 clinical program and highlights our broad efforts in developing new treatment modalities and differentiated treatments for prostate cancer patients, contributing to the ongoing dialogue surrounding prostate cancer care and research," added Dr. Lee.

"This acceptance demonstrates the success of Foresee’s pioneering SIF-LAI technology across several product types and indications, further highlighting the broad potential of this technology in developing best-in-class ready-to-use LAI’s," said Dr. Yuhua Li, Chief Technology Officer at Foresee.

"It represents an important opportunity for our work to be recognized globally," said Dr. Ben Chien, Foresee’s Chairman and CEO. "We are excited to initiate our studies later this year, as we see a remarkable opportunity to capture a significant share of the triptorelin market around the world in view of FP-014’s best-in-class profile."

The abstract will become available on the Foresee website after the conference.

About FP-014 (triptorelin)

FP-014 (triptorelin) is a ready-to-use, subcutaneous, long-acting injectable dosage form administered every three months or six months, thereby reducing the frequency of administration to patients to ensure better compliance.

Triptorelin is a common palliative treatment for men with advanced or metastatic prostate cancer. It is also prescribed for the treatment of premenopausal breast cancer, precocious puberty, endometriosis, uterine fibroids, etc.

On February 10, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the appointment of Joshua Bleharski, Ph.D. as Chief Financial Officer (Press release, Ideaya Biosciences, FEB 10, 2025, View Source [SID1234650144]). Dr. Bleharski joins IDEAYA from J.P. Morgan, where he spent nearly 17 years advising clients in the biopharma sector on capital markets transactions, corporate strategy and other investment banking services. IDEAYA anticipates that Dr. Bleharski will complete the transition into his new role by early May.

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"We are ecstatic to welcome Josh to IDEAYA as we advance our broad potential first-in-class precision medicine oncology pipeline and build a fully integrated biotechnology company. Josh is a highly accomplished finance executive, with extensive corporate finance, strategy, public financing, and strategic transactions experience that will be invaluable as we drive forward our vision to build the industry leading precision medicine oncology company," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

"I am thrilled to be joining IDEAYA during this exciting phase of growth as the company advances 6 potential first-in-class clinical programs and 3 preclinical programs through IND-enabling studies across multiple solid tumor indications. I look forward to working alongside their team of talented, dedicated professionals to realize our collective vision of building a leading precision medicine oncology company focused on scientific innovation and addressing high unmet medical needs in cancer," said Dr. Bleharski.

Prior to IDEAYA, Dr. Bleharski served as a Managing Director and Global Co-Head of Biopharma with J.P. Morgan’s Healthcare Investment Banking group. Over the course of his banking career he advised on numerous financing and strategic transactions representing more than $65 billion of value for biotechnology companies worldwide. Earlier in his career he worked as a Senior Staff Scientist at a private biotechnology company in San Diego and was a post-doctoral fellow at the La Jolla Institute for Allergy and Immunology (LIAI) and the UCLA School of Medicine. Dr. Bleharski holds a BS in Biology from Duke University, a Ph.D. in Immunology from the University of California, Los Angeles and an M.B.A. from the Haas School of Business at the University of California, Berkeley.

On February 10, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company dedicated to developing innovative therapies for unmet medical needs, reported its collaboration with OnTargetx R&D Inc. to advance research for its cancer-fighting therapeutic, HT-KIT (Press release, Hoth Therapeutics, FEB 10, 2025, View Source [SID1234650143]). This immunohistochemistry study, conducted in partnership with Charles River Laboratories Montreal ULC, represents a key step in the preclinical development of HT-KIT.

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The study focuses on:

Development and optimization of staining methods for (c-Kit) markers, a critical target in HT-KIT therapeutic mechanism.

Processing and qualitative evaluation of tissue samples by a board-certified pathologist to determine the presence of markers.

Comprehensive reporting and insights to support the continued development of HT-KIT.

"This partnership is instrumental in our efforts to advance HT-KIT, a promising therapeutic aimed at targeting c-Kit in cancer treatments," said Robb Knie, CEO at Hoth Therapeutics. "We are committed to driving innovative solutions that can transform patient care."

The study aligns with Hoth Therapeutics’ mission to accelerate groundbreaking therapies and address unmet medical needs in oncology.

About HT-KIT

HT-KIT is Hoth’s preclinical therapeutic candidate targeting c-Kit, a receptor tyrosine kinase involved in various cancers. This candidate represents a potential advancement in precision oncology therapies.

On February 10, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported the first Cohort B patient in the ACHIEVE Phase 2B UK clinical trial, evaluating TCB008 in Acute Myeloid Leukemia, has completed the full dosing regiment (Press release, TC Biopharm, FEB 10, 2025, View Source [SID1234650141]).

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The ACHIEVE trial is an open-label Phase II study dedicated to evaluating the efficacy and safety of TCB008. This trial is focused on assessing the treatment’s effectiveness and tolerability on patients suffering from acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML) with challenging cases such as refractory or relapsed conditions. Cohort B recruits patients who have achieved remission following previous treatment yet continue to have a detectable or minimal residual disease (MRD).

Recruitment into Cohort B was initiated during the fourth quarter of 2024, ahead of the Company’s anticipated schedule. The first Cohort B patient received their dose in October 2024. The initial Cohort B patient has completed the dosing regiment, receiving all four planned doses of TCB008, and is expected to receive an additional fifth dose. Enrolment of a second Cohort B patient has also been initiated.

The safety objectives and endpoints of ACHIEVE evaluate patient responses to TCB008, including; grading of adverse events experienced and the incidence and severity of cytokine release syndrome and neurotoxicity. In a review of preliminary data, there are no drug-related adverse events following cumulative infusions of TCB008, containing up to a billion cells. These data continue to support the positive safety profile of TCB008 and the ACHIEVE UK study safety objectives and endpoints.

"The ACHIEVE study progressed at an incredible rate in 2024," stated Alison Bracchi, EVP of Clinical Operations. "Thanks to the hard work and dedication of both the TC BioPharm team and Clinical sites, we’ve reached a significant study milestone in under six months. We’re seeing a fantastic safety profile from our initial data review and exciting efficacy signals that indicate cellular recovery and a reduction of inflammation in AML patients. The TC BioPharm team and I are inspired by the progress to date and look forward to sharing further updates on Cohort B."

"The progression of ACHIEVE, with dosing underway in the second cohort, is a key milestone in the clinical development of our gamma delta therapy candidate TCB008. We believe it has potential to serve as an efficacious treatment for AML patients, whom still have significant unmet needs," said Bryan Kobel, CEO of TC BioPharm. "The therapy has been well-tolerated with no unexpected events or toxicities observed and promising efficacy results observed in some patients, with additional data being collected and analyzed. Cohort B is an extremely compelling patient population for TCB008 for many reasons, including patients having a more intact immune system to amplify the impact of TCB008 and the lack of true treatment options for these patients who are unfortunately on a path to relapse. We expect to complete enrolment in the second cohort in the first half of 2025, with data readout anticipated later this year."