On February 10, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported that data from the ARC-20 study will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium taking place February 13 – 15, 2025, in San Francisco, CA (Press release, Arcus Biosciences, FEB 10, 2025, View Source [SID1234650148]).

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The oral presentation will highlight safety and efficacy data from three cohorts of ARC-20, which evaluated casdatifan monotherapy in patients that had received both prior TKI and anti-PD-1 therapy. The presentation will include initial data for the 100mg QD tablet cohort, our selected dose and formulation for Arcus’s Phase 3 studies, as well as updated data for the 50mg BID and 50mg QD expansion cohorts of ARC-20.

"We look forward to presenting new data from our ARC-20 study evaluating our HIF-2a inhibitor, casdatifan, in an oral presentation at ASCO (Free ASCO Whitepaper) GU," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The data to be shared support the differentiation of casdatifan, across all key efficacy measures, relative to published data from studies with HIF-2a inhibitors. We are continuing to rapidly advance an extensive and robust development program for casdatifan, including the planned initiation of our first Phase 3 study (PEAK-1) in the first half of this year, a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with volrustomig and the addition of new cohorts to ARC-20 to evaluate casdatifan in the first-line setting. We also look forward to presenting additional data from ARC-20 throughout the year."

Study

Title

Abstract
Number

Session Type &
Title

Session Date
& Time

Casdatifan (HIF-2a Inhibitor)

ARC-20

Casdatifan (Cas) Monotherapy in Patients (pts) with Previously Treated Clear Cell Renal Cell Carcinoma (ccRCC): Safety, Efficacy and Subgroup Analysis Across Multiple Doses from ARC-20, a Phase 1 Open-Label Study

441

Rapid Oral Abstract Session C: Renal Cell Cancer and Penile Cancer

2/15/2025
12:45 PM –
12:50 PM PT

Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 331780 on Tuesday, February 18, 2025, at 5:00 AM PT / 8:00 AM ET. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2a, casdatifan is designed to shut down hypoxic oncogenesis, which blocks tumor growth and key oncogenic pathways, leading to cancer cell death. Clear cell RCC (ccRCC) is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma and other cancers.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 81,600 Americans will be diagnosed with kidney cancer in 2024. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 15%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.

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.