On May 28, 2025 Kexing Biopharm (688136.SH) reported that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previously received the clearance from U.S. Food and Drug Administration (FDA) for IND application on May 21st (Press release, Kexing Biopharm, MAY 28, 2025, View Source [SID1234653461]).

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GB18 is an innovative biologic product developed for the treatment of cancer cachexia, a complication with a prevalence up to 40% to 70% among cancer patients. Currently, no specific biological therapies are available to address the condition, presenting vast market potential. Featuring a unique nanobody-Fc fusion molecular structure, the product demonstrates enhanced stability, bettered bioavailability, and significantly improved performance in inhibiting disease-associated signaling pathways.

Benchmarking against globally leading pipelines with the same target (GDF-15) and indication, Kexing Biopharm’s GB18 features a special nanobody-Fc fusion structure (VHH-Fc), with the patents granted or applied for the molecule globally already. Last October, a research article of GB18’s preclinical study was published in the renowned international academic journal mAbs, which demonstrated that GB18 effectively alleviated weight loss in cancer cachexia models, showing superior weight recovery and improved muscle fibers in both quantity and size compared to the comparator.

In cancer cachexia, the expression level of GDF-15 is significantly elevated, which is closely associated with tumor progression and the severity of cachexia. Therefore, targeting GDF-15 has emerged as a new strategy in addressing the clinical challenge of cancer cachexia. This recent FDA IND approval marks a significant milestone in the Company’s globalization of innovative products.

Approximately millions advanced cancer patients annually in the world are suffering from cachexia. There is a significant unmet clinical need for the indication of cancer cachexia.Kexing Biopharm will remain steadfast in its mission to deliver "Precise Products, Predictable Effects, and Health Protection", with a focus on product quality and a commitment to scientific innovation, and improve the lives of patients worldwide.

On May 28, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported that it will present a poster describing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2025) being held May 30-June 3, 2025 in Chicago (Press release, Azitra, MAY 28, 2025, View Source [SID1234653429]).

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The presentation titled, "Epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity treated with topical application of a novel Staphylococcus epidermidis compound," will highlight Azitra’s multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical trial investigating the safety and tolerability of ATR04-484 for the treatment of EGFRi-induced dermal toxicity in adult patients. ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain that was engineered to be safe by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04-484. Azitra has received Fast Track designation from the FDA for EGFRi-associated rash.

Multiple cancers, including non-small cell lung cancer (NSCLC) and colorectal cancer, are treated with EGFRi therapies that work by blocking the activity of the EGFR protein, which plays a crucial role in cell growth and survival. However, EGFRis are also associated with unique dermatologic toxicities that can hamper treatment efforts and cause significant physical and psychological discomfort for patients, leading some to reduce or even stop these effective treatments.

"We believe topical ATR04-484 has the potential to be an important advance in the treatment of EGFRi-associated skin rash, which is a painful and debilitating condition that often leads patients to suspend use of these life-saving cancer therapies," said Mary Spellman MD, CMO of Azitra. "As we prepare to dose the first patient in the Phase 1/2 clinical trial of ATR04-484, we are excited to present an overview of the study at ASCO (Free ASCO Whitepaper) 2025, which is the preeminent global oncology meeting. The product represents a unique and novel method for treating EGFRi-associated skin toxicities, and we look forward to presenting this technology to leaders in the cancer research community."

Details of the presentation are as follows:

Event:

2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Location:

McCormick Place, Chicago, IL

Track:

Symptom Science and Palliative Care

Poster Title:

Epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity treated with topical application of a novel Staphylococcus epidermidis compound

Presenter:

Mary Spellman, MD, Chief Medical Officer

Poster Number

162b

On May 28, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported it has aligned with the U.S. Food and Drug Administration (FDA) to select 90 mg of palazestrant as the dose for Part 2 of the ongoing registrational Phase 3 OPERA-01 trial in second- and third-line estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer (Press release, Olema Oncology, MAY 28, 2025, View Source [SID1234653446]). This update will be presented as part of the OPERA-01 trial-in-progress poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30-June 3 in Chicago, Illinois. The FDA also selected 90 mg of palazestrant in combination with the approved dose of CDK4/6 inhibitor ribociclib for the pivotal Phase 3 OPERA-02 trial in frontline ER+/HER2- metastatic breast cancer.

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"Metastatic breast cancer treatment continues to be challenged by resistance mechanisms resulting in a clear need for innovative new therapies. We believe the clinical results we have achieved to date for palazestrant across ESR1 mutant and wild-type ER+/HER2- tumors, both in the monotherapy and combination treatment settings, support palazestrant’s potential to have a significant positive impact on breast cancer patients," said Naseem Zojwalla, M.D., Chief Medical Officer of Olema Oncology. "We remain steadfast in our commitment to these patients, and with 90 mg of palazestrant confirmed as the selected dose, we are focused on rapidly advancing our OPERA-01 and OPERA-02 pivotal trials with top-line data from OPERA-01 anticipated in 2026 and a potential commercial launch in 2027."

Poster Presentation Details
Title: OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) monotherapy vs standard-of-care endocrine therapy for patients with ER+, HER2- advanced breast cancer after endocrine and CDK4/6 inhibitor therapy
Abstract Number: TPS1131
Poster Number: 104b
Poster Session: Breast Cancer – Metastatic
Date/Time: June 2, 2025 from 9:00am–12:00pm CT / 10:00am–1:00pm ET

Additional information can be found on the ASCO (Free ASCO Whitepaper) Annual Meeting website, including abstracts. A copy of the poster will be made available on the Publications page of Olema’s website in alignment with ASCO (Free ASCO Whitepaper)’s embargo policy.

About Palazestrant (OP-1250)
Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01. Learn more at www.opera01study.com. Palazestrant is also being evaluated in multiple Phase 1/2 trials in combination with ribociclib, palbociclib, alpelisib, and everolimus. It will also be evaluated in combination with ribociclib in the planned pivotal Phase 3 trial, OPERA-02.

On May 28, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Priority Review to satricabtagene autoleucel ("satri-cel", CT041)(an autologous CAR T-cell product candidate against protein Claudin18.2), for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy (Press release, Carsgen Therapeutics, MAY 28, 2025, View Source [SID1234653462]).

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About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China’s NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA.

On May 28, 2025 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on developing cancer therapies, reported that it will have a poster presentation on 303 Study, the investigator-initiated study supported by Merck (known as MSD outside of the United States and Canada) and BeyondSpring in 2L/3L NSCLC who progressed on PD-1/PD-L1 inhibitors at 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place on May 30 through June 3 in Chicago, IL (Press release, BeyondSpring Pharmaceuticals, MAY 28, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-poster-presentation-at-2025-asco-annual-meeting [SID1234653430]).

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​​Presentation details are as follows:

Title: Phase 2 Study of Pembrolizumab (Pembro) plus Plinabulin (Plin) and Docetaxel (Doc) for Patients (Pts) with Metastatic NSCLC after Progression on First-line Immune Checkpoint Inhibitor Alone or Combination Therapy: Initial Efficacy and Safety Results on Immune Re-sensitization
Presenter / Author : Yan Xu, Minjiang Chen, Xiaoxing Gao, Xiaoyan Liu, Jing Zhao, Wei Zhong, RuiLi Pan, Mengzhao Wang
Presentation Time: Saturday, May 31, 2025, at 1:30PM to 4:30PM CDT
Location: McCormick Place Convention Center
Session / Track: Lung Cancer – Non-Small Cell Metastatic
Abstract Number: 8560
Poster Board Number: 40