On April 23, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, reported that it will release the latest clinical data of the CD73 small molecule inhibitor ATG-037 and the mTORC1/2 small molecule inhibitor ATG-008 in Poster Presentations at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 30th to June 3rd in Chicago, IL, the United States (Press release, Antengene, APR 23, 2025, View Source [SID1234652066]).

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Previously, Antengene entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) on the Phase I/IB STAMINA-01 trial evaluating ATG-037 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with anti-PD-1 resistant solid tumors, with encouraging preliminary results in melanoma and non-small cell lung cancer (NSCLC). Currently, the dose optimization and expansion portion of the study is enrolling in China and Australia.

Details of the Poster Presentations:

ATG-037 (CD73 Small Molecule Inhibitor)
Title: A first-in-human phase I/Ib study of ATG-037 monotherapy and combination therapy with pembrolizumab in patients with advanced solid tumors: STAMINA-01
Abstract: 3123
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date: June 2, 2025
Time: 1:30 PM – 4:30 PM (Central Time)
2:30 AM – 5:30 AM, June 3, 2025 (Beijing Time)

ATG-008 (mTORC1/2 Small Molecule Inhibitor)
Title: A TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced cervical cancers with prior anti-PD-(L)1 therapy
Abstract: 5540
Session: Gynecologic Cancer
Date: June 1, 2025
Time: 9:00 AM – 12:00 PM (Central Time)
10:00 PM, June 1, 2025 – 1:00 AM, June 2, 2025 (Beijing Time)

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On April 23, 2025 Grove Biopharma, a private biotechnology company pioneering its Bionic Biologics platform to develop therapies targeting previously intractable intracellular disease targets, reported the close of a $30 million Series A financing (Press release, Grove Biopharma, APR 23, 2025, View Source [SID1234652082]). The round was led by DCVC Bio with participation from Eli Lilly and Company, InVivium Capital, Walder Ventures, Gradiant Corporation, Mansueto Investments, and others. They join existing seed supporters, including Portal Innovations, where Grove was incubated. Proceeds will be used to further advance Grove Biopharma’s proprietary platform and drive its lead oncology programs towards the clinic.

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Bionic Biologics represent a novel therapeutic modality that integrates principles of biologic and synthetic design. This innovative platform enables the targeting of well-validated yet previously intractable disease drivers, unlocking new possibilities for therapeutic intervention. Bionic Biologics combine advancements in precision polymer chemistry with the latest tools of medicinal chemistry, peptide chemistry, AI/ML driven computational chemistry and protein engineering. The result is an integrated platform capable of designing fully synthetic, cell-penetrant, protein-scale molecules that solve protein-scale problems.

"At Grove, we are focused on developing therapeutics for well-understood but historically intractable disease targets, with the goal of delivering better options for patients living with serious illnesses where few, if any, effective therapies exist," said Geoffrey Duyk, M.D., Ph.D., Co-founder and CEO at Grove. "We believe our Bionic Biologics platform represents a true paradigm shift for drug development, enabling us to rapidly develop molecules that can selectively inhibit or degrade even the most challenging intracellular drug targets. We are deeply grateful to our seed and Series A investors for their ongoing confidence and support as we advance this exciting new technology to patients."

"Proteins are the molecular machines that drive all essential cellular function, and dysregulated intracellular protein-protein interactions are the cause of many human diseases," said Nathan Gianneschi, Ph.D., Scientific Founder of Grove Biopharma and Professor at Northwestern University. "Existing drug modalities are either unable to penetrate cells or cannot effectively engage these large disease target domains. Bionic Biologics provide a new approach to this challenge, and I am excited to continue collaborating with the Grove team to advance this new modality to the clinic."

Bionic Biologics provide a new approach to targeting protein-protein interactions (PPI), distinguished by the following key characteristics:

Bionic: Hybrid synthetic biomolecules with enhanced functionality beyond what is possible in nature.
Cell permeable: Multivalent, chameleonic architecture enables membrane permeability for reaching intracellular targets.
Customizable: Plug-and-play design, modular construction and tunable properties to rapidly develop and implement molecules, either monofunctional or bifunctional, against any target.
Grove Biopharma’s Bionic Biologics have been demonstrated in proof-of-concept studies across several validated yet formidable intracellular targets. The company’s pipeline is initially focused on oncology and neurodegenerative diseases, where the advantage of cell-permeability enables therapeutic intervention in these disease pathways. Grove’s lead effort is an androgen receptor signaling program for the treatment of castrate-resistant prostate cancer. Data to date has demonstrated in vivo proof-of-concept and the company is advancing towards an IND submission.

"Grove Biopharma is addressing one of the most important challenges in drug development — targeting intracellular protein-protein interactions—with a novel, synthetic biology-based approach," said Kiersten Stead, Ph.D., Managing Partner at DCVC Bio and Grove board member. "We believe the Bionic Biologics platform has the potential to unlock a whole world of new therapeutic possibilities," Stead highlights. "The combination of approaches Grove is taking will be used to pursue first in-class-medicines with exceptional profiles and ease of manufacturing."

The Grove Biopharma team brings together experienced industry leadership and deep expertise in chemistry, biology, and materials science. Originating from Professor Nathan Gianneschi’s lab at Northwestern University, the Bionic Biologics platform is now being advanced by the Grove Biopharma R&D team, including Paul Bertin, Ph.D., Co-Founder, President and Chief Technology Officer, and Robert Campbell, Ph.D., Chief Scientific Officer.

On April 23, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that an abstract was accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 to June 3, 2025, in Chicago, IL (Press release, Candel Therapeutics, APR 23, 2025, View Source [SID1234652051]). The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer.

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Details are as follows:

CAN-2409 – Localized Prostate Cancer

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Abstract Title: Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard-of-care external beam radiation therapy (EBRT) for newly diagnosed localized prostate cancer
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Presenter: Theodore DeWeese, M.D. *, the Francis Watt Baker, M.D., and Lenox D. Baker Jr., M.D., Dean of the Medical Faculty and CEO, Johns Hopkins Medicine

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Session Title: Oral Abstract Session – Genitourinary Cancer – Prostate, Testicular, and Penile

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Session Date/Time: Tuesday, June 3, 2025; 9:45 AM – 12:45 PM CT

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Location: Hall A, McCormick Place Convention Center, Chicago, IL

Full abstracts will be released by ASCO (Free ASCO Whitepaper) on Thursday, May 22, 2025, at 5:00 PM ET. Details from the presentations will be available following the event on the Candel website at Candel Media.

Dr. DeWeese has no relationship with Candel, other than serving as the national principal investigator for Candel’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer. He has never received reimbursements, consulting fees, or EAB fees from Candel, and he has no shares of common stock, options to purchase common stock or other stake in Candel.

About CAN-2409

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic nucleotide analogue that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of the patient’s own tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity, as well as combination activity with standard of care (SoC) radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors, have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile reported to date, supporting the potential for combination with other therapeutic strategies.

Candel’s clinical development program for CAN-2409 includes completed positive phase 2a clinical trials in both non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), as well as a positive pivotal randomized, placebo-controlled phase 3 clinical trial of CAN-2409 in localized, non-metastatic prostate cancer. In December 2024, Candel announced that CAN-2409 achieved its primary endpoint in this phase 3 clinical trial in men with intermediate-to-high-risk, localized prostate cancer, demonstrating statistically significant and clinically meaningful improvement in disease-free survival when added to SoC radiation therapy +/- androgen deprivation therapy.

In the Company’s randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable PDAC, positive survival data showed notable improvement with an estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 plus SoC versus 12.5 months in the control group in patients with PDAC who only received SoC. Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 6.4 months in the control arm. The final survival data from the phase 2a clinical trial of CAN-2409, in patients with stage III/IV NSCLC, showed an mOS of 24.5 months in 46 evaluable patients receiving 2 courses of CAN-2409 (per protocol population; cohort 1 and 2) and 21.5 months in evaluable patients from cohort 2 (n=41) that had progressive disease at baseline, despite Immune Checkpoint Inhibitor treatment. CAN-2409 plus prodrug has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and localized prostate cancer. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. Candel’s pivotal phase 3 clinical trial in newly diagnosed, localized prostate cancer was conducted under a Special Protocol Assessment agreed with the FDA.

On April 23, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S (Press release, Innovent Biologics, APR 23, 2025, View Source [SID1234652067]).

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Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are delighted to announce that at 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, the first wave of three indications under development for IBI363—melanoma, colorectal cancer(CRC), and non-small cell lung cancer (NSCLC)—have all been accepted for oral presentations, highlighting the significant attention garnered by the next-generation bispecific antibodies, in particular PD-1-based immunotherapy. Additionally, following its oral presentation at ESMO (Free ESMO Whitepaper) Asia last December, the Phase 1b data of IBI343 in pancreatic cancer has once again secured an oral presentation at ASCO (Free ASCO Whitepaper), further solidifying its potential in this challenging therapeutic area. The maturing PoC data for these innovative candidates has strengthened our confidence in advancing them into pivotal-stage development, with the goal of unlocking their clinical value for global unmet clinical needs. As one of the few biopharmaceutical companies with both the advanced technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing physicians and patients with more innovative, effective and safe treatment options."

Details on the abstracts are listed below:

Oral Presentation

1. Presentation Title: Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, in patients with immunotherapy-treated, advanced acral and mucosal melanoma

Abstract Number: 2502
Session Type: Oral Abstract
Session Title: Developmental Therapeutics-Immunotherapy
Session Date & Time: 5/31/2025 3:00 PM-6:00 PM CDT
Presenter: Jun Guo, MD, Beijing Cancer Hospital

2. Presentation Title: Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer

Abstract Number: 104
Session Type: Oral Abstract
Session Title: Clinical Science Symposium—Turning "Cold" Tumors "Hot"
Session Date & Time: 6/1/2025 9:45 AM-11:15 AM CDT
Presenter: Zhenyu Lin, MD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

3. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody, IBI363, in patients with advanced immunotherapy-treated non-small cell lung cancer (NSCLC)

Abstract Number: 8509
Session Type: Oral Abstract
Session Title: Clinical Science Symposium—Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies
Session Date & Time: 6/3/2025 9:45 AM-11:15 AM CDT
Presenter: Jianya Zhou, MD, The First Affiliated Hospital, Zhejiang University School of Medicine

4. Presentation Title: Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): results from a Phase 1 dose expansion cohort evaluating IBI343

Abstract Number: 4017
Session Type: Rapid Oral Abstract
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 6/2/2025 11:30 AM-1:00 PM CDT
Presenter: Xianjun Yu, MD, Fudan University Shanghai Cancer Center

5. Presentation Title: Sintilimab (anti-PD-1) plus ifosfamide, carboplatin and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind Phase 3 study (ORIENT-21)

Abstract Number: 7007
Session Type: Oral Abstract
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Date & Time: 5/30/2025 2:45 PM-5:45 PM CDT
Presenter: Peng Liu,MD, Cancer Hospital, Chinese Academy of Medical Sciences

6. Presentation Title: Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01)

Abstract Number: 3519
Session Type: Rapid Oral Abstract
Session Title: Gastrointestinal Cancer-Colorectal and Anal
Session Date & Time: 6/1/2025 11:30 AM-1:00 PM CDT
Presenter：Changqing Jing, MD, Shandong Provincial Hospital

7. Presentation Title: Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in nasopharyngeal carcinoma: The EP-STAR trial

Abstract Number: 6010
Session Type: Oral Abstract
Session Title: Clinical Science Symposium -Biomarker-Driven Adaptive Therapy: New Horizons in Head and Neck Cancer
Session Date & Time: 6/2/2025 3:00 PM-4:30 PM CDT
Presenter: Ying Sun, MD, Sun Yat-sen University Cancer Center

Poster Presentation

1. Presentation Title: A multicenter, randomized, controlled, open-label, Phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma: Trial in Progress

Abstract Number: TPS9594
Session Type: Poster
Session Title: Melanoma/Skin Cancers
Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT
Presenter: Bin Lian, MD, Peking University Cancer Hospital & Institute

2. Presentation Title: IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: updated results from a Phase 1 trial

Abstract Number: 5565
Session Type: Poster
Session Title: Gynecologic Cancer
Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT
Presenter: Jin Shu, MD, Chongqing University Cancer Hospital

3. Presentation Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients with HER2-positive breast cancer (BC) and other solid tumors: Updates from a Phase 1 study

Abstract Number: 1029
Session Type: Poster
Session Title: Breast Cancer—Metastatic
Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT
Presenter: Charlotte Rose Lemech, BSc, FRACP, MBBS , Scientia Clinical Research

4. Presentation Title: Safety and efficacy of the anti-TROP2 antibody-drug conjugate (ADC) IBI130 in patients with advanced triple-negative breast cancer (TNBC) and other solid tumors: Results from the Phase 1 study

Abstract Number: 1102
Session Type: Poster
Session Title: Breast Cancer—Metastatic
Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT
Presenter: Fan Wu, MD, Fujian Cancer Hospital

5. Presentation Title: A multiregional, randomized, controlled, open-label, Phase 3 study of the anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) arcotatug tavatecan (IBI343) in gastric or gastroesophageal junction adenocarcinoma (G/GEJA): Trial in Progress

Abstract Number: TPS4201
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT
Presenter: Lin Shen, MD, Beijing Cancer Hospital

6. Presentation Title: Phase 2 trial of transarterial chemoembolization followed by sintilimab (anti-PD-1), oxaliplatin, and S-1 combined with either trastuzumab (HER-2 positive) or apatinib (HER-2 negative) as first-line therapy for gastric cancer with liver metastases.

Abstract Number: 4050
Session Type: Poster
Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT
Presenter: Dan Sha, MD, Shandong Provincial Hospital

*Abstracts of TYVYT (sintilimab) are from investigator-initiated clinical trials (IIT), except one abstract, #7007.

On April 23, 2025 Parabilis Medicines (formerly Fog Pharmaceuticals), a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, reported the presentation of preclinical data on its first-in-class targeted protein degrader of ERG at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 25–30, 2025, in Chicago, Illinois (Press release, Parabilis Medicines, APR 23, 2025, View Source [SID1234652083]).

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The transcription factor ERG has been a long-recognized high-value target in prostate cancer, where ERG fusions have been implicated in 40-50% of all cases. Despite its relevance, ERG has remained undrugged by conventional inhibitors or first-generation degraders because the protein lacks small molecule binding pockets.

Parabilis’s ERG degrader overcomes this challenge by using the company’s proprietary Helicon peptide technology, which enables intracellular targeting of "flat" protein surfaces. The company’s prostate cancer franchise also includes a selective degrader of androgen receptor (AR) targeting a site outside the canonical androgen-binding site on the protein, thereby addressing a common resistance mechanism that arises in response to AR antagonist therapies. Together Parabilis’s degraders of ERG and AR could potentially provide meaningful and differentiated therapeutic approaches to treat patients with metastatic castrate-resistant prostate cancer (mCRPC).

Full details of the poster are as follows:

Title: "Degradation of the ETS transcription factor ERG by stabilized helical peptide (Helicon) degraders enables pharmacological validation in ERG-fusion prostate cancer models"
Abstract Number: 4246/3
Presentation Date and Time: Tuesday, April 29, 9:00 a.m. – 12:00 p.m. CDT
Session: New and Emerging Cancer Drug Targets
Location: Poster Section 17