On March 26, 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 preclinical data on multiple novel bispecific antibodies as well as antibody-drug-conjugates (ADCs) from its oncology pipeline will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Innovent Biologics, MAR 26, 2025, View Source [SID1234651476]). The AACR (Free AACR Whitepaper) Annual Meeting will take place from April 25 to April 30, 2025, in Chicago, Illinois.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Late-Breaking Research: Immunology 2

Topic: Preclinical Data of IAR037, A Novel CD40/PD-L1 Bispecific Antibody for the Treatment of Advanced Solid Tumors Resistant to Immune Checkpoint Inhibitors
Abstract Number: LB139
Presentation Time：Monday Apr 28, 2025 9:00 AM – 12:00 PM
Location: Poster Section 52

Late-Breaking Research: Clinical Research 1

Topic: Preclinical characterization of IBI3010, a FRα targeting biparatopic antibody-drug conjugate (ADC), for the treatment of FRα expressing tumors
Abstract Number: LB222
Presentation Time：Monday Apr 28, 2025 2:00 PM – 5:00 PM
Location: Poster Section 53

Poster Session: Experimental and Molecular Therapeutics – New and Emerging Cancer Drug Targets

Topic: IBI3019, a first-in-class EGFR/CDH17/CD16A tri-specific antibody, demonstrated potent efficacy against CRC and an excellent safety profile in preclinical studies
Abstract Number: 4249
Presentation Time: Tuesday Apr 29, 2025 9:00 AM – 12:00 PM
Location: Poster Section 17
Poster Board Number: 6

Poster Session: Experimental and Molecular Therapeutics – Therapeutic Approaches to Attack the Tumor Microenvironment

Topic: IBI3026, a first-in-class anti-PD-1/IL-12 fusion protein, demonstrates the potential to be a new immuno-oncology therapy by releasing the break in immune response and strongly activating T and NK cells in the tumor microenvironment
Abstract Number: 3118
Presentation Time: Monday Apr 28, 2025 2:00 PM – 5:00 PM
Location: Poster Section 24
Poster Board Number: 2

Poster Session: Experimental and Molecular Therapeutics – Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies

Topic: IBI3014, a TROP2xPD-L1 bi-specific ADC integrating ADC killing with checkpoint blockade within one molecule, exhibits promising efficacy and safety in preclinical models
Abstract Number: 344
Presentation Time: Sunday Apr 27, 2025 2:00 PM – 5:00 PM
Location: Poster Section 16
Poster Board Number: 11

Poster Session: Experimental and Molecular Therapeutics – Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies

Topic: Trop2 and B7H4 bi-specific ADC with improved efficacy and safety for gynecologic cancers
Abstract Number: 345
Presentation Time: Sunday Apr 27, 2025 2:00 PM – 5:00 PM
Location: Poster Section 16
Poster Board Number: 12

Poster Session: Immunology – T Cell Engagers

Topic: A 2+1 format MUC16 targeting T cell engager induces MUC16-dependent T cell activity and superior anti-tumor efficacy
Abstract Number: 3510
Presentation Time: Monday Apr 28, 2025 2:00 PM – 5:00 PM
Location: Poster Section 38
Poster Board Number: 18

Poster Session: Immunology – Modulation of Tumor Microenvironment: Modulation of Lymphocyte Influx

Topic: A PD1-IFNα fusion protein, composed of an attenuated IFNα fused to a clinically validated PD1 mAb, induced PD1-dependent IFNα signaling and demonstrated superior anti-tumor efficacy
Abstract Number: 4881
Presentation Time: Tuesday Apr 29, 2025 9:00 AM – 12:00 PM
Location: Poster Section 40
Poster Board Number: 9

Poster Session: Experimental and Molecular Therapeutics – Novel Antitumor Agents 3

Topic: Olverembatinib* (HQP1351) in combination with lisaftoclax (APG-2575) overcomes venetoclax resistance in preclinical models of acute myeloid leukemia (AML)
Abstract Number: 5652
Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM

Poster Session: Experimental and Molecular Therapeutics – Novel Antitumor Agents 3

Topic: Effects of olverembatinib* (HQP1351) in combination with BCL-2 inhibitor lisaftoclax (APG-2575) in T-cell acute lymphoblastic leukemia (T ALL)
Abstract Number: 5648
Presentation Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM

* In July 2021, Innovent and Ascentage Pharma (6855.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

Dr. Kaijie He, Vice President of Innovent, stated: "With the expansion and enhancement of Innovent Academy’s technology platforms, our global R&D efforts are taking shape and accelerating global competitiveness, enabling the efficient generation of novel molecules with global potential. We are proud to showcase a batch of preclinical research findings at this year’s AACR (Free AACR Whitepaper) Annual Meeting, including multiple globally first-in-class bispecific antibodies, multi-specific antibodies, and antibody-drug conjugates (ADCs). These breakthroughs not only demonstrate our growing scientific capabilities but also reaffirm our commitment to delivering transformative therapeutic options for patients worldwide. Moving forward, we remain focused on innovation—optimizing precision targets and exploring novel mechanisms—to provide revolutionary solutions for some of the world’s most challenging diseases and enable more patients to benefit from the rapid advancements in cutting-edge science."

On March 26, 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 final survival data from a phase 2a clinical trial of CAN-2409 in patients with stage III/IV NSCLC, inadequately responding to ICI treatment (Press release, Candel Therapeutics, MAR 26, 2025, View Source [SID1234651475]). mOS was 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 presented with progressive disease at baseline, despite ICI treatment. mOS in patients with progressive disease despite ICI treatment, was 9.8-11.8 months in other studies, including those with standard of care of docetaxel chemotherapy, which has a very poor prognosis, did not exceed 12 months in other published studies.(1, 2) This final analysis included extended follow-up data (1 year after the previous data cut) with a median follow up time for the per protocol population of 32.4 months. Data showed a sizable percentage of patients with survival exceeding 24 months, evidence of a long tail of survival, with 37% of patients with progressive disease despite treatment with ICI alive 2 years after CAN-2409 administration.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Biomarker research showed an enhanced immunological and clinical response after CAN-2409 administration in patients with non-squamous histology compared to squamous histology, and improved mOS was observed in this population (25.4 months in patients with progressive disease despite ICI treatment and non-squamous NSCLC, n=33).

"Treatment options are quite limited for patients with unresectable NSCLC who progress on anti-PD-1 therapy," said Charu Aggarwal, MD, MPH, Leslye Heisler Professor for Lung Cancer Excellence at the University of Pennsylvania’s Perelman School of Medicine and Principal Investigator of the study. "The survival benefit seen in this study is striking, especially when compared to both the current standard of care treatment of docetaxel chemotherapy and other therapies under investigation for this patient group," she added.

Data Highlights:

Pre-treatment and mid-treatment dropout rates were comparable to those reported in other clinical trials in similar populations of patients with advanced NSCLC.(1, 3) Three patients were enrolled, but did not receive treatment, 22 patients received only one injection of CAN-2409, 51 patients received at least 2 injections of CAN-2409, but 5 patients did not complete treatment. 46 patients received complete treatment (2 courses of CAN-2409 plus prodrug) and were included in the evaluable, per protocol population. The per protocol population was representative of the overall enrolled population in terms of baseline demographics and prognostic factors.

Survival data:
In patients with an inadequate response to ICI treatment (Cohort 1+2, n=46), mOS was 24.5 months.
In patients with progressive disease, despite ICI treatment (Cohort 2, n=41), mOS was 21.5 months, which is markedly longer than the 9.8–11.8 months of survival reported in published literature in a similar patient population receiving standard of care of docetaxel chemotherapy.1,2
37% of patients exceeding 24 months survival were still alive at the time of the March 3, 2025 data cut.
Potential precision medicine approach:
Patients with non-squamous histology predominated amongst the long-term survivors: 14/15 patients with OS > 24 months and 9/9 patients with OS > 30 months had non-squamous NSCLC.
Patients with non-squamous histology exhibited larger changes in T cells, B cells, and dendritic cells after CAN-2409 administration compared to patients with squamous NSCLC.
mOS of 25.4 months observed in non-squamous NSCLC patients with progressive disease, despite ICI treatment (n=33).
Although a phase 2a open-label experimental medicine clinical trial is not designed for an intention to treat (ITT) analysis, we conducted an exploratory ITT analysis and observed mOS of 16.7 months after CAN-2409 administration in non-squamous NSCLC patients with progressive disease despite ICI treatment (n=53). Recent trials have reported a mOS of 9.9–12.3 months in ICI-refractory, non-squamous NSCLC patients receiving standard of care docetaxel chemotherapy.(1,2)
Systemic anti-tumor response (abscopal effect) and safety profile:
Decrease in size of uninjected tumors was observed in 69% of patients with multiple lesions (n=35), indicating that local injection may induce a systemic anti-tumor immune response (abscopal effect).
CAN-2409 maintained its generally favorable safety and tolerability profile throughout the extended follow-up period.
"These updated survival data confirm and strengthen our previously reported findings, demonstrating that CAN-2409 has the potential to extend survival for patients with advanced NSCLC, who have limited treatment options after failing to respond to, or progressing, despite immune checkpoint inhibitor therapy," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "CAN-2409 may represent an entirely new approach to solid tumor treatment, with its unique mechanism of action and favorable safety profile to date, enabling potentially meaningful improvements in outcomes beyond current standard of care. These compelling results mark a potentially transformative advance in our fight against this aggressive disease."

"The extension of survival in patients with non-squamous disease is notable even when compared to data that have been reported for other investigational products, such as antibody-drug conjugates, for this patient population," said W. Garrett Nichols, MD, CMO of Candel. "CAN-2409, in addition to continued ICI treatment, may prolong survival beyond that offered by docetaxel chemotherapy, and has the potential to be better tolerated."

Based on these positive findings, the Company will advance its development program for CAN-2409 in NSCLC, including preparation and enabling work for a future, potentially registrational, clinical trial in patients with NSCLC with non-squamous histology. The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation for CAN-2409 plus valacyclovir in combination with ICI treatment for the treatment of 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.

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 vaccination against a variety of 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 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 to date, supporting the potential for combination with other therapeutic strategies.

Candel’s clinical development program for CAN-2409 includes completed 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 a 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 in estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 plus standard of care versus 12.5 months in the control group in patients with PDAC, who received only standard of care. Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 6.4 months in the control arm. CAN-2409 plus prodrug has been granted Fast Track Designation by the 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 primary 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 (SPA) agreed with the FDA.

On March 26, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported it will be presenting a business update today at Trump Mar-a-Lago Club, Florida (Press release, Actinium Pharmaceuticals, MAR 26, 2025, View Source [SID1234651474]). This presentation follows an Investor KOL Call and Company Update hosted by Actinium on Tuesday, March 25th highlighting its revitalized clinical programs and expanded market opportunities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are honored to have this opportunity to present Actinium Pharmaceuticals and highlight the significant progress we have made in the last several months at the Mar-a-Lago Club. We have great enthusiasm for our revamped clinical programs and expect to achieve significant milestones in 2025. If successful, we will have the opportunity to address multiple potential blockbuster market opportunities with Actimab-A in myeloid malignancies and solid tumors and with Iomab-ACT for cell and gene therapy conditioning."

Actinium has outlined its expanded market opportunities and expected 2025 milestones for each of its clinical programs as well as its R&D and radiopharmaceutical manufacturing capabilities as follows:

Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) across multiple treatment settings

Initiate Phase 2/3 trial in combination with CLAG-M in relapsed or refractory AML and seek potential partners or collaborators
Generate initial clinical data in frontline AML in first trial under CRADA with NCI
Initiate additional clinical trials in myeloid malignancies
Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs)

Generate clinical proof of concept data in head and neck squamous cell carcinoma and non-small cell lung cancer
Explore additional solid tumor indications for future trials
Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes

Present initial data from commercial CAR-T trial at University of Texas Southwestern
Generate clinical data in first non-malignant indication from sickle cell disease allogeneic stem cell transplant trial at Columbia University
Pipeline Expansion Leveraging Targeted Radiotherapy R&D Capabilities

Present abstract at AACR (Free AACR Whitepaper) highlighting Actinium-225 targeted radiotherapy for novel radiotherapy cancer target
Establish In-house Radiopharmaceutical Manufacturing & Production

Advance build-out of manufacturing facility
Explore strategic partnerships leveraging proprietary Actinium-225 cyclotron manufacturing technology
Mr. Seth continued, "In addition to the multitude of milestones that lie ahead for our clinical programs, we are excited to highlight our expanding capabilities. As a pioneer in targeted radiotherapy, we are leveraging our robust know-how and intellectual property to develop new pipeline programs to address indications with high unmet needs. In addition, we are investing in our infrastructure and are thrilled to be moving ahead with the build-out of our manufacturing facility starting next quarter in anticipation of future clinical success. Finally, we look forward to fully leveraging our proprietary Actinium-225 cyclotron manufacturing technology to meet our projected demand given our expanding Actinium-225 programs as well as facilitate strategic partnerships. With our strong balance sheet providing runway into mid-2027, our team is focused and committed on execution and value creation."

On March 26, 2025 ImCheck Therapeuticsannounced reported updated results from its ongoing open-label, randomized Phase I/II study EVICTION at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago, Illinois, USA (Press release, ImCheck Therapeutics, MAR 26, 2025, View Source [SID1234651473]). The poster presentation will provide efficacy, safety, pharmacodynamics and dose selection data on the novel γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of patients with newly diagnosed AML.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the poster presentation at AACR (Free AACR Whitepaper) 2025 are:

Late-breaking abstract title: "γ9δ2 T-cell (γδTC) activation and azacitidine-venetoclax (AV) for older/unfit adults with newly diagnosed (ND) acute myeloid leukemia (AML) induces high rates of complete remission (CR): Preliminary efficacy, safety, pharmacodynamics (PD) and dose selection of ICT01 in the phase 1 study EVICTION"

Session: Phase 0 and Phase I Clinical Trials

Abstract number: CT024

Presenter: Abhishek Maiti, University of Texas MD Anderson Cancer Center

Authors:Abhishek Maiti, Pierre Peterlin, Daniel Morillo, Jose-Miguel Torregrosa-Diaz, Matthew Ulrickson, Agustin Penedo, Aude De Gassart, Elisabeth Wieduwild, Emmanuel Valentin, Maelle Mairesse, Patrick Brune, Katrien Lemmens, Stephan Braun, Daniel Olive, Naval G. Daver, Sylvain Garciaz, Pierre-Yves Dumas

Date: Monday, April 28, 2025

Time: 9:00 am- 12:00 pm EST

Location: Poster Section 49 / Poster Board Number: 3

The AACR (Free AACR Whitepaper) poster presentation will provide an update on the data in AML patients most recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2024 showing that ICT01 administered in combination with azacitidine and venetoclax demonstrated promising efficacy without compromising safety.

The AACR (Free AACR Whitepaper) poster will be available on ImCheck’s corporate website after the poster sessions have been opened.

On March 26, 2025, Sonnet BioTherapeutics Holdings, Inc. (the "Company") reported the positive findings from the first safety review of the expansion cohort in its Phase 1 SB101 clinical trial evaluating SON-1010, the Company’s proprietary version of recombinant human interleukin-12 ("rhIL-12") configured using genetic fusion to the Company’s Fully Human Albumin Binding ("FHAB") platform, in combination with trabectedin ("Yondelis") in adult patients with advanced leiomyosarcoma ("LMS") or liposarcoma ("LPS") (Press release, Sonnet BioTherapeutics, MAR 26, 2025, View Source [SID1234651472]).The expansion cohort builds on the successful completion of monotherapy dose escalation and assignment of the SON-1010 maximum tolerated ("MTD") dose of 1200 ng/kg.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The SB101 Safety Review Committee ("SRC") met to evaluate the initial status of the patients in the expansion cohort, all of whom are receiving the SON-1010/trabectedin combination, as enrollment continues. After an average treatment of slightly over two months, one patient progressed and the other six are tolerating treatment. Adverse events ("AEs") considered to be related to either drug have all been mild or moderate, suggesting that the two drugs do not appear to be adversely impacting each other. The annual review including all 30 patients dosed to date showed that common AEs considered related to SON-1010 monotherapy or in combination included fatigue, fever, chills, and myalgia in 15% or more; moderate fatigue was the only related AE in 2 or more of the patients treated with trabectedin to date. Full enrollment of the combination cohort will provide an opportunity to evaluate statistical evidence of benefit in the response using the standard RECIST paradigm, which may also confirm synergy. Meanwhile, five of the six patients in the SON-1010 high-dose monotherapy group (83%) showed stable disease at 4 months and four continue on trial at 6 months with no new safety concerns. The partial response ("PR") in one of those patients persists, confirming the potential for benefit of SON-1010 monotherapy at the MTD in this small cohort. Overall, 13 of the 24 patients studied during SON-1010 dose escalation (54%) had evidence of monotherapy clinical benefit.

The primary outcome measures for the Phase 1 SB101 trial are the safety, tolerability, pharmacokinetics ("PK") and pharmacodynamics ("PD") of SON-1010 and to establish the MTD. The Company has treated 7 patients over 2 months on average and expects to enroll up to 18 patients with unresectable, metastatic LMS or LPS in this open-label, single-arm expansion cohort. Patients are being treated with SON-1010 in combination with the standard 21-day trabectedin cycles, alternating the dosing of the two drugs. Trabectedin, the first approved chemotherapeutic drug for advanced soft-tissue sarcomas ("STS") after failure of primary therapy, works by preventing tumor cells from proliferating but has also been shown to have pro-inflammatory immune effects in the tumor microenvironment ("TME") that may be enhanced by the IL-12 activity in SON-1010. Trabectedin is approved in 76 countries globally for the treatment of advanced STS as a single-agent, and in 69 countries for relapsed ovarian cancer in combination with doxorubicin HCl liposome injection.