On October 8, 2025 Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class cancer therapies targeting the Hippo pathway, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to VT3989, the company’s first-in-class and best-in-class transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor (Press release, Vivace Therapeutics, OCT 8, 2025, View Source [SID1234656525]). The designation pertains to VT3989’s use as a treatment for patients with unresectable malignant nonpleural or pleural mesothelioma whose disease has progressed on prior immune checkpoint inhibitor therapy and platinum-based chemotherapy.

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!

FDA’s Fast Track Designation is granted to drug candidates that are being developed for the treatment of serious or life-threatening conditions and have the potential to fill unmet medical needs. The program is designed to ensure that these important new treatments can reach patients as quickly as possible. A company that receives Fast Track Designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate’s clinical development plan, including possible eligibility for accelerated approval and priority review.

"We are pleased to receive Fast Track Designation from the FDA for VT3989 in this patient population, which is in desperate need of new and effective therapeutic options. This designation represents another important step in our ongoing development of VT3989 and will offer key advantages as we continue on our path toward potential commercialization of this first-in-class and best-in-class therapy," said Sofie Qiao, Ph.D., president and chief executive officer of Vivace Therapeutics.

VT3989 is a novel investigational small molecule cancer therapeutic that is designed to target the Hippo pathway by inhibiting palmitoylation of members of the TEAD protein family. The compound has been evaluated in more than 200 patients to date in an ongoing, open-label Phase 1 clinical study and, to the company’s knowledge, is the first and only member of the TEAD autopalmitoylation inhibitor class for which compelling clinical efficacy data have been publicly reported. In addition to the promising data to date, VT3989 has demonstrated a positive safety profile in the Phase 1 trial, which supports its best-in-class potential.

About Phase 1 study of VT3989
The Phase 1 study of VT3989 (View Source) is a multi-center, open label trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and biological activity of VT3989 in patients with refractory metastatic solid tumors, including refractory pleural and non-pleural malignant mesothelioma.

On October 8, 2025 C-Ray Therapeutics (Shanghai) Co., Ltd. ("C-Ray Shanghai"), a company dedicated to the development of innovative targeted radiopharmaceuticals, reported promising new clinical results for its lead program 225Ac-PSMA-CY313 in the treatment of metastatic castration-resistant prostate cancer (mCRPC) during the 2025 Annual Congress of the European Association of Nuclear Medicine (EANM 2025) (Press release, C-Ray Therapeutics, OCT 8, 2025, View Source [SID1234656524]).

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!

These data, highlighted in two Top Rated Oral Presentations, provide early clinical evidence of the therapy’s significant potential and favorable safety profile, marking an important milestone for C-Ray in the field of targeted alpha therapies. Both presentations were delivered by the company’s Chief Medical Officer.

One presentation, entitled "Feasibility study of 225Ac-PSMA-CY313 dosimetry in mCRPC patients using SPECT", showcased the company’s progress in dosimetry research with 225Ac. The study successfully established and validated a quantitative dosimetry approach using SPECT/CT to evaluate internal radiation doses in patients treated with 225Ac-PSMA-CY313. Findings demonstrated that tumors (particularly soft tissue lesions) received high absorbed doses, while key organs such as the kidneys and liver remained within safe exposure limits—supporting a favorable therapeutic window. Importantly, no severe adverse events (SAEs) or grade ≥3 toxicities were observed during treatment.

The second presentation, "Evaluation of the safety and efficacy of 225Ac-PSMA-CY313 in metastatic castration-resistant prostate cancer: preliminary results", reported clinical outcomes from 13 patients treated with 225Ac-PSMA-CY313. The study results showed encouraging efficacy and manageable safety in heavily pretreated, standard therapy–resistant mCRPC patients. All patients (100%) achieved reductions in prostate-specific antigen (PSA) levels, with 81.8% achieving PSA50 response (≥50% decline). Among evaluable patients, the objective response rate (ORR) reached 60%. Most adverse events were grade 1–2, with the most common being xerostomia (dry mouth) reported in 11 of 13 patients (84.6%), including 10 grade 1 and 1 grade 2 events (per CTCAE v5.0 criteria).

"Presenting these results on such a globally recognized stage as EANM represents a significant milestone for C-Ray," said the Chief Medical Officer of C-Ray Shanghai. "There are only a few teams worldwide that have successfully advanced an alpha-emitting radiopharmaceutical into clinical development. Not only have we developed 225Ac-PSMA-CY313, but we have also generated robust early clinical data from more than a dozen patients. This underscores our strong capabilities and commitment in both radiopharmaceutical R&D and clinical translation."

On October 8, 2025 Biond Biologics Ltd. ("Biond" or the "Company"), a private, clinical-stage biopharmaceutical company developing novel immunotherapies for cancer and autoimmunity, reported the launch of a Phase 2 study of BND-22 (SAR444881) in combination with anti-PD-1 therapy in patients with locally advanced or metastatic NSCLC previously treated with immune-oncology (IO) therapies, and anti–PD-1/PD-L1 naïve patients with MSS-CRC or ovarian cancer (ClinicalTrials.gov Identifier: NCT06651593) (Press release, Biond Biologics, OCT 8, 2025, View Source [SID1234656523]).

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 new study is led by Dr. Aung Naing from The University of Texas MD Anderson Cancer Center and is expected to enroll patients whose tumors are known to express HLA-G, which is the ligand of ILT2 receptor, and that was found to be correlated with response to treatment with BND-22. The primary objective of the study is to identify biomarkers related to the mechanism of action of BND-22 alone and in combination with an anti-PD-1 therapy and predictive biomarkers related to response, survival and resistance. Secondary study objectives include efficacy of BND-22 and its combination with anti-PD-1 therapy, and safety/tolerability. Biond retains worldwide development and commercialization rights to BND-22.

"The foundation of the biomarker study is supported by the results of the first-in-human Phase 1/2 dose-escalation study of BND-22 which demonstrated a favorable safety profile and encouraging anti-tumor activity both as monotherapy and in combination with approved therapies. Dose-dependent activation of ILT2-expressing T cells, NK cells and monocytes were observed, with several confirmed clinical responses in heavily pre-treated patients," said Dr. Natalia Ashtamker, VP Clinical Development at Biond. "This study is an important step toward precision development of BND-22, our multi-cell checkpoint inhibitor, and by combining it with PD-1 blockade and deeply profiling patient samples, we aim to accelerate BND-22 into registrational trials for the tumors most likely to benefit. Additionally, we continue to treat responders from the Phase 1/2 trial that are still benefiting from BND-22. We are excited to collaborate with MD Anderson on this biomarker-rich study, which will guide the design of future registrational programs."

About BND-22

BND-22 is a humanized IgG4 antagonist antibody targeting the ILT2 receptor, developed for the treatment of solid tumors. ILT2 is an inhibitory immuno-modulating receptor expressed on both innate and adaptive immune cells. It binds to major histocompatibility complex (MHC) class I molecules, including HLA-G, an immunosuppressive protein expressed by various tumor types.

Preclinical studies have demonstrated that BND-22 exerts broad anti-tumor effects by disrupting ILT2-mediated "do not eat me" signals in macrophages and activating NK and CD8+ lymphocytes.

BND-22-001, a Phase 1/2 multicenter, open-label, dose-escalation, dose-expansion and dose optimization study enrolled patients with advanced solid tumors known to express HLA-G. The first-in-human Phase 1 study (BND-22-001, NCT04717375), designed to evaluate the safety and tolerability of BND-22, both as a monotherapy and in combination with the approved cancer therapies cetuximab and pembrolizumab. The phase 2 included evaluations of BND-22 as monotherapy in cholangiocarcinoma and in combination with cetuximab in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

View Source (Trial Identifier: NCT04717375).

On October 8, 2025 Accent Therapeutics reported an asset purchase agreement with Boehringer Ingelheim for a preclinical, potentially first-in-class small molecule program. This innovative asset offers a new strategy for treating tumors with high interferon-stimulated gene (ISG) expression, representing a meaningful addition to Boehringer’s portfolio of cancer cell–directed and immuno-oncology therapies.

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!

"We are delighted that Boehringer Ingelheim will now advance this leading preclinical program with the potential to address tumors with high unmet need," said Shakti Narayan, Chief Executive Officer, Accent Therapeutics. "This strategic transaction sharpens our focus on advancing our lead clinical assets through their ongoing Phase 1/2 studies and delivering on our commitment to patients."

Notably, the acquired program is designed to stimulate antitumor immunity and its unique mechanism positions it as a strong candidate for combination with cancer immunotherapies – a cornerstone of Boehringer’s research strategy.

Accent Therapeutics will receive an upfront payment and is entitled to success-based preclinical milestone payments under the terms of the agreement. Boehringer Ingelheim will assume global responsibility for research, development, manufacturing, and commercialization of the program, advancing it toward clinical evaluation.

Source: Press release, Boehringer Ingelheim, OCT 8, 2025, View Source

On October 8, 2025 Aptevo Therapeutics ("Aptevo" or the "Company") (Nasdaq:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology therapeutics, reported its participation in upcoming key financial, industry, scientific and medical conferences this fall, providing the opportunity to highlight continued momentum and recent developments among a broad range of stakeholder audiences (Press release, Aptevo Therapeutics, OCT 8, 2025, View Source [SID1234656521]).

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!

These conferences include:

4th Annual ROTH Healthcare Opportunities Conference
October 9, 2025 – Metropolitan Club, New York City, New York

Aptevo will participate in a panel on Acute Myeloid Leukemia titled "Novel AML Therapies Showing Clear Clinical Progress," discussing progress and recent trial outcomes of its lead asset, mipletamig, and sharing emerging evidence of its differentiated clinical profile in frontline AML-where strong safety, tolerability, and early efficacy continue to demonstrate meaningful potential for improved patient outcomes

Biotechnology Innovation Organization (BIO)-Europe 2025 – 31st Annual International Partnering Conference
November 3-5, 2025 (in-person); Digital Partnering Days: November 11-12, 2025 – Messe Wien Exhibition & Congress Center, Vienna, Austria

The Business Development Team will be on-site and actively participating in meetings at the largest biotechnology meeting in Europe

Society of Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 2025 – 40th Anniversary Annual Meeting
November 5-9, 2025 – Gaylord National Resort & Convention Center, National Harbor, Maryland

Aptevo’s R&D Team will present a poster highlighting a novel trispecific targeting Nectin-4, CD3 and CD40 to overcome the immunosuppressive the tumor microenvironment

American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition
December 6-9, 2025 – Orange County Convention Center, Orlando, Florida

Interim results from the ongoing Phase 1b/2 RAINIER trial evaluating mipletamig in frontline combination therapy for the treatment of AML, will be presented in a poster session by the clinical team.