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Aarvik Therapeutics Announces Investment by Laurus Labs in Aarvik Series Seed 2 Round

On October 8, 2025 Aarvik Therapeutics, an innovative, ADC-focused biotechnology company dedicated to engineering precision medicines for cancer therapy, reported an investment by Laurus Labs, India in Aarvik’s recently-concluded Series Seed 2 financing round (Press release, Aarvik Therapeutics, OCT 8, 2025, View Source [SID1234656527]).

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Since launching in 2021, Aarvik has developed its proprietary MUTTA (MUlti-epitope Targeting Tetravalent Antibody) plaform with a focus on developing next generation antibody drug conjugates (ADCs) that can expand the success of ADCs beyond a limited number of targets. Aarvik’s comprehensive approach facilitiates the lowering of the minimum effective dose (MED) while maintaining or improving the maximum tolerated dose (MTD) thereby significantly improving the therapeutic window. The Series Seed 2 round, which had investments from multiple investors including Laurus, is an acknowledgement of the substantial progress made by Aarvik on the MUTTA platform and will allow Aarvik to further advance its exciting pipeline of ADC assets.

"As part of our global support of innovation and progress in healthcare, we are delighted to invest in Aarvik’s efforts to pursue breakthroughs in oncology therapies," said Dr. Satyanarayana Chava, Founder & CEO of Laurus Labs. "We look forward to a highly productive collaboration that results in tangible benefits for patients across the globe."

"Aarvik is delighted to welcome Laurus Labs as an investor and a partner in our efforts to pursue improved therapies for hard-to-treat indications in cancer," said Jagath Reddy Junutula, PhD, Co-founder, President and CEO of Aarvik Therapeutics. "Our mission to provide transformational benefits for cancer patients is greatly strengthened by our ability to work with outstanding companies like Laurus Labs."

Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin® to Treat Ovarian Cancer

On October 8, 2025 Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, reported positive final 24-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis (Press release, Oncoinvent, OCT 8, 2025, View Source [SID1234656526]). Radspherin, direct intraperitoneal targeting with the alpha-emitter radium-224, aims to eliminate post-surgery micro-metastases and thereby prevent or delay peritoneal recurrence.

In this Phase 1 trial, 10 out of 21 patients received the highest and recommended intraperitoneal dose of 7 MBq Radspherin after dose escalation (1, 2, 4 and 7 MBq). The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%. In similar populations, approximately 55-60% of patients receiving best standard of care would expect disease recurrence at this time point[1],[2],[3].

"These highly encouraging results conclude our Phase 1 program for Radspherin and fuel our determination to advance Radspherin as an innovative treatment for patients with peritoneal metastases as quickly as possible," said Oystein Soug, CEO of Oncoinvent. "We are profoundly grateful to the patients, investigators, and the team for their invaluable contributions and look forward to interim results from our Phase 2 study next year."

"Peritoneal metastases remain a defining challenge in ovarian cancer, often driving recurrence," said Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "These final results are truly encouraging, suggesting that Radspherin could help delay disease progression and offer patients hope for longer, healthier lives. It is particularly promising to see that the new recurrences were limited to lymph nodes, which are typically associated with longer survival compared to peritoneal relapses.

About RAD-18-001

RAD-18-001 was an open label Phase 1 trial conducted in patients with peritoneal metastases in platinum-sensitive recurrent ovarian cancer. The trial was designed to evaluate dosing, safety and tolerability, and signal of efficacy of intraperitoneally administered Radspherin following complete surgical resection. A total of 21 patients were enrolled across sites in Norway, Belgium and Spain.

Vivace Therapeutics’ VT3989 Granted Fast Track Designation by the U.S. Food and Drug Administration for the Treatment of Mesothelioma

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.

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.

C-Ray Therapeutics (Shanghai) Co., Ltd. Presents Breakthrough Clinical Data of Novel Targeted Alpha Therapy 225Ac-PSMA-CY313 at EANM 2025

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]).

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."

Biond Biologics Announces Initiation of a Phase 2 Study of BND-22 in Combination with anti-PD-1 therapy

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]).

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).