On October 15, 2025 Step Pharma ("the Company"), the global leader in CTPS1 inhibition for targeted cancer treatment, reported the completion of a €38 million Series C financing round.

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The Series C round was led by new investor V-Bio Ventures, a Ghent-based life sciences venture capital fund, with participation from existing investors Pontifax, Bpifrance, Kurma Partners, Hadean Ventures, Sunstone Life Science Ventures and Inserm Transfert Initiative.

The financing will enable Step Pharma to continue advancing its ‘pipeline in a product’ strategy for dencatistat, a first-in-class, highly selective, orally bioavailable CTPS1 inhibitor currently in development for the treatment of cancers and blood disorders. All cancers appear to be highly reliant on CTPS1, a key component of the pyrimidine synthesis pathway, for DNA synthesis and cell proliferation.

Dencatistat is being evaluated in a phase 1/2 clinical trial for adult patients with relapsed/refractory T or B cell lymphoma, and received orphan drug designation for the treatment of T cell lymphoma in May 2025. The Company is also evaluating dencatistat in a phase 1 trial in solid tumour patients, with expansion cohorts in CTPS2-null ovarian, endometrial and lung cancer planned.

Clinical trials of dencatistat in lymphoma demonstrated that continual administration results in a dose dependent and reversible lowering of the platelet count. This led to the initiation of Step Pharma’s third clinical programme for dencatistat, in essential thrombocythaemia, a rare clonal blood disorder in which the bone marrow produces too many platelets.

Andrew Parker, Chief Executive Officer, Step Pharma, commented:

"This Series C financing will allow us to build upon the significant clinical progress we have made with dencatistat, with three clinical programmes underpinning our ‘pipeline in a product’ strategy. These funds will enable us to expand our clinical dataset, complete all ongoing phase 1 studies, and further derisk dencatistat as we enter phase 2 and explore its potential to improve patient outcomes through CTPS1 inhibition. I’d like to thank V-Bio Ventures for joining our investor syndicate and leading this round, and our existing investors for their continued participation and support."

Ward Capoen, Partner, V-Bio Ventures, said:

"We are delighted to support Step Pharma in its next phase of growth through this Series C financing. The Company’s approach to inhibiting CTPS1 to selectively block the proliferation of cancer cells is highly promising, and the team has followed the data into essential thrombocythaemia after observing dencatistat’s effect on platelet levels. This multi-pronged clinical plan has further derisked dencatistat and positions Step Pharma to provide new therapeutic options for patients."

(Press release, Step Pharma, OCT 15, 2025, View Source [SID1234656649])

On October 15, 2025 Curium Group reported that together with PeptiDream Inc. and PDRadiopharma Inc., a registrational Phase 2 clinical trial has been initiated in Japan for 64Cu-PSMA-I&T – a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

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64Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, 177Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma, a wholly owned subsidiary of PeptiDream, and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium’s ongoing global clinical trials.

In parallel, a clinical trial for 177Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Renaud Dehareng, CEO of Curium Group commented: "Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan."

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan."

About Prostate Cancer

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases (*1), with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.

*1: National Cancer Center Japan

Clinical trial progress

Phase 3 ECLIPSE trial – 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.

Phase 3 trial SOLAR RECUR and SOLAR STAGE – 64Cu-PSMA-I&T trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

Partnership Details

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 64Cu-PSMA-I&T and177Lu-PSMA-I&T and in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

(Press release, Curium Pharma, OCT 15, 2025, View Source [SID1234656636])

On October 14, 2025 Aanastra, Inc., a biotechnology company leveraging its proprietary targeted peptide delivery technology (PEP-NP) to advance in vivo targeting and reprogramming of cells with RNA therapeutics, reported multiple presentations showcasing preclinical data in its lead programs for anti-CD19 in vivo CAR-T (AAN-14x) and for in vivo P53 rescue in P53 mutant tumors (AAN-53x), at upcoming conferences.

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"Among the broad applications of the PEP-NP technology, we are particularly excited by the preclinical data in our in vivo CAR-T program as well as our ability to target wide-ranging P53 driver mutations in our P53 program for which no therapy exists today ," said Neil Desai Ph.D., Founder and CEO at Aanastra. "These preclinical data highlight the remarkable versatility of the PEP-NP targeted peptide RNA delivery technology, from in vivo reprogramming of immune cells to cause B cell depletion, to in vivo restoration of mutant tumor suppressor function directly in tumors, all with a mRNA approach. Importantly the PEP-NP system can completely bypass the liver, without immunogenicity or safety issues upon repeat administration, uses no lipid, viral or protein components, and is fully owned by Aanastra."

Featured Presentations and Conferences:

Advancing Cell and Gene Therapies for Cancer Conference, Philadelphia, PA, Oct 15-16, 2025

Poster presentation title: In Vivo CAR-T generation of anti-CD19 CAR-T-cells using CAR mRNA delivered with the PEP-NP peptide-based (non-lipid, non-viral) delivery system targeted to CD3/CD5+ T-cells
Presenter: Gilles Divita, Ph.D
Date and time: Oct 15, 2025, 5:00 p.m. – 6.30 p.m. ET

Poster presentation title: P53 mutant tumor regression across P53 mutations with AAN-53x, a P53 mRNA delivered with the PEP-NP tumor-targeted peptide (non-lipid) delivery system
Presenter: Gilles Divita, Ph.D
Date and time: Oct 15, 2025, 5:00 p.m. – 6.30 p.m. ET

mRNA Vaccines and Therapeutics Summit, Barcelona, Spain, Oct 23-24, 2025

Oral Presentation Title: A novel peptide-based nanoparticle platform for systemic targeted delivery of therapeutic mRNA : invivo CAR-T cell engineering and Tumor selectivity
Presenter: Gilles Divita, Ph.D.
Date and Time: Oct 23, 2025, 4.40 pm – 5.20pm. CET

About P53
Known as the "Guardian of the Genome," P53 is a crucial tumor suppressor that preserves DNA integrity by regulating DNA repair and cell division. Loss of functional p53 causes DNA damage to accumulate, driving uncontrolled cell growth and tumor development. It is mutated or inactivated in over 50% of cancers, affecting 400,000 new U.S. patients annually and over 10 million globally. Mutations span hundreds of variants, making broad therapies difficult. These mutations are markers of poor prognosis and key cancer drivers. No existing treatments restore p53 function across this spectrum, leaving a significant unmet need. Aanastra’s RNA-based approach using its targeted PEP-NP delivery offers a promising strategy to broadly restore p53 function, potentially transforming outcomes for aggressive, treatment-resistant cancers.

About In vivo CAR-T
In vivo CAR-T therapy engineers a patient’s T cells inside the body to target and destroy cancer cells, avoiding the costly, complex ex vivo CAR-T process that today is available to less than 20% of eligible patients in the US. Current lentiviral methods for in vivo CAR-T allow only single treatments due to immune responses against viral components. Lipid nanoparticle (LNP)-based mRNA delivery enables transient CAR expression that could be repeated but is limited by liver toxicity and immune related side effects like inflammation. These safety and dosing challenges can restrict sustained treatment effects. Aanastra’s PEP-NP system efficiently targets CAR RNA to T cells for safe, repeat dosing without these toxicities, potentially overcoming current limitations and expanding access for hematological cancers and autoimmune diseases.

About PEP-NP
Aanastra’s PEP-NP technology is based on short, amphipathic peptides that form stable nanoparticles with RNA for efficient delivery. These peptides are designed with distinct hydrophobic and hydrophilic regions, adopting α-helical conformations facilitating membrane interaction and cellular entry. Importantly, PEP-NP peptides can include specific receptor-targeting domains, enabling precise cell and tissue targeting without using antibodies or other large proteins. This antibody-free targeting allows rapid design flexibility and avoids immunogenicity associated with protein-based ligands. PEP-NP nanoparticles can enter cells though a non-endosomal mechanism, enhancing RNA release into the cytoplasm for effective therapeutic action. Together, these features make PEP-NP a highly versatile, scalable, and safe platform for delivering diverse RNA payloads for treating cancer, autoimmune, and genetic diseases.

(Press release, AANASTRA, OCT 14, 2025, View Source [SID1234662316])

On October 14, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that Jarrod Longcor, chief operating officer of Cellectar, presented positive preclinical data in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer Research that took place from September 28 through October 1, 2025, in Boston, Massachusetts. The poster highlighted preclinical data from CLR 121225 (CLR 225), the Company’s novel actinium-based radio conjugate alpha-emitter for treatment in pancreatic ductal adenocarcinoma (PDAC). CLR 225 has completed Investigational New Drug (IND)-enabling studies, and the company maintains the option to advance into a Phase 1 study.

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"We were honored to present these preclinical data before a distinguished audience of oncology professionals. The novel mechanism of action of our phospholipid ethers may enable us to more effectively target and eradicate diverse tumor cell populations and, importantly, penetrate the dense, collagen-rich extracellular matrix that characterizes pancreatic cancer. By overcoming this major barrier to therapeutic delivery, we hope to address one of the fundamental reasons pancreatic tumors remain so refractory to standard treatments and ultimately improve patient outcomes," said Jarrod Longcor, chief operating officer of Cellectar. "These results showcase the robust anti-tumor activity, selective biodistribution, and impressive uptake of CLR 225 in multiple pancreatic cancer tumor models. The data strongly support the therapeutic potential of CLR 225."

A series of studies evaluated three separate pancreatic cancer xenograft models (PANC-1, MIA PaCa-2 human pancreatic carcinoma cells and BxPC-3 tumor fragments) treated with CLR 225 at multiple doses. CLR 225 was deemed safe and well-tolerated at all dosing levels with no changes in body weight or loss of animals. Notably, all three xenograft models treated with CLR 225 demonstrated either meaningful inhibition of tumor growth or reduction in tumor volume, depending on the dose, with potential survival benefit following treatment as tumor growth post treatment was significantly diminished.

Additional pharmacokinetic studies showed excellent biodistribution of CLR 225, indicating predictable behavior with dose linearity, which can assist with future estimation of a likely efficacious dose. Furthermore, in preparation for Phase 1 first-in-human studies, the poster presented data on CLR 225 in various GLP toxicity studies where no toxicities to the compound were noted.

The poster can be accessed on the Company’s website here.

About Pancreatic Ductal Adenocarcinoma
Advanced pancreatic ductal adenocarcinoma (PDAC) is a devastating disease, with less than 10% survival after five years. There are an estimated 67,500 new pancreatic cancer cases in the U.S. each year and PDAC accounts for approximately 90% of these cases, or ~60,700 new PDAC cases annually. Most patients are diagnosed at an advanced stage, which means that between 80%-90% of PDAC patients (~48,000-54,000 patients annually, per the Surveillance, Epidemiology, and End Results (SEER) database) are likely to have advanced disease at diagnosis.

PDACs exhibit a hypoxic environment, resulting in tumor cells employing lipid rafts to transport lipids into the cells. CLR 225 is designed to target lipid rafts and deliver treatment to the tumor cell.

(Press release, Cellectar Biosciences, OCT 14, 2025, View Source [SID1234661195])

On October 14, 2025 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that it has received the first milestone payment under its licensing and collaboration agreements with Shell BioTech and a third party.

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In 2020 Forlong and Shell BioTech, a CDMO in China, entered a technology development collaboration to leverage Forlong’s proprietary Fbody Technology Platform to develop long half-life peptide therapy for a third party. In 2025, Forlong and Shell BioTech entered into a licensing agreement with the third party for selected protein therapy candidates incorporating Fbody, and amended the initial collaboration agreement to restructure terms including upfront and milestones payments as well as royalty on future product sales. Following the upfront payment in 2025, this is the first milestone payment, triggered by IND submission for the Fbody-fusion protein therapy by the third party to China National Medical Products Administration.

Fbody Long-acting Technology is one of synthetic immunology platforms of Forlong. It is a single-chain Fc engineered to maintain FcRn affinity while eliminating binding of FcγRs and complement systems, aiming to optimize protein half-life and biodistribution. Forlong’s lead clinical candidate FL115 is an interleukin-15 (IL-15) superagonist incorporating Fbody. It is in multiple clinical studies in China and the United States, showing favorable safety profile and preliminary clinical responses in patients with advanced solid tumors, and is currently being advanced to combo therapy with PD-(L)1 antibodies in Phase I for patients with advanced solid tumors and combo therapy with Bacillus Calmette-Guérin (BCG) in Phase II for patients with nonmuscle invasive bladder cancer (NMIBC).

"We are excited to see another Fbody fusion protein therapy advancing into clinic, a significant milestone for our synthetic immunology platforms," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "FL115’s best-in-class potential in the challenging IL-15 superagonist class first showcased unique properties of Fbody, and this milestone further validates its ability to enhance profiles for variety of proteins beyond cytokines, and success of our out-licensing strategy and its ability to drive real-world impact through partnerships."

(Press release, Forlong Biotechnology, OCT 14, 2025, View Source [SID1234656666])