On October 15, 2025 Tagworks Pharmaceuticals BV ("Tagworks"), a clinical-stage precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors, reported that the Dutch regulatory authorities approved the Clinical Trial Application (CTA) for the CleavHER Phase 0/1 clinical trial, sponsored by the Radboud University Medical Center (Radboudumc), evaluating TGW211, a first-in-class radioimmunoconjugate, in patients with HER2-positive tumors.

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 CTA approval and initiation of our second clinical trial this year mark a major milestone for Tagworks and validate the potential of our Click-to-Release platform," said Marc Robillard, PhD, Chief Scientific Officer and Co-Founder of Tagworks. "Unlike peptides, radiolabeled monoclonal antibodies avoid high radiation doses in the kidney. Many antibody therapies show strong tumor uptake, making them ideal vehicles for targeted radiotherapy. However, their clinical use has been limited by prolonged blood circulation resulting in myelotoxicity. Our Click-to-Release technology addresses this limitation by enabling precise tumor targeting and rapid clearance from healthy tissue—broadening the therapeutic window and unlocking new potential in radioimmunoconjugate development."

Under an investigator-initiated trial agreement, Tagworks and Radboudumc have initiated the first-in-human Phase 0/1 clinical development of TGW211 in a single center, open-label imaging study in patients with HER2-positive solid tumors. The primary objectives of the study are to determine safety and tolerability of Indium-111 (111In)-labeled TGW211, and secondary endpoints include evaluating the pharmacokinetics and dosimetry of 111In-TGW211 in tumor and healthy tissue. The study is currently recruiting and aims to enroll up to 18 patients.

"The Click-to-Release platform has the potential to redefine the therapeutic window of antibodies as vectors for radioactivity and represents a paradigm shift in the use of radiolabeled monoclonal antibodies in cancer treatment by enabling selective removal of circulating radioactivity after tumor targeting, enhancing the tumor-to-blood dose ratio and reducing healthy tissue exposure," said Prof. James Nagarajah, MD, Principal Investigator of the study at Radboudumc. "We are proud to lead the first clinical evaluation of TGW211 and help advance this innovative approach for patients."

Based on preclinical data recently highlighted at the European Association of Nuclear Medicine Congress, 111In-TGW211 has shown positive results in in vitro functional assays and in vivo animal models. These results suggest that TGW211 may have a positive effect on reducing the unfavorable radiation burden in patients undergoing targeted therapy and improve imaging by reducing background noise.

Preliminary safety and dosimetry data from the Phase 0/1 clinical trial is expected in 2026 and may support continued development towards the application of a Phase 1 therapeutic study with Actinium-225 or Lutetium-177-labeled TGW211.

About TGW211
TGW211 is a radiopharmaceutical targeting Human Epidermal Growth Factor Receptor 2 (HER2), a well-validated target in multiple solid tumors. TGW211 is a HER2-directed antibody (trastuzumab) radioimmunoconjugate linked using Tagworks’ proprietary Click-to-Release linker platform. TGW211 is administered intravenous (IV) first and allowed to bind to HER2 and internalize in the tumor. Then a non-cell permeable, small molecule trigger is administered IV, resulting in selective chemical cleavage of the linker of the remaining systemically circulating TGW211, release and rapid elimination of the radionuclide from the body through the kidneys. 111In-TGW211 is under evaluation in an open-label, Phase 0/1 clinical trial (CleavHER trial) designed to evaluate safety, pharmacokinetics and dosimetry in patients with HER2-positive solid tumors.

(Press release, Tagworks Pharmaceuticals, OCT 15, 2025, View Source [SID1234656681])

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.

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 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 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapy approaches in oncology and inflammation & immunology (I&I), reported it will for the first time present preclinical data on its lead TriSTAR program, TriSTAR0701, a dual-payload T cell engager targeting Nectin-4, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting, taking place November 5–9, 2025, in National Harbor, Maryland.

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 TriSTAR platform represents the next frontier in precision T cell engagers designed to harness the diversity of the T cell repertoire and selectively redirect unique T cell subsets against high value tumor targets," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "The disclosure of Nectin-4 as the first target of our TriSTAR platform marks an important milestone as we expand our pipeline. TriSTAR0701 exemplifies the versatility of our dual-payload design — combining targeted tumor engagement with synergistic T cell activation to unlock potent and durable antitumor activity."

TriSTAR is a first-in-class, dual-payload design that delivers two T cell activation signals to overcome exhaustion in "cold" tumors and improve therapeutic index via selective engagement of unique T cell subsets within the TIL compartment.

Presentation 1 details:

Title: TriSTAR0701, a first-in-class T cell receptor β chain-directed T cell engager, retargets Vβ T cell subsets to Nectin-4-expressing tumors to promote potent and durable antitumor activity
Conference: SITC (Free SITC Whitepaper) Annual Meeting 2025
Abstract Number: 914
Session Title: Immune-Stimulants and Immune Modulators
Session Date: Saturday, November 8
Marengo’s ongoing collaborations with Ipsen and the National Cancer Institute (NCI) are rapidly advancing a new class of immune therapies with the potential to transform outcomes across multiple solid tumor types. The company will feature four preclinical presentations in partnership with NCI evaluating rational combination strategies for Invikafusp alfa, the company’s lead clinical-stage program, with standard-of-care agents including immune checkpoint blockade (ICB), chemotherapies, HDAC inhibitors, and PARP inhibitors.

The results further validate the importance of therapeutic regimens intended to expand and sustain antitumor immune activation with Invikafusp alfa across broader patient populations and in earlier lines of therapy.

Presentation 2 details:

Title: Triple combination therapy with a TCR Vb-directed bifunctional molecule, cisplatin and anti-PD-1 in immune checkpoint blockade-refractory head and neck murine tumor models
Abstract Number: 629
Session Title: Combination Immunotherapies
Session Date: Friday, November 7
Collaboration: NIH/NCI CRADA
Presentation 3 details:

Title: A novel anti-TCR Vb targeted bispecific antibody in combination with a poly ADP-ribose polymerase inhibitor (PARPi) enhances anti-tumor immune response in prostate cancer models
Abstract Number: 916
Session Title: Immune-Stimulants and Immune Modulators
Session Date: Saturday, November 8
Collaboration: NIH/NCI CRADA
Presentation 4 details:

Title: A novel TCRβ-directed IL-2 fusion molecule promotes memory CD8+ T cells with self-renewing properties in tumor ecosystems, further expanded by HDAC inhibition to elicit effective tumor suppression
Abstract Number: 914
Session Title: Combination Immunotherapies
Session Date: Friday, November 7
Collaboration: NIH/NCI CRADA
Presentation 5 details:

Title: Epigenetic modulation synergizes with TCRβ-targeted IL-2 to yield CD8+ T cell dependent, MHC-I independent tumor control via an antibody associated mechanism
Abstract Number: 663
Session Title: Combination Immunotherapies
Session Date: Friday, November 7
Collaboration: NIH/NCI CRADA

(Press release, Marengo Therapeutics, OCT 15, 2025, View Source [SID1234656682])

On October 15, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported that Chairman and Chief Executive Officer Steven Quay, M.D., Ph.D. will participate in the Maxim Growth Summit on October 22–23, 2025 at the Hard Rock Hotel, New York City. Dr. Quay will also be available for one-on-one investor meetings during the conference.

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!

Why attend or follow along?

Clear strategy & focus: Atossa is concentrating capital on programs and data packages that can enable future regulatory submissions and potential commercialization.

Compelling thesis for new investors: Atossa believes the combination of disciplined capital allocation, clear clinical objectives, and a sizeable unmet need in breast cancer creates an attractive setup for long-term value creation.

Direct access to leadership: Conference 1x1s provide an opportunity to discuss Atossa’s development plans, milestones, and how the Company thinks about returns on R&D spend.
Call to Action
Prospective and existing investors are encouraged to visit Atossa website’s Investors section to review latest presentations, SEC filings, and FAQs, and to sign up for email alerts. Learn more about Atossa and $ATOS at www.atossatherapeutics.com (Investors → Events & Presentations).

Note to investors: To request a 1×1 meeting at the Maxim Growth Summit or to obtain the latest investor deck, please visit www.atossatherapeutics.com (Investors) or contact CORE IR at the emails below.

(Press release, Atossa Therapeutics, OCT 15, 2025, View Source [SID1234656683])

On October 15, 2025 Boehringer Ingelheim and AimedBio, a biotechnology company specializing in the development of antibody-based therapeutics, reported a global collaboration and licensing agreement to develop a novel antibody-drug conjugate (ADC) therapy for a broad range of cancers. The agreement further strengthens Boehringer’s growing ADC portfolio, driven by its subsidiary, NBE Therapeutics, to achieve the company’s aim of transforming the lives of people with cancer.

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!

"ADCs are a powerful therapeutic approach that combines biological precision with chemical potency," said Vittoria Zinzalla, Global Head of Experimental Medicine at Boehringer Ingelheim. "Targeting the specific cancer surface marker with AimedBio’s ADC may expand precision medicine treatment options for currently hard to treat cancers and potentially deliver meaningful benefit to patients. We are proud to move this program into the clinic as part of our mission to transform cancer care."

ADCs harness the specificity of monoclonal antibodies and the potency of cytotoxic agents – in this case a derivative of exatecan – to selectively target and eliminate cancer cells while minimizing damage to healthy tissue. The ADC developed by AimedBio targets a protein that is highly expressed across a broad spectrum of cancers, minimally present in normal tissues, and plays a significant role in tumor growth, metastasis and resistance to therapy. Targeting this protein with an ADC is expected to enable highly specific cytotoxic action against the tumor cells, enhancing efficacy and supporting better outcomes for patients.

"We believe this program has the potential to transform the treatment landscape for many cancers that currently lack effective options. Partnering with Boehringer will help advance this program with the speed, scale, and expertise needed to validate this novel target and approach," said Do-Hyun Nam, CTO of AimedBio. "Boehringer’s strong commitment to next-generation cancer therapies makes them the ideal partner to carry this program forward into the clinic and beyond."

Under the terms of the agreement, AimedBio is entitled to receive up to $991 million in total, including an upfront payment, development and regulatory milestones, and commercial milestones, as well as separate royalty payments on net sales.

(Press release, Boehringer Ingelheim, OCT 15, 2025, View Source [SID1234656704])