On September 23, 2025 SEED Therapeutics, Inc. ("SEED"), a clinical-stage biotechnology company pioneering rational molecular glue degraders for historically undruggable disease drivers, reported the successful completion of its $30 million Series A-3 financing, alongside U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for its lead program targeting RBM39 (Press release, Seed Therapeutics, SEP 23, 2025, View Source [SID1234656168]). The company anticipates entering first-in-human clinical trials of ST-01156 in Q1 2026.

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The $30 million Series A-3 financing consists of a $24 million first close completed in August 2024 and a $6 million second close completed in August 2025. In addition, SEED has received close to $60 million in equity, as well as collaboration upfront and milestone payments combined, from its partnerships with Eli Lilly and Eisai reflecting strong partner validation of its scientific platform.

Lan Huang, Ph.D., SEED Co-Founder, Chairman, and Chief Executive Officer, said:
"FDA clearance of our IND is a defining milestone for SEED, marking our transition into a clinical-stage company. ST-01156 represents the first of a new generation of rationally designed molecular glue degraders. We continue to translate innovation into meaningful therapies for patients."

Bill Desmarais, SEED Chief Financial Officer and Chief Business Officer, added:
"Our equity financing, together with collaboration payments from Eli Lilly and Eisai, supplement our resources to move confidently into the clinic and to continue building a broad pipeline. We have the partners, capital, and momentum to deliver on SEED’s strategy."

SEED Therapeutics is a TPD 2.0 company that integrates structure-based drug design, computational chemistry, and chemical biology to discover molecular glues that reprogram the ubiquitin-proteasome system to degrade disease-causing proteins. Its proprietary RITE3 platform has generated a growing pipeline of nine programs spanning oncology, neurodegeneration, immunology, and virology.

On September 23, 2025 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery of next generation targeted protein degradation (TPD) medicines, reported first data on its TEAD oncology therapeutic program including unveiling a new mechanism of action for the degradation of TEAD that is differentiated from cereblon- or VHL-based PROTACs (Press release, Amphista Therapeutics, SEP 23, 2025, View Source [SID1234656167]). Amphista’s novel TEAD Targeted Glues, which are inherently smaller and more drug like molecules than conventional PROTAC binders, have demonstrated:

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Novel mechanism of degradation: Amphista’s pan-TEAD Targeted Glue series induces degradation via functional recruitment of the E3 ligase FBXO22 (F-Box Protein 22), a mechanism of degradation that has not previously been described for TEAD.
Highly specific degradation of TEAD:Global proteomics demonstrates complete, and statistically significant, selective, degradation of TEAD vs >7000 other proteins.
Deep target degradation via oral dosing: Leveraging high-resolution cryo-EM, Amphista has designed sub-nM degraders of TEAD which induce >95% degradation of TEAD in vivo after a single oral dose.
Exceptional degradation dynamics: Amphista’s Targeted Glues achieve >90% TEAD degradation within 2 hours (the first time point measured) of single dosing, sustained at >70% through to at least 72 hours,
Louise Modis, Chief Scientific Officer of Amphista Therapeutics, said: "Soon after disclosing initial details of our SMARCA2 oncology program, the first unveiling of a completely novel mechanism of action for the degradation of TEAD, represents another significant milestone for Amphista, as well as the wider targeted protein degradation field. The development of potent, rapid, orally bioavailable Targeted Glue degraders of TEAD that work via FBXO22 is testament to the power of our Eclipsys platform and our brilliant multidisciplinary team. What is particularly exciting are the structural insights that we are gaining from our technology as we build our cryo-EM datasets. Not only are these helping Amphista generate differentiated, higher quality molecules with the properties that will enable them to become medicines, but they are also unlocking mechanistic insights into the development and optimisation of Amphista’s Targeted Glues which operate through diverse ligases. The progress we have made across our portfolio this year, which includes the disclosure of two completely novel mechanisms for the degradation of therapeutically relevant targets is exceptional. I am looking forward to sharing further data and updates as we look to select our clinical candidates for TEAD and SMARCA next year."

Amphista plans to present data from its TEAD Targeted Glue program at a key forthcoming TPD scientific conference.

This news on Amphista’s TEAD Targeted Glue program follows an announcement by the Company on 17 September 2025, which disclosed first data on its SMARCA2 program including demonstrating exquisite selectivity of its sequentially bifunctional Targeted Glues for SMARCA2 over the closely related homolog, SMARCA4.

On September 22, 2025 OGT, a leading global provider of genomic diagnostic and research solutions, reported that the U.S. Food and Drug Administration (FDA) has granted their De Novo Classification Request for the CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax’s first-in-class menin inhibitor, REVUFORJ (revumenib) (Press release, Sysmex, SEP 22, 2025, View Source [SID1234656163]). Revuforj is FDA approved for the treatment of relapsed or refractory (R/R) acute leukaemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and paediatric patients one year and older.

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OGT’s CytoCell KMT2A Breakapart FISH Probe Kit PDx detects clinically relevant rearrangements that occur in patients with acute leukaemia, providing a robust, accessible, rapid turnaround test for KMT2Ar detection that will maximize the ability for clinicians to quickly identify patients who may be eligible for treatment with Revuforj. It is estimated that more than 95% of patients with KMT2Ar acute leukaemia have a KMT2A translocation, a type of rearrangement that occurs when part of one chromosome breaks and fuses to a different chromosome.

"We are delighted that our CytoCell KMT2A Breakapart FISH Probe Kit PDx has received marketing authorization as a CDx for Revuforj." said Dr. Leila Luheshi, VP of Pharma Partnering at OGT. "The development and subsequent authorization of this new CDx is an important demonstration of the skill and commitment of our clinical scientists and regulatory specialists to deliver safe and effective diagnostics for patients with one of the most devastating forms of leukaemia."

Steve Chatters, OGT’s EVP of Regulatory and Medical Affairs noted "Our strong foundation in haematology diagnostics has been a key factor in our success bringing the KMT2Ar CDx to market as a Class II device, as opposed to the more common Class III classification for companion diagnostics. We have decades of experience developing regulated FISH products, gained from our prior development of IVDR-certified and FDA-cleared FISH probes. Combined with our extensive customer partnerships in haematology labs in the USA, we have refined insights into the application of these products and are able to access a wealth of real-world data across a multitude of clinical and analytical factors, which is invaluable for product development. This is a core pillar of our success."

The emergence of precision therapies, such as the menin inhibitor Revuforj (an oral inhibitor of the menin–KMT2A interaction), offers new avenues for potentially improving outcomes for patients with these challenging acute leukaemia cases.

"Accurately identifying acute leukaemia patients with KMT2Ar is a key factor in selecting appropriate therapeutic options for a group of patients who have traditionally had a very poor prognosis" said Adrian Smith, CEO of OGT. "We are optimistic that the authorization of OGT’s CDx will help this underserved patient group benefit from developments in precision oncology."

On September 22, 2025 Tubulis reported that its late-breaking abstract covering first clinical data from its ongoing Phase I/IIa NAPISTAR 1-01 trial (NCT06303505) has been accepted for oral presentation at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held October 17-21, 2025, in Berlin (Press release, Tubulis, SEP 22, 2025, View Source [SID1234656162]). The presentation by the principal investigator of the study, Dr. Antonio Gonzalez-Martin, will provide interim data from the dose escalation part of the ovarian cancer cohort in the first-in-human study with TUB-040. Tubulis’ lead antibody-drug conjugate (ADC), TUB-040 is a next-generation NaPi2b-targeting ADC developed using Tubulis’ proprietary Tubutecan linker-payload platform. It combines the company’s P5 conjugation system with an exatecan payload enabling the development of stable, highly targeted ADCs, optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. In a range of preclinical models, including ovarian cancer, TUB-040 demonstrated superior biophysical properties as well as effective and durable responses.

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Details of the oral presentation:

Title: NAPISTAR 1-01: A Phase 1 dose escalation study of TUB-040, a novel NaPi2b-targeting exatecan antibody-drug conjugate (ADC) in patients with platinum-resistant ovarian (PROC) high-grade serous carcinoma (HGSC)
Presenter: Dr. Antonio Gonzalez-Martin, Director Medical Oncology Department and Cancer Center Director at Clínica Universidad de Navarra
Session Category and Title: Mini Oral session: Gynaecological cancers
Session Date and Time: October 19, 2025; 10:15 – 11:45 am CEST
Lecture Time: 10:38 – 10:43 am CEST
Location: Cologne Auditorium – CityCube A
Abstract Number: #5520

About TUB-040 and the Tubutecan Technology

Tubulis’ lead antibody-drug conjugate (ADC) TUB-040 is directed against NaPi2b, an antigen highly overexpressed in ovarian cancer and lung adenocarcinoma. It consists of an IgG1 antibody targeting NaPi2b equipped with Tubulis’ proprietary Tubutecan technology, connecting the Topoisomerase I inhibitor, exatecan, through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8. Based on novel chemistry for cysteine-selective conjugation, the technology enables the development of stable, highly targeted ADCs optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. The candidate is currently being investigated in a multicenter Phase I/IIa study (NAPISTAR1-01, NCT06303505) that aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as a monotherapy in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC).

On September 22, 2025 Akeso Inc. (9926.HK) reported that the first patient has been dosed in its registrational Phase II study (AK130-202), evaluating AK130, a fully independently developed TIGIT/TGF-β bifunctional antibody fusion protein, in combination with ivonescimab (PD-1/VEGF bispecific antibody), for treating locally advanced or metastatic pancreatic cancer in patients who have failed up to two prior lines of systemic therapy (Press release, Akeso Biopharma, SEP 22, 2025, View Source;bifunctional-antibody-fusion-protein-ak130-combined-with-ivonescimab-for-advanced-pancreatic-cancer-302562663.html [SID1234656161]).

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AK130 is the world’s first and only TIGIT/TGF-β bifunctional antibody fusion protein in registrational clinical development. The initiation of the AK130-202 study marks a significant milestone in Akeso’s strategy approach of "IO2.0 + IO2.0" combinations. This clinical development strengthens Akeso’s leadership position in the emerging global IO 2.0 cancer therapy landscape.

To date, Akeso has nine self-developed bispecific antibodies or bispecific antibody-drug conjugates (ADCs) in clinical development or received regulatory approval. Leveraging its proprietary bispecific antibody technology platform, Akeso has multiple advanced combination therapy research programs that include commercially approved therapies such as ivonescimab and cadonilimab (PD-1/CTLA-4 bispecific antibody), as well as potentially first -in-class candidates such as AK130 and AK146D1 (Trop2/Nectin4 bispecific ADC).

Preclinical studies indicate that dual blockade of the PD-1/VEGF and TIGIT/TGF-β pathways has synergistic therapeutic potential. This combination could remodel the tumor immune microenvironment and enhance anti-tumor immune responses. Prior clinical data from ivonescimab monotherapy in first-line pancreatic cancer has shown strong efficacy potential. The combination of AK130 and ivonescimab is expected to further improve the therapeutic benefit in this challenging malignancy.

About AK130 (Bifunctional Antibody Fusion Protein)

AK130 is Akeso’s entirely in-house developed bifunctional antibody fusion protein. It combines an anti-TIGIT monoclonal antibody with the extracellular domain of the human TGF-β receptor II. TIGIT is an emerging immune checkpoint, and blocking TIGIT-CD155 interactions can relieve suppression of tumor-infiltrating CD8+ T cells and NK cells, thereby enhancing their anti-tumor activity. TGF-β signaling contributes to immunosuppression, immune evasion, and resistance to checkpoint inhibitors. By blocking both TIGIT and TGF-β, AK130 can activate T-cell responses while reducing the immunosuppressive activity of Tregs, leading to enhanced anti-tumor effects.

As the first and only TIGIT/TGF-β bifunctional antibody fusion protein in registrational clinical development globally, AK130 has now been administered to the first patient in its combination therapy study with ivonescimab for advanced pancreatic cancer. Additional clinical trials are ongoing to evaluate AK130 as a monotherapy for advanced solid tumors and in combination with ivonescimab for advanced hepatocellular carcinoma.