On December 4, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that two posters detailing the preclinical findings and clinical data1 from its Phase 2a trial evaluating amsulostat (200 mg BID) in combination with ruxolitinib (RUX) for the treatment of myelofibrosis (MF) will be presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper), taking place in Orlando, Florida, from 6-9 December 2025.

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One poster presentation, titled "A Phase 1/2a Trial of Amsulostat, a Novel Pan-Lysyl Oxidase Inhibitor, in Patients with Advanced Myelofibrosis as an Add-On to Ruxolitinib Treatment for Up to 52 Weeks," will be featured in the session "Myeloproliferative Syndromes: Clinical and Epidemiological" on Saturday 6 December (EST).

In a concurrent "Bone Marrow Microenvironment" session, Syntara will also present preclinical research highlighting amsulostat-sensitive, lysyl oxidase–mediated modulation of growth factor signaling, titled "Lysyl Oxidases Directly Control Cell Surface Abundance of Platelet-Derived Growth Factor Receptors and Signaling in Osteoblasts."

Attending the ASH (Free ASH Whitepaper) Annual Meeting on behalf of Syntara will be Dr. Jana Baskar, CMO, Dr. Wolfgang Jarolimek, Head of Drug Discovery, and Gary Phillips, CEO.

Mr Phillips said: "The ASH (Free ASH Whitepaper) Annual Meeting and Exposition is the leading global forum for advancing research in haematological malignancies. We welcome the opportunity to present our recent clinical and mechanism of action data on amsulostat to the global haematology community and to discuss future clinical and commercial pathways with potential collaborators."

Syntara has received feedback from the US Food and Drug Administration (FDA) on the recommended pathway for further development of amsulostat and, with the support of an experienced and well renowned advisory board, is progressing the protocol for the next trial. Amsulostat is also being evaluated in two Phase 1c/2 trials of myelodysplastic syndrome which are currently recruiting and expected to deliver preliminary results in 2026.

(Press release, Syntara, DEC 4, 2025, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/a7cc5fc7-eb21-174a-d2db-66f2331f2272/03033592.pdf [SID1234661128])

On December 4, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO (Free ESMO Whitepaper) Asia Congress 2025. Data in previously treated NSCLC patients with EGFR atypical mutations were presented at a mini-oral session, and the presentation can be found in the publication section of ORIC’s website here. In addition, compelling preliminary data in 1L NSCLC patients with EGFR P-loop and alpha C-helix compressing (PACC) mutations were disclosed.

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"Enozertinib was purposefully designed to be highly brain-penetrant and exquisitely selective in order to address the limitations of available therapies and potentially drive differentiated durability. These data provide clinical support for this design approach, demonstrating strong systemic and CNS activity in NSCLC patients with EGFR PACC mutations," said Pratik S. Multani, M.D., chief medical officer. "The profile we have seen with enozertinib compares favorably to other investigational therapies and continues to support enozertinib’s best-in-class potential."

Enozertinib Phase 1b Trial Design
Enozertinib is being evaluated in a Phase 1b trial in patients with locally advanced or metastatic NSCLC with EGFR atypical mutations. Notably, enrollment allows patients with active untreated brain metastases. Prior therapies in previously treated patients include chemotherapy and EGFR targeted therapies. The primary endpoint of the trial is to determine the recommended Phase 2 dose (RP2D), and secondary endpoints include investigator-assessed objective response rate (ORR), disease control rate (DCR), and safety.

Previously Treated NSCLC Patients with EGFR Atypical Mutations
As of the August 29, 2025 cutoff date, 47 patients were dosed — 25 patients received 80 mg QD oral enozertinib and 22 patients received 120 mg QD. Patients were heavily pretreated, having received a median of 2 prior therapies, with 81% of patients having received a prior EGFR targeted therapy, including osimertinib and afatinib. Brain metastases were present in 55% of patients at baseline, including those with active brain metastases.

Preliminary Safety Analysis
Enozertinib was well tolerated with mostly Grade 1 or 2 treatment-related adverse events (TRAEs) and no significant off-target toxicities. Most frequent TRAEs included diarrhea, paronychia, and stomatitis. There were no treatment discontinuations related to TRAEs. High rates of early dose reductions occurred in the 120 mg cohort compared to the 80 mg cohort, such that most patients received an effective dose of 80 mg QD.

22 patients with PACC mutations were efficacy evaluable, all receiving an effective dose of 80 mg QD, consisting of 12 patients from the 80 mg cohort and 10 patients from the 120 mg cohort who underwent early dose reduction.

Preliminary Activity Analysis
In the 22 efficacy evaluable patients with PACC mutations, enozertinib demonstrated strong systemic and CNS antitumor activity.

36% confirmed ORR and 91% DCR, with comparable rates in patients with brain metastases at baseline
Responses observed across a wide range of EGFR PACC mutations including in the most prevalent mutations (i.e., G719X, S768I), and in a broad spectrum of PACC complex mutations
As of the data cutoff (at a median follow-up of over 32 weeks), 75% of responders remained on treatment
1L NSCLC Patients with EGFR PACC Mutations (Preliminary)
As of the November 18, 2025 cutoff date, 10 efficacy evaluable patients were dosed with 80 mg QD oral enozertinib. 60% of these patients had brain metastases at baseline, all of which were active and untreated. The safety profile to date in this cohort of patients is in line with the safety profile at the 80 mg QD dose level in other cohorts. Enozertinib demonstrated strong preliminary systemic and CNS activity, including 80% ORR and 100% intracranial ORR in patients with measurable CNS disease (investigator-assessed by RECIST).

Next Steps
Based on these data, 80 mg QD oral enozertinib has been selected as the dose for potential Phase 3 development. Enrollment and follow-up continues in 1L EGFR PACC patients with the next update expected in mid-2026, ahead of initiation of a potential Phase 3 trial.

Conference Call and Webcast Details
In conjunction with the ESMO (Free ESMO Whitepaper) Asia Congress, ORIC will host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of ORIC’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

(Press release, ORIC Pharmaceuticals, DEC 4, 2025, View Source [SID1234661127])

On December 4, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA) ("Protara"), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that it has commenced an underwritten public offering of $75 million in aggregate of shares of its common stock or, in lieu of issuing common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares of common stock and pre-funded warrants to be sold in the proposed offering will be offered by Protara. In addition, Protara expects to grant the underwriters a 30-day option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Protara intends to use the net proceeds received from the offering to fund the clinical development of TARA-002, as well as the development of other clinical programs. Protara may also use the net proceeds from the offering for working capital and other general corporate purposes.

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J.P. Morgan, TD Cowen and Piper Sandler are acting as joint book-running managers of the proposed offering.

The shares of common stock and the pre-funded warrants will be issued pursuant to a shelf registration statement on Form S-3 (File No. 333-275290) that was declared effective on November 14, 2023 by the U.S. Securities and Exchange Commission (the "SEC"). The offering is being made only by means of a preliminary prospectus supplement and the accompanying prospectus. A preliminary prospectus supplement and the accompany prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from the offices of J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at [email protected] and [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at [email protected]; or Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

Before investing in the offering, interested parties should read the preliminary prospectus supplement and related prospectus for this offering, the documents incorporated by reference therein and the other documents Protara has filed with the SEC. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.

(Press release, Protara Therapeutics, DEC 4, 2025, View Source [SID1234661126])

On December 4, 2025 NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, reported that new data from the expanded Phase 1 dosing study for ragistomig, a 4-1BB X PD-L1 bispecific antibody, will be presented in a poster at the European Society for Medical Oncology – Immuno-Oncology Congress 2025 (ESMO-IO 2025) by co-developer ABL Bio. The poster (Abstract #688) will be presented by Gerald Falchook, MD, Director of the Sarah Cannon Research Institute (SCRI) at HealthONE Denver, on Wednesday, December 10th at 5:30 PM GMT.

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"The expanded Phase 1 dosing study achieved its objective of extending the therapeutic window for ragistomig by defining a new dosing schedule that could provide strong anti-tumor efficacy and a more manageable tolerability profile, including improved hepatic safety. The data build on promising Phase 1 data presented at ASCO (Free ASCO Whitepaper) 2024 and support progression to combination studies which could significantly advance patient care," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.

"Ragistomig was designed to deliver new therapeutic options for patients who have developed resistance or relapsed after treatment with checkpoint inhibitors, a multi-billion dollar drug class that serves as the cornerstone of care for many cancers. We are encouraged by the promising ragistomig advancements and data that will be presented at ESMO (Free ESMO Whitepaper)-IO and look forward to continuing the program in collaboration with our partner, ABL Bio," said Sean Fu, PhD, Chief Executive Officer of NovaBridge.

ESMO-IO Meeting information:

•
Title: Phase 1 Clinical Trial of Ragistomig (ABL503/TJ-L14B: PD-L1 × 4-1BB bispecific antibody) Q6W Dosing Balances Favorable Safety and Sustained Efficacy Through Extended Immunologic Memory and Reinvigoration of CD8+ T Cells
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Abstract #688
•
Date and Time: Wednesday, December 10th at 5:30 PM GMT
A copy of the poster will be available here after the session. To review an overview of the Phase 1 dose escalation data, click here.

About Ragistomig

Ragistomig (also known as ABL503) is a differentiated novel bispecific that integrates a single-chain, Fc-silent PD-L1 segment as a tumor engager and 4-1BB segment as a conditional T cell activator. It was developed using ABL Bio’s "Grabody-T" bispecific antibody platform technology to overcome resistance to PD-(L)1 inhibition and stimulate 4-1BB activation only in the presence of PD-L1 expressing tumor cells, to minimize the risk of off-tumor toxicity. Preclinical studies demonstrated that the bispecific antibody showed better anti-tumor activity than its single-agent components. A Phase 1 dose expansion study (NCT04762641) is currently being conducted in the U.S. and South Korea. The study was designed with a primary endpoint of defining the dose-limiting toxicity and adverse event profile of ragistomig, as well as to observe the objective response rate, pharmacokinetic and immunogenicity profiles and other secondary endpoints.

Ragistomig (also known as ABL503) is being jointly developed with ABL Bio

ASCO 2024: the 2024 American Society for Clinical Oncology Annual Meeting; Q6W: every six weeks

(Press release, NovaBridge Biosciences, DEC 4, 2025, View Source [SID1234661123])

On December 4, 2025 LabGenius Therapeutics ("LabGenius"), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise potential therapeutic antibodies, reported a second collaboration with Sanofi. This collaboration combines LabGenius’ AI/ML-driven antibody design capabilities with Sanofi’s expertise in the development of therapeutic NANOBODY molecules to co-optimise proteins for therapeutically valuable properties. Following the success of their first collaboration, LabGenius will apply the EVA platform to optimise NANOBODY molecules for multiple new targets in the area of inflammation.

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"We are truly excited about this new collaboration with Sanofi," said LabGenius’ CSO, Dr. Angus Sinclair. "This partnership serves as strong validation of our platform’s unique ability to tackle complex antibody co-optimisation challenges across a wide range of therapeutic targets, ultimately driving better outcomes for patients."

(Press release, LabGenius Therapeutics, DEC 4, 2025, View Source [SID1234661122])