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:

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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
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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])

On December 4, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs, and Crescent Biopharma, Inc. ("Crescent") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported that the companies have entered into a strategic partnership to develop and commercialize oncology therapeutics, including novel combinations.

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The partnership involves Crescent’s CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech’s SKB105, an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload. Both candidates are being developed for the treatment of solid tumors and are expected to enter Phase 1/2 monotherapy clinical trials in the first quarter of 2026.

Under the terms of the collaboration, Crescent has granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105 in the United States, Europe and all other markets outside of Greater China. The partnership includes the development of these candidates as monotherapies, and also the evaluation of CR-001 in combination with SKB105. Both Crescent and Kelun-Biotech have the right to independently develop CR-001 in additional combinations, including combinations of CR-001 with proprietary ADC pipeline assets.

Dr. Michael Ge, chief executive officer of Kelun-Biotech, said, "We are pleased to have entered into a partnership with Crescent for two innovative assets, CR-001 and SKB105. This collaboration complements and strengthens our differentiated oncology pipeline by the addition of CR-001 and also enables us to advance the development of SKB105 in the global market, bolstering its potential commercial value and our global collaboration network. Our creative global partnership combines the capabilities of both companies to explore novel monotherapies and combination strategies for tumor treatments with SKB105 and CR-001. By leveraging China’s abundant clinical resources and execution efficiency, we aim to expedite clinical development while rigorously maintaining the highest global standards. We believe this partnership creates a powerful synergy to maximize the potential of these two drug candidates for the treatment of patients in both China and the rest of the world."
"We are thrilled to be partnering with Kelun-Biotech, an established leader in the development and commercialization of ADCs who shares our commitment to bringing next generation therapeutics that can improve outcomes for people living with cancer," said Joshua Brumm, chief executive officer of Crescent. "This collaboration expands our pipeline with the addition of SKB105, furthers our strategy of advancing multiple modalities across our portfolio, and accelerates our efforts to deliver synergistic combinations with CR-001, which has the potential to be a foundational backbone therapy. We look forward to working with Kelun-Biotech to drive innovative therapeutics with the potential to address multiple tumor types and transform cancer care."

Under the collaboration, Kelun-Biotech will receive an upfront payment of US$80 million from Crescent and is also eligible to receive additional milestones of up to US$1.25 billion, plus tiered middle single-digit to low double-digit royalties on net sales of SKB105. Kelun-Biotech is also eligible to receive additional payment from Crescent if Crescent undergoes a near-term change of control or enters into a sublicense agreement with a third party. Crescent will receive an upfront payment of US$20 million from Kelun-Biotech and is also eligible to receive additional milestones of up to US$30 million, plus tiered low to middle single digit royalties on net sales of CR-001.

About CR-001 (also known as SKB118)

CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with antibody-drug conjugates (ADCs). A global Phase 1/2 trial of CR-001 in patients with solid tumors is anticipated to commence in the first quarter of 2026.

About SKB105 (also known as CR-003)
SKB105 is a differentiated ADC targeting integrin beta-6 (ITGB6) with a topoisomerase 1 inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. The molecule incorporates proprietary Kthiol irreversible conjugation technology, designed to enhance stability and tumor-specific payload delivery while reducing adverse effects. SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile in preclinical models. A Phase 1/2 clinical trial of SKB105 in patients with solid tumors is anticipated to commence in the first quarter of 2026.

(Press release, Crescent Biopharma, DEC 4, 2025, View Source [SID1234661121])