On December 5, 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 HER2 exon 20 mutations were presented at a poster session, and the poster can be found in the publication section of ORIC’s website here.

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Enozertinib Phase 1b Trial Design
Enozertinib is being evaluated in a Phase 1b trial in patients with locally advanced or metastatic NSCLC with HER2 exon 20 mutations. Notably, enrollment allows patients with active untreated brain metastases. Prior therapies include chemotherapy and HER2 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 HER2 Exon 20 Mutations
As of the August 29, 2025 cutoff date, 49 patients were dosed — 26 patients received 80 mg QD oral enozertinib and 23 patients received 120 mg QD. Patients were treated with up to 4 prior therapies, with 80% of patients having received prior chemotherapy and 35% having received a prior HER2 targeted therapy. Brain metastases were present in 47% 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 paronychia, diarrhea, and dermatitis acneiform. Only 2 patients discontinued treatment due to TRAEs. Higher rates of dose reductions occurred in the 120 mg cohort compared to the 80 mg cohort.

Preliminary Activity Analysis
Tumor responses were observed in both the 80 mg and 120 mg cohorts, including in patients with baseline brain metastases. Patients in the 80 mg cohort experienced deeper tumor regressions potentially due to the lower rate of dose reductions.

35% ORR (26% confirmed ORR) and 100% DCR in the 80 mg cohort
As of the data cutoff (at a median follow-up of 50 weeks), 32% of patients remained on treatment in both the 80 mg and 120 mg cohorts
Next Steps
Based on data generated in patients with EGFR exon 20 and EGFR atypical mutations, 80 mg QD oral enozertinib has been selected as the dose for potential Phase 3 development. Enrollment and follow-up continues in 1L NSCLC patients with EGFR exon 20 and EGFR P-loop and alpha C-helix compressing (PACC) mutations, with the next update expected in mid-2026, ahead of initiation of potential Phase 3 trial(s). Enrollment in HER2 exon 20 has been completed with no further development planned in this patient population.

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 5, 2025, View Source [SID1234661169])

On December 5, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported that it has agreed to sell 12,500,000 ordinary shares at $10.00 per share in an underwritten offering. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be $125 million. The offering is expected to close on December 8, 2025, subject to customary closing conditions.

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Jefferies, Leerink Partners and Cantor are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on April 3, 2025. The offering is being made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, telephone: (877) 821-7388, email: [email protected];
Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: [email protected];
Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, e-mail: [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

(Press release, Immatics, DEC 5, 2025, View Source [SID1234661168])

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.

On December 04, 2025 (GLOBE NEWSWIRE) — Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported an exclusive partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") and a comprehensive pipeline update, as well as a $185 million private placement, which is expected to close on or about December 8, 2025, subject to satisfaction of customary closing conditions.

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"We’re excited to share the tremendous progress we’ve made executing on our strategy of building a robust portfolio of next generation oncology therapeutics," said Joshua Brumm, chief executive officer of Crescent. "CR-001, our PD-1 x VEGF bispecific antibody, has the potential to be a foundational immuno-oncology backbone and the partnership we announced with Kelun-Biotech today has enhanced our pipeline of ADCs and accelerated our efforts to deliver potentially best-in-class novel combination therapies. Crescent is now poised to have three distinct programs entering the clinic in 2026 and multiple data readouts anticipated from both monotherapy and novel combination therapy studies by the end of 2027. Additionally, the financing we announced today with leading healthcare investors strengthens our balance sheet, providing anticipated cash runway through multiple key inflection points. Our comprehensive update today underscores Crescent’s commitment to deliver on our vision of building the next leading biotech oncology company."

Kelun-Biotech and Crescent Strategic Partnership

In a separate release today, Kelun-Biotech and Crescent announced a strategic partnership to develop and commercialize next generation oncology therapeutics, including novel combinations. The partnership involves Crescent’s CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech’s SKB105 (also known as CR-003), an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload.

Under the terms of the collaboration, Crescent has granted Kelun-Biotech exclusive rights to research, develop, 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, and commercialize SKB105 (CR-003) in the United States, Europe and all 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 (CR-003). 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.

Key Pipeline Updates

New details on Crescent’s portfolio, including the clinical development plan for CR-001 as well as supporting preclinical data and plans for its ADC programs, will be shared during today’s conference call and webcast.

CR-001, a PD-1 x VEGF bispecific antibody

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. It was intentionally designed to replicate the cooperative pharmacology of ivonescimab, which demonstrated superior efficacy results compared to the current market leader, pembrolizumab, in a large, third-party Phase 3 trial in non-small cell lung cancer.1 Because of this similar cooperativity, there is the opportunity for rapid and efficient clinical development for CR-001 as Crescent pursues both first-in-class and fast-follower solid tumor indications.
Crescent is on track to initiate a global Phase 1/2 clinical trial of CR-001 in patients with solid tumors in the first quarter of 2026. The trial is designed to enroll both treatment-naïve and previously-treated patients with multiple solid tumor types, including non-small cell lung cancer and various gastrointestinal and gynecological tumors. The trial plans to include dose-escalation, back-fill and dose-optimization cohorts to enable robust assessment of the clinical profile of CR-001. Crescent anticipates reporting proof-of-concept clinical data from the Phase 1/2 trial of CR-001 in the first quarter of 2027, including safety, pharmacokinetic, pharmacodynamic and early anti-tumor activity.
CR-001’s anti-VEGF activity may normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the planned administration of CR-001 with ADCs. The partnership with Kelun-Biotech accelerates the scope and number of combination studies planned with CR-001 as a potential foundational immuno-oncology backbone. Crescent plans to evaluate CR-001 in combination with multiple ADCs, including CR-002 and CR-003 (SKB105), with initial combination data expected by year-end 2027.
CR-002, topoisomerase inhibitor ADC targeting PD-L1

CR-002 is a topoisomerase inhibitor ADC directed to PD-L1, a validated target known to have high expression in multiple solid tumors. CR-002 incorporates a PD-L1 antibody selected for high internalization to facilitate payload release in target cells and a linker designed for intracellular cleavage and high stability in circulation.
Crescent is on track to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration for CR-002 in mid-2026 to support the initiation of a Phase 1/2 trial in solid tumors in the second half of 2026, with proof-of-concept data expected in the second half of 2027.
CR-003 (SKB105), topoisomerase inhibitor ADC targeting Integrin beta-6

CR-003 (SKB105), discovered by Kelun-Biotech, is a topoisomerase inhibitor ADC directed to integrin beta-6 (ITGB6), which is overexpressed in many solid tumors with minimal expression in most normal tissues. CR-003 (SKB105) consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. CR-003 (SKB105) demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile in preclinical models.
Kelun-Biotech plans to initiate a Phase 1/2 trial of CR-003 (SKB105) in Greater China in the first quarter of 2026, with proof-of-concept data expected in the first quarter of 2027. A combination study of CR-003 and CR-001 is planned to initiate in the first half of 2027 with initial data anticipated by year-end 2027.
Pipeline Expansion Opportunities

Crescent also continues to pursue opportunities to advance its strategy in immuno-oncology and best-in-class ADC combinations through internal efforts and with leading partners, including Kelun-Biotech and Paragon Therapeutics.
Anticipated Milestones

First Quarter of 2026

Initiation of Phase 1/2 trial of CR-001
Initiation of Phase 1/2 trial of CR-003 (SKB105)
Second Half of 2026

Initiation of Phase 1/2 trial of CR-002
Initiation of the first Phase 1/2 ADC combination trial with CR-001
First Quarter of 2027

Proof-of-concept clinical data from Phase 1/2 trial of CR-001
Proof-of-concept clinical data from Phase 1/2 trial of CR-003 (SKB105)
First Half of 2027

Initiation of Phase 1/2 trial of CR-001 in combination with CR-003 (SKB105)
Second Half of 2027

Proof-of-concept clinical data from Phase 1/2 trial of CR-002
By Year-End 2027

Initial clinical data from first ADC combination Phase 1/2 trial with CR-001
Initial clinical data from Phase 1/2 trial of CR-001 in combination with CR-003 (SKB105)
Private Placement Financing

Crescent also announced today that it entered into a securities purchase agreement for a private investment of securities to institutional and other accredited investors that is expected to result in gross proceeds of approximately $185 million to the Company, before placement agent fees and offering expenses. The private placement included participation from both new and existing investors, including Forbion, Fairmount, Vestal Point Capital, BVF Partners, ADAR1, Balyasny Asset Management and Venrock Healthcare Capital Partners.

Pursuant to the terms of the securities purchase agreement, the investors agreed to purchase an aggregate of 13,795,685 ordinary shares of Crescent ("Ordinary Shares") at a purchase price of $13.41 per share (or, for certain investors in lieu of Ordinary Shares, pre-funded warrants to purchase Ordinary Shares). The pre-funded warrants are to be issued for a purchase price equating to $13.409 per pre-funded warrant share (which is the per share purchase price for the Ordinary Shares less the $0.001 per share unfunded exercise price for each pre-funded warrant share) and have an exercise price of $0.001 per share. Following the transaction, there will be approximately 33.3 million Ordinary Shares and Ordinary Share equivalents issued and outstanding, including Ordinary Shares underlying pre-funded warrants and Series A non-voting convertible preferred stock. The PIPE financing is expected to close on or about December 8, 2025, subject to satisfaction of customary closing conditions.

Jefferies, TD Cowen, Guggenheim Securities, Cantor and Wedbush & Co. served as placement agents to Crescent and Piper Sandler served as financial advisor.

The Company intends to use the net proceeds from the private placement, together with the Company’s existing cash and cash equivalents, to advance the preclinical and clinical development of the Company’s product candidates and for working capital and other general corporate purposes. Based on Crescent’s current plans, Crescent believes its existing cash and cash equivalents, together with the net proceeds from the private placement, will be sufficient to fund the Company’s operations and capital expenditure requirements into 2028.

(Press release, Crescent Biopharma, DEC 4, 2025, View Source [SID1234663681])

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, Crescent and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the Ordinary Shares and the Ordinary Shares issuable upon exercise of the pre-funded warrants, in each case sold in the private placement.

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

Investor Conference Call and Webcast

Crescent will host a conference call and webcast today, December 4, 2025, at 8:00 a.m. ET. To access the conference call, please dial (877)-346-6112 (U.S. & Canada) or +1 (848)-280-6350 (international) at least 10 minutes prior to the start time and ask to be joined into the Crescent Biopharma conference call. A live webcast will be available in the Investors section of Crescent’s website at View Source, and a replay will be accessible for at least 90 days. An accompanying slide presentation will also be available on Crescent’s website at the start of the presentation.

On December 4, 2025 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that it has received clearance from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct a global registrational Phase III study (POLARIS-1; NCT06051409) of its compound under investigation, olverembatinib, in combination with chemotherapy for the treatment of newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). As the second global registrational Phase III study of olverembatinib that has been cleared by regulators in the US and Europe, the POLARIS-1 study is simultaneously enrolling patients across trial centers in multiple countries in order to accelerate olverembatinib’s path to registration worldwide, particularly in the US and European markets.

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The POLARIS-1 trial is a global, multicenter, randomized controlled, open-label Phase III study designed to evaluate the efficacy and safety of olverembatinib in combination with chemotherapy in newly diagnosed patients with Ph+ ALL. The POLARIS-1 study was also initiated in China after it was cleared by the China Center for Drug Evaluation (CDE) in 2023.

The POLARIS-1 study is set to release its first dataset at the upcoming 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Data disclosed in the ASH (Free ASH Whitepaper) 2025 abstract showed that among treatment-naïve patients with Ph+ ALL who received olverembatinib in combination with low-intensity chemotherapy, the minimal residual disease (MRD) negativity rate and the molecular MRD-negative complete response (CR) rate at the end of three treatment cycles both reached approximately 65%, which significantly improved the efficacy reported for other drugs in the same class. Notably, the combination regimen also demonstrated favorable clinical benefit in patients with certain high-risk subtypes such as those harboring the IKZF1plus mutation. In addition, the combination regimen demonstrated a favorable safety profile, with a low incidence of adverse events which were mostly manageable.

Accounting for 20%-30% of all ALL cases in adults, Ph+ ALL is commonly associated with a disproportionately high incidence in the elderly population, a high relapse rate, short disease-free survival, and poor prognosis. Prior to the introduction of tyrosine kinase inhibitors (TKIs), chemotherapy-only treatment delivered a five-year overall survival (OS) rate of less than 20%. The clinical adoption of TKIs has resulted in a new clinical paradigm for patients with Ph+ ALL. However, first- and second-generation TKIs have considerable limitations in the treatment of Ph+ ALL.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "Clearances from the U.S. FDA and the EMA for this global registrational Phase III study mark a significant step forward in the global development of olverembatinib in Ph+ ALL. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will press ahead with the clinical development of olverembatinib in Ph+ ALL and strive to bring a new treatment option to patients around the world as soon as possible."

Developed by Ascentage Pharma, olverembatinib is an orally administered, third-generation TKI and the first China-approved third-generation BCR-ABL inhibitor, currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. Olverembatinib has already been approved in China in multiple indications in drug-resistant chronic myeloid leukemia (CML) and all of the approved indications are now covered by the China National Reimbursement Drug List (NRDL). Being developed for the treatment of Ph+ ALL, olverembatinib has received consecutive recommendations in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Hematologic Malignancies and a Breakthrough Therapy Designation by the China CDE.

On June 14, 2024, Ascentage signed an exclusive option agreement to enter into an exclusive license agreement with Takeda for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.

* Olverembatinib is currently under investigation and has not yet been approved by the FDA in the US.

(Press release, Ascentage Pharma, DEC 4, 2025, View Source [SID1234663141])