On December 9, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Bristol Myers Squibb Company (NYSE: BMY, "BMS") reported the first interim data from a global randomized Phase 2 trial (NCT06449222) evaluating pumitamig (BNT327/BMS986545), an investigational bispecific antibody targeting PD-L1 and VEGF-A, plus chemotherapy in patients with locally advanced/metastatic triple-negative breast cancer ("TNBC") irrespective of PD-L1 expression levels.

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The data showed encouraging anti-tumor responses and a manageable safety profile for pumitamig plus chemotherapy in first-line and second-line treatment setting. The data will be presented at the 2025 San Antonio Breast Cancer Symposium ("SABCS").

"Triple-negative breast cancer is a highly aggressive disease with a poor prognosis and 5-year survival rate of just 15% in advanced stages.1 There remains an urgent need for new treatment options – particularly for patients with PD-L1 low or negative tumors (CPS<10), a subgroup for whom the current standard of care is chemotherapy alone and existing PD-(L)1 inhibitors have historically shown limited benefit," said Peter Schmid, M.D., Ph.D., Lead Investigator and Director of the Breast Cancer Centre at St. Bartholomew’s Hospital, London, UK. "The anti-tumor efficacy observed in this interim analysis is encouraging and supports the ongoing investigation of pumitamig in the Phase 3 ROSETTA BREAST-01 trial."

The trial evaluated pumitamig in two dose levels and in combination with four different chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic TNBC. In Cohort 1, reported in this analysis, patients received pumitamig (15 or 20 mg/kg Q2W) plus nab-paclitaxel until disease progression or unacceptable toxicity. In Cohort 2, patients received the flat-dose equivalent of 20 mg/kg in combination with three different chemotherapy regimens (Arm 1: paclitaxel; Arm 2: gemcitabine + carboplatin; Arm 3: eribulin).

The interim analysis at the October 1, 2025 data cut-off included 74 patients with 1L/2L+ locally advanced/metastatic TNBC who received pumitamig in combination with standard of care chemotherapy. Key data highlights are provided below:

Efficacy:

Among 39 efficacy-evaluable first-line and second-line patients, all in Cohort 1, the confirmed objective response rate ("cORR") was 61.5% (24/39), the unconfirmed objective response rate ("uORR") was 71.8% (28/39) and the disease control rate ("DCR") was 92.3% (36/39).
Efficacy was encouraging across dose levels, PD-L1 expression levels and lines of treatment and higher doses correlated with higher response (dose levels: uORR: 63.2% at 15 mg/kg dose; 80.0% at 20 mg/kg dose; PD-L1 expression levels: uORR: 70.6% in CPS ≥10; 70.6% in CPS <10; lines of treatment: uORR: 76.5% in 1L and 68.2% in 2L).
The progression-free survival ("PFS") rate at 9 months was 59.3%. Median PFS, median duration of response ("DOR") and median overall survival ("OS") were not mature at the time of analysis.
Safety:

Pumitamig plus chemotherapy demonstrated a manageable safety profile in both Cohorts in combination with all four chemotherapy regimens.
Grade ≥3 treatment-related adverse events (TRAEs) were reported in 17/40 (42.54%) and 13/34 (38.2%) patients in Cohorts 1 and 2, respectively, with no pumitamig-related deaths reported.
"We are encouraged by these first locally advanced/metastatic TNBC data from a global patient population that indicate the potential of pumitamig in patients with advanced TNBC irrespective of PD-L1 status," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "The activity we see in TNBC is consistent with findings in other solid tumors and further supports the pan-tumor potential of pumitamig, which we are advancing together with BMS in a broad development program that also includes novel/novel combination regimens."

"These data add to the growing evidence from global pumitamig studies across multiple indications," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology, Cell Therapy at Bristol Myers Squibb. "The encouraging results are especially meaningful in patients with PD-L1 low or negative tumors (CPS<10), representing the potential of pumitamig to deliver meaningful benefit across PD-L1 expression levels, including patients who historically have had fewer effective treatments."

A global randomized Phase 3 trial, ROSETTA-BREAST-01 (NCT07173751), is evaluating pumitamig plus chemotherapy versus placebo plus chemotherapy in patients with previously untreated locally advanced/metastatic TNBC determined ineligible for PD-(L)1 therapy based on PD-L1 negative disease. Pumitamig is also being studied in more than 20 clinical trials as monotherapy, in combination with chemotherapy, or with other novel treatment modalities in more than 10 solid tumor indications.

About the BNT327-02 Phase 2 clinical trial
The global randomized, open-label Phase 2 clinical trial (BNT327-02; NCT06449222) evaluated pumitamig (BNT327/ BMS986545) in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic TNBC. In Cohort 1, patients received pumitamig Q2W (15 or 20 mg/kg) plus chemotherapy (nab-paclitaxel) until disease progression or unacceptable toxicity. In Cohort 2, patients received the flat dose equivalent of 20 mg/kg in combination with chemotherapy (Arm 1: paclitaxel Q2W; Arm 2: gemcitabine + carboplatin Q3W; Arm 3: eribulin Q3W). The primary endpoints of the trial were objective response rate (ORR) per investigator’s assessment (RECIST 1.1), change in tumor size and early tumor shrinkage, and safety per NCI CTCAE v5.0. Secondary endpoints include duration of response (DoR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS).

About Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC), which is defined by a lack of hormone receptors (estrogen or progesterone) and HER2 protein, accounts for about 10-15% of all invasive breast cancer cases.1 It is an aggressive type of breast cancer that tends to grow and spread faster and has a worse prognosis compared to other breast cancer types. The addition of PD-(L)1 immune checkpoint inhibitors to chemotherapy for the first-line treatment of TNBC has improved outcomes in patients with high levels of PD-L1 expression (CPS ≥ 10) on the surface of tumor cells, but many patients experience relapse. In addition, for patients with PD-L1 negative TNBC (CPS<10), the current standard of care is chemotherapy alone, as other PD-(L)1 inhibitors have historically demonstrated poor efficacy in this subgroup. The 5-year survival rate for patients with advanced TNBC is only 15%, emphasizing the need for new treatment options.1

About pumitamig (also known as BNT327 or BMS986545)
Pumitamig is a novel investigational bispecific antibody, jointly developed by BioNTech and BMS, combining two complementary, validated mechanisms in oncology into one single molecule. Pumitamig combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. The blocking of VEGF-A is aimed at reversing the tumor’s immuno-suppressive effect in its microenvironment and cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), with the intention of preventing the tumor from growing and proliferating. Pumitamig may be differentiated via its mechanism of action of targeting PD-L1 on tumor cells to localize anti-VEGF activity within the tumor microenvironment, aiming to enhance therapeutic precision and minimize systemic exposure.

More than 1,400 patients have been treated with pumitamig in clinical trials to date. More than 20 clinical trials are currently ongoing or planned to evaluate pumitamig either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in more than 10 solid tumor indications. Multiple global trials are ongoing or planned to start, including five global clinical trials with registrational potential evaluating pumitamig plus chemotherapy compared to standard of care treatments in first-line small cell lung cancer (ROSETTA LUNG-01; NCT06712355), first-line non-small cell lung cancer (ROSETTA LUNG-02; NCT06712316), first-line triple-negative breast cancer (ROSETTA BREAST-01, NCT07173751), first-line microsatellite stable colorectal cancer (ROSETTA CRC-203; NCT07221357), and first-line gastric cancer (ROSETTA GASTRIC-204, NCT07221149). Additional trials are ongoing exploring novel treatment combinations of pumitamig, including combinations with BioNTech’s proprietary antibody-drug conjugate candidates ("ADCs") or immunomodulator candidates.

(Press release, BioNTech, DEC 9, 2025, View Source [SID1234661308])

On December 9, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that it has entered into a securities purchase agreement with new and existing healthcare focused investors and certain insiders of the Company to sell an aggregate of 2,623,023 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 2,623,023 shares of common stock, in a private placement priced at-the-market under Nasdaq rules (the "Offering"). The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrant to be issued is $1.165. The warrants to be issued will have an exercise price of $1.04 per share, will be exercisable immediately upon issuance, and will expire on the five-year anniversary of the earlier of the effectiveness date of the registration statement covering the resale of the securities purchased in the Offering and the date the shares underlying the warrants are eligible for resale under Rule 144.

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The gross proceeds to the Company from the Offering are estimated to be approximately $3.1 million before deducting the placement agent’s fees and other estimated Offering expenses. The Company intends to use the upfront net proceeds from the private placement for general corporate purposes and for research and development expenses. The Company believes the aggregate net proceeds from the Offering will be sufficient to fund the Company into 2027 based on current projections. The Offering is expected to close on or about December 10, 2025, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the Offering.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities 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 of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

(Press release, Aprea, DEC 9, 2025, View Source [SID1234661307])

On December 9, 2025 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported that the first patient has been treated in its pilot study for the treatment of patients with recurrent glioblastoma multiforme (GBM) using the Alpha DaRT technology.

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Uzi Sofer, CEO of Alpha Tau, stated, "This is a historic day for Alpha Tau and for GBM patients around the world, with the first treatment ever of a brain cancer using Alpha DaRT. Given the devastating prognosis of GBM, and its high rate of rapid recurrences, generally within 6-9 months, there is a desperate need for new local therapies with an appropriate safety profile for such a critical and sensitive area like the brain. This pilot study is a key part of our broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs, supported by the FDA’s Breakthrough Device Designation and acceptance into the FDA’s prestigious Total Product Life Cycle Advisory Program designed to accelerate the Alpha DaRT treatment to market and to GBM patients who may stand to benefit greatly."

The first patient was treated at The Ohio State University Center in Columbus, Ohio, by a multidisciplinary team led by Principal Investigator and Radiation Oncologist Joshua D. Palmer, MD, Medical Physicist Michael Degnan, MS, DABR and Neurosurgeon J. Bradley Elder, MD, using a novel delivery approach designed specifically for intracranial use.

Dr. Joshua Palmer, commented: "Patients with recurrent glioblastoma face one of the most difficult cancer diagnoses in medicine. There is an urgent unmet need for new therapeutic approaches that can be delivered locally while minimizing harm to surrounding healthy brain tissue. Intratumoral alpha-emitting radiotherapeutics such as Alpha DaRT offer a highly compelling novel scientific approach by delivering potent, short-range radiation precisely where it is needed most."

Dr. J. Bradley Elder, who led the procedure with Dr. Palmer, added: "From a technical standpoint, this procedure demonstrated excellent feasibility. The novel delivery device allowed us to place the Alpha DaRT sources in a precise radial configuration that achieved more than 95% coverage of the tumor volume. Importantly, the system integrates seamlessly as an add-on to the standard brain navigation platform that I use routinely in surgery, making it simple to adopt without disrupting existing workflow."

"This achievement represents the culmination of many years of dedicated teamwork within Alpha Tau – including extensive preclinical research, developing a unique delivery system designed specifically to integrate seamlessly into a standard neurosurgical workflow and, of course, partnership with our wonderful clinical collaborators at OSU," commented Dr. Robert Den, Chief Medical Officer of Alpha Tau. "This is a transformational patient-centric moment of great scientific and clinical significance for the entire field of neuro-oncology."

About the Study

The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at View Source

(Press release, Alpha Tau Medical, DEC 9, 2025, View Source [SID1234661306])

On December 9, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported on the announcement by Shanghai Henlius Biotech, Inc. that applications for Phase 2/3 clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) in combination with HLX87 (an antibody-drug conjugate targeting HER2) have been approved by China’s National Medical Products Administration (NMPA). The trials are intended for first-line treatment of HER2-positive breast cancer and for neoadjuvant treatment of HER2-positive breast cancer.

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HLX22 is an anti-HER2 monoclonal antibody being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"Shanghai Henlius regulatory approvals to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer represent continued progress for this programme and broaden its clinical development," said Søren Bregenholt, CEO of Alligator Bioscience. "While Alligator is not directly involved in the development, we follow HLX22 closely as it represents an opportunity for future revenue streams from milestones and royalties upon potential approval."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius. For further information and the latest updates on HLX22’s clinical development, please refer to Henlius’ announcement available on HKEXnews.

(Press release, Alligator Bioscience, DEC 9, 2025, View Source [SID1234661305])

On December 8, 2025 Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, reported its entry into a definitive agreement to acquire Bluejay Therapeutics, a privately held biotechnology company focused on viral and liver diseases. The transaction would add worldwide rights to brelovitug, a late-stage, fully human monoclonal antibody with Breakthrough Therapy and PRIME designations for chronic hepatitis delta virus (HDV) to Mirum’s portfolio of rare liver programs. This acquisition is expected to advance Mirum’s leadership in rare disease, build on its deep expertise in rare liver disorders and add a fourth potential registrational readout for the company over the next 18 months.

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Brelovitug is being evaluated in the AZURE Phase 3 registrational program for HDV, the most severe form of viral hepatitis. HDV occurs in people already infected with hepatitis B; nearly half of those affected progress to liver-related death within 10 years of diagnosis due to rapid progression to fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer. In Phase 2 studies, brelovitug demonstrated strong antiviral activity in HDV, achieving 100% HDV RNA response, along with improvements in liver enzyme levels and a favorable safety profile, with the most common adverse event being injection-site erythema. The ongoing global AZURE Phase 3 program is currently enrolling patients, with top-line data expected in 2H 2026 and potential BLA submission and launch in 2027.

"This acquisition fits squarely with what we do best – advancing high-impact medicines for patients with rare diseases through disciplined development, regulatory innovation, and commercial excellence," said Chris Peetz, Chief Executive Officer of Mirum Pharmaceuticals. "Brelovitug in HDV leverages our deep expertise in rare liver disease and builds on the relationships we’ve established with key providers through the volixibat and LIVMARLI programs. The Bluejay team has done commendable work advancing brelovitug to this stage and we look forward to building on that progress to bring this important new treatment to people living with HDV."

"Bluejay was founded to develop transformative therapies for people with viral and liver diseases and, working with regulatory agencies, such as the FDA and the European Medicines Agency, the Bluejay team developed brelovitug from clinical development candidate to global Phase 3 trial in four years," said Keting Chu, Founder and CEO of Bluejay Therapeutics. "Brelovitug has the potential to redefine HDV treatment, and Mirum’s rare disease leadership, commitment to rare liver communities and commercialization expertise make it the right company to carry this program forward globally."

Under the terms of the definitive agreement, Mirum has agreed to acquire all outstanding shares of Bluejay for $250 million in cash and $370 million in Mirum common stock, plus potential tiered sales-based milestone payments of up to $200 million in cash. The Mirum common stock issued to the Bluejay security holders at closing will be priced at $71.2085 per share. Mirum has also entered into a definitive agreement with a syndicate of existing and new healthcare investors, for the sale of Mirum common stock and, to certain investors, in lieu of Mirum common stock, pre-funded warrants, in a private placement. The private placement is expected to close concurrently with the acquisition and result in gross proceeds to Mirum of approximately $200 million before deducting placement agent and other offering expenses. The proceeds from the private placement are intended to fund clinical development and commercial activities following the proposed acquisition. The Mirum common stock issued to the private placement investors at closing will be priced at $68.48 per share (or $68.4799 per pre-funded underlying share of Mirum common stock, which equals the purchase price per share of Mirum common stock, less the $0.0001 per share exercise price of each pre-funded warrant). The transaction with Bluejay has been approved by the Boards of Directors of both companies and is expected to close in the first quarter of 2026, subject to regulatory approval and other customary closing conditions.

Beyond brelovitug for HDV, Mirum will evaluate strategic options for Bluejay’s additional investigational programs after close.

Morgan Stanley & Co. LLC acted as exclusive financial advisor to Mirum, and Cooley LLP served as legal counsel. Centerview Partners LLC acted as financial advisor to Bluejay, and Latham & Watkins LLP served as legal counsel. J.P. Morgan Securities LLC also provided financial advice to Bluejay. Mirum has engaged Morgan Stanley & Co. LLC, Leerink Partners LLC, Cantor Fitzgerald & Co., Raymond James & Associates, Inc. and Citizens JMP Securities, LLC as placement agents for the private placement.

Mirum to Host Conference Call

Mirum will host a conference call today, December 8, 2025 at 8:30 a.m. ET/5:30 a.m. PT, to provide further details on the transaction. Join the call using the following information:

United States/Toll-free: +1 833 470 1428
International: +1 646 844 6383
Access code: 490519
You may also access the call via webcast by visiting the Events & Presentations section on Mirum’s website. A replay of this webcast will be available for 30 days.

(Press release, Mirum Pharmaceuticals, DEC 8, 2025, View Source [SID1234661303])