On December 22, 2025 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported updates on zugocaptagene geleucel (zugo-cel), formerly known as CTX112, its investigational allogeneic CAR T targeting CD19, in development for autoimmune disease and hematologic malignancies.

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"Preliminary data from zugo-cel in patients with rheumatologic autoimmune diseases have been encouraging, and the therapy has been well tolerated to date. We have also initiated an additional Phase 1 basket study in immune thrombocytopenia purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA), two autoimmune hematologic diseases," said Naimish Patel, M.D., Chief Medical Officer of CRISPR Therapeutics. "In hematologic malignancies, clinical experience to date supports continued advancement of the program. Together with our recently established collaboration with Lilly to evaluate zugo-cel with pirtobrutinib in aggressive B-cell lymphomas, these developments reflect the breadth of opportunity for zugo-cel. We look forward to sharing additional data at future scientific meetings."

Autoimmune Disease

Zugo-cel, targeting CD19, is in an ongoing Phase 1 basket trial in autoimmune rheumatologic diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and inflammatory myositis. Patients in the study may have active SLE (with or without renal involvement), SSc, or idiopathic inflammatory myopathy (IIM) despite the use of standard therapies.

Preliminary clinical data from the Phase 1 study has been encouraging, and zugo-cel has been well tolerated to date.

As of the data cut-off on December 17, 2025, four patients (2 SLE and 2 immune-mediated necrotizing myopathy (IMNM) with interstitial lung disease) have been treated at a dose of 100 million cells and followed for at least 28 days post-infusion:

Zugo-cel cell expansion is comparable to that observed at the same dose in patients in the ongoing B-cell lymphomas trial.
Rapid and deep B-cell depletion in the periphery was observed within the first 1-2 days and maintained over the first month of treatment, with repopulating B-cells demonstrating a shift toward an unswitched, naïve repertoire.
All patients demonstrated significant clinical improvement at the Day 28 assessment.
The first patient with SLE, refractory to 9 prior therapies with a baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 8, has maintained drug-free DORIS clinical remission through Month 6 following CAR T therapy.
Treatment has been well-tolerated, with no high-grade cytokine release syndrome (CRS) or immune-effector cell-associated neurotoxicity syndrome (ICANS) observed.
Clinical trials in autoimmune disease remain ongoing across indications. The Company expects to provide additional updates in the second half of 2026. In addition, a Phase 1 clinical trial for zugo-cel has been initiated in ITP and wAIHA.

Immuno-Oncology

Positive clinical data generated to date support the advancement of zugo-cel into the Phase 2 portion of the ongoing Phase 1/2 trial in patients with (R/R) CD19-positive B-cell malignancies. Eligible disease subtypes include large B-cell lymphoma (LBCL), follicular lymphoma (FL) grade 1-3a, marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL).

Zugo-cel was administered after a standard course of lymphodepletion with fludarabine and cyclophosphamide. A total of 39 patients have been treated across all 4 dose levels. The recommended Phase 2 dose (RP2D) was recently endorsed at the 600 million cell dose for the large B-cell lymphoma (LBCL) cohort.

As of the data cut-off of November 20, 2025, 10 patients with R/R LBCL have been treated at the RP2D of 600 million cell dose and have had at least one month of follow-up, with the following observations:

An overall response rate (ORR) of 90% (9/10) and a complete response rate (CRR) of 70% (7/10) were observed, including a complete response (CR) in a patient who relapsed following autologous CAR T cell therapy.
Among patients who have completed 12-months of follow-up, 67% (2/3) remained in CR at the 12-month evaluation.
Peak mean CAR T cell expansion of approximately 1,700 cells/µL was observed at the RP2D, representing approximately a four-fold higher expansion compared with patients receiving 300 million cells.
Rates of Grade 3 CRS, ICANS and serious infections were 17%, 17%, and 8%, respectively, among all LBCL patients treated at the RP2D (n=12).
No Grade 3 ICANS or CRS has been observed at the 100 million cell dose, which is the dose currently being studied in the autoimmune basket trials.
The Phase 1/2 clinical trial in R/R B-cell malignancies is ongoing. The Company expects to provide additional updates in the second half of 2026. CRISPR Therapeutics has also established a new collaboration and clinical supply agreement with Lilly to evaluate zugo-cel together with pirtobrutinib in aggressive B-cell lymphomas, further expanding the program’s development in oncology.

About Zugocaptagene Geleucel (zugo-cel; formerly CTX112)
Zugocaptagene geleucel (zugo-cel) is a wholly-owned, allogeneic chimeric antigen receptor (CAR) T cell therapy product candidate targeting Cluster of Differentiation 19 (CD19), in development for both autoimmune and immuno-oncology indications. Zugo-cel is an off-the-shelf allogeneic CAR T that utilizes CRISPR Cas9 for targeted gene knockout and CAR insertion for immune evasion and enhanced T effector cell potency. Zugo-cel is given following a standard lymphodepletion regimen without the need for HLA matching. Zugo-cel is being investigated in ongoing clinical trials in adult patients with systemic lupus erythematosus, systemic sclerosis, and inflammatory myositis and in adult patients with relapsed or refractory B-cell malignancies.

(Press release, CRISPR Therapeutics, DEC 22, 2025, View Source [SID1234661577])

On December 22, 2025 Ginkgo Bioworks (NYSE: DNA) reported its partnership with Carnegie-Mellon University (CMU) for an award by the Advanced Research Projects Agency for Health (ARPA-H) for its POSEIDON program (Platform Optimizing SynBio for Early Intervention and Detection in Oncology). With Ginkgo Bioworks serving as the Commercial Partner, the project will also be led by Rebecca Taylor (principal investigator), professor of mechanical engineering at Carnegie Mellon University.

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Combining recent advancements in synthetic biology with cutting-edge detection technology, the team expects to develop both a highly innovative orally administered pill containing specially engineered, tumor-targeting sensors and a user-friendly cancer screening device designed for at-home testing. As part of this team, Ginkgo plans to apply its cell and enzyme engineering expertise to support development of these new diagnostic tools.

Using a combination of synthetic biology and nucleic acid nanotechnology, the pill’s specially engineered, tumor-targeting sensors aim to detect tumor-specific conditions, such as low oxygen, acidity, and lactate—hallmarks of cancer. The sensors will then release reporters to indicate the presence of a tumor and its specific tissue of origin. Synthetic reporters will then be excreted into urine to collect the results.

"Our dual-function approach is designed to provide an unprecedented level of precision, effectively illuminating hidden tumors from within the body, which then signals the presence of disease through a simple urine test," explained Taylor. "This is a scientific leap forward that we believe will profoundly change how we approach early cancer diagnostics."

"We are truly excited to get to support this effort," said Jesse Dill, Government BD Lead at Ginkgo Bioworks. "This type of interdisciplinary teaming, and ambitious vision, are essential for bringing transformative new diagnostics to the market. We hope that patients and doctors will be empowered to make well-informed decisions, to the benefit of all."

In addition to Carnegie Mellon researchers, the multidisciplinary project team includes academic experts from the University of Pittsburgh, the University of Massachusetts Amherst, and KU Leuven, as well as corporate partners at Ginkgo Bioworks, Velentium Medical, Clinical Research Strategies, and Platypus Bio.

(Press release, Ginkgo Bioworks, DEC 22, 2025, View Source [SID1234661593])

On December 22, 2025 Alphamab Oncology (stock code: 9966.HK) reported that that the clinical trial application for the independently developed TROP2/HER3 bispecific antibody-drug conjugate (ADC) JSKN016, in combination with InventisBio’s oral selective estrogen receptor degrader (SERD) D-0502, has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The trial (Study Number: JSKN016-204) is for the treatment of locally advanced or metastatic HR-positive, HER2-negative (HR+/HER2-) breast cancer.

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Breast cancer is the most prevalent malignancy among Chinese women, with the HR+/HER2- subtype accounting for approximately 70% of all breast cancer cases. The current first-line standard of care involves endocrine therapy combined with CDK4/6 inhibitors. However, primary or acquired resistance often leads to disease progression, resulting in a significant unmet clinical need in later-line treatment. Therefore, it is crucial to explore novel-mechanism drugs and combination therapies.

JSKN016 is a novel bispecific ADC that simultaneously targets TROP2 and HER3 on the surface of tumor cells. It blocks the corresponding signaling pathways while enhancing cellular endocytosis and release of topoisomerase I inhibitors, enabling precise tumor killing. Early phase clinical studies have shown promising antitumor activity and a favorable safety profile in various solid tumors, including breast cancer. D-0502 is a novel, oral SERD independently developed by InventisBio. Early phase clinical studies have demonstrated its antitumor activity and good tolerability as monotherapy. The combination of both drugs is expected to achieve multiple synergistic effects, which may lead to prolonged disease control and improved survival outcomes for patients.

JSKN016-204 is a multicenter, open-label, randomized controlled phase Ib/II clinical study. It aims to evaluate the safety, tolerability, dose-limiting toxicity (DLT), preliminary antitumor activity, and pharmacokinetics (PK)/pharmacodynamics (PD) of JSKN016 in combination with D-0502 in patients with locally advanced or metastatic HR+/HER2- breast cancer who have been previously treated with CDK4/6 inhibitor in combination with endocrine therapy.

Ms. Yang Liu, Chief Operating Officer of Alphamab Oncology, stated: "Oral SERDs, including InventisBio’s D-0502, have recently demonstrated superior efficacy in HR+ breast cancer. Currently, there are no global precedents for combining an ADC with an oral SERD. Our JSKN016 has shown excellent efficacy and safety in later-line HR+ breast cancer. By combining with D-0502, we hope to further extend the progression-free survival for HR+ breast cancer patients after front-line therapy resistance and translate it into high-quality, long-term survival benefits. We greatly look forward to this collaboration."

Dr. Ling Zhang, Chief Medical Officer of InventisBio, stated: "We are very pleased that the clinical trial application for the combination therapy of D-0502 and JSKN016 has been approved. Drug resistance in HR+/HER2- breast cancer remains a major clinical challenge, with limited treatment options in later lines. D-0502, an oral SERD with a favorable safety profile and high bioavailability, in combination with the ADC JSKN016, is expected to synergistically inhibit tumor growth through a dual mechanism of action, offering new hope for patients with refractory disease."

About JSKN016

JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. Upon binding to TROP2 and/or HER3 on the tumor cell surface, JSKN016 blocks the corresponding signaling pathways and enhances cellular endocytosis to release topoisomerase I inhibitors, thereby exerting anti-tumor effects.

JSKN016 has demonstrated promising antitumor activity and a favorable safety profile across multiple solid tumors. Dose optimization and dose confirmation have been completed, and it is poised to advance into Phase III clinical studies.

About D-0502 (Taragarestrant)

D-0502 is a novel, oral selective estrogen receptor degrader (SERD) independently developed by InventisBio, intended for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Compared to existing injectable SERDs, its oral administration offers greater convenience for patients. D-0502 has demonstrated favorable antitumor activity and a promising safety profile in both preclinical studies and clinical trials. In October 2021, the Center for Drug Evaluation (CDE) granted approval to initiate a registrational Phase III clinical trial in China for D-0502. This trial is designed as a head-to-head comparison against standard of care in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. The first patient was successfully enrolled in this registrational Phase III trial in September 2022, and the trial is currently proceeding as planned.

(Press release, Alphamab, DEC 22, 2025, View Source [SID1234662085]).

On December 22, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported additional updates on FLAMINGO-01 and the Company’s corporate strategy.

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Corporate Strategy

The Company recently attended a Noble Capital conference on December 3, 2025, where further details of the Company’s FLAMINGO-01 clinical strategy, financing strategy, and partnering strategy were discussed in a fireside chat with the Noble analyst. The video is now available on the Company’s website at the bottom of the Welcome page: View Source

Below are highlights from the discussion with additional information:

Clinical strategy – The FLAMINGO-01 clinical strategy continues to evolve with various options to further reduce risk and increase the chances of marketing approval supported by the current financing strategy that is supporting the current burn rate, the increasing interest from investigators and patients, cost reduction activities, and continued interest to add additional sites and countries to the study.

Approximately 140 sites are actively enrolling patients, and there are plans to activate an additional 10 already approved sites in 2026 and additional EU countries.

Quality improvement and cost reduction may be realized by moving more clinical trial operations internally and ending the use of a CRO for the US operations and global management.

The study has transitioned from strong interest from principal investigators to patient driven interest, including the formation of wait lists at certain sites.

The Company has entered into discussions with leading clinical sites in the United Kingdom and Canada regarding joining the study, which would require regulatory approval in each country, independent from the FDA and EMA regulatory approval that the Company has already received.

Financing strategy – The ATM financing is being used judiciously and efficiently to keep up with the burn rate in 2025, potentially exceeding the burn rate by year end. This ATM strategy reduces the likelihood of the Company doing a near term financing, increasing the chances for non-dilutive strategic partnerships at any time before or after an interim analysis.

The Company’s annual burn rate was approximately $7 million in 2024 and 2023. The income statements for these periods have been reported as losses of $16 million and $9 million respectively, but the cash flow used for operations is much lower at $7 million due to the non-cash stock and options expenses added to the income statements.

For the first three quarters of 2025, the burn rate is approximately $7 million, representing a gradual increase in burn rate over 2024, but not a substantial increase due to the Company’s lean structure and ongoing cost saving initiatives. In addition, a large part of the clinical expenses is from the upfront costs and the first 6 months of monthly vaccinations or Primary Immunization Series, after which the cost per patient should be lower when boosters are given once every 6 months.

Partnering strategy – The Company continues to attend partnering conferences.

Large pharma dominates the breast cancer drug market, including acquiring or partnering with smaller biotechs who have promising new breast cancer drugs.

We believe patent filings for treating non-HLA-A*02 patients with GLSI-100 will strengthen the patent portfolio for GLSI-100, in addition to the biologics data exclusivity available to GLSI-100 in the US.

FLAMINGO-01 Data Safety Monitoring Board (DSMB) & Steering Committee

The FLAMINGO-01 DSMB met twice in 2025, most recently in December 2025, and recommended to continue the study as is without modification. The Steering Committee also met at SABCS 2025 and discussed the clinical strategy, endorsing the planned modifications to FLAMINGO-01. The planned modifications subject to regulatory approval include:

increasing the size of the study, which would increase the power of the study thus decreasing the risk by designing the study to assume more recurrences even though fewer recurrences may be anticipated and observed,

doubling or quadrupling the enrollment rate, which will increase the patient years in the study more rapidly thus proportionately increase the event rate, which may shorten the time to reach an interim analysis or milestone,

continuing to enroll past the interim analyses so that the current momentum at the clinical sites continues,

using the interim analysis to potentially resize the study or to change the subsequent interim analysis, to change the number of events triggering an analysis, or to change the timing of the study based on recommendations by an independent committee, and

using a recently manufactured GP2 commercial drug product lot in FLAMINGO-01

CEO Snehal Patel commented, "We are looking forward to continuing our financing strategy and implementing the planned Phase III trial derisking modifications, pending regulatory approvals. The discussions with clinicians at SABCS 2025 were encouraging, as the study has become more widely recognized by the breast cancer community, leading to patient and investigator driven interest to expand FLAMINGO-01 into the United Kingdom and Canada. The potential for GLSI-100 to save lives by preventing metastatic breast cancer recurrences and thus reduce overall healthcare costs was also highlighted at the Noble conference. The open label data of FLAMINGO-01 in the non-HLA-A*02 arm has helped to increase the probability of success, while potentially doubling the market for GLSI-100, and will continue to be analyzed as we may provide updates or publications at any time."

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, DEC 22, 2025, View Source [SID1234661578])

On December 22, 2025 Flagship Pioneering, a scientific innovation engine for transformative platforms and products, reported a research program under its strategic collaboration with Pfizer whereby Flagship-founded Repertoire Immune Medicines will identify and optimize TCR bispecifics for metastatic prostate cancer.

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Pioneering Medicines, Flagship’s in house drug discovery and development unit, is responsible for leading the strategic partnership with Pfizer, including driving the exploration process to rapidly surface potential drug development programs built on Flagship’s diverse bioplatforms and modalities. The Repertoire agreement is the eighth program initiated under Flagship’s strategic partnership with Pfizer announced in July 2023.

"Repertoire’s DECODE platform uniquely maps the entire immune synapse, presenting enormous uncharted potential to discover new antigens capable of activating the immune system to fight cancer, and when coupled with Repertoire’s immune medicine engineering technologies and capabilities, places us in a strong position to generate targeted medicines to engage them," said Torben Straight Nissen, Ph.D., Chairman and CEO of Repertoire and Executive Partner at Flagship Pioneering. "Guided by Pfizer’s drug development expertise in oncology, we will apply our platform to uncover new potential T-cell targeted medicines."

As many as one in five men with prostate cancer progress to metastatic disease with many going on to develop resistance to successive lines of therapy. T cell receptor (TCR) bispecifics have emerged as a promising immunotherapy with the potential to overcome several barriers associated with disease progression. The aim of the research program is to identify and develop an early optimized TCR bispecific lead that could provide durable disease control and reduced toxicity.

"This research program with Repertoire demonstrates both the continued momentum in our strategic alliance with Pfizer and the breadth of novel modalities our Flagship companies offer as a supply chain of potential therapeutic innovation," said Paul Biondi, Flagship Pioneering Managing Partner. "We have now collaborated on eight programs across multiple modalities and five therapeutic areas in our shared commitment with Pfizer to co-create a pipeline of novel candidates that have a potential to become differentiated medicines with greater precision, speed, and scale for the patients who need them most."

(Press release, Pfizer, DEC 22, 2025, View Source [SID1234661594])