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 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conference:

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J.P. Morgan Healthcare Conference on Monday, January 12, 2026 beginning at 11:15 a.m. Pacific Time
The live webcast can be accessed at investors.gilead.com and the replay will be available for at least 30 days following the presentation.

(Press release, Gilead Sciences, DEC 22, 2025, View Source [SID1234661589])

On December 22, 2025 Merck, a leading science and technology company, reported that following Priority Review, the China National Medical Products Administration (NMPA) has approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause functional limitation or relatively severe morbidity. Pimicotinib, a colony stimulating factor-1 receptor (CSF-1R) inhibitor developed by Abbisko Therapeutics Co., Ltd., Shanghai, China, is the first Chemical Drug Class 1 approved in China for the treatment of TGCT.

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"We are continuing to deliver on our commitment to improving the lives of patients with rare tumors with this first-in-the-world regulatory approval of pimicotinib," said Danny Bar-Zohar, CEO Healthcare and Member of the Executive Board of Merck. "This approval is a significant step forward in further strengthening our leadership in rare tumors, while offering patients the opportunity to change the course of their disease and help alleviate symptoms that impact their daily lives. We are now working to make pimicotinib available to patients in China as quickly as possible, as we continue to progress applications with regulatory authorities in additional markets."

TGCT is a rare, locally aggressive tumor of the joint leading to progressive swelling, stiffness and reduced mobility of the affected joint, significantly impacting daily activities and quality of life in the otherwise healthy population that it affects. If left untreated or in recurrent cases, TGCT can result in irreversible damage to the bone, joint and surrounding tissues. Historically TGCT may have been known by several different names, including pigmented villonodular synovitis (PVNS).

The approval of pimicotinib by the China NMPA is based on results from the global Phase 3 MANEUVER study, in which pimicotinib demonstrated the highest objective response rate (ORR) based on RECIST v1.1 seen in a Phase 3 trial of a systemic TGCT treatment, as well as meaningful improvements in clinical outcomes. At week 25, pimicotinib demonstrated a statistically significant improvement in the primary endpoint of ORR assessed by blinded independent review committee (BIRC) based on RECIST v1.1 compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). Pimicotinib also demonstrated clinically meaningful and statistically significant improvements across secondary endpoints relevant to patients’ daily lives, improving relative range of motion (p=0.0003) and physical function measured by PROMIS-PF scale (p=0.0074) and reducing worst stiffness (p<0.0001) and worst pain (p<0.0001). These findings were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. Longer-term results presented at the ESMO (Free ESMO Whitepaper) Congress 2025 showed that with a median follow-up of 14.3 months, ORR per RECIST v1.1 increased considerably among patients treated with pimicotinib from the beginning of the study, to 76.2% (95% CI: 63.8, 86.0).

"Many people living with TGCT in China have faced a long and difficult journey due to the lack of approved options beyond surgery, which may not address the needs of patients whose tumors recur or are not amenable to resection," said Prof. Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital. "With the approval of pimicotinib based on the results of the global MANEUVER study, healthcare professionals in China will soon have the opportunity to prescribe their patients an effective and well-tolerated systemic treatment option, offering a much-needed advance in how they manage this challenging condition."

In MANEUVER, pimicotinib was well-tolerated, with no evidence of cholestatic hepatotoxicity or hair/skin hypopigmentation. During the randomized, double-blind treatment phase of the trial, treatment-emergent adverse events (TEAEs) leading to treatment discontinuation occurred in one patient (1.6%) treated with pimicotinib; TEAEs leading to dose reduction occurred in 7.9% (n=5) of pimicotinib-treated patients.

"Pain and restricted mobility induced by TGCT impair patients’ daily functioning and impose huge psychological burden on them," commented Kevin Huang, Founder and President of Chinese Organization for Rare Disorders (CORD), and Founder and Secretary-General of the Hope For Rare Foundation. "Following the approval of pimicotinib in China, this systemic therapeutic regimen enables effective control of tumor progression and alleviation of clinical symptoms, bringing hope for patients who may regain the ability to join in activities deemed common by the most, such as climbing stairs, commuting to work, or playing with their children."

About MANEUVER

The pivotal global Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21).

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint was objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in the intent-to-treat (ITT) population. Secondary endpoints include ORR per tumor volume score (TVS), relative range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS-PF).

After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of further treatment. Patients who completed Part 2 could then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

About pimicotinib (ABSK021)

Pimicotinib, developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. It has been granted breakthrough therapy designation (BTD) for the treatment of inoperable TGCT by the U.S. Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for pimicotinib.

(Press release, Merck KGaA, DEC 22, 2025, View Source [SID1234661588])

On December 22, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of unresectable thymic carcinoma. Tecentriq received orphan drug designation for this indication from the MHLW on March 31, 2025. Chugai subsequently filed an application on May 14, 2025, which underwent Priority Review.

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"We are very pleased to be able to deliver Tecentriq as a new treatment option for unresectable thymic carcinoma. Effective treatment options for this disease are limited, and new therapies have been highly anticipated. We will continue our efforts to provide information on the proper use of Tecentriq to contribute to the patients with thymic carcinoma." said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results from the investigator-initiated phase II MARBLE study conducted in Japan, which evaluated the efficacy and safety of Tecentriq in combination with carboplatin and paclitaxel as first-line treatment for patients with unresectable thymic carcinoma.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

Approval Information *Excerpt from related parts

Indication: Unresectable thymic carcinoma
Dosage and administration:
All indications: The initial dose of Tecentriq must be administered over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be administered over 30 minutes.
Unresectable thymic carcinoma: The usual adult dosage is 1200 mg atezolizumab (genetical recombination) in combination with carboplatin and paclitaxel by intravenous infusion once every 3 weeks.

[Reference]
Chugai Files for Additional Indication of Tecentriq for the Treatment of Thymic Carcinoma
(Press release by Chugai issued on May 14, 2025)
View Source

About MARBLE study1
MARBLE study (jRCT2031220144) is a Japanese Phase II, multicenter, open-label, single-arm study led by investigators to evaluate the efficacy and safety of Tecentriq in combination with carboplatin and paclitaxel in patients aged 20 years or older with unresectable or advanced recurrent thymic carcinoma. The study evaluated safety and efficacy in 48 patients. The primary endpoint was overall response rate, and secondary endpoints included progression-free survival, overall survival, and safety.

About thymic carcinoma
Thymic carcinoma is a type of thymic epithelial tumor that originates from the thymic epithelium, which plays an important role in T-lymphocyte maturation, and is characterized by cellular atypia. The annual incidence in Japan is estimated to be 0.29 per 100,000 people2. The prognosis for unresectable cases is poor, highlighting the need for new therapeutic options.

About Tecentriq
Tecentriq is a cancer immune checkpoint inhibitor targeting PD-L1, which is a protein expressed on tumor and tumor-infiltrating immune cells. PD-L1 blocks T cell activity by binding with PD-1 and B7.1 receptors on the T cell surface. By inhibiting PD-L1, Tecentriq may enable the activation of T cells and boost immune response against cancer cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 6 tumour types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, and extranodal NK/T-cell lymphoma, nasal type).

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, DEC 22, 2025, View Source;category= [SID1234661587])

On December 22, 2025 AstraZeneca and Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.

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The Food and Drug Administration (FDA) BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.

The FDA granted this BTD based on results from the DESTINY-Breast05 Phase III trial presented in a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and subsequently published in The New England Journal of Medicine.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "For patients with residual disease after neoadjuvant treatment, the post-neoadjuvant setting represents a critical opportunity to reduce the risk of recurrence and prevent progression to metastatic disease. This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care and underscores its potential to become an important treatment option in the post-neoadjuvant setting."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "This tenth Breakthrough Therapy Designation reinforces how Enhertu continues to deliver transformational results that advance the treatment of breast cancer. We look forward to working with the FDA with the goal of bringing Enhertu to the post-neoadjuvant setting of HER2-positive early breast cancer, as DESTINY-Breast05 clearly demonstrated that Enhertu may help halt invasive disease recurrence over the current standard of care, resulting in potentially more patients achieving a cure."

DESTINY-Breast05 is the second positive trial of Enhertu in early breast cancer in 2025. The first trial, DESTINY-Breast11, evaluating patients with high-risk HER2-positive disease in the neoadjuvant setting, is currently under review by the FDA.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Post-neoadjuvant Treatment for HER2-Positive Early Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.2 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.2 Approximately one in five cases of breast cancer are considered HER2 positive.3

For patients with HER2-positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival.4 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.5-9

Despite receiving additional treatment with T-DM1 for residual disease in the post-neoadjuvant setting, approximately 20% of patients still experience invasive disease or death, with no reduction in the risk of central nervous system recurrence.10-11 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.12

Post-neoadjuvant therapy represents a key opportunity to minimise the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.13,14

DESTINY-Breast05
DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed invasive disease-free survival (IDFS). IDFS is defined as the time from randomisation until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 55 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

(Press release, AstraZeneca, DEC 22, 2025, View Source [SID1234661586])