On October 21, 2026 Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic solid tumors with HER2 expression (immunohistochemistry [IHC] 3+) who have received prior treatment or have no satisfactory alternative treatment options. This indication was granted as a conditional approval based on the results of single-arm studies. Full approval of this indication will depend on the clinical benefit of a confirmatory trial.

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Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).

The approval by China’s National Medical Products Administration (NMPA) is based on results from four phase 2 trials, including DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and DESTINY-PanTumor03 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors.

In DESTINY-PanTumor02, Enhertu demonstrated a confirmed objective response rate (ORR) of 51.4% (95% confidence interval [CI]: 41.7-61.0) with four complete responses (CRs) and 53 partial responses (PRs) in a subgroup of previously treated patients (n=111) with centrally or locally confirmed HER2 positive (IHC 3+) solid tumors. Median duration of response (DOR) was 19.4 months (95% CI: 10.0-29.9). Median progression-free survival (PFS) was 10.1 months (95% CI: 7.0-14.2) and median overall survival (OS) was 17.7 months (95% CI: 12.8-23.4).

In DESTINY-Lung01, Enhertu demonstrated a confirmed ORR of 52.9% (95% CI: 27.8-77.0) with one CR and eight PRs in a subgroup of previously treated patients (n=17) with centrally confirmed HER2 positive (IHC 3+) nonsmall cell lung cancer (NSCLC). Median DOR was 6.9 months (95% CI: 4.0-9.8). Median PFS was 7.5 months (95% CI: 3.1-11.0) and median OS was 12.5 months (95% CI: 9.3-not evaluable [NE]).

In DESTINY-CRC02, Enhertu demonstrated a confirmed ORR of 46.9% (95% CI: 34.3-59.8) with zero CRs and 30 PRs in a subgroup of previously treated patients (n=64) with centrally confirmed HER2 positive (IHC 3+) colorectal cancer. Median DOR was 5.5 months (95% CI: 4.2-8.1). Median PFS was 7.0 months (95% CI: 5.7-8.2) and median OS was 15.1 months (95% CI: 12.6-NE).

In DESTINY-PanTumor03, Enhertu demonstrated a confirmed ORR of 58.0% (95% CI: 43.2-71.8) with one CR and 28 PRs in previously treated patients in China (n=50) with centrally confirmed HER2 positive (IHC 3+) solid tumors, including biliary tract, bladder, cervical, colorectal, endometrial, NSCLC, ovarian and parotid gland cancer. Median DOR was 15.4 months (95% CI: 12.5- not calculable [NC]). Median PFS was 15.7 months (95% CI: 7.2- NC) and median OS was not reached (95% CI: 11.0-NC).

"HER2 overexpression occurs across multiple tumor types and is associated with aggressive disease and a poor
prognosis," said Xiaohua Wu, MD, Supervisor of Oncology of Fudan University Shanghai Cancer Center, Chairman and Chief Expert of the Multidisciplinary Team in Gynecologic Oncology, Principal Investigator in China of the DESTINY-PanTumor03 trial. "Until now, HER2 directed therapies were only available for specific tumor types. The approval of trastuzumab deruxtecan as a tumor agnostic HER2 directed therapy, supported by clinically meaningful responses observed across a broad range of HER2 positive solid tumors, offers a new treatment for patients who have historically had limited options."

The safety profile of Enhertu in DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and DESTINYPanTumor03 was consistent with previous clinical trials with no new safety concerns identified. Grade 3 or grade 4 adverse reactions from a pooled safety analysis of 4,146 patients treated with Enhertu (5.4 mg/kg) across multiple tumor types in clinical studies included neutropenia (18.7%), anemia (8.2%), fatigue (7.4%), leukopenia (6.6%), thrombocytopenia (5.4%), lymphopenia (5.0%), nausea (4.5%), increased transaminases (3.3%), hypokalemia (3.1%), diarrhea (2.1%), vomiting (2.0%), decreased appetite (1.4%) and pneumonia (1.2%). Grade 5 adverse reactions occurred in 0.9% of patients, including interstitial lung disease (ILD) (0.7%). Discontinuation of treatment due to an adverse reaction occurred in 10.1% of patients treated with Enhertu. The most frequent adverse reaction associated with permanent discontinuation was ILD (7.6%).

"This approval of Enhertu reflects the continued evolution of cancer care toward treatment regimens focused on the underlying biology of the disease rather than where a tumor originates in the body," said Michio Hayashi, China President, Daiichi Sankyo. "As the first tumor agnostic HER2 directed medicine approved in China, Enhertu has the potential to expand treatment for eligible patients across a broad range of HER2 positive metastatic cancers."

"Precision medicine is playing an increasingly important role in guiding treatment decisions based on the molecular and biological characteristics of a patient’s disease," said Mary Guan, General Manager, China Oncology Business, AstraZeneca. "This approval marks the tenth indication for Enhertu in China and provides clinicians with a targeted option for patients with HER2 positive metastatic cancer across tumor types. It also reinforces the importance of biomarker testing to identify patients who may be eligible for HER2 directed treatment, supporting more personalized treatment decisions."

Enhertu (5.4 mg/kg) is approved in more than 50 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior treatment and/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02, DESTINY-PanTumor03 and/or HERALD trials.

About DESTINY-PanTumor02

DESTINY-PanTumor02 is a global, multicenter, multi-cohort, open-label, phase 2 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) for the treatment of previously treated HER2 expressing tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer or other tumors

The primary endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DOR, disease control rate (DCR), PFS, OS, safety, tolerability and pharmacokinetics. Results from DESTINY-PanTumor02 were published in the Journal of Clinical Oncology. Results from patients with HER2 positive (IHC 3+) disease identified by local or central testing (n=111) were published in Advances in Therapy.

DESTINY-PanTumor02 enrolled 267 patients, including 111 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe, North America, South America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-Lung01

DESTINY-Lung01 is a global, open-label, two-cohort, phase 2 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg or 6.4 mg/kg) in patients with HER2 mutant (Cohort 2, n=91) or HER2 overexpressing (defined as IHC 3+ or IHC 2+) (Cohort 1 and 1a, n=90) unresectable or metastatic NSCLC who had progressed after one or more systemic therapies.

The primary endpoint of DESTINY-Lung01 is confirmed ORR by independent central review. Key secondary endpoints include DOR, DCR, PFS, OS and safety. Results from the HER2 mutant cohort were published in The New England Journal of Medicine and results from the HER2 overexpressing cohort were published in The Lancet Oncology.

DESTINY-Lung01 enrolled 181 patients, including 17 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-CRC02

DESTINY-CRC02 is a global, randomized, two arm, parallel, multicenter, phase 2 trial evaluating the efficacy and safety of two doses (5.4 mg/kg or 6.4 mg/kg) of Enhertu in patients with locally advanced, unresectable or metastatic HER2 positive colorectal cancer of BRAF wild-type, RAS wild-type or RAS mutant tumor types previously treated with standard therapy. The trial was conducted in two stages. In the first stage, patients (n=80) were randomized 1:1 to receive either 5.4 mg/kg or 6.4 mg/kg of Enhertu. In the second stage, additional patients (n=42) were enrolled in the 5.4 mg/kg arm.

The primary endpoint in DESTINY-CRC02 is confirmed ORR as assessed by blinded independent central review. Secondary endpoints include DOR, DCR, investigator-assessed confirmed ORR, clinical benefit ratio, PFS, OS and safety. Results from DESTINY-CRC02 were published in The Lancet Oncology.

DESTINY-CRC02 enrolled 122 patients, including 64 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-PanTumor03

DESTINY-PanTumor03 is a multicenter, open-label, phase 2 trial in China evaluating the efficacy and safety of Enhertu (5.4 mg/kg) as a monotherapy or in combination with anti-cancer agents for the treatment of patients with HER2 expressing (IHC 3+) locally advanced, unresectable or metastatic solid tumors that have progressed following at least one prior systemic regimen or have no satisfactory alternative treatment options.

The primary endpoint of DESTINY-PanTumor03 is confirmed ORR as assessed by independent central review. Secondary endpoints include DOR, PFS, OS, DCR, best objective response and safety. Results from DESTINYPanTumor03 were published in the Journal of Clinical Oncology.

DESTINY-PanTumor03 enrolled 50 patients at multiple sites in China. For more information about the trial, visit
ClinicalTrials.gov.

About HER2 Expression in Solid Tumors

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth.1 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in some cancers.2 HER2 overexpression occurs in a range of solid tumors with the prevalence varying by tumor type.

HER2 directed therapies have been used to treat HER2 overexpression in bladder, breast, colorectal, gastric, NSCLC and biliary tract cancers in China. 1,4,5,6,7,8,9 Although HER2 is overexpressed in additional solid tumor types including lung, cervical, endometrial, ovarian, salivary gland and pancreatic cancers, HER2 testing is not routinely performed in these additional tumor types. Prior to this approval of Enhertu, there were no HER2 directed treatments approved in China to treat a broad range of solid tumors.

About Enhertu

Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program 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 (5.4 mg/kg) followed by THP is approved in more than five countries/regions worldwide as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial.

Enhertu (5.4 mg/kg) is approved in more than five countries/regions worldwide for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in more than 40 countries/regions worldwide as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4 mg/kg) is approved in more than 100 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 antiHER2-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 (5.4 mg/kg) is approved in more than 75 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 (5.4 mg/kg) is approved in more than 100 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 (5.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors 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 U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4 mg/kg) is approved in more than 90 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-Gastric04 trials.

Enhertu (5.4 mg/kg) is approved in more than 50 countries/regions worldwide for the treatment of adult patients
with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior treatment and/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02, DESTINY-PanTumor03 and/or HERALD trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the Enhertu Clinical Development Program

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

(Press release, Daiichi Sankyo, OCT 21, 2026, View Source [SID1234673663])

On October 21, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) cancers, reported that it has signed a Memorandum of Understanding (MoU) with the Department of Health – Abu Dhabi (DoH) to cooperate on the development of research and clinical capability in oncology and central nervous system therapeutics in the Emirate of Abu Dhabi. The MoU was signed on the sidelines of the Abu Dhabi Future Health Summit (ADFHS) 2026.

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Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer of NeOnc Technologies Holdings, Inc., said: "For families facing brain cancer, access to investigational treatments and clinical research opportunities matters deeply. This proposed collaboration creates a framework to bring NeOnc’s development expertise together with Abu Dhabi’s clinical capabilities, with the goal of advancing research and expanding opportunities for patients closer to home. We are grateful to the Department of Health – Abu Dhabi for its commitment to addressing the needs of patients with complex and rare CNS cancers, including children."

H.E. Dr. Noura Khamis Al Ghaithi, Undersecretary of the Department of Health – Abu Dhabi (DoH), said: "For patients and families facing complex CNS cancers, every advance in research offers hope for more effective care and better quality of life. Our proposed collaboration with NeOnc connects international expertise with Abu Dhabi’s clinical capabilities to strengthen the evidence and skills needed to evaluate new approaches responsibly. By developing specialist knowledge and a deeper understanding of these critical conditions, we aim to support care that responds more closely to each patient’s needs, reflecting our commitment to bringing scientific advances closer to our community and beyond."

The MoU builds on NeOnc’s existing activity in the Emirate, where DoH is the government entity responsible for regulating the health sector. In June 2026, DoH granted Investigational New Drug (IND) status for NEO100, covering the Company’s NEO100-01, NEO100-02 and NEO100-03 protocols across Phase 1, Phase 1b and Phase 2 studies in adults with progressive or recurrent Grade III or IV gliomas, together with pediatric studies authorized for Phase 1 and Phase 1b pending further protocol review. That authorization followed DoH’s IND clearance for NEO212, also announced in June 2026. The DoH clearances apply to the conduct of clinical research and do not constitute marketing authorization, and NeOnc must satisfy additional conditions, including separate DoH Institutional Review Board approval, before patient enrollment in the UAE. Two children in Abu Dhabi are currently receiving investigational NEO100 through NeOnc’s Compassionate Care program. A third child is expected to be onboarded from India this week. Building on that experience and on the Company’s existing DoH clearances, NeOnc is working to open a Phase 1 study of NEO100 in the Emirate.

Under the MoU, the parties will exchange scientific and clinical knowledge and expertise in CNS oncology and in the development and translation of therapeutics for rare, pediatric and high-unmet-need conditions; exchange expertise on clinical development methodologies, including trial design, endpoint selection and response assessment criteria, in support of strengthening clinical development capability in the Emirate; and cooperate on the generation and exchange of real-world evidence and clinical insights relating to CNS tumors in Abu Dhabi, including epidemiological and outcomes data, in accordance with applicable data protection legislation and subject to the required approvals.

The parties will also collaborate on training, capacity-building and professional development initiatives for investigators, clinical research coordinators and allied healthcare professionals, including in clinical trial conduct, neuro-oncology imaging assessment methodologies and molecular diagnostics relevant to CNS tumors, and on the development of Abu Dhabi’s life sciences ecosystem.

The MoU further provides for cooperation on the advancement of clinical research in CNS oncology, including studies of NeOnc’s investigational programs, subject to a separate agreement between the parties and to all applicable regulatory requirements and approvals. Subject to a separate agreement and to all applicable laws, regulations and approvals, the parties will also explore the potential establishment of a regional presence and manufacturing, supply or distribution activities by NeOnc in the Emirate, and the positioning of Abu Dhabi as a potential regional platform for NeOnc’s future development activities. These potential activities remain subject to further assessment, applicable approvals and any necessary definitive agreements.

The MoU is not a binding contract on either party. It takes effect upon signature by representatives of both parties and remains in effect for two years, unless either party gives at least three months’ notice of its wish to terminate. The MoU does not restrict either party from entering into similar arrangements with other institutions.

(Press release, Neonc, OCT 21, 2026, View Source [SID1234673661])

On October 21, 2026 Avance Clinical, a global full-service CRO headquartered in Australia dedicated to servicing international biotechs, reported it will meet European biotech sponsors at ESMO (Free ESMO Whitepaper) Congress 2026, 23–27 October at IFEMA Madrid, Spain. Leading the team is Dr George Peoples, Executive Medical Director, Oncology Center of Excellence. The company also announces the appointment of Wendy Hamon as Senior Vice President, Oncology Center of Excellence.

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Dr Peoples brings more than three decades of cancer vaccine and immunotherapy development. An MD Anderson-trained surgical oncologist, he served 30 years in the US military as a surgeon, oncologist, and research scientist, retiring as a Colonel. He founded the Cancer Vaccine Development Program, which licensed four cancer vaccines for commercial development, and the oncology-focused CRO LumaBridge, and has authored more than 350 peer-reviewed publications.

"European biotechs are deciding how and where to advance their oncology assets," said Dr Peoples. "We support them from preclinical planning through to the end of Phase II, with continuity of leadership at every step."

Wendy Hamon joins the Center with more than 28 years of pharmaceutical and CRO experience, including over 20 years in oncology drug development. Her appointment will support the continued growth of the Center, which is purpose-built for cancer drug development.

"It is an honor to join Avance Clinical and its Oncology Center of Excellence as it evolves," said Hamon. "Oncology sponsors need a partner who operates as an extension of the sponsor team and who is committed to asset development through the product lifecycle. We combine specialist oncology expertise with best-in-class delivery, wherever sponsors are and whatever their phase."

The Center brings together scientific, medical, regulatory, and operational leadership. Its capabilities include:

complex early-phase designs, including adaptive and Bayesian dose escalation
translational and biomarker strategy
disciplined patient selection
oncology-focused site networks across Australia, New Zealand, Asia Pacific, North America, and Europe
The team has delivered more than 260 oncology trials in five years, across solid tumors (including non-small cell lung cancer, melanoma, ovarian cancer, glioblastoma and hepatocellular carcinoma), hematological malignancies (including multiple myeloma, lymphoma and leukemia), and novel modalities such as RNAi, cell-based therapies and targeted small molecules. Sponsors can start fast in Australia and New Zealand, or begin wherever their program fits best, with one team throughout.

(Press release, Avance Clinical, OCT 21, 2026, View Source [SID1234673659])

On October 21, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to onvansertib for the treatment of patients with chronic myelomonocytic leukemia (CMML).

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"CMML remains a difficult-to-treat hematologic malignancy with limited treatment options for patients, and 40-50% of myeloproliferative CMML1 patients harbor RAS-pathway mutations, which are associated with more aggressive disease," said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. "Receiving Orphan Drug Designation for onvansertib in CMML further validates the therapeutic potential of PLK1 inhibition in cancers with significant unmet need and adds to the growing body of evidence supporting this mechanism across both solid tumors and hematologic malignancies. We believe this designation highlights the broader clinical opportunity for onvansertib as a monotherapy as we continue advancing therapies for patients across cancers where new therapeutic approaches are urgently needed."

Onvansertib is being evaluated in both company-sponsored and investigator-initiated clinical studies, including a Phase 1 investigator-initiated study in relapsed/refractory CMML. As presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, onvansertib was relatively well-tolerated as a monotherapy and demonstrated preliminary efficacy in approximately 40% of myeloproliferative CMML patients in the dose ranging trial. The responses included three patients experiencing clinical benefits (38%), with one each of the following: a 100% platelet response, normalization of White Blood Cells, WBC (baseline WBC count > 50 x 109/L), and spleen response. Additionally, one patient (12.5%) had optimal marrow response with bone marrow blast reduction from 8% to 2% facilitating for allogeneic hematopoietic stem transplant and 3 patients experienced stable disease (38%).

Orphan Drug Designation is granted by the FDA to support the development of therapies intended to treat rare diseases or conditions affecting fewer than 200,000 people in the United States. Benefits of the designation may include tax credits for qualified clinical trials, exemption from certain FDA user fees, and up to seven years of market exclusivity upon regulatory approval. Orphan Drug Designation does not alter the standard regulatory requirements or approval process.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab as the regimen to advance into the planned registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

About Chronic Myelomonocytic Leukemia
Chronic myelomonocytic leukemia (CMML) is a rare and aggressive hematologic malignancy characterized by features of both myelodysplastic syndromes and myeloproliferative neoplasms. CMML primarily affects older adults and is associated with poor clinical outcomes, including progressive bone marrow failure and risk of transformation to acute myeloid leukemia (AML). Current treatment options remain limited, highlighting the need for novel targeted therapies that can improve outcomes for patients with this disease.

(Press release, Cardiff Oncology, OCT 21, 2026, View Source [SID1234673658])

On October 21, 2026 Okomera, a TechBio company pioneering personalized cancer care through a proprietary technology platform combining tumor mini-avatars, microfluidics, and AI-powered imaging, reported the signing of a commercial agreement with Servier, an independent international pharmaceutical group, to use its technology in the development of new cancer treatments.

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With more than 90% of oncology drug candidates never reaching the market, identifying early on the therapeutic approaches most likely to succeed is a critical challenge for the pharmaceutical industry. Okomera’s technology helps precisely reduce this attrition, by steering development toward candidates that demonstrated real, measurable activity against tumors.

This collaboration marks an important milestone for Okomera, which is signing its first commercial agreement with an international pharmaceutical group. Under the terms of the agreement, Servier will operate Okomera’s platform fully independently. Its teams will be able to generate standardized spheroid cultures, assess the response of these "miniaturized tumor avatars" to potential treatments, and generate actionable data on key biological mechanisms to support the development of new therapies, notably for pancreatic cancer and glioblastoma.

Nicolas Molinié, Group Leader Target Discovery at Servier, said: "Okomera’s technology allows us to easily generate standardized data from human tumor models. The integrated platform will help us better characterize treatment response mechanisms and identify faster the most promising therapeutic avenues."

Silvère Lucquin, CEO of Okomera, added: "We are particularly proud of this collaboration with Servier, which underscores the value of our platform in meeting the needs of both industry and research teams developing new therapies. This agreement is the result of several years of R&D efforts and reflects the growing adoption of our technology."

Okomera deploys its technology across the entire therapeutic innovation value chain: from preclinical research, as with Servier, to clinical trials and patient care by clinicians. Using patient biopsies, its miniaturization technology reproduces tumor behavior and analyzes how tumors respond to different treatments. Designed as a decentralized laboratory, it delivers the capabilities of a state-of-the-art infrastructure within a single machine, enabling users to independently manage the entire workflow, from culture generation to actionable data production.

Today, nearly one in two oncology patients does not respond to their initial treatment. By placing patient biology at the heart of therapeutic decision-making, Okomera is paving the way for a new generation of precision medicine.

(Press release, Servier, OCT 21, 2026, View Source [SID1234673657])