Verastem Oncology Announces Updated Data from Partner GenFleet Therapeutics’ Phase 1 Study in China of GFH375 (VS-7375), an Oral KRAS G12D (ON/OFF) Inhibitor

On June 2, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported positive updated data from the dose escalation phase of the Phase 1/2 trial of GFH375 (known as VS-7375 in the U.S.). As of May 16, 2025, 23 efficacy-evaluable patients with pancreatic ductal adenocarcinoma (PDAC) and 12 efficacy-evaluable patients with non-small cell lung cancer (NSCLC) achieved an overall response rate (ORR) of 52% and 42%, respectively (Press release, Verastem, JUN 2, 2025, View Source [SID1234653635]). The updated data were presented by Verastem’s partner, GenFleet Therapeutics, in a rapid oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2025, in Chicago, IL.

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"We are encouraged by the initial efficacy and safety results from the Phase 1 portion of the study of GFH375 in China by our partner, GenFleet Therapeutics. The results presented at ASCO (Free ASCO Whitepaper) further support our advancement of our clinical program for VS-7375 in the U.S., as we believe there remains a significant opportunity to further improve on the efficacy seen to date with other KRAS G12D-selective agents. VS-7375’s dual inhibition of both the ON/OFF states has the potential to drive deep and durable cancer responses and allow for better combinability with other agents," said Dan Paterson, president and chief executive officer of Verastem Oncology.

ASCO 2025 Presentation Highlights

GenFleet reported that 62 patients were enrolled in the Phase 1 portion of the study in China, receiving oral doses ranging from 100 to 900 mg daily. In the study, 98% of patients had metastatic disease, and 75% had received ≥2 prior lines of therapy. As of the data cutoff of May 16, 2025, 23 efficacy-evaluable patients with PDAC and 12 efficacy-evaluable patients with NSCLC, who received daily dosages of 400 or 600 mg and had at least one post-treatment tumor assessment, achieved an ORR of 52% and a disease control rate (DCR) of 100%, and an ORR of 42% and a DCR of 83%, respectively.

As of the cutoff date of March 31, 2025, GenFleet reported that there were no dose-limiting toxicities (DLTs) observed across all dose levels (100-900 mg QD), and the treatment-related adverse events (TRAEs) were mostly Grade 1/2. The most common TRAEs occurring in at least 20% of patients were diarrhea, nausea, vomiting, and anemia. TRAEs ≥ Grade 3 consisted mainly of decreased neutrophil count (8%) and diarrhea (5%). No TRAE-related deaths were reported.

Webcast Information

Verastem will hold an investor webcast on Monday, June 2, at 11:00 am CDT, to review the RAMP 205 updated data and the VS-7375 program including updated data from the study in China. The event will feature members of Verastem’s management team and key opinion leaders. A live audio webcast of the call, along with accompanying slides, will be accessible here. A replay of the webcast will be archived on the website for approximately 90 days following the presentation.

U.S. Phase 1/2a Study of VS-7375

The Phase 1/2a study will be conducted in the U.S., with the potential to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The starting dose for the Phase 1 study of 400 mg is based on the dose identified in the initial data from the GenFleet study to accelerate the trial’s progress. Verastem plans to dose escalate across levels where responses were observed in GenFleet’s study and will assess in the Phase 2a portion the efficacy and safety of VS-7375, both as monotherapy and in combination, in patients with advanced solid tumors, such as pancreatic, colorectal, and non-small cell lung cancers.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared and plans to initiate a Phase 1/2a clinical trial in mid-2025. GenFleet’s IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024.

Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy in patients with HER2-positive metastatic breast cancer in DESTINY-Breast09 Phase III trial

On June 2, 2025 Astrazeneca and Daiichi sankyo reported positive results from the DESTINY-Breast09 Phase III trial showed Enhertu (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer (Press release, AstraZeneca, JUN 2, 2025, View Source [SID1234653634]).

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Results will be presented today during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (abstract #LBA1008).

In a prespecified interim analysis, Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP (based on a hazard ratio [HR] of 0.56; 95% confidence interval [CI] 0.44-0.71; p<0.00001). Median PFS was 40.7 months with Enhertu plus pertuzumab compared to 26.9 months for THP, as assessed by blinded independent central review (BICR). The PFS benefit for Enhertu plus pertuzumab versus THP was consistent across subgroups, including for the prespecified stratification factors of de novo or recurrent disease, hormone receptor status and PIK3CA mutation status.

Investigator-assessed PFS demonstrated a median PFS of 40.7 months for Enhertu plus pertuzumab compared to 20.7 months for THP (HR 0.49; 95% CI 0.39-0.61; nominal p-value <0.00001).

Confirmed objective response rate (ORR) with Enhertu plus pertuzumab was 85.1% versus 78.6% with THP. There were 58 complete responses (CRs) with Enhertu plus pertuzumab compared to 33 with THP. Median duration of response (DOR) for Enhertu plus pertuzumab exceeded three years (39.2 months) versus 26.4 months with THP.

Overall survival (OS) was not mature at the time of the interim analysis (16% maturity at data cut-off); however, interim OS data showed an early trend favouring the Enhertu combination compared to THP (HR 0.84; 95% CI 0.59-1.19).

Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology, Dana-Farber Cancer Institute and principal investigator in the trial, said: "Patients with HER2-positive metastatic breast cancer often experience disease progression around two years after initiating standard-of-care first-line treatment. With a median progression-free survival of more than three years, the DESTINY-Breast09 results show trastuzumab deruxtecan combined with pertuzumab has the potential to become a new first-line standard of care for these patients."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Bringing Enhertu earlier in the treatment of HER2-positive metastatic breast cancer may represent an important advancement for patients. The DESTINY-Breast09 trial showed the combination of Enhertu and pertuzumab in the first-line setting substantially increased the amount of time before a patient’s cancer progressed compared to standard of care and nearly doubled the number of patients showing no signs of disease on imaging. Establishing a strong therapeutic response as soon as metastatic disease is diagnosed is critical given that about one in three patients do not receive further treatment after progressing in the first-line setting."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "Enhertu continues to transform the treatment of metastatic breast cancer with the first new data in more than a decade to demonstrate improved outcomes for a broad population of patients with HER2-positive disease compared to THP in the first-line setting. DESTINY-Breast09 shows that initiating treatment with Enhertu in combination with pertuzumab at the time of metastatic diagnosis can delay disease progression."

Summary of DESTINY-Breast09 interim analysis results

Efficacy Measure

Enhertu (5.4 mg/kg) + pertuzumab

(n=383)

THP

(n=387)

PFS by BICRi

Median PFS (months) (95% CI)

40.7

(36.5-NC)

26.9

(21.8-NC)

Hazard ratio (95% CI)

HR 0.56 (0.44-0.71)

p-value

p<0.00001ii

24-month PFS rate (%) (95% CI)

70.1

(64.8-74.8)

52.1

(46.4-57.5)

PFS by investigator

Median PFS (months) (95% CI)

40.7

(36.5-NC)

20.7

(17.3-23.5)

Hazard ratio (95% CI)

HR 0.49 (0.39-0.61)

Nominal p-value

p<0.00001ii

PFS2 by investigatoriii

Median PFS2 (months) (95% CI)

NC

(NC-NC)

36.5

(36.1-NC)

Hazard ratio (95% CI)

HR 0.60 (0.45-0.79)

Nominal p-value

0.00038ii

ORR by BICR iv

Confirmed ORR (%) (95% CI)v

85.1

(81.2-88.5)

78.6

(74.1-82.5)

CR % (n)

15.1 (58)

8.5 (33)

PR % (n)

70 (268)

70 (271)

SD % (n)

9.9 (38)

14.5 (56)

Median DOR in months (95% CI)

39.2

(35.1-NC)

26.4

(22.3-NC)

Remaining in response at 24 months (%)​

73.3​

54.9​

THP, taxane, trastuzumab and pertuzumab; PFS, progression-free survival; BICR, blinded independent central review, CI, confidence interval; NC, not calculable; HR, hazard ratio; ORR, objective response rate; CR, complete response; PR, partial response, SD, stable disease; DOR, duration of response

i. Interim analysis was based on a data cut-off of 26 Feb 2025; interim analysis criterion for superiority for primary endpoint (P-value <0.00043); ~38% maturity at data cut-off
ii. Stratified log-rank test
iii. PFS2 was defined by investigators according to local standard clinical practice as the time from randomisation to second progression (earliest progression event following first subsequent therapy) or death
iv. ORR is (CR + PR) based on RECIST v1.1
v. Response required confirmation after 4 weeks

Median duration of follow-up was nearly 2.5 years (29.2 months). As of the data cut-off, 302 (39.6%) patients remained on treatment, 174 in the Enhertu plus pertuzumab arm and 128 in the THP arm.

The safety profile of Enhertu in combination with pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual therapy with no new safety concerns identified. Interstitial lung disease (ILD)/pneumonitis occurred in 12.1% of patients treated with Enhertu in combination with pertuzumab, as determined by an independent adjudication committee. The majority of ILD events were low Grade (Grade 1 [n=17; 4.5%] or Grade 2 [n=27; 7.1%]). There were no Grade 3 or Grade 4 ILD events. There were two Grade 5 (0.5%) ILD events in the Enhertu plus pertuzumab arm.

An additional investigational arm of the trial assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

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

Enhertu is already approved in more than 80 countries as 2nd-line treatment for patients with HER2-positive breast cancer based on the results from the DESTINY-Breast03 trial.

Notes

HER2-positive metastatic 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 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification.4

HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.5,6 Approximately 23,000 patients are treated each year in the 1st-line HER2-positive setting across G7 countries alone.7

While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of 1st-line treatment with THP, which has been the standard of care for more than a decade.4,8-10 Further, approximately one in three patients do not go on to receive treatment following 1st-line therapy due to disease progression or death.11,12

DESTINY-Breast09
DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a 1st-line treatment in patients with HER2-positive metastatic breast cancer.

Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include OS, ORR, DOR, investigator-assessed PFS and PFS2 and safety.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America 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) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC 3+ or in-situ hybridisation [ISH]+) breast cancer who have received a (or one or more) 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 80 countries 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 30 countries 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 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 is contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 70 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 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 will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population.

Enhertu (5.4mg/kg) is approved in the US and other countries 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 the results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication in the US is contingent upon verification and description of clinical benefit in a confirmatory trial.

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

Allarity Therapeutics Announces First Patient Enrolled in New Phase 2 Clinical Trial Protocol of Stenoparib in Advanced Ovarian Cancer

On June 2, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—today announced that the first patient has been enrolled in its new Phase 2 clinical trial protocol of stenoparib for the treatment of advanced, platinum-resistant or platinum-ineligible ovarian cancer (Press release, Allarity Therapeutics, JUN 2, 2025, https://allarity.com/press-release/allarity-therapeutics-announces-first-patient-enrolled-in-new-phase-2-clinical-trial-protocol-of-stenoparib-in-advanced-ovarian-cancer/ [SID1234653633]).

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The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval. It builds on encouraging data from Allarity’s earlier and still ongoing Phase 2 study, which demonstrated that patients on twice-daily stenoparib showed durable clinical benefit and that stenoparib was well tolerated. Two patients remain on treatment and continue to derive benefit after more than 20 months. Reflecting the compelling and durable clinical responses observed in platinum-resistant patients to date, the new trial protocol specifically focuses on evaluating stenoparib in patients with advanced, recurrent, platinum-resistant, or platinum-ineligible ovarian cancer—patients for whom current treatment options are extremely limited and typically involve additional chemotherapy, which is associated with well-documented side effects.

"With the enrollment of the first patient, we are fulfilling our promise to accelerate stenoparib’s clinical development as a potentially safer, more effective alternative to chemotherapy for women with advanced, recurrent ovarian cancer," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "This new protocol reflects critical input from leading gynecologic oncologists, and allows us to solidify the importance of DRP for patients who are most likely to receive clinical benefit from stenoparib. This study also allows us to confirm and extend our current findings that show clinical benefit from twice daily dosing."

In addition to assessing overall efficacy and safety, the new trial protocol is designed to further advance the Company’s understanding of stenoparib’s modulation of the WNT signaling pathway—a key driver of disease progression in ovarian and other cancers. The Company is actively pursuing ways to deepen its insights into the therapeutic importance of this WNT-modulating activity and how this, in addition to a cleaner safety profile, distinguishes stenoparib from first-generation PARP inhibitors.

Building on the clinical benefit of the current dosing schedule, this updated study design also includes an additional dosing level to explore the optimal dose for enhancing clinical benefit, aligning Allarity with the FDA’s Project Optimus initiative to inform the start of pivotal registration trials.

The trial is expected to generate significant clinical data by late summer 2026. Allarity plans to pursue multiple advantaged regulatory pathways to expedite potential approval of both stenoparib and its DRP companion diagnostic (CDx).

About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the Wnt signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking Wnt pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

PharmaMar presents at ASCO that the Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) combination significantly improves survival as first-line maintenance therapy for extensive-stage small cell lung cancer

On June 2, 2025 PharmaMar (MSE:PHM) reported positive results from the Phase 3 IMforte study of Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab (Press release, PharmaMar, JUN 2, 2025, View Source [SID1234653632]). The study met both primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to atezolizumab alone.

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IMforte is the first global Phase 3 trial to demonstrate clinically meaningful PFS and OS benefits in the first-line maintenance setting for ES-SCLC and supports maintenance therapy with lurbinectedin plus atezolizumab as a new standard of care for patients. The data were presented today in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago and published simultaneously in The Lancet. Data from the trial served as the basis for the supplemental New Drug Application (sNDA) submission to the FDA by Jazz Pharmaceuticals, as well as for the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by PharmaMar.

Following induction therapy with carboplatin, etoposide and atezolizumab, patients who did not have disease progression were randomized to receive lurbinectedin plus atezolizumab or atezolizumab alone. From the point of randomization, the median PFS was 5.4 months for the lurbinectedin plus atezolizumab combination versus 2.1 months for atezolizumab alone (stratified HR = 0.54, 95% CI: 0.43–0.67; p < 0.0001), and median OS was 13.2 months versus 10.6 months (stratified hazard ratio [HR] = 0.73; 95% CI: 0.57–0.95; p = 0.0174). The combination reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to atezolizumab alone. The lurbinectedin plus atezolizumab combination had no new or unexpected safety signals.

"Small cell lung cancer is an aggressive and devastating disease; at the time of diagnosis, the large majority of patients have already progressed to extensive-stage disease and only one out of five survive longer than two years," said Luis Paz-Ares, M.D., Ph.D., head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and the IMforte trial principal investigator. "The IMforte results are very encouraging showing a potentially practice-changing option that could improve survival for patients with a very high unmet need."

"Upon approval, patients will have access to lurbinectedin earlier in the treatment paradigm, where there’s potential to increase duration of response in a broader patient population, delaying disease progression and extending survival," said Javier Jiménez Jiménez, Chief Medical Officer of PharmaMar.

Each year, approximately 63,000 to 72,000 new cases of small cell lung cancer (SCLC) are reported in Europe. Most of these patients are diagnosed with extensive stage disease, which is aggressive and often difficult to treat, with poor prognosis.

mAbxience and Corapharm Announce Strategic Licensing Agreement for Biosimilar Candidate in Southeast Europe

On June 2, 2025 mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, and Corapharm reported a new strategic licensing agreement to develop and commercialize a biosimilar candidate in Southeast Europe (Press release, mAbxience, JUN 2, 2025, View Source [SID1234653631]).

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Under the terms of the agreement, mAbxience will hold the marketing authorization for the biosimilar candidate in Croatia and Slovenia, while Corapharm will assume this role across Serbia, Bosnia and Herzegovina, North Macedonia, Montenegro, Kosovo, and Albania. Corapharm will lead commercialization efforts throughout these territories, with mAbxience overseeing the product’s development and manufacturing at its state-of-the-art facilities.

"We are excited to partner with Corapharm to bring this biosimilar candidate to patients across Southeast Europe. Our collaboration reflects mAbxience’s commitment to delivering high-quality, accessible therapies across various geographies," said José Ramón Millán, Global Partnering & Portfolio Director at mAbxience.

"Building on our successful track record in the pharmaceutical industry, we look forward to working with mAbxience to improve patient outcomes and expand access to critical treatments in these countries," noted Mr. Miroslav Roca, CEO of Corapharm d.o.o.. "Together, we remain dedicated to enhancing patient care and addressing the rising costs of biologic therapies."

This agreement marks another milestone in mAbxience’s strategy to provide affordable, life-saving therapies worldwide. Both mAbxience and Corapharm expect that this partnership will enhance patient access to advanced treatments, while also helping healthcare systems manage the rising costs of biologic therapies.