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.

On June 2, 2025 KAHR, a clinical-stage biotech company developing DSP107, a first-in-class bi-specific 4-1BB T-cell engager that activates innate and adaptive immunity to treat solid tumors, reported positive results from the Phase 2 dose expansion cohort of DSP107 in combination with atezolizumab (Tecentriq), an anti-PD-L1 cancer immunotherapy, in patients with 3rd line microsatellite stable metastatic colorectal cancer (MSS-CRC) (Press release, KAHR Medical, JUN 2, 2025, View Source [SID1234653647]). In addition to its favorable safety profile, the combination has shown anti-tumor activity and extended survival including in patients with liver metastases. The results were presented in an oral presentation by Anwaar Saeed, MD, Associate Professor of Medicine, University of Pittsburgh Medical Center and Director, Gastrointestinal Disease Center, UPMC Hillman Cancer Center at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, May 30 – June 3, 2025, in Chicago, IL.

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"Colorectal cancer, the second largest cause of cancer deaths worldwide, is considered a ‘cold’ tumor that usually does not elicit an efficient immune response," said Dr. Saeed. "This immunotherapy combination showed durable results in MSS-CRC patients. Not only is the median survival of DSP107 with atezolizumab longer than current standard treatments, it is also very well tolerated by patients, without the severe, sometimes life-threatening side effects of chemotherapy in such advanced lines of treatment. Importantly, the majority of patients in the combination cohort had active liver metastases and the activity and survival benefit were also seen in these patients, who are very difficult to treat, suggesting that DSP107 in combination with a PD1/PD-L1 checkpoint inhibitor may become an effective immunotherapy treatment option for this patient population."

Yaron Pereg, Ph.D., Chief Executive Officer of KAHR, said, "We are extremely encouraged by the dose expansion data, showing objective responses and extended survival in response to DSP107 in combination with atezolizumab in patients with 3rd line MSS-CRC. We look forward to initiating a Phase 2b, randomized, controlled study to confirm these promising efficacy signals. In addition, we expect data in 2026 from a Phase 2 dose expansion cohort in Non-small Cell Lung Cancer (NSCLC), the leading cause of cancer deaths worldwide."

Results from the completed dose expansion cohort show that DSP107 monotherapy and combination treatment with atezolizumab were well tolerated with no dose limiting toxicities. The median OS from the efficacy-evaluable patients who received DSP107 monotherapy (n=19) and combination therapy with atezolizumab (n=21) has not been reached, but currently (May 2025 cutoff) stands at 8.1 and 17 months, respectively. Disease control was demonstrated in 21% (monotherapy) and 62% (combination) of evaluable patients including a patient who achieved a complete response (> 2.5 years) and a patient with a deep (86% target lesion reduction) and durable (> 16 months) confirmed partial response and disappearance of pulmonary and hepatic metastases. Immunofluorescence analysis of baseline tumor biopsies demonstrated very high levels of CD47 expression, the DSP107 target, in all samples collected from liver metastases.

The MSS-CRC dose expansion phase of the study was an open label, multi-center trial (NCT04440735) that enrolled patients with 3rd line MSS colorectal cancer patients, treated weekly with 10 mg/kg DSP107 infusions and atezolizumab (1200 mg) every three weeks, until disease progression. The primary objective was to determine the safety and tolerability of DSP107 in combination with atezolizumab. The secondary objective was to assess the preliminary efficacy of DSP107 in combination with atezolizumab.

Presentation information:

Abstract Title: Phase 2 dose expansion study of DSP107, a first-in-class bi-specific 4-1BB T-cell engager, with and without atezolizumab in metastatic MSS colorectal cancer patients.

Abstract Number for Publication: 3517

About DSP107

KAHR’s lead drug candidate, DSP107, is a first-in-class bi-specific 4-1BB T-cell engager utilizing CD47 overexpression as a tumor anchor. DSP107 binds to CD47 that cancer cells express on their cell surface. Once bound, DSP107 converts the CD47 signal, which cancer uses to camouflage itself from the innate immune system, into a 4-1BB signal, which attracts and activates adaptive immune cells, primarily cancer cytotoxic CD8 T-cells. In this way, DSP107 engages both parts of the immune system in a wholistic anti-cancer response. This is particularly relevant in colorectal cancer, where 70%+ of the metastatic patients have metastases in the liver, and where liver metastases highly express CD47 in response to first- and second-line chemotherapy treatments. Previous attempts to treat colorectal cancer with immunotherapy have failed as there is a lack of immune cells in the tumor. DSP107 is unique in that it takes advantage of CD47 expression to drive immune cells into the tumor. DSP107 is also being tested in Phase 2 expansion cohort in 2L/3L PD1-experienced NSCLC.

About microsatellite stable metastatic colorectal cancer (MSS-CRC)

Microsatellite stable metastatic colorectal cancer (MSS-CRC) is a subtype of colorectal cancer that lacks deficiencies in the DNA mismatch repair system, resulting in stable microsatellite regions within the genome. Unlike microsatellite instability-high (MSI-H) tumors, MSS-CRC exhibits lower tumor mutational burden and is less responsive to immunotherapy. MSS tumors represent the majority of colorectal cancer cases and are typically more challenging to treat. Standard treatment for metastatic MSS-CRC often involves a combination of chemotherapy, targeted therapy, and in select cases, surgical intervention.

On June 2, 2025 AimedBio reported it has successfully secured $38 million in a Pre-IPO funding round. The round was led by existing key investors—InterVest, DS Asset Management, Samsung Life Public Welfare Foundation, and SMB Investment Partners. Mirae Asset Securities joined as the sole new investor.

With the newly secured funding, AimedBio plans to accelerate the development of its next-generation ADC pipeline and advance preparations for global clinical trials. Following the licensing of its lead asset, AMB302, to U.S.-based Biohaven in December 2024, the company is now focusing on the preclinical development of the next candidates AMB303 and AMB304. At the same time, AimedBio aims to significantly expand its pipeline through next-generation ADC platform technologies.

Dr. Nam-Gu Her, CEO of AimedBio stated, "This Pre-IPO round closed earlier than expected, reflecting strong confidence from our existing shareholders. Mirae Asset Securities’ participation signals growing market confidence in AimedBio’s vision and potential."

"Based on our successful licensing deal to date, AimedBio is projected to achieve operating profitability for two consecutive half-years—the second half of 2024 and the first half of 2025. This is a significant milestone, as it demonstrates that the company has moved beyond potential to proving its ability to generate sustainable revenue," he added.

AimedBio also noted, "Additional technology licensing deals are expected within this year, and with the rapid expansion of our preclinical pipeline, we are set to accelerate high-growth momentum. Through the development of globally competitive ADC therapies, we aim to provide meaningful treatment options to patients and continuously enhance corporate value."

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(Press release, AimedBio, JUN 2, 2025, View Source;s_keyword=&s_where=&start=0 [SID1234656917])

On June 2, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (" BriaCell " or the " Company "), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported clinical data in three clinical poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, BriaCell Therapeutics, JUN 2, 2025, View Source [SID1234653600]). BriaCell has featured robust survival and clinical benefit data from its Bria-IMT Phase 2 clinical study, clinical progress data from its ongoing pivotal Bria-IMT Phase 3 study (ClinicalTrials.gov identifier: NCT06072612 ), and Phase 1/2 study of Bria-OTS (ClinicalTrials.gov identifier: NCT06471673 ) in metastatic breast cancer.

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"Prolonging survival and providing meaningful clinical benefit for patients whose disease has demonstrated resistance to multiple treatment options remains a critical unmet need in breast cancer. These Bria-IMT regimen results are promising for individuals with metastatic breast cancer," said Sara A. Hurvitz, MD, FACP, Senior Vice President, Director of the Clinical Research Division, and Smith Family Endowed Chair in Women’s Health at Fred Hutch Cancer Center, as well as Professor and Head of the Division of Hematology and Oncology at the University of Washington, Seattle, WA, and co-author of one of the clinical posters. "The low incidence of all grade and grade 3/4 adverse events is particularly notable."

"We are thrilled with our Phase 2 overall survival and clinical benefit data which meets and exceeds those of FDA approved drugs — even in very heavily pre-treated patients in our study," noted Dr. William V. Williams, BriaCell’s President & CEO. "We look forward to further confirming these impressive results in our ongoing pivotal Phase 3 study with the ultimate goal of bringing novel treatments to cancer patients in need."

The details of the poster presentation sessions and publish-only abstract are listed below.

Poster Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician’s choice in advanced metastatic breast cancer (BRIA-ABC)
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1138
Poster Board Number: 108a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

"Trial in Progress" poster presents early enrollment data and the overall design of the Phase 3 pivotal trial along with updated clinical outcomes from the Phase 2 Bria-IMT study.

Poster Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: 1096
Poster Board Number: 75
Session Type and Title: Poster Session – Breast Cancer—Metastatic

In the Phase 2 study of Bria-IMT combined with an immune checkpoint inhibitor (CPI) in 54 heavily pre-treated metastatic breast cancer (MBC) patients (median of six prior systemic therapies; range 2–13), Bria-IMT demonstrated promising efficacy and safety. Notably, 44% of patients had failed a prior antibody-drug conjugate, and 20% had failed a prior CPI. Among these patients, the overall clinical benefit rate (CBR; defined as CR, PR, or SD) was 55%, with CBRs of 100% in HER2+, 55% in HR+/HER2-, and 45% in triple-negative breast cancer (TNBC) subgroups, indicating antitumor activity across MBC subtypes. Additionally, patients treated with the selected Phase 3 formulation (without IFNγ; N=37) experienced significantly improved overall survival (13.9 vs. 6.93 months; P=0.01) compared to those receiving the alternate formulation, highlighting the potential of Bria-IMT for advancing in clinical development.

Table 1. Median overall survival (OS) in BriaCell Phase 2 Study patients who were treated with Phase 3 formulation (without IFNγ) compared with comparable patients in the literature

N = 54 Breast Cancer
Types Median Prior
Lines of Therapy Median (months)
Phase 3 formulation
(without IFNγ) 61% HR+
33% TNBC
6% HER2+ 6 17.3*
13.9
Cortes et al. 1 57% HR+
18-19% TNBC
18-20% HER2+ 4 9.1-9.3
Kazmi et al. 2 51-52% HR+
25-29% TNBC
9-24% HER2+ 2 7.2-9.8
* Patients treated since 2022
1. Cortes J, et al. Annals of Oncology 2018
2. Kazmi S, et al. Breast Cancer Res Treat. 2020
Table 2. Median overall survival (OS), and clinical benefit rate (CBR) in TNBC patients treated with Bria-IMT Phase 3 formulation compared with pivotal Phase 3 ASCENT 1 study results (Trodelvy (SG) vs. Treatment of Physicians Choice (TPC) in triple-negative breast cancer (TNBC))
Trial (Cohort) Age (Median,
Range) Prior
Therapies
(Median) Prior ADC/CPI
(%) CNS
Mets OS
(Median,
Months) CBR
(%)
TNBC Bria-
IMT (Phase 3
Formulation) 62 (44-80) 6 (2-13) 20/19 4 11.4 45 %
ASCENT (SG) 54 (27-82) 4 (2-17) 27/None Listed None
Listed 11.8 40%
ASCENT (TPC) 53 (27-81) 4 (2-14) 27/None Listed None
Listed 6.9 8%

1 Bardia, A., et al Journal of Clinical Oncology, 42(15), 1738–1744.
As shown in table 2, both OS and CBR values were in line or higher than those reported in the treatment arm of the ASCENT study for TNBC patients treated with Phase 3 formulation of Bria-IMT regimen but were almost 2 times higher than those shown in the TPC comparator arm.
Table 3: Median overall survival (OS), and clinical benefit rate (CBR) in HR+/HER2- patients treated with the Bria-IMT (Phase 3 formulation) compared with pivotal Phase 3 TROPiCS-02 2 study results (SG or Chemo in Hormone Receptor +/HER2- MBC)
Trial (Cohort) Age
(Median,
Range) Prior
Therapies
(Median) Prior
ADC/CPI
(%) CNS
Mets OS
(Median,
Months) CBR (%)
HR+/HER2-
Bria-IMT (Phase 3
Formulation) 62 (44-80) 6 (2-13) 17/2 1 17.3 60 %
TROPiCS (SG) 57 (49-65) 3 None
Listed None
Listed 14.4 34%
TROPiCS (Chemo) 55 (48-63) 3 None
Listed None
Listed 11.2 22%

2 Rugo, H. S., et al. The Lancet, 402(10411), 1423–1433.
As shown in table 3, both OS and CBR values for patients treated with Phase 3 formulation of the Bria-IMT regimen were higher than those reported in both arms of the TROPICS study.
Favorable tolerability profile: Bria-IMT was well-tolerated with no treatment-related discontinuations. 22% of patients are still in active survival follow up with one patient remaining on study now for over 18 months.
The efficacy data and favorable safety profile of the Phase 3 formulation support the continued evaluation of Bria-IMT in BriaCell’s ongoing pivotal Phase 3 trial ( NCT06072612 ), which compares Bria-IMT to the treatment of physician’s choice. The ongoing patient subset analysis in this trial aims to identify the patients who may derive the greatest benefit from Bria-IMT treatment.

Poster Title: Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1136
Poster Board Number: 107a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

In a dose-escalation Phase 1/2 study, heavily pre-treated MBC patients received Bria-OTS monotherapy (single agent Bria-OTS cells only). The Phase 1 segment enrolled and treated 3 patients with the first patient achieving a confirmed resolution of a breast cancer lung metastasis and remaining on study with single agent Bria-OTS. Following successful completion of safety evaluations, BriaCell has initiated the combination cohort dosing the first patient with Bria-OTS plus checkpoint inhibitor (CPI).

Publish-Only Abstract Title : Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT Plus Anti PD1 in Advanced Breast Cancer

Following the presentations, copies of the presentations will be posted on View Source

On June 2, 2025 NuCana plc (NASDAQ: NCNA) reported financial results for the first quarter ended March 31, 2025 and provided an update on its clinical development program with its two lead anti-cancer medicines (Press release, Nucana, JUN 2, 2025, View Source [SID1234653616]).

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"We have entered 2025 with a clear focus on the advancement of our pipeline through key milestones, into late-stage development, and towards commercialization," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Our lead program, NUC-7738, continues to show significant promise. NUC-7738 is a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. In our ongoing Phase 1/2 NuTide:701 study, we have observed a favorable safety profile, meaningful tumor volume reduction and prolonged progression free-survival in patients with PD-1 inhibitor refractory and resistant metastatic melanoma. Based on these compelling results, we have recently initiated an expansion trial of NUC-7738 in an additional 28 patients with PD-1 inhibitor-resistant melanoma, that supports our registrational path. Based on this, we plan to meet with the U.S. Food and Drug Administration to determine the optimal regulatory strategy forward towards commercialization."

Mr. Griffith continued, "Turning to our second program, NUC-3373 is a targeted thymidylate synthase inhibitor with immune modulating properties. We are encouraged by the data from the ongoing Phase 1b/2 NuTide:303 study. This study is evaluating NUC-3373 in combination with pembrolizumab in patients with advanced solid tumors, and NUC-3373 with docetaxel in patients with lung cancer. To date, we have seen notable tumor volume reductions and prolonged progression free survival in these patients. We look forward to sharing additional data from this trial later this year."

Mr. Griffith concluded, "Lastly, we strengthened our balance sheet with a financing in May, extending our cash runway through key value-driving milestones. With multiple data readouts ahead, we are well-positioned to deliver on our mission of improving treatment outcomes for patients with cancer."

2025 Anticipated Milestones

NUC-7738

Initiate an expansion of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;

Announce data from the Phase 1/2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab; and

Obtain regulatory guidance from the U.S. Food and Drug Administration on pivotal study design for NUC-7738 in melanoma.

NUC-3373

Announce additional data from the Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors.

First Quarter 2025 Financial Highlights and Cash Position

As of March 31, 2025, NuCana had cash and cash equivalents of £4.0 million compared to £6.7 million at December 31, 2024. Subsequent to March 31, 2025, NuCana completed a financing, raising an additional £8.8 million in gross proceeds before expenses and commission. NuCana expects that its cash and cash equivalents as of March 31, 2025, together with amounts raised through its financing, will be sufficient to fund its planned operations into Q4 2026.

NuCana continues to advance its numerous clinical programs and reported a net loss of £2.5 million for the quarter ended March 31, 2025, as compared to a net loss of £6.8 million for the quarter ended March 31, 2024. Basic and diluted loss per ordinary share was £0.02 for the quarter ended March 31, 2025, as compared to £0.13 per ordinary share for the comparable quarter ended March 31, 2024.