On June 17, 2025 Roche reported to have invited investors and analysts to participate in its virtual event on Monday, 23 June 2025, to highlight new results from Roche’s Hematology pipeline including Phase III (STARGLO) Columvi in R/R DLBCL 2-year data , first presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from 30 May-3 June, 2025, Phase III (SUNMO) data for Lunsumio + Polivy in R/R DLBCL primary analysis, accepted as a late breaking abstract at the International Conference on Malignant Lymphoma (ICML) from 17-21 June 2025, Phase III (POLARGO) data for Polivy in R/R DLBCL selected for Plenary presentation at both the European Hematology Association (EHA) (Free EHA Whitepaper) Congress from 12-15 June 2025 and ICML as well as Phase I/II (NXTAGE) data for NXT007 in Hemophilia A presented at the Congress of the International Society on Thrombosis and Haemostasis (ISTH) from 21-25 June 2025 (Press release, Hoffmann-La Roche, JUN 17, 2025, View Source [SID1234653947]).

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19:00 – 20:15 CEST / 18:00 – 19:15 BST
13:00 – 14:15 am EDT / 10:00 – 11:15 am PDT

The webinar will start with a presentation, followed by a Q&A session (live access to the speakers). The slides will be available for download at 18:00 CEST on the day of the event.

On June 17, 2025 SunRock Biopharma and Escugen reported to have joined forces in a strategic partnership to co-develop SRB123, a First-in-Class antibody-drug conjugate (ADC) targeting C-C motif chemokine receptor 9 (CCR9), a tumor-associated antigen overexpressed in multiple solid tumors, including pancreatic, ovarian and lung cancer (Press release, SunRock Biopharma, JUN 17, 2025, View Source [SID1234653964]).

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The collaboration combines SunRock’s proprietary SRB1 antibody, selected for its high binding affinity and efficient tumor cell internalization, with Escugen’s EZWi-Fit linker-payload platform, a next-generation ADC technology optimized for the linker stability and selective tumor release of the potent payload. The result is a highly differentiated therapeutic candidate designed exclusively for solid tumors with high CCR9 expression and internalization rates.

Under the agreement, both companies will share development responsibilities, file joint patents, and hold reciprocal licensing option rights. The primary goal is to generate robust preclinical proof-of-concept data to support early clinical entry in the near term.

"Combining our deep antibody engineering expertise with Escugen’s innovative conjugation platform enables us to deliver a precision oncology candidate with First-in-Class potential," said Dr. Laureano Simón, CEO of SunRock. "CCR9 remains an underexploited but clinically validated target. This program addresses real unmet needs in aggressive tumors with poor prognosis."

Dr. Qing Zhou, Co-Founder and CEO of Escugen, stated, "This strategic collaboration with SunRock Biopharma aligns with our vision of developing First-in-Class precision oncology candidates through technological innovation. It further highlights the unique advantages of our EZWi-Fit platform technology in next-generation ADC development. The platform’s strong anti-tumor activity and favorable tolerability provide a solid foundation for targeting high CCR9-expressing solid tumors. We are confident that combining our expertise will accelerate SRB123’s progress and bring new hope to patients."

CCR9 has been associated with metastatic potential and chemoresistance, particularly in pancreatic and ovarian cancers. SRB1, the unconjugated antibody from SunRock, has already demonstrated strong preclinical efficacy in these models. The ADC format (SRB123) leverages this targeting while enhancing tumor cell killing via Escugen’s payload delivery system.

The partnership will be showcased during the BIO International Convention 2025, where both companies will engage with potential development and commercialization partners.

On June 17, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, reported positive data from its ongoing Phase 2a clinical trial evaluating atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (Press release, Immuneering, JUN 17, 2025, View Source [SID1234653948]).

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"These exceptional data demonstrate the potential of atebimetinib plus mGnP to dramatically extend the lives of patients with advanced pancreatic cancer," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "94% overall survival at 6 months is remarkable in first-line pancreatic cancer patients. Atebimetinib was designed to deliver exceptional durability and tolerability to a broad range of patients with different cancers, and it is deeply gratifying to see evidence of that playing out first in one of the most aggressive and deadly types of cancer. Our ultimate goal is to help cancer patients outlive their disease, and today’s announcement represents an important milestone on that journey."

Durability and Tolerability of Atebimetinib + mGnP Demonstrated in Phase 2a Data

94% overall survival (OS) was observed at 6 months in first-line (1L) pancreatic cancer patients treated with atebimetinib + mGnP at the 320 mg once-daily dose of atebimetinib (N=34). The benchmark 6-month OS for the standard of care treatment in this population (full dose and schedule GnP) is 67%.1 The median OS was not yet reached at the data cutoff date.
72% progression-free survival (PFS) was observed at 6 months in first-line (1L) pancreatic cancer patients treated with atebimetinib + mGnP at the 320 mg dose level (N=34). The benchmark 6-month PFS for the standard of care treatment in this population (full dose and schedule GnP) is 44%.1 The median PFS was not yet reached at the data cutoff date.
An overall response rate (ORR) of 39% and a disease control rate (DCR) of 81% were observed in response evaluable patients at both the 240 and 320 mg dose levels of atebimetinib + mGnP (N=36), including many patients with deepening, durable regressions and multiple examples of individual lesions rendered undetectable.
Atebimetinib continued to demonstrate a markedly favorable tolerability profile in combination with mGnP. No Grade 3+ events were observed in a majority of the adverse event categories commonly observed with standard of care chemotherapy in first line pancreatic cancer.
Based on these data, the Company has increased target enrollment in the 1L pancreatic cancer atebimetinib + mGnP combination arm to approximately 50 patients.
All results are reported using a data cutoff date of May 26, 2025.

"The encouraging clinical data reported thus far for atebimetinib (IMM-1-104) represent a potential new and significantly more durable treatment option for pancreatic cancer patients, for whom limited therapeutic options are currently available," said Vincent Chung, M.D., F.A.C.P., Professor, Department of Medical Oncology and Therapeutics Research at City of Hope, and principal investigator of the Phase 2a clinical trial. "I have treated pancreatic cancer patients with atebimetinib who have experienced exceptional durability. Current standard of care therapies in pancreatic cancer can be associated with limited durability and severe side effects, leading to poor patient outcomes. We have not seen significant improvement in standard of care for decades, and there is an urgent need for more durable and better tolerated new treatments that help patients live longer."

"These data clearly establish atebimetinib’s potential as a more durable and better tolerated MEK inhibitor positioned to help patients both live longer and live better, with exciting potential opportunities in pancreatic cancer and a variety of other cancers," said Igor Matushansky, M.D. Ph.D., Chief Medical Officer of Immuneering. "We look forward to advancing atebimetinib to a pivotal trial as rapidly as possible."

Dr. Chung is a paid advisory board member of Immuneering.

Near-Term Milestone Expectations

Building on these new Phase 2a clinical data, Immuneering is planning for several additional milestones related to atebimetinib, including:

Regulatory feedback on pivotal study plans in 4Q 2025
Data from additional patients in Phase 2a trial in 4Q 2025
Initiation of pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026
Initiation of additional atebimetinib clinical trial combination arms in 2026
Conference Call

Immuneering will host a conference call and live webcast at 8:00 a.m. ET / 5:00 a.m. PT on June 17, 2025, to discuss the data and provide a business update. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 for U.S callers and (646) 307-1963 for other locations and reference conference ID 5641694, or from the webcast link in the "investors" section of the company’s website at www.immuneering.com. A webcast replay will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

On June 17, 2025 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported the launch of its DIRECT-AI registry study (Press release, Artera, JUN 17, 2025, View Source [SID1234653965]). This study will assess how the ArteraAI Prostate Test influences treatment decision-making between clinicians and patients with localized prostate cancer. Additionally, the study will monitor participants to evaluate their long-term cancer outcomes, reinforcing Artera’s commitment to advancing personalized cancer treatment and identifying future opportunities for test optimization.

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The DIRECT-AI study centers on the award-winning ArteraAI Prostate Test—the only test included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for localized prostate cancer that can both predict therapy benefit and prognosticate long-term outcomes.

"Harnessing the power of AI, the ArteraAI Prostate Test marks a significant advancement in the personalized treatment of localized prostate cancer. Through the DIRECT-AI registry, we are rigorously evaluating how this technology can enhance clinical decision-making and improve patient outcomes, providing clinicians and patients with the most accurate, tailored insights available," said Dr. Tim Showalter, Chief Medical Officer at Artera.

The study is structured into two phases. The initial phase captures real-world insights into how the Artera Prostate Test informs clinical decision-making, with feedback collected from participating clinicians and patients. The second phase will monitor long-term health outcomes at key intervals of 2 and 5 years, looking at endpoints such as distant metastasis, survival rates, and treatment effectiveness. This research will help Artera understand how its test impacts cancer outcomes and monitor its performance so that it can be improved for patients in the future.

Any patient receiving the commercial ArteraAI Prostate Test and whose ordering physician is associated with an enrolling clinic is eligible to participate in the study. Patients must have localized prostate cancer and must not have started or received treatment for their condition. The study is non-interventional, meaning it does not require additional procedures or tests, and there will be no changes to the care participants receive, regardless of their participation.

For clinics participating in the DIRECT-AI Registry, physicians can enroll all patients for whom they order an ArteraAI Prostate Test in the study.

On June 16, 2025 Duke Street Bio, a clinical-stage biotechnology company focused on precision oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DSB2455, its next-generation, CNS-active selective PARP1 inhibitor, for the treatment of patients with brain metastases originating from primary triple-negative breast cancer (TNBC) tumors harboring BRCA1/2 and/or homologous recombination repair (HRR) alterations (Press release, Duke Street Bio, JUN 16, 2025, View Source [SID1234653916]).

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DSB2455 is a potentially best-in-class agent within the PARP1-selective inhibitor space, offering a differentiated profile that may expand therapeutic possibilities in hard-to-treat indications. The compound is a next-generation, highly PARP1-selective inhibitor with demonstrated brain penetrance and potent anti-tumour activity in preclinical models of homologous recombination-deficient cancers, including brain metastases.

The Fast Track designation is intended to facilitate the development of new therapies for serious conditions where there is significant unmet medical need. It allows for more frequent interactions with the FDA, eligibility for rolling review of an NDA, and potential consideration for Priority Review or Accelerated Approval.

"Receiving Fast Track designation for DSB2455 represents an important milestone in our mission to develop more targeted and effective therapies for patients with limited treatment options," said Alan Wise, Chief Executive Officer of Duke Street Bio. "Next-generation PARP1-selective inhibitors such as DSB2455 are expected to offer a wider therapeutic window than earlier PARP inhibitors, potentially enabling broader use both as monotherapy and in combination with other anti-cancer agents across a range of tumors."

"DSB2455’s ability to achieve therapeutically relevant concentrations in the CNS represents a key differentiator," added Dónal Landers, Chief Medical Officer of Duke Street Bio. "This could offer a new treatment option for patients with secondary HRD brain metastases, where clinical need remains high and current therapeutic choices are limited."

About Fast Track Designation
The FDA’s Fast Track program is designed to accelerate the development and review of new drugs for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Companies granted this designation benefit from more frequent communication with the FDA and eligibility for rolling submissions and other expedited review processes.