On April 30, 2025 Starpharma, an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its Quarterly Activities Report and Appendix 4C for the quarter ended 31 March 2025 (Q3 FY25) (Press release, Starpharma, APR 30, 2025, View Source [SID1234654130]).

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Starpharma’s Chief Executive Officer, Cheryl Maley, commented:
"It is almost 12 months since we announced our revised strategy. We have made significant progress towards achieving our objectives during this time, and we acknowledge that some outcomes are taking longer than we initially anticipated. The Starpharma team remains intensely focused on delivering on our strategic priorities, and we are committed to achieving the outcomes agreed with the Board in May 2024 with a high sense of urgency. Earlier this month, the Board and Leadership team convened to reflect on Starpharma’s progress and to reaffirm our strategic direction going forward

"Our top priorities this quarter have been to advance existing and potential new partnerships, develop the clinical program for DEP SN38 to get to market in the most time- and commerciallyeffective way and build robust pre-clinical data in our radio program that exemplifies the benefits of our dendrimer technology in radiopharmaceuticals.

"The dual goals of our radio program over the past months have focused on creating valuable preclinical data for the development of further enhanced HER2 assets and compelling data for potential partners interested in the application of the DEP platform to radiopharmaceuticals. This will delay the commencement of our clinical program; however, we are excited about the data generated thus far and the potential opportunities to partner in this area.

"This past quarter, we also launched new promotions for Viraleze in the UK and developed a program to make VivaGel BV available online in Europe in FY26.

"We continue managing costs effectively through clear prioritisation, resource management and implementing cost-saving strategies, whilst focusing on revenue generation opportunities such as partner licensing of the DEP platform and assets and product sales for Viraleze and VivaGel BV. We are also enhancing efficiency in drug development by leveraging outsourcing, automation, and exploring the use of AI.

"Whilst the past few months have been challenging across many sectors, including the Australian Biotech sector, we are confident that our versatile platform drug delivery technology offers multiple opportunities for value generation through partnerships and innovative asset development, which we aim to maximise through our strategic priorities.

"I would like to thank our shareholders for your patience and ongoing support as we work diligently to restore value to Starpharma investors."

On April 30, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, will present at the Citizens Life Sciences Conference taking place in New York City on Wednesday, May 7, 2025 beginning at 3:30 p.m. Eastern Time (Press release, Quince Therapeutics, APR 30, 2025, View Source [SID1234652391]).

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A live webcast of the presentation will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.

On April 29, 2025 D3 Bio, a clinical-stage biotechnology company pioneering precision oncology therapies, reported the simultaneous publication of landmark clinical data on its lead investigational drug D3S-001 in Nature Medicine and oral presentation of updated results at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, D3 Bio, APR 29, 2025, View Source [SID1234652334]). These data affirm D3S-001’s differentiated mechanism of action, favorable safety profile and compelling efficacy in patients with KRAS G12C mutation–addicted cancers, including patients previously treated with first-generation KRAS G12C inhibitors.

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Promising Efficacy in G12Ci-Naïve and Resistant Patients

In a Phase 1a/1b clinical study (NCT05410145), D3S-001 demonstrated an overall objective response rate (ORR) of 73.5% in KRAS G12C inhibitor-naïve patients across multiple tumor types, including:

66.7% in non–small cell lung cancer (NSCLC)
88.9% in colorectal cancer (CRC)
75.0% in pancreatic ductal adenocarcinoma (PDAC)
Additionally, in 20 patients with NSCLC who had previously been treated with and progressed on first-generation G12C inhibitors, including sotorasib and adagrasib, D3S-001 achieved a 30.0% overall response rate (ORR) and 80.0% disease control rate (DCR), providing direct clinical evidence of its ability to overcome acquired resistance to first-generation G12Ci therapies.

"These findings demonstrate that D3S-001 fulfills the defining qualities of a next-generation KRAS G12C inhibitor: fast and complete target engagement, favorable safety, consistent and promising efficacy across all tumor types, brain penetration, and ability to overcome first-generation resistance," said Byoung Chul Cho, MD, PhD, lead and co-supervisory author and Professor and Head of Yonsei Cancer Center, Yonsei University College of Medicine. "We believe it is a truly new-generation KRAS G12C inhibitor with the potential to overcome the limitations of the first-generation inhibitors and become a cornerstone therapy for KRAS G12C-driven cancers."

AACR 2025 Data Highlights the Activity of D3S-001 in Overcoming Resistance in Patients with NSCLC Who Have Progressed on First-Generation G12C Inhibitors

At AACR (Free AACR Whitepaper) 2025, D3 Bio shared updated results from a Phase 2 expansion cohort of NSCLC patients who had previously been treated with FDA-approved or other experimental G12C inhibitors. The compound demonstrates encouraging clinical benefits in this patient population. The data include:

60% of patients experienced tumor shrinkage
30% achieved partial responses
80% disease control rate
11 of 14 ctDNA-positive patients achieved >90% G12C MAF reduction, with 6 achieving partial response (a 43% response rate in the ctDNA-positive population)
Responses were observed in patients with KRAS G12C amplification, a known resistance mechanism to first-generation inhibitors, consistent with previous preclinical observations
The results support D3S-001’s unique ability to overcome molecular resistance in a population with urgent unmet medical needs.

"The clinical data, published at Nature Medicine and presented at AACR (Free AACR Whitepaper), validates D3S-001 as a promising treatment for patients with KRAS G12C–driven tumors, both naïve and refractory, to first-generation inhibitors," said Tony Mok, MD, co-supervisory author of the Nature Medicine paper, Professor of Clinical Oncology at the Chinese University of Hong Kong, and a global thought leader in targeted therapy for lung cancer. "Its potential to induce compelling responses in these challenging cases offers hope for a patient population with limited treatment options."

"At D3 Bio, we believe that solid science, combined with strong collaboration with global thought leaders, is the foundation for driving the field forward," said George Chen, MD, Founder, Chairman, and CEO of D3 Bio. "Our Cancer Discovery paper reported the new mechanism and properties of D3S-001 in preclinical settings, and now we are excited to witness the nearly seamless translation of these important features into the clinic. The continued clinical advancement of D3S-001 reflects not only the innovation behind its design, but also the strength of these collaborations to bring meaningful therapies to patients worldwide."

About D3S-001

D3S-001 is a next-generation KRAS G12C inhibitor designed to achieve rapid and complete KRAS G12C target engagement. In preclinical investigations, D3S-001 has demonstrated high covalent potency, complete engagement of KRAS G12C at clinically relevant doses and CNS penetration properties. D3S-001 is currently in a Phase II global clinical trial in patients with advanced solid tumors harboring KRAS G12C mutations, including NSCLC, CRC, and other tumor types. Key publications:

D3S-001, a KRAS G12C Inhibitor with Rapid Target Engagement Kinetics, Overcomes Nucleotide Cycling, and Demonstrates Robust Preclinical and Clinical Activities. Cancer Discov (2024) 14 (9): 1675–1698.
D3S-001 in advanced solid tumors with KRAS G12C mutations. Nature Medicine (View Source)

On April 29, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported it will host a virtual KOL investor event on Friday, May 9 at 1:00 PM ET / 10:00 AM PT to provide an overview of anemia of myelofibrosis (MF) and discuss the evolving treatment landscape for this disease (Press release, Disc Medicine, APR 29, 2025, View Sourcenews-releases/news-release-details/disc-medicine-host-webinar-key-opinion-leaders-anemia" target="_blank" title="View Sourcenews-releases/news-release-details/disc-medicine-host-webinar-key-opinion-leaders-anemia" rel="nofollow">View Source [SID1234653894]). The event will also include an overview of Disc’s clinical data and development plans for DISC-0974 in MF anemia.

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Intended for investors and other interested audiences, the virtual event will feature presentations from leading experts on myeloproliferative neoplasms (MPNs), including MF. The KOL speakers will provide an overview of MF anemia, its epidemiology, pathogenesis, and impact on patients, then discuss the current and emerging therapeutic landscape for MF and highlight the clear unmet need for anemia-focused treatments. Invited speakers include:

Dr. Aaron Gerds, M.D., M.S., a hematologist-oncologist at Cleveland Clinic and associate professor at Case Western University School of Medicine, where he runs the cancer center’s Clinical Research Office. Dr. Gerds has been a principal investigator in various clinical trials for MPNs.
Dr. Prithviraj Bose, M.D., a professor at MD Anderson Cancer Center with a focus on MPNs. Dr. Bose has been a leader in multiple clinical trials in myelofibrosis.
Members of Disc’s leadership team will review the therapeutic rationale for DISC-0974, summarize clinical data from the Phase 1b trial of DISC-0974 in MF anemia originally presented at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, discuss the design for its ongoing Phase 2 trial, and reiterate expected timing for an interim Phase 2 data readout in 2025. Management will also provide a view of the expected market opportunity and positioning for DISC-0974 in MF anemia.

A live webcast of the event will be available in the Events and Presentations section of the Investor Relations page of Disc’s website (View Source). A webcast replay will be available after the live presentation and will be accessible for 90 days. Please register for the event on the Events and Presentations page of Disc’s website (View Source).

About DISC-0974

DISC-0974 is an investigational monoclonal antibody (mAb) targeting a BMP-signaling co-receptor called hemojuvelin (HJV) and is designed to suppress hepcidin production and increase serum iron levels in patients suffering from anemia of inflammation. DISC-0974 was in-licensed by Disc from AbbVie in 2019. Anemia of inflammation arises from abnormally elevated hepcidin and is the second most common form of anemia, affecting millions of patients in the US across numerous diseases, such as chronic kidney disease, myelofibrosis, cancer, autoimmune diseases, and other conditions with an inflammatory component. Disc has established clinical proof-of-mechanism of DISC-0974 in a Phase 1 trial of healthy volunteers, completed a Phase 1b clinical trial in patients with myelofibrosis and anemia, and initiated a Phase 2 clinical trial of DISC-0974 in patients with MF anemia, as well as a Phase 1b/2a clinical trial of DISC-0974 in patients with chronic kidney disease and anemia who are not receiving dialysis.

DISC-0974 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide.

About Anemia of Myelofibrosis

Myelofibrosis (MF) is a rare, chronic blood cancer that currently affects an estimated 25,000 patients in the United States alone. Severe, progressive, and treatment resistant anemia is a primary clinical manifestation of MF. At diagnosis, over 80% of MF patients have anemia, which progressively worsens and ultimately renders the majority of patients dependent on chronic red blood cell transfusions. Recent studies have shown hepcidin to be a key molecular driver of anemia in myelofibrosis. Hepcidin is elevated by approximately 12-fold in MF patients, and is correlated with disease severity, anemia, and the need for red blood cell transfusions.

On April 29, 2025 Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), reported new data on the mechanism of action of MB097 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting held in Chicago, April 25-30 (Press release, Microbiotica, APR 29, 2025, View Source [SID1234652313]). MB097 is an LBP in development as a co-therapy for immune checkpoint inhibitors (CPI) such as MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

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The composition of a patient’s intestinal microbiome is known to impact the response to immunotherapies, most noticeably CPI, but the mechanisms are poorly understood. MB097 comprises nine different species of gut commensal bacteria, all linked to positive CPI response in multiple clinical studies. Microbiotica has developed in vitro human systems using primary immune cells to investigate how gut bacteria modulate the immune response to cancer. These assays have demonstrated that three of the MB097 strains induce dendritic cells to produce high levels of IL-12, which in turn stimulates Cytotoxic T Lymphocytes and NK cells with potent tumour cell killing activity. Dr Mat Robinson, Microbiotica’s Senior Vice-President Research, presented these novel findings in a poster entitled ‘Clinical response to immune checkpoint inhibitors in melanoma is associated with distinct gut bacterial species that promote anti-tumour immunity by different mechanisms’. The poster can be accessed here.

Dr Mat Robinson, Microbiotica’s SVP Research, said, "These exciting results start to unravel the complex biology of how gut commensal bacteria drive immune checkpoint inhibitor responses. The induction of dendritic cells to produce IL-12 complement the recently reported data showing that other MB097 strains release metabolites that enhance immune-mediated cancer cell killing. Together, these findings demonstrate that the different strains within MB097 can interact with the immune system of cancer patients in multiple ways to enhance immunotherapy efficacy."

MB097 is being tested in an international Phase 1b clinical study, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. Data readout is expected by the end of 2025.