Immunocore to present at upcoming investor conferences

On March 3, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported that management will participate in the following investor conferences in March (Press release, Immunocore, MAR 3, 2025, View Source [SID1234650829]).

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TD Cowen 45th Annual Healthcare Conference
Presentation: Tuesday, March 4, 2025, at 3:10 p.m. EST

Barclays 27th Annual Global Healthcare Conference
Fireside Chat: Tuesday, March 11, 2025, at 3:00 p.m. EST

Jefferies Biotech on the Beach Summit
1×1 and small group meetings: Wednesday, March 12, 2025

Where relevant, the presentations will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentations will be made available for a limited time.

Myosin Therapeutics Closes Second Seed Round to Advance Clinical Trials for Innovative Cancer and Neuroscience Therapies

On March 3, 2025 Myosin Therapeutics, Inc., a biotechnology company developing novel therapies for cancer and neurological disorders, reported it has closed its second seed funding round, raising over $3 million to supplement significant investment from the National Institutes of Health (Press release, Myosin Therapeutics, MAR 3, 2025, View Source [SID1234650849]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Myosin Therapeutics, Inc. (the "Company") is advancing its lead compound, MT-125, to treat glioblastoma, the most aggressive brain cancer with an average survival time of only 8 months. MT-125 targets a molecular nanomotor, blocking both tumor growth and invasion. The FDA granted orphan drug designation to MT-125 for malignant gliomas, underscoring its potential to improve outcomes for patients with this devastating disease.

The company is also progressing MT-110 for the treatment of methamphetamine use disorder (MUD), Millions worldwide suffer from MUD, yet no FDA-approved treatments currently exist. The latest funding, combined with NIH support, will allow MT-110 to enter Phase 1 clinical trials.

"This funding is pivotal as it will allow us to initiate multiple clinical trials this year, including a Phase 1b trial for MT-125 in glioblastoma patients," said Dr. Courtney Miller, co-founder and CEO of Myosin Therapeutics. "We are deeply grateful to our investors for their support as we work to bring innovative therapies to patients with cancer and substance use disorders."

The seed funding round was led by repeat investors, DeepWork Capital, Florida Opportunity Fund, and Mint12 Pharma, along with Dynagrow Capital, the private investment management affiliate of Fred Hassan. Also participating in the round were Mayo Clinic Ventures and The Sontag Innovation Fund, which is focused on accelerating solutions to change the standard of care in brain cancer. Dave Adams, co-Founder of Mint12 Pharma, stated, "Myosin Therapeutics exemplifies a well-run organization, consistently achieving key milestones to advance MT-125 and MT-110. Their dedication to innovative treatments for devastating conditions is inspiring, and we are confident in their ability to deliver meaningful solutions to patients."

IN8bio Announces Advanced Gamma-Delta (??) T cell Engager (TCE) Platform for Oncology and Autoimmune Diseases

On March 3, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies, reported INB-600, its potentially breakthrough next generation γδ T cell-based TCE platform. It is designed to address one of the biggest shortcomings of current existing γδ TCEs – insufficient numbers of γδ T cell effector cells to drive real clinical impact (Press release, In8bio, MAR 3, 2025, View Source [SID1234650830]). This groundbreaking platform leverages γδ T cells’ unique properties targeting applications in both oncology and autoimmune indications with potentially greater safety and tolerability than current CAR-T and TCE approaches.

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The platform’s first candidate, INB-619, targets CD19, a key marker broadly found on B cells, which play a central role in leukemias, lymphomas, and autoimmune diseases. In preclinical models, INB-619 demonstrated:

Rapid and sustained B-cell depletion – target cells were eradicated as γδ T cells continued expanding up to 450-fold with continued proliferation until the target cells were undetectable.
Simultaneous expansion and activation of both major γδ T cell subsets (Vδ1+ and Vδ2+) leverages both the rapid antigen presenting properties of Vδ2+ T cells and the longer-term resistance against exhaustion and tissue residence properties of Vδ1+ T cells, potentially resulting in deeper B cell depletion.
Lower cytokine (IL-6) secretion, potentially reducing the risk of dangerous side effects such as CRS and ICANs, two of the most severe side effects limiting CAR-T and traditional CD3-TCE adoption in autoimmune indications.
William Ho, Chief Executive Officer and co-founder of IN8bio, commented, "As the industry rapidly chased immunology and inflammation (I&I) indications, we saw a major unmet need for a therapy that provides deep B cell depletion, ease of delivery with no required lymphodepletion, and improved overall safety and tolerability. Most γδ TCEs have failed because they can’t engage the limited number of effector cells to eliminate their targets. Our INB-600 platform is working to change the equation by not only targeting B cells, but also by actively expanding the γδ T cell immune army needed for deep, lasting B cell depletion. By leveraging our expertise in γδ T cell biology, we have worked to develop a breakthrough technology that combines exceptional preclinical potency, while broadly expanding immune surveillance and potentially avoiding the dangerous side effects of existing approaches. We believe this platform could have significant applications across oncology as well as autoimmune diseases."

TCEs are a class of bispecific antibody therapies that work by binding both a target cell and a T cell, bringing them into close proximity so the T cell can efficiently attack and destroy its target. Traditional TCEs, such as those targeting CD3 – have demonstrated strong target killing abilities but often have severe limitations, including the potential to drive T cells to exhaustion and induce severe toxicities such as CRS and ICANs. γδ T cells naturally secrete lower levels of inflammatory cytokines such as IL-6, which suggests substantially less risk of CRS, which may translate to improved safety and tolerability in future clinical applications. Notably, to date, IN8bio has not observed any CRS or neurotoxicities in any of its on-going γδ T cell clinical programs.

IN8bio plans to evaluate INB-619 in preclinical studies and seek potential partners to support future IND-enabling trials. We remain focused on to pushing the boundaries of next generation γδ cell-based immunotherapies as it pursues its mission of Cancer Zero – a future where cancer is fully eliminated.

Webcast details
TD Cowen 45th Annual Health Care Conference
Date/Time: Monday, March 3, 2025, at 10:30 a.m. ET.
Webcast link: https://wsw.com/webcast/cowen177/inab/1991262

A live webcast and replay will also be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

Callio Therapeutics Launches with US$187 Million Series A to Advance Multi-Payload Antibody-Drug Conjugate Platform Through Clinical Proof-of-Concept

On March 3, 2025 Callio Therapeutics, a biotechnology company focused on realizing the promise of multi-payload antibody-drug conjugates (ADCs) to improve cancer therapy, reported its launch with the closing of a $187.0 million Series A financing round (Press release, Callio Therapeutics, MAR 3, 2025, View Source [SID1234650850]). This financing was led by Frazier Life Sciences with significant participation from Jeito Capital alongside other life sciences investors, including Novo Holdings A/S, Omega Funds, ClavystBio, Platanus, Norwest, Pureos Bioventures, SEEDS Capital and EDBI. The newly formed company, with headquarters in Seattle and Singapore, intends to use the proceeds from the Series A financing to achieve clinical proof-of-concept for its HER2-targeted dual-payload ADC and a second undisclosed ADC program.

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In conjunction with the financing, Callio Therapeutics has entered into an exclusive worldwide license agreement with Hummingbird Bioscience for its multi-payload ADC platform in oncology, and associated intellectual property and pipeline assets, in exchange for equity, potential milestone payments and royalties.

"We are delighted to be launching Callio Therapeutics with the support of Frazier Life Sciences and this syndicate of investors. Multi-payload ADCs have the potential to enable the targeted delivery of rational drug combinations to cancer cells, and may provide significantly enhanced efficacy," said Piers Ingram, PhD, co-founder and Chief Executive Officer of Callio Therapeutics. "This new generation of ADC therapies may meaningfully improve outcomes for patients."

Leadership Team

The founding Callio Therapeutics management team comprises individuals with extensive experience from leading biotechnology and biopharmaceutical companies including ProfoundBio, Silverback Therapeutics, SeaGen, Medarex, Hummingbird Bioscience and Genentech:

Piers Ingram, PhD, Chief Executive Officer
Jerome Boyd-Kirkup, PhD, Chief Scientific Officer
Naomi Hunder, MD, Chief Medical Officer
Angèle Maki, PhD, Chief Business Officer
"The multi-payload ADCs being developed at Callio Therapeutics have the potential to address large unmet medical needs by overcoming many of the limitations of existing ADCs," said Adam Simpson, Executive Board Chair of Callio Therapeutics and Venture Partner at Frazier Life Sciences. "With the expertise of the Callio Therapeutics team, together with access to the innovative multi-payload ADC technology, we believe that Callio Therapeutics will be the first company to show the clinical benefit of this exciting new multi-payload ADC approach and is well positioned to transform cancer therapy."

TYPE D MEETING OUTCOME WITH US FOOD AND DRUG ADMINISTRATION

On March 3, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported a regulatory update on its planned US clinical trial following its Type D meeting with the United States Food and Drug Administration (FDA) (Press release, Amplia Therapeutics, MAR 3, 2025, View Source [SID1234650784]).

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The Company has previously disclosed plans for a clinical trial in the US of its best-in-class FAK inhibitor narmafotinib, in combination with the chemotherapy regime FOLFIRINOX, in advanced pancreatic cancer patients. FOLFIRINOX, which is a mixture of four different drugs, is the preferred first-line treatment option for advanced pancreatic cancer in the US. The Company has previously reported1 that narmafotinib enhances the activity of FOLFIRINOX in preclinical models of pancreatic cancer.

A Type D meeting is an opportunity for a company to seek feedback from the FDA for specific questions regarding clinical development activities. The Company sought the FDA’s feedback regarding modifications to the clinical trial protocol previously submitted as part of the Investigational New Drug application cleared by the FDA in January 20242 . Specifically, the Company was seeking commentary regarding changes to the dose-escalation and dose-optimization phase of the study and concerning removal of a pharmacokinetic assessment of FOLFIRINOX in the trial. In the written response received by the Company, the FDA noted that the proposed changes ‘appear reasonable’ clearing the way for the Company to finalise the study protocol and initiate the final stages of trial planning prior to commencing the study.

Amplia CEO and MD Dr Chris Burns commented: "We are grateful for the thoughtful input from the FDA regarding the modifications to our clinical trial protocol. These changes will allow the Company to progress the trial in a more time-efficient and capital-efficient manner, and we are now in the final planning stages to start the trial in the coming months."

Dr Burns continued: "Positive data from this clinical study, combined with promising data from the current ACCENT trial – where narmafotinib is combined with gemcitabine and Abraxane – will position narmafotinib as the preferred drug to combine with the two main chemotherapy regimes used for the treatment of pancreatic cancer across the globe."