On January 7, 2025 Interius BioTherapeutics, a clinical-stage company engineering targeted, programmable vectors for the precision delivery of genetic medicines, reported that the German regulatory agency, the Paul Ehrlich Institute (PEI), has approved expansion of the INVISE first-in-human Phase 1 clinical trial evaluating INT2104 for the treatment of B-cell malignancies to Europe (Press release, Interius BioTherapeutics, JAN 7, 2025, View Source [SID1234649468]). INVISE is the first clinical trial to announce clearance to evaluate in vivo CAR gene therapy in Europe. INT2104 is a first-in-class gene therapy that delivers a CAR transgene to generate effector CAR-T and CAR-NK cells in vivo for the targeting of CD20-positive B cells.

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"We are thrilled to have received approval from PEI regulators to expand our INVISE clinical study into the EU," said Interius President and CEO, Phil Johnson, M.D. "The PEI has a rich history in supporting the advancement of novel medicines, including foundational research for in vivo CAR T therapy, and this approval highlights the strength of our preclinical data and the breakthrough potential of INT2104 to broaden access to CAR therapies. We are also thankful for our Australian clinical sites that have paved the way for our continued expansion, having recently dosed our first study participant there in October. We remain committed to transforming the current treatment paradigm through clinical evaluation of our novel products, and the PEI’s approval marks a significant step."

Dr. Marion Subklewe, M.D., Ph.D., full professor and consultant in the Department of Hematology of the LMU University Hospital, head of the Cellular Immunotherapy program and head of the Laboratory for Translational Cancer Immunotherapy at the Ludwig-Maximillian University in Munich, and INVISE Principal Investigator, added, "I am honored to collaborate with the Interius team to bring their innovative in vivo CAR gene therapy to patients in Germany and other European countries. Cancer is an incredibly complex disease that demands bold and creative solutions. Interius’ groundbreaking approach has the potential to simplify treatment, provide faster and more accessible care, and significantly improve patient outcomes while transforming the treatment journey by reducing delays and eliminating complicated procedures."

About INVISE
INVISE (INjectable Vectors for In Situ Engineering) is a first-in-human Phase 1 clinical trial evaluating the safety of INT2104 intravenous infusion in adults with refractory/relapsing B cell malignancies. The study is a global, two-part, multicenter, open-label, single dose design with a dose escalation portion designed to inform the dose of INT2104 to be used in the dose confirmation part of the trial and future studies. INVISE has been granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) and Paul Ehrlich Institute (PEI) regulatory clearance in Germany. Additional information and enrollment criteria may be found on clinicaltrials.gov (NCT06539338).

About INT2104
INT2104 is a wholly-owned investigational gene therapy candidate, which specifically targets CD7-positive T and NK cells and delivers a CAR transgene to create effector CAR-T and CAR-NK cells in vivo. The CAR cells target CD20-positive B cells for the treatment of B cell malignancies. Unlike ex vivo CAR-T therapies, INT2104 is an off-the-shelf, single dose treatment, administered systemically through intravenous infusion without the need for lymphodepletion or for any special equipment or training.

On January 7, 2025 Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company, reported that John S. Yu, M.D., Chief Executive Officer, and Neil Bhowmick, Chief Scientific Officer, will present a corporate overview at the Lytham Partners Investor Healthcare Summit (Press release, Kairos Pharma, JAN 7, 2025, View Source [SID1234649488]). The conference is being held virtually on January 13, 2025.

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Event:

Lytham Partners Investor Healthcare Summit

Presentation Date:

Monday, January 13, 2025

Time:

2:00 PM ET

Webcast Link:

View Sourcekapa" target="_blank" title="View Sourcekapa" rel="nofollow">View Source

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners or register for the event at View Source

The webcast will also be available for replay following the event.

On January 7, 2025 Alivexis, Inc. (Headquartered in Minato-ku, Tokyo; CEO S. Roy Kimura, "Alivexis") a preclinical-stage computation-driven drug discovery firm, reported the first closing of its Series D round in the amount of 800M JPY (approximately $5.1M USD) (Press release, Alivexis, JAN 7, 2025, View Source [SID1234649452]). Investors participating in the first closing include funds managed by JIC Venture Growth Investments Co., Ltd., DBJ Capital Co., Ltd., and Fast Track Initiative, Inc. Alivexis has raised a total of 6.66B JPY (approximately $42.3M USD) to date.

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Alivexis will use the proceeds to further research and development programs utilizing its cutting-edge computational science-based drug discovery platform "ModBindTM", in addition to accelerating over 10 in-house R&D programs. Alivexis will expand key business strategies in early out-licensing and drug discovery collaboration, with the aim of further increasing its corporate value.

Comment from S. Roy Kimura, Ph.D., Co-founder and CEO:
"We are excited to announce the first closing of our latest funding round led by the JIC Venture Growth Investments Co., Ltd. with follow-on investments from existing shareholders. Since our last fund-raise, we have successfully licensed our cathepsin C inhibitor program and are currently working together with our partner toward IND submission. We also published a scientific article on the first version of our ModBindTM simulation platform, based on a unique theoretical approach that enables accurate absolute ligand efficacy predictions at ~2000x speeds relative to existing methods. In the next several months, we expect to sign additional licensing partnerships from our portfolio of immunology and oncology R&D programs, as well as additional ModBindTM-related alliances and collaborations. We look forward to continuing our mission with our shareholders and partners to accelerate discovery of new medicines for patients and their families in need."

Comment from Hanae Suzuki, JIC Venture Growth Investments Co., Ltd.:
"We are thrilled to announce our recent investment in Alivexis and are honored to collaborate with their exceptional team, renowned for its extensive expertise in the pharmaceutical a industries and its globally integrated operations. In this era of rapid innovation in AI and semiconductor technologies, we recognize the significant potential of Alivexis’s cutting-edge computational chemistry-based simulation platform.
Our firm is deeply committed to supporting Alivexis in driving its continued growth and innovation. We are confident that this investment will not only accelerate the development of groundbreaking medicines for patients and their families but also play a pivotal role in advancing Japan’s drug discovery ecosystem"

On January 7, 2025 Nerviano Medical Sciences S.r.l. (NMS), a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported that it has entered into a clinical trial supply agreement with Roche for provision of atezolizumab (Tecentriq)1 to be combined with the Monopolar Spindle 1 (MPS1) inhibitor NMS-153, and cGAS/STING pathway activator, for the treatment of hepatocellular cancer patients (Press release, Nerviano Medical Sciences, JAN 7, 2025, View Source [SID1234649469]).

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The new study, recently approved by health authorities, is a: "Phase II Combination Study of NMS-01940153E and Atezolizumab with or without a prior priming with low dose decitabine for the Treatment of Adult Patients with Unresectable Hepatocellular Carcinoma (HCC) Previously Treated with Immune Checkpoint Inhibitors" (EUCT Number: 2024-516737-12-00).

The trial is a Phase IIa, open-label, non-randomized, 2-part multicenter study to explore the safety, tolerability, and antitumor activity of NMS-153 administered with atezolizumab to adult patients with unresectable HCC previously treated with an approved immune checkpoint inhibitor and that have experienced clinical benefit to this treatment.

NMS has recently completed the monotherapy "Phase I/II Study on Safety and Efficacy of NMS-01940153E in Adult Patients with Unresectable Hepatocellular Carcinoma (HCC) Previously Treated with Systemic Therapy" (NCT05630937), identifying early signs of clinical activity, with an adequate safety profile.

"MPS1 inhibition has been shown to be a potent upstream re-activator of the cGAS/STING pathway in multiple cancer types, including hepatocellular carcinoma. Coupling this with decitabine to reverse tumor cell epigenetic silencing of STING, along PD-L1 blockade, is an exciting novel strategy to attempt to restore immunogenicity in treatment-refractory disease", David A. Barbie, MD, Director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, Associate Professor of Medicine at Harvard Medical School, and NMS Scientific Advisory Board member commented.

"Our goal is to bring valid therapeutic options to liver cancer patients", said Hugues Dolgos, Pharm.D., Chief Executive Officer, NMS: "The combination of atezolizumab, a drug already approved for use in hepatocellular cancer, together with NMS-153, has strong potential since each has shown clinical activity in HCC2,3, bringing hope to improve outcomes for these patients. We sincerely thank Roche for their collaboration on the trial and for providing atezolizumab".

"Unmet medical need in hepatocellular cancer remains high and this novel combination with the MPS1 mechanism offers hope. NMS is committed to development of new therapies for cancer patients." according to Lisa Mahnke, MD, PhD, Chief Medical Officer, NMS.

On January 7, 2025 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer and infectious diseases, reported an agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to supply etakafusp alfa (formerly known as AB248), Asher Bio’s investigational CD8+ T cell targeted interleukin-2 (IL-2) immunotherapy, to be evaluated in combination with rilvegostomig, AstraZeneca’s investigational PD-1/TIGIT immuno-oncology bispecific antibody, in patients with advanced or metastatic NSCLC (Press release, Asher Biotherapeutics, JAN 7, 2025, View Source [SID1234649489]).

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"This exciting agreement with AstraZeneca is a reflection of the emerging clinical data from our Phase 1 study of etakafusp alfa. Initial data demonstrate a highly differentiated clinical pharmacodynamic profile with unprecedented levels of selective CD8+ T cell activation as well as initial evidence of anti-tumor effect including confirmed objective responses," said Don O’Sullivan, Ph.D., Chief Business Officer of Asher Bio. "We look forward to collaborating with AstraZeneca to expand the potential impact of our lead cis-targeted immunotherapy in patients worldwide."

As part of this agreement, AstraZeneca will sponsor and operationalize a global study to evaluate the safety and early efficacy of etakafusp alfa as a first-line treatment in combination with rilvegostomig in patients with advanced or metastatic NSCLC. Asher Bio will retain full ownership of etakafusp alfa and will supply AstraZeneca with etakafusp alfa at no cost.

About NSCLC

NSCLC is the most common type of lung cancer, accounting for 80-85% of the ~235,000 new cases in the US this year1. NSCLC originates in cells that line the airways and can invade surrounding tissues or metastasize to other parts of the body. The condition is often diagnosed at an advanced stage when it is harder to treat and is associated with a poor prognosis. Treatment options for NSCLC are tailored to the stage, subtype, and biomarker status of the disease, and may include surgery, radiation, chemotherapy, targeted therapies, immunotherapy, or a combination of these. Lung cancer has a 5-year relative survival rate of only 26.7% 2, representing a significant unmet need for additional treatment options for people living with advanced or metastatic NSCLC.

About Etakafusp Alfa (AB248)

Etakafusp alfa (AB248) is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. It was specifically engineered to selectively and potently activate CD8+ T-cells, while avoiding natural killer (NK) cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T (Treg) cells, which are immunosuppressive. Asher Bio is currently evaluating etakafusp alfa in a Phase 1a/1b clinical trial, AB248-101. The trial consists of a dose escalation and expansion phase to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of etakafusp alfa alone and in combination with pembrolizumab in subjects with locally advanced/metastatic solid tumors who failed prior therapies. Initial pharmacokinetic and pharmacodynamic data from the ongoing Phase 1a/1b clinical trial support etakafusp alfa’s proof of mechanism and activity with a highly differentiated clinical profile. Early data shows potent and selective CD8+ T cell activation without substantial changes to Treg and NK cell numbers and initial evidence of anti-tumor activity, including confirmed objective responses, with a generally well-tolerated safety profile. Please refer to www.clinicaltrials.gov (NCT05653882) for additional details related to this Phase 1a/1b clinical trial.