On October 7, 2025 Kernal Biologics, Inc., a venture-backed TechBio company pioneering novel therapeutics to program human cells directly inside the body, reported that it has been awarded up to $48 million in funding by the Advanced Research Projects Agency for Health (ARPA-H) (Press release, Kernal Biologics, OCT 7, 2025, View Source [SID1234656500]). This project is to be funded by ARPA-H’s EMBODY program, which focuses on the engineering of immune cells inside the body. EMBODY is led by ARPA-H Program Manager Daria Fedyukina, Ph.D.

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The funds will be used to support the clinical development of Kernal Bio’s in vivo mRNA-encoded CAR T-cell program, KR-402, which targets multiple sclerosis and B-cell malignancies, including acute lymphoblastic leukemia, large B-cell lymphoma and chronic lymphocytic leukemia. As part of this project, Kernal Bio will collaborate with sub-awardees – Stanford University School of Medicine, Dana-Farber Cancer Institute, and The Jackson Laboratory – to engineer targeted, mRNA-encoded CARs, as well as develop novel manufacturing strategies and preclinical models for testing these therapies.

"We’re honored to join the elite cohort of ARPA-H awardees," said Yusuf Erkul, M.D., MBA., cofounder and chief executive officer of Kernal Bio. "Current CAR-T therapies heralded a true revolution in cancer treatment. Yet, they have their limitations, including a three-week vein-to-vein turnaround time, tumor resistance leading to relapse, and side effects such as cytokine release syndrome or secondary T-cell malignancies. At Kernal Bio, we believe that we have the tools to evolve the CAR-T modality towards in vivo therapies."

KR-402 is a next-generation CAR-T therapy program developed using Kernal Bio’s mRNA 2.0 platform. This platform achieves exceptional precision using a unique two-pronged strategy. First, it uses a highly selective mRNA that only translates in specific cells — intelligently designed by analyzing thousands of multi-omics datapoints across various cell types. Second, this RNA is delivered by a targeted lipid nanoparticle (LNP) delivery vehicle decorated with antibodies that allow it to home in directly on target T cells.

By reprogramming T cells inside the body with this approach, KR-402 is positioned to be a differentiated in vivo CAR-T therapy that minimizes the risk of genomic integration, while offering tremendous cost efficiencies over traditional ex vivo therapies. Furthermore, the in vivo CAR-T approach may also improve patients’ treatment journey by eliminating the need for additional toxic procedures, such as lymphodepletion agents.

"Manufacturing ex vivo CAR-T therapies is a complex and expensive process. However, with our proprietary platform, there is a potential of reducing the cost of manufacturing in vivo CAR T-cell therapies by as much as 100-fold," commented Burak Yilmaz, president of Kernal Bio. "In addition, chemotherapy drugs used for lymphodepletion prior to CAR-T therapies carry significant toxicity, making these therapies viable for just a small group of patients. We believe that with our technology and the support of our partners and ARPA-H, we can greatly transform access to this category of therapies."

On October 7, 2025 Kincell Bio, a leading US cell therapy CDMO, reported a partnership with Moonlight Bio, Inc., a Seattle-based biotech company pioneering advanced T cell therapies for solid tumors (Press release, Moonlight Bio, OCT 7, 2025, View Source [SID1234656499]). In this partnership, Kincell provides CMC development and GMP manufacturing services to advance Moonlight’s lead T cell therapy program into clinic trials.

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Under the agreement, Kincell is providing process and analytical transfer and GMP manufacturing services to support the scale-up and clinical supply of Moonlight’s lead T cell therapy product. The collaboration between Moonlight and Kincell is designed to accelerate clinical supply and meet the needs of patients, advancing Kincell’s mission to support innovators in the rapidly growing cell therapy sector.

"At Moonlight, we are dedicated to delivering T cell therapies that address barriers obstructing successful outcomes in solid tumors – the vast majority of the global cancer disease burden," said Jordan Jarjour, PhD, Moonlight’s CSO. "We are very excited to collaborate with Kincell to advance our lead program into the clinic."

"I am excited to partner with the team at Moonlight as they develop an innovative cell therapy that has the potential to make a significant impact on patient disease burden. Kincell has a strong and agile team that thrives on finding technical solutions to deliver for our clients and their patients," said Bruce Thompson, PhD.

"We are thrilled to partner with Moonlight, a technology leading cell therapy innovator," said Mark Bamforth. "Kincell excels at finding solutions for CMC development and clinical supply for product innovators, and we are demonstrating these capabilities for Moonlight’s clinical trial."

Kincell provides industry-leading process and analytical development, and early clinical and late-stage clinical and commercial cGMP manufacturing capabilities that are serving the needs of biotech and pharmaceutical companies and is committed to advancing the field of cell therapy with tailored solutions that empower innovators to bring their therapies to market efficiently and effectively.

On October 7, 2025 Eradivir Inc., a clinical-stage biotechnology company that harnesses the power of the immune system to target and treat disease, reported the recent closing of a $10 million private financing round (Press release, Eradivir, OCT 7, 2025, View Source [SID1234656498]). The investment will support continued clinical development of the company’s lead antiviral therapeutic for influenza, EV25, and advancement of a second molecule, EV148, for the treatment of respiratory syncytial virus (RSV).

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A significant amount of the $10 million raised came from previous investors, reflecting their continued confidence in Eradivir’s platform and vision.

"The funding marks a pivotal moment for Eradivir as we prepare to share EV25 Phase 2a results and underscores the confidence investors have in our ability to build out our toolkit of small molecule immunotherapies," said Martin Low, Chief Executive Officer of Eradivir. "We’ve minimized dilution by raising our first $30 million in milestone-based tranches. This disciplined financing strategy has preserved shareholder value while driving meaningful progress in our lead programs."

The funds have been used to complete the EV25 Phase 2a influenza challenge study and will also support IND-enabling studies of Eradivir’s RSV development candidate, EV148. The results from the EV25 Phase 2a challenge study will be publicly released in the coming weeks.

EV25 and EV148 were built on Eradivir’s BAiT (Bispecific Antigenic immuno-Therapy) platform that combines the simplicity of small molecules with the efficacy of antibodies. The simplicity of the platform’s technology provides the opportunity to address multiple diseases, including additional viruses and cancer, by switching the targeting ligand to another that binds specifically to a pathological cell.

On October 7, 2025 Adicet Bio, Inc. ("Adicet") (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported the pricing of an underwritten registered direct offering of 70,001,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 10,000,000 shares of common stock (Press release, Adicet Bio, OCT 7, 2025, View Source [SID1234656497]). The shares of common stock are being sold at a price of $1.00 per share, and the pre-funded warrants are being sold at a price of $0.9999 per pre-funded warrant, which represents the per share price of the common stock less the $0.0001 per share exercise price for each pre-funded warrant. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $80.0 million. All of the securities in the offering are to be sold by Adicet. The offering is expected to close on or about October 8, 2025, subject to customary closing conditions.

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Jefferies and Guggenheim Securities are acting as joint book-running managers for the offering. Truist Securities is also acting as a joint bookrunner. Wedbush PacGrow and H.C. Wainwright & Co. are acting as lead managers for the offering.

The securities described above are being offered by Adicet pursuant to a shelf registration statement on Form S-3 (File No. 333-285609) that was previously filed with, and subsequently declared effective on March 14, 2025 by, the U.S. Securities and Exchange Commission ("SEC"). A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offered securities may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 7, 2025 Precision NeuroMed (PNM), a clinical-stage biotechnology company pioneering advanced drug delivery technologies for central nervous system (CNS) diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational therapy for glioblastoma (GBM) (Press release, Precision NeuroMed, OCT 7, 2025, View Source [SID1234656496]).

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PNM is reintroducing cintredekin besudotox (IL13-PE38QQR), a potent cytotoxic protein designed to target and kill cells that express the IL-13 alpha-2 receptor (IL13aR), uniquely present on tumor cells such as glioblastoma. The protein’s selective expression allows it to precisely attack cancer cells while minimizing damage to normal brain tissue.

Despite advancements in understanding the genetics of glioblastoma and identifying novel drug targets, the blood–brain barrier (BBB) remains a significant obstacle, severely limiting the effectiveness of many potential therapies delivered through the bloodstream. PNM’s platform uses convection-enhanced delivery (CED) to bypass the BBB and enable direct, targeted administration of nanoparticles, including proteins, liposomes, and gene therapy at therapeutic concentrations to the brain.

"Receiving Orphan Drug Designation is an important milestone for Precision NeuroMed as we advance our mission to transform treatment for patients with glioblastoma, one of the most aggressive and devastating brain cancers," said Sandeep Kunwar, MD, CEO and Co-Founder, Precision NeuroMed. "By combining innovative drugs with our next-generation delivery system, we hope to dramatically improve outcomes where few effective options currently exist."

Each year, more than 12,000 individuals in the United States are expected to succumb to glioblastoma. The five-year survival rate for patients is just 5%, with an average life expectancy of 12 to 18 months following diagnosis. Standard treatment consists of maximal tumor resection followed by radiation therapy with temozolomide with no major innovations since the approval of temozolomide for glioblastoma in 2005.

PNM is developing a personalized approach that targets both molecular and regional aspects of tumor cells within the brain. By improving drug delivery at the site of disease, PNM aims to extend survival and enhance quality of life for patients with glioblastoma in a meaningful way.

Orphan Drug Designation from the U.S. Food and Drug Administration is reserved for therapies intended to treat, diagnose, or prevent rare diseases affecting fewer than 200,000 people in the United States. This designation provides development benefits — such as tax credits for eligible clinical research and exemption from applicable FDA user fees — and, upon approval for the designated indication, confers seven years of market exclusivity.