On August 25, 2026 AIVITA Biomedical, Inc., a biotechnology company developing personalized vaccines for the prevention of infectious disease and treatment of cancer, reported a new study published in Cell Stem Cell describing a universal, stem cell-derived dendritic cell platform that can be personalized to an individual patient’s tumor and used to train the immune system to attack cancer. The study, "Engineered Human iPSC-Derived Dendritic Cells Dressed with Tumor MHC Complexes as a Cancer Vaccine," was led by senior author Robert Blelloch, M.D., Ph.D., of UC San Francisco (UCSF), and includes AIVITA’s Krystal Godding, Gabriel I. Nistor, M.D., and Hans S. Keirstead, Ph.D. among its authors (Cell Stem Cell).

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The UCSF team engineered dendritic cells, the immune system’s primary antigen-presenting cells, from induced pluripotent stem cells (iPSCs) and used gene editing to remove the surface markers that would normally trigger immune rejection, creating an unlimited, "off-the-shelf" cell source. They then "dressed" these universal dendritic cells with the complete antigen signature carried on a patient’s own tumor cells, rather than a single synthetic target. The resulting dressed dendritic cells trained matched patient T cells to recognize and kill tumor cells from both blood cancer (leukemia) and solid tumor samples, and slowed tumor growth in an animal model.

AIVITA’s contribution was central to extending this proof-of-concept from blood cancer into solid tumors. Drawing on de-identified tumor tissue and matched naive peripheral blood mononuclear cells (PBMCs) from ovarian cancer patients enrolled in AIVITA’s own Phase 2 clinical trial (ClinicalTrials.gov NCT00331526), AIVITA’s team grew and supplied the patient-specific tumor cells that gave UCSF’s dressed dendritic cells their antigen target and collaborated with the UCSF team throughout the studies that followed. T cells trained by dendritic cells dressed with this AIVITA-supplied material showed a marked increase in T-cell stimulation and killing of matched ovarian tumor cells, extending validation of the platform beyond blood cancer into solid tumors, the category at the center of AIVITA’s own therapeutic pipeline.

"This study is an important external validation of a scientific thesis AIVITA has pursued since our founding: that a patient’s own tumor holds the most complete and personalized map of the antigens the immune system needs to see," said AIVITA CEO Dr. Hans S. Keirstead. "The UCSF team has built an elegant, scalable way to put that map onto an unlimited supply of lab-grown dendritic cells."

"Our pan-antigenic platform and UCSF’s dressing approach solve the same problem from two different angles: an unlimited, personalized supply of a patient’s true antigen repertoire," said Gabriel I. Nistor, M.D., chief science officer at AIVITA. "We supplied the complete antigen signature of a real tumor rather than a single synthetic peptide, which is why the T-cell response was so strong."

The study was supported by the National Institutes of Health (U01CA244452), the California Institute for Regenerative Medicine (DISC0-13806, EDUC4-12812), a NIH Cancer Moonshot Award, a Sandler Program for Breakthrough Biomedical Research New Frontiers Award, and the Benioff Initiative for Prostate Cancer Research (UCSF News).

(Press release, AIVITA Biomedical, AUG 25, 2026, View Source [SID1234670344])

On August 25, 2026 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, reported that it has agreed to sell 12,945,916 ordinary shares at $8.69 per share and, in lieu of ordinary shares to certain investors, pre-funded warrants to purchase 4,315,304 ordinary shares at a purchase price of $8.689 per pre-funded warrant, which represents the per share offering price less the $0.001 per share exercise price for each pre-funded warrant, in an underwritten offering. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be $150 million. The offering is expected to close on August 26, 2026, subject to customary closing conditions. In addition, Immatics has granted the underwriters a 30-day option to purchase up to 2,589,184 additional shares at the public offering price, less the underwriting discount.

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Jefferies, Leerink Partners and Cantor are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on April 3, 2025. The offering is being made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from:

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, telephone: (877) 821-7388, email: [email protected];
Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: [email protected];
Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, email: [email protected].
This press release shall not constitute an offer to sell or a 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

(Press release, Immatics, AUG 25, 2026, View Source [SID1234670336])

On August 25, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on developing novel fusion immunotherapeutics to treat autoimmune diseases, cancer, and senescence-associated dysplasia, together with collaborators at leading research institutions, reported to have identified a TGF-β trap and IL-15 fusion as a novel moiety with potential applications against diseased cells and viral infections. Human studies showed that the TGF-β trap and IL-15 fusion promoted expansion of progenitor CD8+ T cells and Natural Killer ("NK") cells, provided clinical benefit, and was well tolerated in cancer patients. In addition, the fusion demonstrated activity against HIV-1 and bronchopulmonary dysplasia in highly stringent, relevant animal models. Several publications in leading scientific journals include extensive human and animal study data regarding the TGF-β trap and IL-15 fusion (see References below).

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The Company has incorporated these ground-breaking discoveries into its second-generation T Cell Engager ("TCE") and Immune Checkpoint Inhibitor ("ICI") programs, created with its TRBC drug development platform, to strengthen anti-tumor activity and help address the effects of senescent cell accumulation. Its lead product candidate in the TCE Program, HCW11-018b, combines a TGF-β trap and IL-15 fusion with a tissue-factor-targeting BiTE (Bispecific T-cell Engager). This design provides IL-15-driven immune stimulation while using the TGF-β trap to counter immunosuppression and poor T-cell infiltration in solid tumors. HCW11-040, lead candidate of the Company’s second-generation ICI program, is a unique combination of pembrolizumab, a generic form of Keytruda, and the added-on TGF-β/IL-15 moiety, which has demonstrated superior immune-cell activation, expansion, tumor infiltration, and cytotoxicity against cancer cells and tumors compared with pembrolizumab in in-vitro and in-vivo preclinical studies. Both molecules are at IND-enabling stage, and the Company plans to initiate clinical studies in 2027.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, "HCW Biologics is the leader in creation of multi-valent immunotherapeutics with a unique protein-based scaffold, without the antibody Fc domain. By leveraging our ground-breaking discovery of the novel properties of the TGF-β/IL-15 fusion moiety and incorporating it into our second-generation fusion molecules, we have demonstrated enhanced therapeutic activity over traditional immune checkpoint inhibitor- and BiTE-based approaches. We believe our novel multi-valent immunotherapeutics could revolutionize the immunotherapy field, especially against cancers and senescence-associated dysplasia."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. and the company is not affiliated with HCWB.

(Press release, HCW Biologics, AUG 25, 2026, View Source [SID1234670335])

On August 25, 2026 Beyond Air, Inc. (NASDAQ: XAIR) reported that they have entered into a definitive agreement under which UNIVO Pharmaceutical Industries Ltd ("UNIVO") Univo Pharmaceutical Industries Ltd. ("UNIVO"), a public company whose shares are listed for trading on the Tel Aviv Stock Exchange (TASE:UNVO), will acquire control over the outstanding shares of NeuroNOS Israel Ltd. ("NeuroNOS"), a biopharmaceutical company focused on developing treatments for neurological disorders and neuro-oncology. The transaction is intended to provide NeuroNOS with dedicated resources, funding and strategic focus to advance its pipeline candidates targeting complex neurological disorders, including Autism Spectrum Disorder (ASD), brain cancers including Glioblastoma (GBM), and Alzheimer’s disease.

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Currently, Beyond Air, through its wholly owned Irish subsidiary, NeuroNOS Limited, holds 5,000,000 ordinary shares of NeuroNOS, representing approximately 58% of NeuroNOS’s issued share capital on a fully diluted basis. Upon closing, UNIVO will purchase NeuroNOS Limited’s entire stake in NeuroNOS pursuant to a share purchase agreement among Beyond Air, NeuroNOS Limited and UNIVO. In exchange, Beyond Air will receive UNIVO ordinary shares representing 19.99% of UNIVO’s issued and outstanding share capital, together with warrants to purchase additional UNIVO ordinary shares representing 19.99% of UNIVO’s total outstanding options, warrants and other awards, exercisable at $0.01 per share for five years following closing.

Separately, under an intellectual property transfer agreement between Beyond Air and NeuroNOS Beyond Air will transfer to NeuroNOS certain intellectual property rights and other assets relating to NeuroNOS’s development programs, in consideration for development and commercial milestone payments up to $6.5 million in cash development milestone payments tied to the clinical advancement, regulatory approval and commercialization of a therapeutic product based on NeuroNOS intellectual property. Beyond Air will also be eligible to receive up to $26.0 million in additional commercial milestone payments upon achievement of specified net sales thresholds.

"This transaction marks an important next chapter for NeuroNOS and reflects our confidence in the science and the potential of its pipeline. By combining NeuroNOS with UNIVO, we are creating a more focused path to advance the company’s programs with dedicated resources, while allowing Beyond Air to remain focused on the continued growth and execution of our core LungFit business. We are proud of what has been built at NeuroNOS and look forward to remaining aligned with its progress as a UNIVO shareholder and long-term partner," said Robert Goodman, Chief Executive Officer of Beyond Air.

The transaction is expected to close following satisfaction of the conditions set forth in the definitive agreement, including applicable board and shareholder approvals, regulatory and stock exchange approvals, completion of the contemplated investment and other customary closing conditions.

(Press release, Beyond Air, AUG 25, 2026, View Source [SID1234670334])

On August 25, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the publication of pharmacokinetic and pharmacodynamic (PK/PD) data from a sub-study of its ongoing Phase III TIGeR-PaC clinical trial (NCT03257033) in the journal Cancer Chemotherapy and Pharmacology.

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The data shows that TAMP (Trans-Arterial Micro-Perfusion)-mediated delivery concentrated chemotherapy at the tumor site, extracting roughly 51% of the drug locally before it entered the bloodstream, meaningfully lowering systemic exposure in a way that could reduce systemic side effects. In addition, a statistically significant correlation between the drug’s local metabolism and a drop in the CA 19-9 tumor marker provided an early indication of improved drug penetration into the tumor area and potential tumor response with intra-arterial delivery.

RenovoRx also recently announced the closing of enrollment of the TIGeR-PaC trial, with trial completion expected in the first half of 2027 and expected initial top line data availability in the second half of 2027.

"The findings from this PK/PD study provide additional meaningful mechanistic support for our TAMP platform’s targeted drug-delivery approach," said Ramtin Agah, M.D., Executive Chairman, Chief Medical Officer, and Founder of RenovoRx. "The results provide direct pharmacokinetic evidence supporting TAMP’s potential to deliver chemotherapy more selectively to the tumor while limiting systemic exposure. These findings strengthen TAMP, enabled by our RenovoCath device, as a differentiated approach to improving the therapeutic index of chemotherapy in patients with LAPC."

The PK/PD study, titled "Pharmacokinetic and Pharmacodynamic Sub-study of Trans-arterial vs Intravenous Gemcitabine in the TIGeR-PaC Phase 3 Clinical Trial," compared the systemic drug levels of intra-arterial gemcitabine (IAG) delivered via TAMP using RenovoCath against standard intravenous gemcitabine (IVG) delivered systemically in 16 patients with LAPC across six clinical sites (11 patients received IAG; 5 received IVG). Funding for this study was provided by RenovoRx.

Key Findings:

Reduced systemic exposure: IAG resulted in significantly lower total systemic gemcitabine exposure compared to IVG, despite being administered at a 50% higher infusion concentration rate, supporting the potential of TAMP to concentrate therapy at the intended treatment site while limiting systemic exposure.
Substantial local drug extraction: A targeted extraction ratio of 0.511 was observed (derived from a bioavailability estimate of 0.489), indicating approximately 51% of the intra-arterially delivered gemcitabine was extracted at the site of intra-arterial delivery before entering systemic circulation. This finding provides direct pharmacokinetic evidence supporting the targeted drug-delivery mechanism underlying the TAMP platform.
Tumor marker response: A statistically significant correlation was observed between higher systemic levels of dFdU and greater reductions in CA 19-9 tumor marker levels following IAG treatment (Pearson’s r = -0.75; P = 0.034; based on eight evaluable patients, with three excluded for normal baseline CA 19-9). dFdU is gemcitabine’s inactive metabolite, and higher dFdU levels are consistent with rapid local uptake and metabolism of gemcitabine at the treatment site, providing an initial pharmacodynamic signal linking drug exposure with a biomarker of tumor response.
Consistent delivery across arterial sites: No statistically significant differences in gemcitabine or dFdU pharmacokinetic parameters were observed based on IAG delivery site, whether administered via the superior mesenteric artery or the celiac artery.

The Company believes this data provides evidence that IAG delivery via the TAMP therapy platform achieves meaningful local drug extraction while reducing systemic gemcitabine exposure, supporting RenovoRx’s differentiated approach to targeted intra-arterial chemotherapy in patients with LAPC.

Publication Details
Title: Pharmacokinetic and Pharmacodynamic Sub-study of Trans-arterial vs Intravenous Gemcitabine in the TIGeR-PaC Phase 3 Clinical Trial
Journal: Cancer Chemotherapy and Pharmacology
DOI: 10.1007/s00280-026-04939-0

(Press release, Renovorx, AUG 25, 2026, View Source [SID1234670333])