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.

On October 7, 2025 Cyteph Pty Ltd, a biotechnology company developing novel immunotherapies for difficult-to-treat cancers, reported that it has successfully completed recruitment for its first-in-human Phase I clinical trial of CYT-101 (Press release, Cyteph, OCT 7, 2025, View Source [SID1234656495]).

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CYT-101 is a novel off-the-shelf, HLA-matched CMV-specific T cell therapy for the treatment of glioblastoma multiforme (GBM) and other solid cancers. GBM is an aggressive brain cancer and one of the deadliest solid cancers in adults, with limited treatment options available.

The unique advantage of targeting CMV antigens on GBM cells is that they are detected on tumour cells while not found in surrounding healthy tissue. This characteristic allows for a highly targeted approach. By harnessing the power of allogeneic CMV-specific T cell therapy, CYT-101 has the potential to offer improved outcomes for GBM patients.

The Phase I study is being conducted in collaboration with Briz Brain & Spine and Newro Foundation and is evaluating the safety, tolerability, and preliminary signals of efficacy of CYT-101 in patients with recurrent GBM.

"We are pleased to have completed enrolment, reflecting the strong demand from clinical collaborators and patients for innovative treatment options for GBM," said Professor Rajiv Khanna, Chief Scientific Officer and Founder of Cyteph. "This milestone marks an important step forward in our mission to bring transformative therapies to patients with few existing options."

The Phase I trial follows participants through dose-escalation cohorts, with key readouts expected at the end of Q4 2025.

Results from this study will inform the design of subsequent clinical trials and support the continued development of CYT-101 as a novel treatment approach for glioblastoma and other high-unmet-need solid cancers.

"Completing recruitment is a critical milestone for any clinical program, and it underscores the dedication of our team, and the patients who make this research possible," said Professor David Walker, neurosurgeon and spinal surgeon at Briz Brain & Spine and lead clinical investigator for the CYT-101 clinical trial.

The CYT-101 Phase I clinical trial is funded through Australia’s national biotech incubator CUREator.

Cyteph is a spin-out biotechnology company from QIMR Berghofer, a leading medical research institute based in Brisbane, Australia.

On October 7, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the results of CT071 (an autologous CAR T-cell product targeting GPRC5D) for the treatment of relapsed/refractory multiple myeloma (R/R MM) in an investigator-initiated trial (NCT05838131) have been published in The Lancet Haematology (Press release, Carsgen Therapeutics, OCT 7, 2025, View Source [SID1234656494]). The article was titled "GPRC5D-targeted CAR T-cell therapy (CT071) in patients with relapsed or refractory multiple myeloma: a first-in-human, single-centre, single-arm, phase 1 trial".

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This trial aimed to assess the safety, preliminary activity of CT071 in R/R MM. 20 patients received CT071 infusion. Patients had received a median of 5 prior lines of therapy (IQR 3.0-6.5); 19 (95%) were double-class refractory, 13 (65%) were triple-class refractory, 5 (25%) were penta-drug refractory, 10 (50%) had received autologous stem cell transplantation (ASCT), and 5 (25%) had relapsed after CAR T-cell therapies targeting BCMA or BCMA/CD19. Four (20%) patients had extramedullary disease (EMD), 14 (70%) had ≥1 high-risk cytogenetics and 19 (95%) had a Revised International Staging System (R-ISS) 2 or 3 disease at baseline.

No dose-limiting toxicities (DLTs) were observed. The recommended phase 2 dose was determined at 0.1×106 CAR T cells/kg. Cytokine release syndrome occurred in 12 patients (60%), all graded as 1 or 2. No Grade ≥3 cytokine release syndrome (CRS) occurred. One patient (5%) experienced Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS). No treatment-related deaths occurred.

With a median follow-up of 10.71 months (IQR 6.13-12.02), the objective response rate (ORR) was 100% (95%CI, 83.2-100). 10 (50%) patients achieved stringent complete response (sCR), 4 (20%) had very good partial response (VGPR) and 6 (30%) had partial response (PR). One patient with a large EMD (125 mm×99 mm at baseline) achieved a 67.6% reduction at month 10 with ongoing PR. All 5 patients previously treated with an anti-BCMA CAR T (n=1) or anti-BCMA/CD19 CAR T (n=4) responded; 2 achieved PR, 1 achieved VGPR and 2 achieved sCR. 18 of 20 (90%) evaluable patients achieved MRD negativity at 10−6 including all 10 with CR or sCR. Median time to MRD negativity was 29 days (IQR 29-29). Median duration of response (DoR), progression-free survival (PFS) and overall survival (OS) were not reached. The data cutoff for all analyses was December 9, 2024.

About CT071
CT071 is a CAR T-cell therapy candidate developed utilizing the proprietary CARcelerate platform targeting GPRC5D for the treatment of relapsed/refractory multiple myeloma (R/R MM) or plasma cell leukemia (PCL). Initiated trials include an investigator-initiated trial for R/R MM or PCL in China (NCT05838131), and an investigator-initiated trial for newly diagnosed multiple myeloma (NDMM) in China (NCT06407947).

On October 7, 2025 Blue Earth Therapeutics reported new modelling results demonstrating that front-loaded dosing of its radiohybrid lutetium labelled, PSMA targeted, investigational radioligand therapy Lutetium (177Lu) rhPSMA-10.1 Injection may increase cumulative tumour absorbed radiation dose without a proportional increase in normal organ exposure or total administered radioactivity (Press release, Blue Earth Therapeutics, OCT 7, 2025, View Source [SID1234656493]). These findings are being presented at the European Association of Nuclear Medicine (EANM) Annual Meeting (poster EPS-187) and have been used to shape the design of the Phase 2 portion of the Phase 1/2 clinical trial (NCT05413850). The model was built from patient data from the Phase 1 portion of the trial.

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In the Phase 1 study, tumor absorbed radiation doses in cycles 2 and 3 declined by 37% and 56% respectively from cycle 11. In contrast, healthy organ-absorbed doses remain broadly the same across cycles. In the model, maximum cumulative administered radioactivity was defined by the current limit of 23 Gy absorbed dose to kidneys. With the Phase 1 trial showing 0.30 Gy/GBq absorbed dose to the kidneys, administration of up to 60GBq or more was possible.

The model assessed three dosing scenarios, all with dosing at six-weekly intervals:

10 GBq in cycles 1 and 2, followed by five cycles of 7.4 GBq
14.8 GBq in cycles 1 and 2, followed by four cycles of 7.4 GBq
7.4 GBq in each of cycles 1-8 (flat dosing)
The model extrapolated the reductions in tumour-absorbed radiation doses across each of cycles 4-8 using data available from cycles 1-3 and predicted the cumulative tumour absorbed radiation dose for each dosing scenario. The results showed that the front-loaded regimens both increase tumour-absorbed radiation dose; by 15% for regimen #1 and by 34% for regimen #2 vs. a flat dosing regimen (#3).

Commenting on the results, Dr Dan Stevens, Blue Earth Therapeutics’ Chief Medical Officer, said, "There is increasing interest in exploring alternative dosing schedules for radiopharmaceutical therapies to try and optimise the potential for clinical benefit. We are taking observed data from our Phase 1 and attempting to apply this scientifically in testing different front-loading approaches in our ongoing Phase 2 study. The data collected should allow us to assess the potential benefit and any risks."

About metastatic prostate cancer
In 2025 it is estimated that there will be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).2 Five-year survival for newly diagnosed metastatic prostate cancer is low, 36.6%.3 While death rates from prostate cancer have declined over the past three decades3, there is still considerable room to improve patient outcomes.

About Radiohybrid Prostate–Specific Membrane Antigen (rhPSMA)
rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate–Specific Membrane Antigen–targeted receptor ligand. It is attached to two labelling moieties which may be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.