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 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported the pricing of its previously announced underwritten public offering consisting of (i) 11,195,121 shares of its common stock and accompanying warrants to purchase an aggregate of 11,195,121 shares of common stock (or pre-funded warrants in lieu thereof) and (ii) in lieu of common stock, to certain investors, pre-funded warrants to purchase an aggregate of up to 1,000,000 shares of its common stock and accompanying warrants to purchase an aggregate of up to 1,000,000 shares of common stock (or pre-funded warrants in lieu thereof), at an exercise price of $0.0001 per pre-funded warrant (Press release, Biomea Fusion, OCT 7, 2025, View Source [SID1234656479]). In addition, Biomea has granted the underwriters a 30-day option to purchase up to an additional 1,829,268 shares of common stock and/or warrants to purchase 1,829,268 shares of common stock at the public offering price, less underwriting discounts and commissions. The common stock and pre-funded warrants are being sold in combination with an accompanying warrant to purchase one share of common stock (or a pre-funded warrant in lieu thereof) issued for each share of common stock or pre-funded warrant sold. The accompanying warrant has an exercise price of $2.50 per share, is immediately exercisable from the date of issuance and will expire three years from the date of issuance. The combined offering price of each share of common stock and accompanying common stock warrant is $2.05. The combined offering price of each pre-funded warrant and accompanying common stock warrant is $2.0499.

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All of the shares, pre-funded warrants and accompanying common stock warrants in the offering are being sold by Biomea. The gross proceeds to Biomea from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $25.0 million, excluding any exercise of the underwriters’ option to purchase additional shares and/or warrants. The offering is expected to close on October 8, 2025, subject to the satisfaction of customary closing conditions.

Jefferies is acting as sole book-running manager for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

The shares of common stock, pre-funded warrants and common stock warrants and shares of common stock issuable upon the exercise of the pre-funded warrants and common stock warrants are being offered by Biomea pursuant to an effective shelf registration statement on Form S-3 (File No. 333-289262), that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on August 5, 2025 and declared effective on August 15, 2025. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on October 6, 2025, and is available for free on the SEC’s website located at View Source The final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source

Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from: Jefferies LLC by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

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 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 6, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), the global leader in relapsed/refractory AL Amyloidosis, reported that it will present a NXC-201 abstract at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 67th Annual Meeting and Exposition to be held December 6-9, 2025, in Orlando, Florida (Press release, Immix Biopharma, OCT 6, 2025, View Source [SID1234656460]).

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About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart, kidney, and liver, causing heart and renal failure, leading to mortality.

The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 37,270 patients in 2025.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

On October 6, 2025 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that the first patient has been treated in the Company’s OTS program, with encouraging preliminary safety data (Press release, Marker Therapeutics, OCT 6, 2025, View Source [SID1234656461]).

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Marker is evaluating the safety and efficacy of escalating doses of MT-401, a multi-antigen recognizing (MAR) T cell product targeting four antigens, as an OTS product in the Phase 1 RAPID study (clinicaltrials.gov Identifier: NCT06552416). The first study participant received the OTS product at the initial dose level (100×106 cells) and was monitored for 28 days. The therapy was well tolerated with no treatment-related adverse events. This observation is consistent with the favorable safety profile and tolerability previously reported for MAR-T cells. The OTS product will be initially tested in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), with the potential to be expanded to other indications.

"The initiation of our OTS program represents a major achievement," said Juan Vera, M.D., President and CEO of Marker Therapeutics. "One of the biggest limitations to cell therapy is the time-consuming manufacturing of individualized products. With our OTS product, we are aiming to remove this bottleneck and provide a fast treatment option for patients with aggressive and rapidly progressing diseases. We believe that using commercially available leukapheresis material from healthy donors can facilitate large-scale manufacturing and expedite treatment as fast as 72 hours, while also enabling broader scalability and accessibility of cell therapies at a lower per-dose cost."

"Having a rapid available alternative to individualized T cell production allows us to broaden our clinical investigation of MAR-T cells and to extend the OTS program to other indications," commented Dr. Vera. "Looking ahead, we will remain focused on advancing our clinical investigation of MAR-T cells in lymphoma. We recently reported promising clinical efficacy and durability data from our APOLLO study where we have observed an objective response rate of 66%, with durable complete responses in patients with non-Hodgkin lymphoma, and we believe our lymphoma program has the potential to qualify for expedited approval."

Marker has secured non-dilutive funding from the Food and Drug Administration (FDA), the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas (CPRIT) to support the clinical investigation of the OTS product. Using these allocated non-dilutive funds will allow the Company to proceed with the OTS program without affecting the Company’s runway and its efforts to advance its lead asset, MT-601, in the ongoing Phase 1 APOLLO study in patients with lymphoma. Marker recently reported an update from the APOLLO study (Press Release, August 26, 2025) highlighting a favorable safety profile and durable clinical responses.

To facilitate the OTS program, the Company has established a cellular inventory from commercially available leukapheresis material that was carefully selected to cover a large patient population with partially human leukocyte antigen (HLA) matched material. This approach has been validated and extensively tested in the clinic (Leen et al., Blood, 2013; Tzannou et al, Blood Adv, 2019; Tzannou et al, J Clin Oncol, 2017). Data from the ongoing RAPID trial will help inform future clinical developments of MAR-T cell products and guide their potential use as an OTS product in other indications.

"Behind this milestone is a set of scientific data and a significant body of research and development. This strategy has been tested extensively in the clinic at Baylor College of Medicine in the context of virus-specific T cells (VST). As we enroll additional patients in the Phase 1 RAPID study, we will continue to closely monitor the safety and long-term treatment effects of our OTS product. The collected data from this trial will serve as a foundation for refining and understanding the performance of MAR-T cells as an OTS product to potentially expand the OTS approach to other product candidates in our pipeline with the goal to accelerate time to treatment in other indications," concluded Dr. Vera.

About MAR-T cells

The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.

About the Off-the-Shelf Program

MT-401-OTS is an Off-the-Shelf (OTS) multi-antigen recognizing (MAR) T cell product that targets four different tumor antigens upregulated in cancer cells (Survivin, PRAME, NY-ESO-1, WT-1). MT-401-OTS is currently investigated in the Company-sponsored Phase 1 multicenter, open-label RAPID trial (clinicaltrials.gov identifier: NCT06552416) for the treatment of patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The Company’s OTS program is supported by the National Cancer Institute of the National Institutes of Health (Award Number 1R44CA285177), the Food and Drug Administration Department of Health and Human Services (R01FD007272), and the Cancer Prevention and Research Institute of Texas (CPRIT, Award Number DP210042).