On November 24, 2025 Kelonia Therapeutics, Inc., a clinical-stage biotechnology company pioneering in vivo gene delivery, reported that its first results from the ongoing inMMyCAR study, a Phase 1 clinical trial evaluating KLN-1010, a novel in vivo gene therapy that generates anti-BCMA CAR-T cells in patients with relapsed and refractory multiple myeloma, will be presented in a late-breaking oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting in Orlando, Florida.

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The late-breaking abstract features results from the first three patients treated with KLN-1010. All patients achieved minimal residual disease (MRD) negativity at month 1 that persisted through three months in the patient with the longest follow up. CAR-T cell expansion and persistence of memory CAR-T cells occurred without the use of lymphodepleting chemotherapy, apheresis, or ex vivo cell manufacturing.

"KLN-1010 is beginning to show the extraordinary clinical outcomes that may be possible with in vivo CAR-T therapy — early, deep responses from a single infusion without the barriers that limit access to traditional CAR-T treatments," said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia. "These initial data point to a potentially powerful medicine while also providing clear clinical validation of our iGPS platform; enabling a growing number of partnered programs as well as our wholly owned pipeline that includes KLN-1010. We are encouraged by these first-in-human results and looking forward to sharing additional details from the study with the scientific and medical communities at the ASH (Free ASH Whitepaper) Annual Meeting."

"In these early patients, we are seeing both rapid MRD-negative responses and persistent memory-phenotype CAR-T cells, a combination that has been strongly prognostic for durable clinical benefit with existing CAR-T approaches," said Simon Harrison, MBBS, MRCP(UK), FRCPath(UK), FRACP, Ph.D., Director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre and lead author of the late-breaking abstract. "Achieving these outcomes without lymphodepleting chemotherapy or CAR-T cell manufacturing underscores the potential of this in vivo approach to fundamentally expand access to CAR-T therapy for patients with relapsed and refractory multiple myeloma."

Oral Presentation Details:

Minimal residual disease (MRD)-negative outcomes following a novel, in vivo gene therapy generating anti–B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR)-T cells in patients with relapsed and refractory multiple myeloma (RRMM): Preliminary results from inMMyCAR, the first-in-human Phase 1 study of KLN-1010

Date: Tuesday, December 9, 2025, 7:30 – 9:00 AM EST

Location: West Hall D2 (Orange County Convention Center)

Session Title: Late-Breaking Abstracts Session

About inMMyCAR

inMMyCAR is a Phase 1, open-label, dose-escalation clinical trial designed to assess the safety, tolerability, pharmacology and preliminary efficacy of a single dose of KLN-1010 in up to 40 patients. The primary endpoints are incidence and severity of treatment-emergent adverse events (TEAEs), including dose limiting toxicities (DLTs), and to establish the recommended Phase 2 dose of KLN-1010. KLN-1010 has been granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA). This Phase 1 clinical trial marks the first time KLN‑1010 will be evaluated in humans. Additional information and study site information may be found on clinicaltrials.gov (NCT07075185).

About Relapsed and Refractory Multiple Myeloma

Multiple myeloma is a hematologic malignancy characterized by the proliferation of plasma cells in the bone marrow, leading to bone destruction, anemia, renal dysfunction, and immunosuppression. It is driven by complex genetic and epigenetic alterations that promote malignant cell survival and resistance to apoptosis. Relapsed and refractory multiple myeloma is characterized by clonal evolution, drug resistance, and increased disease heterogeneity, heightening the need for accessible, personalized therapeutic strategies.

About KLN-1010

KLN‑1010 is an investigational in vivo gene therapy that generates anti-BCMA CAR-T cells, targeting a protein expressed on the surface of multiple myeloma cells. Unlike traditional CAR‑T treatments, KLN‑1010 is administered to patients via direct transfusion and is designed to generate durable CAR‑T cells inside the body after a single dose, potentially eliminating the need for long wait times to receive treatment. This may overcome several limitations faced by current CAR-T approaches, including limited access to treatment and preconditioning chemotherapy.

(Press release, Kelonia Therapeutics, NOV 24, 2025, View Source [SID1234660923])

On November 24, 2025 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported that three abstracts will be presented at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12.

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The studies collectively highlight the prognostic and predictive power of Artera’s MMAI model to help personalize treatment decisions, particularly in evaluating chemotherapy benefit in post-menopausal women. Leveraging data from four independent Phase III trials across Germany, Austria, and North America, these studies validate the performance of this unique AI model across more than 7,000 patients.

"These abstracts hold tremendous weight as they cover a diverse set of patients with HR+ early breast cancer, giving clinicians a lot of confidence in the validity of these results," said Prof. Nadia Harbeck, Director of the Breast Center at LMU University Hospital in Munich, Germany. "Traditional approaches can result in patients, especially those who are post-menopausal with node-negative tumors, receiving chemotherapy with limited benefit while still facing significant toxicities. It’s exciting to witness the emergence of new technologies that allow us to deliver the optimal breast cancer care."

Approximately 1 in 8 women (13%) in the U.S. will develop invasive breast cancer at some point in their lives, and many face complex treatment decisions. Chemotherapy carries well‑documented side effects, including neuropathy, risk of infection, and, for younger women especially, infertility and impaired fertility potential. These risks underscore the need for tools that help clinicians tailor treatment decisions, ensuring each patient receives care that is necessary, appropriate, and aligned with their unique clinical profile.

"Advancing precision medicine means ensuring every patient can benefit from individualized care," said Andre Esteva, CEO of Artera. "As we validate this technology across countries and cancer types, we’re showing that precision medicine can be more personalized and accessible while helping clinicians avoid unnecessary treatments without added time, cost, or complex processes."

Presentations at SABCS 2025

Poster Spotlight 11 (PD11-01) Development of a Multi-Modal Artificial Intelligence (MMAI) Model for Predicting Distant Metastasis in HR+ Early-Stage Invasive Breast Cancer (Abstract #1251)

Demonstrates the development of Artera’s MMAI model using data from over 12,000 patients enrolled in six Phase III clinical trials conducted in the United States, Germany, and Austria. The model effectively stratifies patients by 10-year risk of distant metastasis, identifying high-risk individuals who may benefit from closer monitoring, while 68% of patients were classified as low-risk and achieved an estimated 10-year DM-free survival of approximately 95%. These findings show the model’s potential to provide actionable prognostic information across diverse, international populations.

Poster Session 3 (PS3-04-08) Independent Validation of a Pathology-Based Multimodal Artificial Intelligence Biomarker for Predicting Risk of Distant Metastasis in Postmenopausal, Estrogen Receptor-Positive, Early-Stage Breast Cancer Patients: Analysis of the ABCSG Trial 8 (Abstract #1410)

Focuses on postmenopausal patients in the ABCSG 8 trial, a prospective study of individuals receiving endocrine therapy only. MMAI successfully classified patients into low, intermediate, and high-risk groups, with corresponding 10-year DM-free survival rates of roughly 95%, 89%, and 77%, respectively. Validation confirmed robust performance across clinical subgroups, including lymph node status, tumor grade, histology, and proliferation markers. The study further highlights the advantages of MMAI as a non-tissue-destructive, fast-turnaround test, providing an accessible alternative to more costly genomic assays.

Rapid Fire 3 (RF3-03) Evaluation of a digital pathology-based multimodal artificial intelligence model for prognosis and prediction of chemotherapy benefit in node-negative, hormone receptor-positive breast cancer patients: analysis of the NSABP B-20 trial. (Abstract #3685)

Evaluates MMAI’s ability to predict benefit from chemotherapy in node-negative HR+ patients in the NSABP B-20 trial. Among patients aged 50 and older, MMAI high-risk individuals experienced a 52% relative reduction in 10-year DM with chemotherapy, while MMAI low-risk patients derived no additional benefit. These findings demonstrate MMAI’s potential to guide personalized treatment decisions, helping clinicians avoid unnecessary chemotherapy for low-risk patients while identifying high-risk patients who are most likely to benefit.

Artera will be exhibiting at booth #1525 during SABCS, where attendees can learn more about the MMAI platform and the ArteraAI Breast Test.

(Press release, Artera, NOV 24, 2025, View Source [SID1234660922])

On November 24, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) reported that the Independent Data Monitoring Committee (IDMC) concluded that the Phase III clinical study (OptiTROP-Lung05) of the company’s TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870), in combination with MSD’s anti-PD-1 therapy KEYTRUDA[1] (pembrolizumab), as a first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC), has demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the study’s primary endpoint. A positive trend in overall survival was also observed. This is the first Phase III clinical trial of ADC combined with immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC.

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OptiTROP-Lung05 is a randomized, open-label, multicenter Phase III clinical study evaluating the efficacy and safety profile of sac-TMT in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment of patients with PD-L1-positive locally advanced or metastatic NSCLC with PD-L1 TPS ≥ 1%. At a pre-specified interim analysis, the sac-TMT combination therapy demonstrated a statistically significant and clinically meaningful improvement in PFS. Based on the results from the interim analysis, the Company plans to communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China regarding the submission of a supplemental new drug application (sNDA) of sac-TMT.

Sac-TMT is already approved in China for the treatment of EGFR-mutant NSCLC in the second-line and later settings and has achieved dual benefits in PFS and overall survival (OS) in the EGFR-TKI-resistant lung cancer population, making it the first ADC to show statistically significant and clinically meaningful improvements in both PFS and OS compared to platinum doublet chemotherapy. These research findings have been published in internationally renowned journals, The New England Journal of Medicine and The BMJ.

Sac-TMT is currently being evaluated in ten registrational studies in lung cancer, including five registrational studies in China and five global multicenter Phase III studies.

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, GC, gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the first TROP2 ADC drug approved for marketing in lung cancer globally. In addition, the sNDA for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and was included in the priority review and approval process.

As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, NOV 24, 2025, View Source [SID1234660921])

On November 24, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the closing of its previously announced underwritten public offering of 4,950,496 shares of Class A common stock at a price to the public of $101.00 per share. The offering closed on November 20, 2025. The gross proceeds to Nuvalent from the offering were approximately $500.0 million, before deducting underwriting discounts and commissions and other offering expenses.

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On November 20, 2025, the underwriters exercised in full their option to purchase an additional 742,574 shares of Class A common stock (the "Additional Shares") from Deerfield Healthcare Innovations Fund, L.P. and Deerfield Private Design Fund IV, L.P. (together, the "Selling Stockholders") at the public offering price less underwriting discounts and commission. The sale of the Additional Shares by the Selling Stockholders closed on November 24, 2025. Nuvalent did not receive any proceeds from the sale of the Additional Shares by the Selling Stockholders.

J.P. Morgan, Jefferies, TD Cowen and Cantor acted as joint book-running managers for the offering.

The shares were offered by Nuvalent pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 16, 2023. The offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus can be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; 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]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, 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.

(Press release, Nuvalent, NOV 24, 2025, View Source [SID1234660920])

On November 24, 2025 Pin Therapeutics, a clinical-stage biotechnology company specializing in targeted protein degradation, reported that it has administered the first dose of its CK1α-selective degrader PIN-5018 in a Phase 1 clinical trial. The first patient enrolled has adenoid cystic carcinoma (ACC), a rare malignancy with limited treatment options.

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PIN-5018 is an oral CK1α degrader developed based on the novel hypothesis of "synthetic activation of p53." The company is evaluating PIN-5018 as both a monotherapy and in multiple combination regimens. The Phase 1 study employs a dose-escalation design to assess safety, pharmacokinetics (PK), and target engagement/pharmacodynamics (PD). Pin Therapeutics also plans to expand development into additional indications.

PIN-5018 Achieves Complete Response in ACC PDX Models
The company highlighted compelling preclinical data in ACC, a disease with no approved standard-of-care therapy. In two patient-derived xenograft (PDX) models, treatment with PIN-5018 resulted in a complete response (CR) in one model and marked tumor regression in the other, demonstrating robust antitumor activity and supporting clinical translation.

Expansion Planned into mCRPC, Colorectal Cancer, and Other Rare Tumors
Pin Therapeutics notes that CK1α plays a key biological role in resistance mechanisms that emerge during androgen receptor (AR) inhibitor therapy. Based on this insight, the company is pursuing a strategy aimed at enabling rapid entry into the first-line (1L) setting for metastatic castration-resistant prostate cancer (mCRPC) through combination therapy with an AR signaling inhibitor (ARSI). In colorectal cancer, the company is advancing a clinical program based on the innovative concept of "synthetic activation of WNT signaling."

Advancing Mechanism-Based Precision Oncology
Pin Therapeutics emphasized its commitment to mechanism-based precision oncology across its entire pipeline by applying sophisticated biological mechanisms. Ongoing initiatives include mode-of-action studies, integrated PK/PD analysis, and biomarker development to identify the most appropriate patient populations for each indication.

"Our goal is to leverage our innovative degradation modality and novel biological frameworks to provide meaningful therapeutic options for cancer patients with limited or no existing treatments," Pin Therapeutics CEO Hyunsun Jo said. "We look forward to demonstrating the clinical value of PIN-5018 across multiple tumor types."

(Press release, Pin Therapeutics, NOV 24, 2025, View Source [SID1234660919])