On April 23, 2026 CatalYm reported that the first patient has been dosed in the Phase 2/3 VINCIT trial (Visugromab IN Cachexia International Trial, NCT07112196). The global study is evaluating the company’s lead anti-GDF-15 antibody visugromab in patients with cancer-associated cachexia.

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The randomized, double-blind, placebo-controlled Phase 2/3 trial will enroll about 518 patients with cachexia associated with a range of advanced cancers, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other solid tumors.

Cachexia is a severe metabolic condition marked by involuntary weight loss, muscle wasting, and impaired treatment tolerance. In some types of cancer, it can affect up to 70% of patients and is responsible for 20-40% of cancer-related deaths1. Elevated GDF-15 levels are known to play a central role in the development of cachexia. Despite a high unmet medical need, there are currently no approved pharmacological treatments available.

"Cachexia remains one of the most debilitating and under-addressed complications in oncology," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "Following the promising weight gain data observed in our earlier trial and growing evidence of GDF-15’s role in metabolic wasting, this trial is a critical step in establishing visugromab as a novel therapeutic option for patients with advanced cancers."

"The data guiding this trial show that GDF-15 is more than a bystander in cancer progression. It plays a central role in both immune resistance and metabolic decline," said Scott Clarke, Chief Executive Officer at CatalYm. "By targeting GDF-15, visugromab has the potential to open a new therapeutic path for patients whose treatment outcomes are severely impacted by cachexia."

The VINCIT trial is an adaptive Phase 2/3 study to evaluate the efficacy and safety of visugromab in reversing cachexia. In Part 1, participants are randomized to receive one of three visugromab dose levels or placebo every four weeks for 12 weeks. Based on interim analyses, a recommended dose will be selected for Part 2, which will randomize patients 2:1 to visugromab or placebo for up to 52 weeks. The trial will include clinical sites across the globe. Primary endpoints include changes in body weight and appetite over 12 weeks. Secondary endpoints assess muscle mass and function, physical activity, tumor response, overall survival, patient-reported quality of life, and safety. The study also includes exploratory pharmacodynamic and biomarker assessments.

Visugromab is a humanized, monoclonal antibody that targets Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine known to drive immune suppression and cachexia. In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab in combination with PD-1 inhibitor nivolumab demonstrated deep and durable anti-tumor activity as well as a favorable safety profile in patients with relapsed or refractory NSCLC, hepatocellular carcinoma (HCC) and urothelial cancer (UC). The trial also provided early clinical evidence for visugromab’s potential to alleviate cancer cachexia, including meaningful weight gain in the subset of patients with moderate or severe weight loss at trial entry. These findings support visugromab’s dual potential to maintain or restore immune function and counteract cancer cachexia.

About cancer cachexia and GDF-15

Cancer cachexia is a complex and debilitating syndrome that affects up to 70% of patients with advanced cancer1. The condition is closely linked to elevated GDF-15 levels, which drive severe and progressive weight loss, muscle wasting, reduced appetite, and metabolic disturbances through activation of the GFRAL receptor in the brainstem. Unlike starvation, cachexia cannot be fully reversed with nutritional support alone, as it is driven by a combination of systemic inflammation, tumor-derived factors, and metabolic dysregulation. This condition significantly diminishes the quality of life for cancer patients and severely impacts their ability to tolerate and respond to treatment, often leading to poorer outcomes and increased mortality.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

(Press release, Catalym, APR 23, 2026, View Source [SID1234664738])

On April 23, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, and the Keck School of Medicine of USC and Keck Medicine of USC, reported a multi-faceted collaboration aimed at transforming patient care and accelerating research through the power of data and AI. This collaboration is designed to transform care delivery across more than 1.5 million annual patient visits to the USC Norris Comprehensive Cancer Center, the Keck Hospital of USC, USC Verdugo Hills and all USC-affiliated hospitals and clinics across Southern California.

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The collaboration is built on four foundational pillars, co-created to drive clinical impact, research scale, and long-term innovation. These include clinical testing, which enables personalized medicine by integrating Tempus’ advanced molecular diagnostics and comprehensive genomic profiling into Keck Medicine’s clinical workflows; clinical trial matching, which automates the identification of eligible patients for targeted therapies and clinical trials through Tempus’ TIME Trial Program; clinical care gap pathways, which use AI-driven insights to identify and close gaps in patient care; and research collaboration and co-development, which accelerates the translation of academic insights into validated diagnostics and therapies while jointly developing AI tools that connect research discoveries to clinical care.

"By working closely with Tempus, and in collaboration with clinical, research, and operational leaders across USC, we are aligning research, clinical care, and innovation priorities that put the patient first," said Vasiliki Anest, PhD, Chief Innovation Officer at the Keck School of Medicine of USC. "Our patient-focused commitment is to ensure discoveries and clinical innovations move thoughtfully and responsibly into practice, expanding access to personalized care and clinical trials, supporting physicians, and improving patient outcomes."

"We are tremendously excited to embark on this collaboration with USC, an institution that shares our commitment to advancing healthcare through data and technology," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "By bringing together Tempus’ AI-powered platform with USC’s world-class research and clinical expertise, we have the opportunity to create a powerful, integrated ecosystem that meaningfully transforms care delivery."

(Press release, Tempus, APR 23, 2026, View Source [SID1234664737])

On April 23, 2026 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, reported the closing of its underwritten public offering of $373.8 million of shares of its common stock. Nektar sold 4,062,500 shares of common stock in the offering, which includes 529,891 shares sold upon exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering. The shares of common stock were sold at a public offering price of $92.00 per share. The gross proceeds to Nektar from the offering were approximately $373.8 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the securities sold in this offering were offered by Nektar.

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Jefferies, TD Cowen, and Piper Sandler acted as joint bookrunning managers for the offering. Citigroup also acted as a bookrunner for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3ASR (No. 333-291466) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on November 12, 2025 and automatically became effective upon filing. This offering was made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A final prospectus supplement related to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and an accompanying prospectus related to the offering may also 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]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected]; or Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 (Tel: 800-831-9146).

This press release shall not constitute an offer to sell or a solicitation of an offer to buy 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 that state or jurisdiction.

(Press release, Nektar Therapeutics, APR 23, 2026, View Source [SID1234664736])

On April 23, 2026 Repertoire Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell-targeted immune medicines, reported that the first participant has been dosed in a Phase 1/2 clinical trial of RPTR-1-201, a novel TCR bispecific therapy designed to treat advanced solid tumors. The trial is being conducted at multiple clinical sites in the United States and Europe following clearance of Repertoire’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration and authorization via the Clinical Trials Information System (CTIS) in Europe.

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"T cell-targeted immune medicines have shown they can drive deep and durable responses in some cancers, yet many patients with advanced solid tumors still have limited treatment options," said Robert Andtbacka, MD, CM, Chief Medical Officer of Repertoire. "RPTR-1-201 is designed to direct a patient’s own T cells toward a shared, tumor-selective target. Dosing the first participant is a major milestone for Repertoire and the start of evaluating RPTR-1-201’s safety and potential benefit in the clinic."

RPTR-1-201 is a TCR bispecific molecule comprised of an engineered TCR that binds with high affinity and precision to a tumor-selective epitope and an anti-CD3 moiety that engages and redirects T cells to kill tumor cells. In preclinical studies, RPTR-1-201 has demonstrated potent killing of both immunologically "hot" and "cold" tumors and a favorable preclinical safety profile. Unlike many other T cell-targeted approaches that focus on well-known antigens specific to a single tumor type, RPTR-1-201 binds to a novel epitope discovered using Repertoire’s DECODETM platform that is shared across multiple solid tumors and may be relevant for as many as 200,000 patients with metastatic or unresectable cancer each year in the U.S. and Europe.

The Phase 1/2 trial is designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose-escalation and dose-expansion phases and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody. Enrollment is ongoing at sites in the United States and Europe.

"The development of RPTR-1-201 was enabled by our platform, which identified unique TCRs against a pan-tumor, tumor-selective epitope. Subsequent TCR engineering by the Repertoire team generated an optimized TCR bispecific immune medicine that harnesses the immune system against difficult-to-treat solid tumors," said Anthony J. Coyle, PhD, President, Research and Development at Repertoire. "The initiation of this trial marks an important milestone, as RPTR-1-201 is the first validation of our ability to convert immune codes into potential immune medicines for cancer. We are both excited and humbled by the opportunity to test this drug candidate in participants with advanced cancers."

For more information about the trial, visit clinicaltrials.gov and use study identifier NCT07293754.

(Press release, Repertoire, APR 23, 2026, View Source [SID1234664735])

On April 23, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that two latest clinical study results of its Nectin-4-targeting ADC 9MW2821 in combination with toripalimab for urothelial carcinoma will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, USA from May 29 to June 2, 2026 (local time), as an oral presentation and a poster presentation, respectively.

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Oral Presentation

Title: Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Follow-up results from a phase 1b/2 study.

Abstract Number for Publication: 4518

Presenter: Prof. Sheng Xinan, Chief Physician, doctoral supervisor, Dept. of Urologic Oncology (Beijing Cancer Hospital)

Session Date and Time: 6/1/2026 8:00AM-9:30AM CDT

Poster Presentation

Title: Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in perioperative patients with muscle-invasive bladder cancer (MIBC): Results of cohort A from a phase 2 study.

Abstract Number for Publication: 4609

Principal Investigator: Prof. Liu Zhuowei, Chief Physician, Dept. of Urology (Sun Yat-sem University Cancer Center)

Session Date and Time: 5/31/2026 9:00AM-12:00PM CDT

(Press release, Mabwell Biotech, APR 23, 2026, View Source;mabwell-to-present-latest-clinical-data-on-9mw2821-combined-with-toripalimab-for-urothelial-carcinoma-in-oral-and-poster-presentations-302751449.html [SID1234664734])