On June 22, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology (IO), reported the completion of enrollment in its Phase 2 study of spevatamig in combination of standard of care chemotherapy for metastatic PDAC in the 1L setting.

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"This marks an important milestone in our mission to advance innovative therapies that help improve outcomes for patients with hard-to-treat cancers," said Ming Wang, PhD, MBA, CEO of Phanes. "PDAC is the first cancer type we are targeting with spevatamig; there is more to come."

Spevatamig is a bispecific antibody targeting CLDN18.2 and CD47 that functions as an innate immunity enhancer (I2E), an emerging class of IO agents. I2Es are expected to activate macrophages and dendritic cells to recognize and destroy cancer cells, providing an alternative immune-stimulating mechanism complementary to immune checkpoint inhibitors (ICIs) to attack tumors, especially "cold tumors" that are less likely to respond to ICIs.

Spevatamig is being evaluated in various GI cancers, including 1L metastatic PDAC, and has been dosed in over 200 patients globally. PDAC is a devastating cancer, and treatment has been largely limited to systemic chemotherapy which only offers a short duration of benefit due to development of resistance and cumulative toxicity. The impact on society is only expected to increase, as incidence of PDAC is rising. Thus, novel approaches capable of producing more durable responses are urgently needed. Although immunotherapies such as agents targeting PD-1/PD-L1 or CTLA-4 have been explored in many PDAC trials, few have demonstrated meaningful therapeutic benefit.

"Spevatamig was discovered in our lab in San Diego; its unique molecular design enables targeting solid tumors without causing significant hematological toxicity, an issue that has been seen with other CD47-targeting agents in the past," said Phanes’ CEO. "We believe our approach can be applied to other tumor types. This could be a new frontier for targeting solid tumors."

ABOUT SPEVATAMIG

Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple cancer indications, including a Phase 2 study evaluating the safety, tolerability and efficacy of spevatamig in combination with chemotherapy in patients with PDAC in the first-line setting. Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. It has the potential to become the first I2E for a solid tumor indication and is combinable with various anti-cancer therapies.

(Press release, Phanes Therapeutics, JUN 22, 2026, View Source [SID1234668883])

On June 22, 2026 Delphi Diagnostics reported the publication of findings from the GEICAM/9906 clinical trial demonstrating that the company’s Endocrine Activity Index (EAI) can identify patients with hormone receptor-positive, HER2-negative (HR+/HER2−) breast cancer who derive meaningful benefit from adjuvant chemotherapy containing weekly paclitaxel.

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The study, published in Clinical Cancer Research, is titled "Sensitivity to endocrine therapy index predicts benefit from weekly adjuvant paclitaxel for hormone receptor-positive breast cancer in the GEICAM/9906 trial," and was conducted by investigators from the GEICAM Spanish Breast Cancer Group and The University of Texas MD Anderson Cancer Center.

This prospective-retrospective analysis independently validated previous findings and further helps to establish EAI as the first genomic assay shown to predict benefit from a contemporary taxane-based chemotherapy regimen in HR+/HER2− breast cancer.

The study evaluated tumor samples and outcomes from patients enrolled in the landmark GEICAM/9906 randomized phase III trial. Investigators found that patients with very low endocrine activity, score of <0.75 as measured by EAI, experienced significantly improved distant recurrence-free outcomes when weekly paclitaxel was added to anthracycline-based chemotherapy. In contrast, patients with higher endocrine activity did not demonstrate additional benefit from paclitaxel treatment.

"This study represents an important milestone for precision oncology and provides independent confirmation that endocrine activity within an HR+/HER2- breast tumor can predict sensitivity to specific chemotherapy approaches," said Federico A. Monzon, MD, Chief Medical Officer at Delphi Diagnostics. "These findings support the potential for EAI to help clinicians personalize treatment decisions and select chemotherapy regimens more likely to benefit individual patients."

The results build upon previous clinical evidence and demonstrate reproducibility across two independent randomized clinical trials. Together, these studies suggest that EAI may provide oncologists with actionable information beyond traditional prognostic tests by helping determine not only whether chemotherapy should be considered, but which chemotherapy strategy is most likely to provide clinical benefit.

"Current genomic assays primarily estimate recurrence risk, but they generally do not predict which specific chemotherapy regimen will be most effective," said Winz Casagrande, Chief Executive Officer, Delphi Diagnostics. "EAI represents a new generation of predictive biomarkers designed to guide treatment selection and help deliver more individualized care for patients with breast cancer."

The GEICAM/9906 analysis showed that approximately 16% of HR+/HER2− tumors exhibited low endocrine activity and were associated with improved outcomes from weekly paclitaxel-containing therapy. The findings support the growing role of biologically informed treatment selection and may help reduce unnecessary exposure to treatments unlikely to provide benefit.

(Press release, Delphi Diagnostics, JUN 22, 2026, View Source [SID1234668881])

On June 22, 2026 RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the closing of its previously announced private placement for the purchase and sale of an aggregate of 8,571,429 American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing ten thousand (10,000) ordinary shares of the Company, series A-1 warrants to purchase up to an aggregate of 8,571,429 ADSs and series A-2 warrants to purchase up to an aggregate of 8,571,429 ADSs, at a combined purchase price of $0.70 per ADS (or ADS equivalent in lieu thereof) and accompanying warrants. The Series A-1 warrants have an exercise price of $0.86 per ADS, are exercisable immediately and have a term of five years following the Effectiveness Date (as defined below), and the Series A-2 warrants have an exercise price of $0.70 per ADS, are exercisable immediately and have a term of 18 months following the Effectiveness Date.

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The upfront proceeds are expected to strengthen RedHill’s near-term liquidity and support a strategic, transformative, potential acquisition of commercial-stage, revenue-generating pharmaceutical product assets, which, if completed, would significantly expand the Company’s commercial portfolio and revenue base. No definitive acquisition agreement has been executed, and the potential transaction remains subject to various conditions. There can be no assurance that any such transaction will be completed.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering were approximately $6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series A-1 warrants and the series A-2 warrants, if fully exercised on a cash basis, will be approximately $13.4 million. No assurance can be given that any of the series warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the series warrants.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the ordinary shares of the Company represented by ADSs underlying the warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities issued in the private placement and ordinary shares of the Company represented by ADSs underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with the investors, the Company has agreed to file a resale registration statement covering the securities described above (such date of effectiveness of the resale registration statement, the "Effectiveness Date").

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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, RedHill Biopharma, JUN 22, 2026, View Source [SID1234668879])

On June 22, 2026 USWM CT, LLC (US WorldMeds) reported that the U.S. Food and Drug Administration (FDA) has granted full approval of TECELRA (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Administered as a single infusion, TECELRA became the first engineered T-cell therapy for a solid tumor cancer to receive accelerated FDA approval in the United States, granted in August 2024.

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"Today’s approval marks an important milestone not only for US WorldMeds, but for the synovial sarcoma community," said Breck Jones Sr., Founder and CEO of US WorldMeds. "With the transition to full approval, TECELRA continues to represent an important treatment option for appropriate patients with biomarker-eligible, advanced synovial sarcoma. This approval is supported by additional clinical evidence which may provide physicians, patients, and families with confidence as they consider treatment decisions. The expansion to include patients as young as 12 years old further broadens access to this personalized approach."

"What sets TECELRA apart is that it is personalized to each individual, engineering a patient’s own T-cells to detect, target, and attack their cancer. Until today, that option was only available to adults," said Kristen Gullo, Senior Vice President of US WorldMeds. "For patients 12 years of age and older with biomarker-eligible, advanced synovial sarcoma, today’s decision opens the door to a new treatment approach that was previously out of reach and offers hope where options have been extremely limited."

The full FDA approval and expanded indication for TECELRA was based on results of the SPEARHEAD-1 study (Cohorts 1, 2 and 3), an open-label, single-arm clinical study, which included 137 patients. The primary efficacy outcome was overall response rate (ORR) determined by independent review and supported by duration of response. TECELRA treatment resulted in an ORR of 43.8% with a complete response rate of 3.6%. The median duration of response was 5.3 months (95% CI: 4.5, 8.2). Among patients who were responsive to the treatment, 31.9% had a duration of response of 24 months or longer.*

"For children as young as 12 with advanced synovial sarcoma, treatment options have been limited and navigating care decisions can be challenging," said Amy Armstrong, MD, Associate Professor of Pediatrics at Washington University School of Medicine in St. Louis and Director of the Solid Tumor Program at Siteman Kids at St. Louis Children’s Hospital. "The availability of an engineered cell therapy for adolescents introduces an important new option for patients who are biomarker-eligible, allowing us to incorporate this approach into treatment planning based on the same evidence that has guided adult care. This is a meaningful step forward for the field."

For more information about TECELRA visit www.TECELRA.com.

About Synovial Sarcoma
There are more than 50 different types of soft tissue sarcomas which can arise in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.1 Synovial sarcoma accounts for approximately 5 to 10% of all soft tissue sarcomas (there are approximately 13,400 new soft tissue sarcoma cases in the U.S. each year).1,2 Approximately one-third of patients with synovial sarcoma are diagnosed under the age of 30.2 The five-year survival rate for people with metastatic disease is approximately 20% and recurrence is common in advanced disease.1,3

About TECELRA
TECELRA (afamitresgene autoleucel) is a genetically modified autologous T cell immunotherapy indicated for adult and pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. TECELRA is made from a patient’s own white blood cells that are genetically modified to recognize and attack cancer cells. A healthcare provider will perform tests to see if TECELRA is right for each patient.

IMPORTANT SAFETY INFORMATION
Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 2 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 2 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.

Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.

The most common side effects of TECELRA include nausea, fatigue, infection, fever (100.4°F/38°C or higher), constipation, vomiting, headache, diarrhea, fast heart rate, cough, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, decreased red blood cell count, and decreased platelet count.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to US WorldMeds at 1-855-246-9232.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

(Press release, US WorldMeds, JUN 22, 2026, View Source [SID1234668876])

On June 22, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company") reported that translational research results on its sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) in combination with osimertinib as first-line treatment for advanced epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) have been published online in Cancer Cell, an international academic journal.

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The paper, titled "Targeting TROP2 in drug-tolerant persister cells delays EGFR tyrosine kinase inhibitor resistance in non-small-cell lung cancer," was led by Professor Li Zhang and Professor Wenfeng Fang from the Sun Yat-sen University Cancer Center. The study shows that trophoblast cell-surface antigen 2 (TROP2) expression is upregulated in residual drug-tolerant persister (DTP) cells after EGFR tyrosine kinase inhibitor (TKI) treatment; in preclinical models, sac-TMT combined with osimertinib inhibited DTP cell formation and delayed tumor recurrence. These findings provide translational medicine evidence for the combination of TROP2-directed antibody drug conjugate (ADC) and EGFR‑TKI in delaying drug resistance, and further underscore the differentiated value of sac-TMT as a key combination partner for EGFR-TKIs.

Building on the above research and clinical development plans, the Company is advancing a Phase III registrational study (NCT06670196) of sac-TMT in combination with osimertinib versus osimertinib monotherapy as first-line treatment for locally advanced or metastatic EGFR-mutant non-squamous NSCLC. The study is designed to evaluate the efficacy and safety of sac-TMT (4 mg/kg, Q2W) plus osimertinib compared with osimertinib monotherapy in this indication. Patient enrollment in China has been completed, and the study is currently in the follow-up and data maturity phase.

In addition, the Company is advancing clinical exploration of sac-TMT for earlier-stage EGFR-mutant NSCLC. A Phase II study (NCT07329322) is ongoing to evaluate sac-TMT in combination with osimertinib or as monotherapy in the neoadjuvant setting for EGFR-mutant resectable NSCLC, further exploring the potential value of sac-TMT in perioperative treatment.

This publication in Cancer Cell reinforces the scientific foundation for combining sac-TMT with EGFR-TKIs as first-line treatment for EGFR-mutant NSCLC. The Company will continue to explore the potential of this combination regimen in earlier-line treatment, resistance delay, and long-term benefit, building on the approved indications and clinical development plan of sac-TMT in EGFR-mutant NSCLC. Kelun-Biotech remains committed to driving innovation in treatment paradigms for EGFR-mutant NSCLC and expanding therapeutic options for patients.

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, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, 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, four indications for sac-TMT have been approved and marketed in China for: 1) 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); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the National Medical Products Administration (NMPA).

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA[1]) as first‑line treatment for locally advanced or metastatic NSCLC who have programmed death ligand 1 (PD-L1) tumor proportion score (TPS)≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, JUN 22, 2026, View Source [SID1234668873])