Taletrectinib

In June 2025, several breakthrough drugs received their first global approvals and market launches, marking significant advances in therapeutic innovation. 1. Genakumab (Firsekibart) Firsekibart (Genakumab), developed by Changchun Genescience Pharmaceutical, is a fully human monoclonal antibody targeting interleukin-1β (IL-1β). It functions as an IL-1β inhibitor and was approved in China on June 30, 2025, for the treatment of gouty arthritis, especially in patients who are intolerant or unresponsive to NSAIDs or colchicine. The approval addresses a significant gap in long-acting, targeted anti-inflammatory therapies in China, offering a new option for over 14 million gout patients. Gout is a chronic inflammatory disease caused by urate crystal deposition in joints. It is often referred to as the "king of pain" due to its severe and recurrent attacks. The underlying pathology involves activation of the NLRP3 inflammasome in macrophages, leading to a surge in IL-1β secretion, which triggers a cascade of inflammatory responses. Firsekibart is a fully human anti-IL-1β monoclonal antibody that binds specifically to IL-1β and neutralizes its biological activity, blocking receptor interaction and suppressing inflammation at its source. This mechanism allows for rapid pain relief during acute attacks and sustained anti-inflammatory effects during intercritical periods, helping reduce recurrence rates and inflammatory flares during urate-lowering therapy. It may also offer systemic benefits for cardiorenal and metabolic comorbidities. The approval was based on data from a randomized, double-blind, multicenter Phase III trial involving 313 patients with acute gout flares. Results showed that a single dose of Firsekibart provided pain relief within 6 hours, with a comparable 72-hour efficacy to compound betamethasone. The primary endpoint—the difference in VAS pain score at 72 hours—was -3.32 mm (95% CI: -7.56, 0.91), confirming non-inferiority. Notably, Firsekibart demonstrated superior performance in preventing recurrence: ·Median time to first gout recurrence: not reached (Firsekibart) vs. 45 days (steroid group) ·Risk reduction in first recurrence within 6 months: up to 90% ·Recurrence reduction over 24 weeks: 87%, with 85.3% of patients remaining recurrence-free—the best result among its class. The drug was well tolerated, with a treatment-related adverse event rate similar to the control group and no serious adverse events reported. Future indications for Firsekibart may include cardiovascular inflammation, osteoarthritis, diabetes, obesity, and tumor microenvironment modulation, suggesting broad clinical potential. 2. Gemcitabine (AVGEMSI, D07001-Softgel) Gemcitabine, a small-molecule chemotherapeutic agent originally developed by FUJIFILM Corporation, received its first approval in the United States on June 27, 2025, for the treatment of multiple malignancies, and was granted orphan drug designation. Gemcitabine is a pyrimidine-based antitumor drug with a mechanism of action similar to cytarabine (Ara-C). It is activated intracellularly by deoxycytidine kinase (dCK) and metabolized by cytidine deaminase. Once metabolized, its active form incorporates into DNA during the G1/S phase, inhibiting DNA synthesis. Unlike cytarabine, gemcitabine also inhibits ribonucleotide reductase, decreasing intracellular dNTP pools and further impairing DNA replication. Additionally, it inhibits deoxycytidine deaminase, reducing the degradation of its own active metabolites—effectively self-potentiating its efficacy. These pharmacodynamic features give gemcitabine a broader antitumor spectrum than cytarabine, and it has demonstrated efficacy across multiple solid tumors, including metastatic breast cancer, non-small cell lung cancer (NSCLC), ovarian cancer, and pancreatic adenocarcinoma. Clinically, gemcitabine has become a standard first-line therapy for locally advanced and metastatic NSCLC. A pivotal Phase III trial in advanced NSCLC patients showed that the gemcitabine + cisplatin combination significantly improved overall survival compared to cisplatin alone: ·Median OS: 10.7 months (combination) vs. 8.6 months (cisplatin monotherapy) ·The difference was statistically significant (p < 0.05) Gemcitabine’s safety profile has been extensively studied. While myelosuppression, gastrointestinal discomfort, and fever are common adverse effects, they are generally manageable and acceptable, confirming the drug’s suitability for routine clinical use in oncology. 3. Mazdutide (IBI362) Mazdutide (also known as IBI362) is a synthetic polypeptide drug co-developed by Eli Lilly & Co. and Innovent Biologics. It acts as a dual agonist of GLP-1 and GIP receptors, designed for the treatment of endocrine and metabolic disorders. On June 24, 2025, it received its first market approval in China, with an indication for obesity and overweight. The drug also shows promising potential in other metabolic conditions such as type 2 diabetes, obstructive sleep apnea, non-alcoholic steatohepatitis (NASH), and various forms of heart failure. Mazdutide exerts synergistic effects by simultaneously activating GLP-1 and glucagon (GCG) receptors. Activation of GLP-1 receptors delays gastric emptying, suppresses appetite, and enhances satiety, leading to reduced caloric intake. Activation of the GCG receptor promotes lipolysis and increases energy expenditure, thereby enhancing weight loss. This dual mechanism provides superior efficacy compared to single-target agents, positioning Mazdutide as a representative of next-generation metabolic regulators. Clinical studies in Chinese populations have demonstrated significant weight loss and good safety. The pivotal Phase III GLORY-1 trial, published in the New England Journal of Medicine (NEJM), enrolled 610 Chinese subjects who were overweight or obese. After 48 weeks of once-weekly subcutaneous injections, the 4 mg group experienced a mean weight loss of 11.00%, and the 6 mg group lost 14.01%, compared to 0.3% in the placebo group. Notably, nearly 50% of patients in the 6 mg group achieved at least 15% body weight reduction, with effects evident as early as week 32. Beyond weight reduction, Mazdutide also improved glycemic control, lipid profiles, and blood pressure, making it particularly beneficial for Chinese patients with metabolic syndrome. In terms of safety, Mazdutide was well tolerated. The most common adverse events were mild to moderate gastrointestinal symptoms, including nausea, vomiting, and diarrhea, which mostly occurred during early treatment and resolved over time. The once-weekly injection regimen enhances patient adherence and supports long-term disease management. 4. Tetravalent Influenza Vaccine Developed by Fosun Apexvac (Dalian) Biopharmaceutical Co., Ltd., the tetravalent split inactivated influenza vaccine was first approved in China on June 17, 2025, for the prevention of influenza virus infection. The vaccine is produced using internationally standardized embryonated egg-based manufacturing techniques, free from antibiotics and preservatives, and provides broad protection by inducing immunity against four different influenza virus strains. Influenza is an acute respiratory infectious disease caused by influenza viruses. Due to the virus’s high genetic variability and broad host range, it spreads easily among humans, resulting in 3–5 million severe cases and 290,000–650,000 deaths globally each year. The World Health Organization (WHO) emphasizes that vaccination is the most effective method for influenza prevention, especially for high-risk individuals and their close contacts. This tetravalent vaccine contains inactivated antigens from four influenza strains: two A subtypes (e.g., H1N1 and H3N2) and two B lineages. The viruses are chemically split to release key antigens, such as hemagglutinin (HA) and neuraminidase (NA), which trigger immune responses. Upon administration, antigen-presenting cells (e.g., dendritic cells) process these viral antigens and present them to helper T cells, which in turn activate B cells to produce strain-specific antibodies—especially anti-HA antibodies capable of neutralizing the virus. The vaccine also induces memory B and T cells, enabling rapid immune responses upon future exposure to similar strains. 5. 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT) The 13-valent pneumococcal polysaccharide conjugate vaccine, developed by CanSino Biologics, was first approved in China on June 17, 2025, for the prevention of Streptococcus pneumoniae infections. This multivalent conjugate vaccine targets 13 distinct pneumococcal serotypes responsible for pneumonia, meningitis, septicemia, and other invasive diseases. The vaccine functions by covalently linking capsular polysaccharide antigens of pneumococcal serotypes to protein carriers such as CRM197 (a non-toxic diphtheria toxin mutant) and tetanus toxoid (TT). This conjugation converts the normally T cell-independent polysaccharides into T cell-dependent antigens, capable of eliciting a stronger and longer-lasting immune response, particularly in infants and young children. After administration, the conjugated antigens are taken up and processed by antigen-presenting cells, then presented to CD4+ T helper cells, which activate B cells to generate serotype-specific antibodies. Additionally, the vaccine promotes the formation of memory B cells, providing long-term protection. This mechanism enables the immune system to mount a robust defense against the 13 pneumococcal serotypes, significantly reducing the risk of invasive pneumococcal disease (IPD). The vaccine is especially effective in pediatric populations, offering enhanced and durable immunity. 6. Garadacimab Garadacimab (formerly CSL312) is a fully human recombinant IgG4/λ monoclonal antibody developed by CSL Behring LLC. It was approved in the United States on June 16, 2025, for the treatment of hereditary angioedema (HAE), with additional potential applications in diseases such as idiopathic pulmonary fibrosis. HAE is a rare but potentially life-threatening genetic disorder that affects approximately 1 in 50,000 individuals. It is characterized by recurrent, painful episodes of swelling (angioedema), which can involve the larynx, gastrointestinal tract, and other critical areas. Garadacimab exerts its therapeutic effect by selectively binding to and inhibiting coagulation factor XIIa (FXIIa), a key initiator in the contact activation system involved in inflammatory and coagulation cascades. By targeting FXIIa, Garadacimab helps reduce pathological processes such as vascular leakage and inflammation, which are central to HAE pathogenesis. FXII is particularly important in HAE patients due to its role in activating the kallikrein-kinin system, leading to bradykinin-mediated angioedema. Garadacimab features an unusually long CDR-H3 loop, allowing specific binding to the β-chain of FXIIa, thereby blocking its protease activity and downstream pro-inflammatory and pro-coagulant pathways. The FDA approval was supported by efficacy and safety data from the pivotal Phase III VANGUARD trial (NCT04656418) and its open-label extension (NCT04739059). VANGUARD evaluated Garadacimab as a routine prophylactic treatment in 64 patients aged ≥12 years with Type I or II HAE, all of whom experienced ≥2 attacks during the run-in period and discontinued prior prophylactic therapies. Participants were randomized 3:2 to receive 400 mg loading dose followed by 200 mg monthly Garadacimab (n=39) or matched placebo (n=25) for 6 months. On-demand medication for breakthrough attacks was allowed. At baseline, 59.4% of participants had ≥3 HAE attacks per month (mean: 3.07/month in the Garadacimab group vs. 2.52/month in the placebo group). Garadacimab significantly reduced attack frequency and demonstrated a favorable safety profile, reinforcing its potential as a long-term preventive therapy for HAE. Additional trials in fibrotic and inflammatory diseases are ongoing, highlighting its broad therapeutic promise. 7. Taletrectinib Taletrectinib, also known by its compound name ADCT-601 or AnHeart Therapeutics' ROS1 inhibitor, is a next-generation small molecule tyrosine kinase inhibitor (TKI) targeting ROS1-positive non-small cell lung cancer (NSCLC). Co-developed by AnHeart Therapeutics (Hangzhou) and Innovent Biologics, Taletrectinib received FDA approval on June 11, 2025, for the treatment of locally advanced or metastatic ROS1-positive NSCLC. ROS1 gene rearrangements are oncogenic drivers found in approximately 1–2% of NSCLC cases and are associated with poor response to standard chemotherapy. Taletrectinib is a highly potent and selective ROS1 TKI, designed to inhibit the aberrant signaling caused by ROS1 fusions, which drive tumor growth in affected patients. Notably, it also shows efficacy against certain resistance mutations, offering therapeutic options for both treatment-naïve patients and those with acquired resistance to first-generation ROS1 inhibitors like crizotinib. FDA approval was based on results from two pivotal Phase II global multicenter studies, TRUST-I and TRUST-II, which evaluated the efficacy and safety of Taletrectinib in ROS1-positive advanced NSCLC across both treatment-naïve and pretreated populations. Patients received 600 mg orally once daily, and endpoints included objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), and intracranial response in patients with brain metastases. Taletrectinib demonstrated robust clinical activity in both cohorts. It achieved high ORR, prolonged PFS, and demonstrated notable intracranial efficacy, making it a strong candidate for managing CNS-involved disease. Safety outcomes were favorable, with manageable adverse events, supporting its use as a next-generation targeted therapy for ROS1-positive NSCLC. Its ability to overcome resistance mechanisms further positions it as a valuable treatment option for patients who have progressed on earlier ROS1-targeted agents. 8. Clesrovimab Clesrovimab (MK-1654), developed by Merck Sharp & Dohme Corp., is a long-acting monoclonal antibody that received its first FDA approval on June 9, 2025, for the prevention of respiratory syncytial virus (RSV) infection. Clesrovimab specifically targets the RSV fusion (F) protein, a critical viral surface protein required for viral entry into host cells. By binding with high affinity to the F protein, Clesrovimab not only blocks the fusion process between the virus and host cell membranes—thereby preventing viral entry—but also enhances the immune system’s ability to recognize and eliminate the virus. Importantly, since the F protein is highly conserved across all RSV subtypes, Clesrovimab exhibits broad-spectrum antiviral activity against a wide range of RSV strains. As a passive immunization therapy, Clesrovimab’s extended half-life allows it to deliver direct, rapid, and long-lasting protection against RSV infection in healthy preterm infants, full-term infants, and high-risk infants. The antibody is designed to protect infants during their first RSV season against mild, moderate, and severe RSV disease. Data from the pivotal Phase 2b/3 CLEVER trial demonstrated that a single dose of Clesrovimab reduced medically attended RSV lower respiratory tract infections by 60.5% and hospitalizations due to RSV by 84.3% within 150 days post-treatment. Further evidence from the SMART Phase 3 study validated Clesrovimab’s efficacy and safety in both preterm and full-term infants, as well as high-risk populations, where it showed superior performance compared to existing standard preventive therapies. 9. Amlodipine Besylate/Indapamide/Telmisartan Amlodipine Besylate/Indapamide/Telmisartan, marketed as Widaplik, is a fixed-dose triple combination therapy developed by George Medicines Pty Ltd. It received its first FDA approval on June 5, 2025, for the treatment of hypertension. Widaplik is the first and currently only FDA-approved triple-combination product specifically designed for patients who may require multiple antihypertensive agents to achieve optimal blood pressure control. Widaplik combines three active components, each with a distinct antihypertensive mechanism: ·Amlodipine, a calcium channel blocker, relaxes vascular smooth muscle by inhibiting calcium influx into cardiac and arterial wall cells. ·Telmisartan, an angiotensin II receptor blocker (ARB), prevents vasoconstriction and reduces fluid retention by blocking angiotensin II. ·Indapamide, a thiazide-like diuretic, promotes the excretion of sodium and water, further lowering blood pressure. Approval was supported by two pivotal clinical studies: Study 1 enrolled 295 patients with systolic hypertension who were either treatment-naïve or on monotherapy. Following a 2-week placebo run-in, patients were randomized to receive different doses of Widaplik or placebo. At week 4, both Widaplik doses significantly reduced home-measured systolic blood pressure compared to placebo (P < 0.0001), with most of the antihypertensive effect observed within the first two weeks. Study 2 compared Widaplik to dual-component therapies. At week 12, Widaplik achieved superior reductions in home systolic blood pressure versus all dual-therapy arms (P < 0.0001). The effect was consistent across age, sex, and racial subgroups. In terms of safety, Widaplik was generally well tolerated. The most common adverse events were symptomatic hypotension and electrolyte imbalances such as hyponatremia and hypokalemia. Summary June 2025 marked the approval and launch of several milestone new drugs in the global pharmaceutical landscape, representing significant advances across multiple therapeutic areas. From targeted precision therapies like Taletrectinib and Garadacimab, to multimodal combination regimens like Widaplik, and passive immunization agents such as Clesrovimab and Genakumab, to next-generation vaccines like the quadrivalent influenza vaccine and the 13-valent pneumococcal conjugate vaccine, these innovative products exemplify the synergistic potential of biologics and small molecules. Together, they are not only enhancing treatment efficacy across various diseases but are also shaping the future of personalized, effective, and sustainable medicine. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 10, 2025 /PRNewswire/ -- USA News Group News Commentary – Cancer rates are rising everywhere, but more dramatically in some places. According to a new analysis of CDC data, Maine currently has the highest rates among US states, while Utah has the lowest. However, another study found that survival rates for cancer patients on immunotherapy depend on their insurance coverage, whether it be through private, Medicaid, or those who are uninsured. With cases for several types of cancers, such as breast cancer, there is plenty of new tech innovation for diagnosis and treatments coming from the private sector. With public resources under pressure, and the cancer research budget for the National Cancer Institute set to be slashed by up to 40%, the oncology landscape is looking towards a new generation of biotechs to step up—including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Kazia Therapeutics Limited (NASDAQ: KZIA), Immuneering Corporation (NASDAQ: IMRX), Nuvation Bio Inc. (NYSE: NUVB), and Calidi Biotherapeutics Inc. (NYSE-American: CLDI). Continue Reading Cancer Innovation Accelerates as Funding Cuts Loom and Biotechs Step Up While U.S. cancer death rates continue to decline, global cancer cases are expected to rise sharply. As well, early-onset diagnoses in younger patients are climbing at a troubling pace. Now, industry analysts are estimating the global oncology drug market could surpass US$900 billion in revenue by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently highlighted survival data and an upcoming KOL webinar that together underscore growing expert and clinical support for its virus-based immunotherapy, pelareorep, in hard-to-treat cancers like metastatic pancreatic and breast cancer. In first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), pelareorep-based treatment regimens have shown a two-year overall survival rate of 21.9% across pooled data from more than 100 patients—more than double the historical benchmark of 9.2%. In a separate single-arm study combining pelareorep with chemotherapy and a checkpoint inhibitor, the objective response rate reached 62% in evaluable patients. No immunotherapy is currently approved in this indication. "We are no longer in the business of funding proof-of-concept studies," said Jared Kelly, newly-appointed CEO of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology." HR+/HER2- metastatic breast cancer (mBC) has also shown strong survival numbers. In HR+/HER2- mBC, pelareorep extended median overall survival by more than 10 months across two randomized trials. The BRACELET-1 trial also showed median progression-free survival of 12.1 months, nearly double the 6.4 months in the control arm. The company recently reinforced its leadership bench with two high-profile appointments—naming Jared Kelly as Chief Executive Officer and Andrew Aromando as Chief Business Officer—as it sharpens its focus on late-stage development and strategic transactions. Both Kelly and Aromando played instrumental roles in Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson, and bring deep experience in value creation, partnerships, and registration pathways in oncology. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Oncolytics will host a KOL webinar on July 22 featuring leading GI and immuno-oncology experts to discuss pelareorep's data and positioning in pancreatic and gastrointestinal cancers. Participating physicians include the GOBLET trial's primary investigator as well as global leaders in immunotherapy and clinical trial design, underscoring the growing interest in pelareorep's mechanism and outcomes. Pelareorep currently holds FDA Fast Track designation in both mPDAC (pancreatic cancer) and HR+/HER2- mBC (breast cancer), with Orphan Drug status for pancreatic cancer in the U.S. and Europe. Across more than 1,100 patients treated to date, pelareorep has maintained a favorable safety profile, with most adverse events limited to flu-like symptoms. The drug has shown broad synergy with checkpoint inhibitors and chemotherapies and continues to generate immune responses in multiple solid tumor types. Oncolytics is advancing toward registration-enabling trials and partnership opportunities with a disciplined, investor-aligned approach to growth. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Kazia Therapeutics Limited (NASDAQ: KZIA) shared encouraging early data from its Phase 1b trial evaluating paxalisib alongside Keytruda and chemotherapy in triple-negative breast cancer. The first patient, a 61-year-old woman with lung metastases, experienced a greater than 50% reduction in circulating tumor cells (CTCs) after just one treatment cycle. "The degree of reduction in tumor cell dissemination markers in just 21 days gives us strong reason for optimism as we continue this clinical trial," said Dr. John Friend, MD, CEO of Kazia Therapeutics. "CTC clusters are emerging as key drivers of metastatic spread—they're 20–100X more efficient at seeding than single CTCs—and the sharp decline we're seeing is truly encouraging. We believe this combination may offer a meaningful early intervention against systemic disease progression." Notably, both single CTCs and clusters—key drivers of metastasis—were sharply reduced, along with the mesenchymal phenotype often linked to aggressive disease. These initial results echo Kazia's preclinical findings and hint at the potential for meaningful anti-metastatic activity early in treatment. Immuneering Corporation (NASDAQ: IMRX) has been granted a U.S. composition of matter patent for atebimetinib, a once-daily oral cancer drug designed to overcome resistance and deliver longer-lasting benefits. In an ongoing Phase 2a study, the drug showed a 94% six-month survival rate in first-line pancreatic cancer—compared to 67% with standard care—while maintaining a strong safety profile. "Our priorities are to make medicines that keep working, so cancer patients keep living, and to make medicines that have fewer side effects, so cancer patients can feel like themselves and live normal lives," said Ben Zeskind, Ph.D., Co-founder and CEO of Immuneering. "We have already observed exceptional durability and a markedly favorable tolerability profile in first-line pancreatic cancer patients treated with atebimetinib+mGnP, and this is just the beginning of the important impact that we believe atebimetinib and our entire pipeline of deep cyclic inhibitors will have on the treatment of cancer." The patent provides exclusivity into 2042, with potential extension, supporting Immuneering's broader strategy to advance this "deep cyclic" MEK inhibitor across multiple tumor types. Nuvation Bio Inc. (NYSE: NUVB) has announced that IBTROZI (taletrectinib)—its newly FDA-approved targeted therapy for advanced ROS1+ non-small cell lung cancer (NSCLC)—has now been added as a Preferred Agent in the latest National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines. This designation applies to both first-line and follow-up treatment, and specifically highlights IBTROZI's benefit for patients with brain metastases and resistance mutations. "We are very pleased the NCCN acted with such urgency to review and update the NCCN Guidelines to include taletrectinib (IBTROZI) as a preferred option for advanced ROS1-positive NSCLC across treatment lines, with particular recognition of benefit for patients with brain metastases and those with acquired resistance after first-line therapy," said David Hung, M.D., Founder, President and CEO of Nuvation Bio. "These updates address critical needs for patients across their treatment journeys, especially with the prevalence of CNS involvement for those living with ROS1+ NSCLC. Additionally, this version builds further upon a previous guideline update that importantly highlights preferred utilization of ROS1-targeted agents instead of immunotherapy and chemotherapy for these patients." The update strengthens IBTROZI's position as a next-generation treatment in a rare, aggressive lung cancer that often spreads to the brain. Calidi Biotherapeutics Inc. (NYSE-American: CLDI) is gaining traction as it advances CLD-401, a next-generation systemic virotherapy armed with CD55-enhanced shielding and an IL-15 superagonist payload to improve immune activation and tumor penetration. Preclinical data presented at ASCO 2025 showed the platform's potential to evade immune clearance, target metastatic tumors, and stimulate both NK and CD8+ T cell responses—supporting its promise as an off-the-shelf immunotherapy for difficult-to-treat cancers. The company recently secured $4.6 million in funding through warrant exercises and reaffirmed its IND submission timeline and partnering goals in a shareholder update. "Looking ahead, our roadmap for the next 18 months includes multiple critical milestones," said Eric Poma, PhD, CEO of Calidi in a shareholder letter. "We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an aggressive dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of Redtail in patients with metastatic disease." With clinical readiness targeted for 2026, Calidi appears well-positioned at the intersection of innovation, execution, and immuno-oncology momentum. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). 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