On June 15, 2026 TuHURA Biosciences, Inc. (NASDAQ: HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the study of its TBS-2025 VISTA inhibiting antibody for the treatment of molecularly defined subsets of AML and other blood related cancers. The IND is being filed following detailed feedback and guidance from the FDA on the IND filed in February 2026.

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"We are excited to be the first company to advance a VISTA-inhibiting antibody for investigation in hematologic cancers, targeting molecularly defined subsets of AML, including those with NPM1 and in the future, FLT3-ITD mutations, two of the most common mutations present in approximately 60-70% of patients with AML. We also plan to include patients with relapsed/refractory (r/r) high-risk myelodysplasia (MDS), where VISTA expression, like in AML, generally correlates with low response rates and poor survival outcomes," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "Currently, there are no approved or effective treatment options for these patient populations, representing a significant unmet medical need."

Dr. Craig Tendler, Chief Medical Officer consultant overseeing the TBS-2025 development program and Board member of TuHURA Biosciences, added, "The FDA provided valuable feedback and comprehensive guidance on trial design, which we incorporated into our proposed Phase1b dose optimization trial. Our plan is to combine the Phase 1b with the Phase 2 study for a combination study design that is much more efficient and could potentially save 4-6 months in development time. We look forward to FDA’s written responses anticipated to be received next month and, depending on the responses, are targeting initiating the Phase 1b/2 trial of TBS-2025 in the second half of 2026."

The Phase 1b portion of the study will examine the safety and potential efficacy of monotherapy dose levels in relapsed/refractory (r/r) AML patients, most of whom will harbor the NPM1 mutation and have failed to respond or relapsed after menin inhibitor therapy. In the planned protocol, if a safe and biologically effective dose is identified, the Company will review the data with the FDA to discuss the potential to expand the study at a recommended Phase 2 dose determined in the Phase 1b, to pursue a potential accelerated approval pathway, a development path similar to that of menin inhibitors in this molecular subset of patients with r/r mutNPM1 AML.

It is anticipated that the Phase 2 portion of the study will explore the potential of TBS-2025 to improve complete response rates and duration of response when used in combination with menin inhibitors in patients with mutNPM1 r/r AML.

About TBS-2025
TBS-2025 is a unique VISTA-inhibiting monoclonal antibody. VISTA is a novel checkpoint expressed on quiescent (resting) T cells and highly expressed on myeloid cells, notably myeloid derived suppressor cells (MDSCs). Scientific evidence demonstrates that mutNPM1 has demonstrated the mutation drives the expression of VISTA on leukemic blasts, which is reported to be the primary mechanisms by which AML escapes recognition by the patient’s immune system, resulting in low response rates of short duration following current therapies, including recently approved menin inhibitors. When VSIR, the gene that encodes for VISTA, is removed in murine models of mutNPM1 AML, an immune response is observed and survival is enhanced. Similarly, in a murine model of AML, TBS-2025 resulted in an increase in survival comparable to intensive chemotherapy regimen that is currently used in front line treatment of patients with AML. When combined with intensive chemotherapy, survival was markedly improved. Collectively, these data underscore the potential for TBS-2025 in the treatment of patients with AML

TBS 2025 was initially investigated in a large Phase 1 trial as either monotherapy (n=24) or in combination with pembrolizumab (n=15) among patients with advanced, therapy refractory cancers, including breast, lung, colorectal, and ovarian cancer. The purpose of the study was to investigate its safety profile and determine the recommended Phase 2 dose for solid tumors. The drug demonstrated a favorable safety profile even at the highest dose level of 1,000mg administered every two weeks. Safety and pharmacokinetic data from this trial was helpful in designing the Phase 1b segment of the planned trial in AML.

(Press release, TuHURA Biosciences, JUN 15, 2026, View Source [SID1234668741])

On June 15, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) seeking approval of ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. The FDA has not identified any filing review issues at this time and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027. "The FDA’s acceptance of our BLA for ozekibart is a monumental milestone for Inhibrx and, more importantly, for the chondrosarcoma community," said Mark Lappe, Chief Executive Officer of Inhibrx. "Chondrosarcoma is an aggressive and devastating bone cancer and there are currently no approved therapies for patients suffering from this disease. We look forward to working closely with the FDA during this review process to potentially bring this first-in-class targeted therapy to patients as quickly as possible."

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The BLA is supported by positive results from the ChonDRAgon study, a randomized, blinded, placebo-controlled, registrational trial of ozekibart in patients with metastatic or unresectable conventional chondrosarcoma, which met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio [HR] 0.479; 95% CI: 0.33, 0.68; P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Importantly, ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a blinded, randomized trial for chondrosarcoma, a disease with no approved systemic options.

If approved, ozekibart would become the first commercial product for Inhibrx and the first-ever approved systemic therapeutic for patients with unresectable or metastatic conventional chondrosarcoma.

About Chondrosarcoma
Chondrosarcoma is a rare type of cancer that primarily develops in the cartilage cells of bones, most commonly affecting the pelvis, hip, and shoulder. It stands as the second most common primary bone malignancy. When the disease becomes unresectable or metastatic, the prognosis is historically poor because the tumors are largely unresponsive to traditional oncology treatments, leaving surgical resection as the only effective management strategy for localized disease.

About ozekibart (INBRX-109)

Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.

In June 2021, Inhibrx initiated the ChonDRAgon study, a randomized, blinded, placebo-controlled, registrational trial of ozekibart in metastatic, unresectable conventional chondrosarcoma. The trial enrolled a total of 206 patients across 67 different sites worldwide. The primary objective of the trial was the evaluation of the efficacy of ozekibart as measured by median PFS, assessed by central real-time independent radiology review per RECIST 1.1. Secondary objectives were the evaluation of overall survival, median PFS by investigator assessment, quality of life, objective response rate, duration of response, disease control rate, safety and tolerability, pharmacokinetics and anti-drug antibodies to ozekibart.

Key enrollment criteria in order for patients to qualify for inclusion in the trial were grade 2 or 3 unresectable or metastatic conventional chondrosarcoma. Patients received either ozekibart or placebo every three weeks at a randomization of 2:1, stratified by the line of therapy, grade and IDH1/2 mutation status.

Patients randomized to the placebo arm were allowed to crossover to receive ozekibart upon confirmation of progression as reported by central independent radiology review.

The ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio [HR] 0.479; 95% CI: 0.33, 0.68); P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Importantly, ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options.

The benefit of ozekibart was consistent across all pre-specified subgroups, including patients with IDH-wild-type and IDH-mutant tumors. Other key secondary endpoints, including disease control rate (54% vs 27.5%), and delay to deterioration in pain and physical function, further supported the clinical benefit observed with ozekibart.

Ozekibart was generally well tolerated, with a manageable safety profile. The most common treatment-related adverse events were fatigue, constipation, and nausea. Hepatotoxicity, a known risk for this mechanism of action, occurs during the first treatment cycle and is in patients with underlying hepatic impairment. One hepatotoxicity-related fatal event occurred early in the study, prior to the implementation of mitigation measures. Over the course of the ChonDRAgon study, this risk was effectively mitigated by excluding patients with severe liver impairment and by implementing close monitoring during early treatment cycles, allowing for prompt management of liver enzyme elevations. This approach resulted in a low overall incidence of treatment-related hepatic adverse events, 11.8% compared to 4.5% in the placebo arm, the majority of which were Grade 1 or 2 in severity.

In addition to the registrational trial in chondrosarcoma, Inhibrx is advancing ongoing expansion cohorts, evaluating ozekibart in combination with irinotecan-based regimens in Ewing sarcoma and colorectal cancer. Encouraging early signals support further exploration of ozekibart’s potential in these difficult-to-treat tumor types with high unmet medical need.

(Press release, Inhibrx, JUN 15, 2026, View Source [SID1234668740])

On June 15, 2026 Lonza and Antharis Therapeutics, Inc., a biopharmaceutical company developing next-generation antibody-based therapeutics for oncology, reported an exclusive, target-specific licensing agreement to develop novel dual-payload ADCs targeting gastrointestinal (GI) cancers.

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Antharis Therapeutics utilizes cutting-edge proprietary antibody engineering and target biology expertise to develop next-generation therapeutic monoclonal antibodies (mAbs), bispecifics and ADCs, designed to address unmet medical needs in oncology. Through this agreement, Antharis will integrate its proprietary antibody engineering and target biology expertise with Lonza’s clinically validated, site-specific ADC technologies.

Under the terms of the agreement, Antharis will secure rights to Lonza’s dual-payload ADC technology platform, which will be combined with Antharis’ proprietary discovery and development capabilities to advance highly differentiated, next generation ADC programs for multicancer applications.

The collaboration will initially support Antharis’ lead ADC program, about to enter the clinic, targeting GI cancers, and reflects the shared commitment of Antharis and Lonza to developing first-in-class and best-in-class, biology-driven ADCs with potential for overcoming multi-drug resistance and increasing overall survival rates.

Jan Vertommen, Vice President of Commercial Development, Advanced Synthesis, Lonza, said: "This licensing agreement highlights an exciting new innovation based on Lonza’s proprietary dual payload technology. We are excited to combine our platform with Antharis’ deep expertise in antibody engineering and target biology to evaluate its potential to advance next generation ADCs. We are pleased to see this collaboration applied within Antharis’ ambitious and scientifically rigorous ADC programs."

Raphael Ribeiro Pinaud, CEO of Antharis Therapeutics, said: "This collaboration represents a major strategic milestone for Antharis. By combining Lonza’s clinically validated ADC technology platform with Antharis’ antibody engineering, target biology and translational expertise, we are well positioned to advance next-generation dual-payload ADCs. We believe this collaboration creates a powerful and highly differentiated approach to oncology drug development."

Under the terms of the agreement, Antharis will retain full responsibility for research, clinical development, manufacturing and commercialization of the ADCs, while Lonza will manufacture components related to its proprietary payload and linker technologies. Lonza will be eligible to receive upfront, potential milestone payments and royalty payments on net sales.

(Press release, Lonza, JUN 15, 2026, View Source [SID1234668739])

On June 15, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported it will host an investor conference call and webcast on Tuesday, June 23 at 4:30 pm ET to report progress across the VS-7375 oral KRAS G12D (ON/OFF) TARGET-D clinical program and updated preliminary data from the Phase 1/2 TARGET-D 101 dose escalation and dose expansion trial evaluating VS-7375 alone and in combination in patients with KRAS G12D-mutated advanced solid tumors.

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During the call, Verastem’s management team will present preliminary data from the TARGET-D 101 dose-escalation and dose expansion cohorts across pancreatic, colorectal, and non-small lung cancers, including updated safety and tolerability, pharmacokinetic findings, as well as patient case studies evaluating VS-7375 both as a monotherapy and in combination across multiple tumor types.

Webcast Information
On June 23rd at 4:30 p.m. ET, a live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be archived and available following the event.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor & TARGET-D Clinical Program
VS-7375 is a potential best-in-class, potent, and selective investigational oral KRAS G12D dual ON/OFF inhibitor. It is designed to uniquely bind to both the active (ON) and inactive (OFF) states of KRAS G12D, with the potential to inhibit KRAS G12D signaling and tumor growth more completely than compounds that block KRAS G12D only in the OFF state or only in the ON state.

In June 2025, Verastem initiated TARGET-D 101, a Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. Verastem has further expanded the VS-7375 clinical program with the initiation of three Phase 2 registration-directed, open-label clinical trials: TARGET-D 201 (NCT07644559) in second-line advanced or metastatic pancreatic ductal carcinoma, TARGET-D 202 in second/third-line advanced or metastatic non-small cell lung cancer, and TARGET-D 203 in metastatic colorectal cancer.

In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic pancreatic ductal carcinoma who have received at least one prior line of standard systemic therapy. In June 2026, the FDA also granted FTD to VS-7375 for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially.

In December 2023, Verastem selected VS-7375 as its lead program from its collaboration with GenFleet Therapeutics, which aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. In January 2025, Verastem exercised its license for VS-7375. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. GenFleet is developing VS-7375 as GFH375 in China.

(Press release, Verastem, JUN 15, 2026, View Source [SID1234668738])

On June 15, 2026 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE) reported that it has changed its corporate name to Faeth Therapeutics, Inc. (the "Company"). The Company’s common stock is expected to begin trading on the Nasdaq Capital Market under the new ticker symbol "FTH" on June 16, 2026, and the Company has launched a new corporate website at www.faeththerapeutics.com.

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On June 10, 2026, stockholders approved the conversion of the Company’s Series B preferred stock issued in connection with the February 2026 acquisition of Faeth Therapeutics and concurrent private placement. As a result, outstanding shares of the Company’s Series B convertible preferred stock will automatically convert into common stock effective at 5:00 p.m. ET on June 15, 2026, subject to certain beneficial ownership limitations set by each holder. The Company received approximately $200 million in gross proceeds from the private placement that closed concurrently with its February 2026 acquisition of Faeth.

"Starting tomorrow, we will begin trading on Nasdaq under our new name and ticker as a well-capitalized public company backed by a syndicate of leading life sciences investors, and focused on a clear set of clinical catalysts," said Anand Parikh, Chairman and Chief Executive Officer. "For two decades, drugs that block a single node of the PI3K/AKT/mTOR pathway have been undone by the tumor’s ability to route around them. PIKTOR represents our answer to this challenge: an all-oral regimen that patients can take at home, designed to inhibit PI3K-alpha, mTORC1 and mTORC2 at once, close the routes tumors may use to escape, and potentially drive deeper, more durable suppression, with the potential for a best-in-class profile. We believe we now have the capital and the team to put that approach to the test, beginning with topline Phase 2 data in advanced endometrial cancer, expected in the second half of this year, and interim Phase 1b/2 data in HR+/HER2- advanced breast cancer, expected in 2027."

Leadership and Board

Effective June 12, 2026, the Company appointed a new executive leadership team. Anand Parikh, a co-founder of Faeth who has led the company since its founding in 2019, has been appointed Chairman, President and Chief Executive Officer. Brian Stephenson, Ph.D., CFA, who previously served as the Company’s Head of Operations and Finance and as Chief Financial Officer of BridgeBio Pharma, Inc., has been appointed Chief Financial Officer. Oliver Maddocks, Ph.D., a co-founder of Faeth and a cancer-metabolism researcher, serves as Chief Scientific Officer, and Debbie Chirnomas, M.D., M.P.H., serves as Chief Medical Officer.

The Company’s board of directors consists of five members: Anand Parikh (Chair); Bob Holmen; Phillip B. Donenberg; Stephen M. Hahn, M.D.; and Saira Ramasastry. Dr. Hahn, the 24th Commissioner of the U.S. Food and Drug Administration and a former Faeth director, and Ms. Ramasastry, a life sciences strategic advisor and experienced public-company director, joined the board on June 12, 2026.

"In a career spent in oncology and at the FDA, I’ve learned how rarely a program pairs a high-prevalence target with a potentially differentiated mechanism," said Stephen M. Hahn, M.D., the 24th Commissioner of the U.S. Food and Drug Administration and a member of the Company’s board of directors. "I believe Faeth’s multi-node, all-oral approach to the PI3K/AKT/mTOR pathway is scientifically rigorous and aimed at a real unmet need. I’m looking forward to guiding the company through this next stage of clinical development."

About PIKTOR

PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. According to published literature, this pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated in the second half of 2026, and in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April 2026 and interim data is anticipated in 2027.

(Press release, Faeth Therapeutics, JUN 15, 2026, View Source [SID1234668737])