On June 16, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that the first patient has been dosed in the TARGET-D 201 Phase 2 registration-directed trial (NCT07644559) evaluating VS-7375, an investigational oral KRAS G12D (ON/OFF) inhibitor with best-in-class potential, to treat patients with KRAS G12D-mutated metastatic pancreatic ductal carcinoma (mPDAC).

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"Dosing the first patient in the TARGET-D 201 trial marks an important milestone in the development of VS-7375 for patients with KRAS G12D-mutated metastatic pancreatic cancer, where unmet need remains high," said Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology. "We believe VS-7375 has a differentiated profile, including potent KRAS G12D target inhibition and sustained target coverage, supporting its potential to play a significant role in treating multiple KRAS G12D-mutated tumor types. With three registration-directed Phase 2 clinical trials now underway across pancreatic, non-small cell lung, and colorectal cancers, and FDA Fast Track designations in pancreatic and non-small cell lung cancers, we are focused on accelerating development of VS-7375 as quickly as possible across multiple tumor types where no approved treatments exist."

TARGET-D 201 is a Phase 2, open-label, multi-center study to evaluate VS-7375 at 900 mg once daily (QD) both as monotherapy and in combination with full-dose cetuximab in patients with second-line metastatic pancreatic ductal carcinoma. The study is also evaluating VS-7375 900 mg and cetuximab in the first-line mPDAC setting, representing a potential chemotherapy-free frontline regimen. FDA Fast Track Designation was previously granted for VS-7375 for the treatment of KRAS G12D-mutated advanced or metastatic pancreatic cancer in both the first- and second-line treatment settings.

In June 2025, Verastem initiated TARGET-D 101, its Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating VS-7375 in patients with advanced KRAS G12D-mutated pancreatic, non-small cell lung, colorectal, and other solid tumor cancers. Enrollment is ongoing with monotherapy dose escalation progressing from 400 mg through 900 mg QD doses without dose-limiting toxicities or major safety concerns observed to date. The study is currently evaluating a 1200 mg QD monotherapy dose and a 900 mg QD dose of VS-7375 in combination with full-dose cetuximab, as well as combinations with either gemcitabine plus nab-paclitaxel or carboplatin/pemetrexed/pembrolizumab.

About Pancreatic Cancer
Pancreatic cancer is the third leading cause of cancer-related death in the U.S. and seventh leading cause of cancer-associated mortality worldwide. Metastatic pancreatic cancer, or stage IV disease, occurs when the cancer spreads beyond the pancreas to distant organs. More than 90% of pancreatic cancers harbor KRAS mutations, underscoring the central role of KRAS in the development and the progression of the disease. Approximately 40% of pancreatic tumors harbor a KRAS G12D mutation, the most prevalent subtype in pancreatic cancer. Each year, more than 30,000 people in the U.S. and over 240,000 people globally are diagnosed with metastatic pancreatic cancer. There has been minimal progress with treatment, and the five-year survival rate remains approximately 3%. Current treatment approaches may include surgery, chemotherapy, radiation therapy, targeted therapies, or a combination of these modalities.

About KRAS G12D
KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. When the KRAS gene is mutated, it can promote cancer development and growth. Patients with KRAS G12D-mutant tumors often have poorer outcomes, underscoring the need for therapies designed specifically to inhibit this mutation potently and for a long duration. The KRAS G12D mutation occurs most commonly in pancreatic (40%), colorectal (15%), endometrial (8%), biliary tract (7-15%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor & the 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 metastatic pancreatic ductal carcinoma, TARGET-D 202 in advanced non-small cell lung cancer, and TARGET-D 203 in metastatic colorectal cancer.

In July 2025, the 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 16, 2026, View Source [SID1234668761])

On June 16, 2026 Vivesto AB, an oncology-focused development company, reported positive results from its exploratory pharmacokinetic (PK) and toxicology study with Cantrixil. The study is the first conducted with Cantrixil administrated intravenously (i.v.) in a larger animal species (dog). The data support continued development of Cantrixil toward a Phase I clinical trial in acute myeloid leukemia (AML) in humans, and a pilot study in dogs with cancer.

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The study results demonstrate that i.v. Cantrixil was well tolerated at all dose levels, with no adverse findings, no cardiovascular effects, and no signs of local irritation or toxicity at the injection site. Pharmacokinetic parameters, including blood concentration levels and half-life, were consistent with expectations and complement prior preclinical data.

"We are pleased to report that intravenous administration of Cantrixil was well tolerated and that both primary objectives were met in this exploratory study. We now have important information to complete the preclinical package needed to prepare a Phase I clinical trial in human AML, and the pharmacokinetic and safety data required to initiate a pilot study in dogs with cancer," says Erik Kinnman, CEO of Vivesto.

In the PK/toxicology study, four dogs received increasing i.v. doses of Cantrixil in three rounds at 2, 5 and 10 mg/kg. The study design and day 7 assessments support the intended once-weekly dosing frequency for both humans and dogs.

Cantrixil was well tolerated by all dogs, with no adverse or toxicologically relevant findings. No cardiovascular adverse effects were reported, a particularly important finding as cardiovascular toxicity is a known and often dose-limiting risk for cytotoxic agents. Furthermore, there were no local signs of irritation or toxicity at the injection site.
Hematological and clinical biochemistry parameters, which were analyzed before treatment start and 7 days after each treatment administration, a common timepoint for assessing cytotoxic agents, showed no alterations.

The pharmacokinetic parameters of Cantrixil, including blood concentration levels, were in line with previous observations from the in vivo study performed in a mouse model of AML earlier last year. Drug half-life was as expected, confirming that the i.v. formulation performs as intended and is consistent with existing preclinical documentation.

Together with previous findings, these new results support the continued advancement of Cantrixil toward a Phase I clinical trial in AML in humans, in parallel with continued CMC development to produce clinical trial material.

As previously announced, Vivesto is also developing Cantrixil for dogs with cancer, building on its anti-cancer mechanism of action and synergies with the company’s existing veterinary oncology program.

(Press release, Vivesto, JUN 16, 2026, View Source [SID1234668760])

On June 16, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported the closing of its license agreement for VEPPANUTM (vepdegestrant), following the early termination of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976 and satisfaction of other customary closing conditions. Rigel previously announced it entered into an exclusive, global license agreement with Arvinas, Inc. (Arvinas) and Pfizer Inc. (Pfizer) to develop, manufacture and commercialize VEPPANU. VEPPANU is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

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The agreement is effective as of June 11, 2026 and Rigel has made the upfront payment of $70.0 million to be distributed evenly between Arvinas and Pfizer, consistent with the terms of the agreement.

Rigel expects to make VEPPANU commercially available in August.

About VEPPANUTM (vepdegestrant)

INDICATION
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor–1 (ESR1)–mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
QTc Interval Prolongation
VEPPANU can cause QT (QTc) interval prolongation. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and during treatment with VEPPANU. Perform an ECG prior to initiation of treatment with VEPPANU and do not initiate VEPPANU in patients with QTc >470 msec. Repeat ECG approximately 4 weeks after initiating treatment and as clinically indicated. Avoid concomitant use of VEPPANU with strong CYP3A inhibitors or drugs known to prolong the QTc interval.

Embryo-Fetal Toxicity
Based on findings from animal studies and its mechanism of action, VEPPANU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose.

ADVERSE REACTIONS
Serious adverse reactions occurred in 9% of patients who received VEPPANU. The serious adverse reactions included any fracture (1.3%), fall, hypercalcemia, hepatic injury, pneumonia, musculoskeletal pain (0.6% each), and QTc prolonged (0.3%). Fatal adverse reactions occurred in 1.0% of patients who received VEPPANU, including dyspnea, cerebral ischemia, and unknown cause (one patient each).

Permanent discontinuation of VEPPANU due to an adverse reaction occurred in 2.9% of patients, dosage interruptions of VEPPANU due to an adverse reaction occurred in 14% of patients, and dosage reductions of VEPPANU due to an adverse reaction occurred in 1.9% of patients.

The most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation.

Clinically relevant adverse reactions in <10% of patients who received VEPPANU included headache, hot flush, diarrhea, vomiting, bradycardia, and urinary tract infection.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid concomitant use of VEPPANU with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce VEPPANU dosage.
Strong CYP3A Inducers: Avoid concomitant use with strong CYP3A inducers in patients receiving VEPPANU. If concomitant use cannot be avoided, increase VEPPANU dosage.
Certain P-gp Substrates: Avoid concomitant use with certain P-gp substrates where minimal increases in concentration may lead to serious adverse reactions.
Certain UGT1A9 Substrates: Refer to the Prescribing Information for UGT1A9 substrates where minimal increases in the concentration may lead to serious adverse reactions.
Avoid concomitant use of VEPPANU with other drugs with a known potential to prolong the QTc interval.

LACTATION
Advise lactating women not to breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.

Click here for Important Safety Information and Full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

VEPPANU is a trademark of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, JUN 16, 2026, View Source [SID1234668759])

On June 16, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported it has amended the clinical study protocol for the Phase 1/1b trial of PAS-004 in neurofibromatosis type 1 (NF1) patients with symptomatic inoperable, incompletely resected, or recurrent plexiform neurofibroma (PN). The amendments include an update to the dose escalation part of the study (Part A) to allow for the enrollment of additional participants at two additional higher dose levels (24mg and 32mg), the ability to backfill completed dose cohorts (4mg, 8mg, 12mg and 18mg) with up to two participants, and the evaluation of intermediate dose levels.

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In addition, the protocol amendments allow patients to remain on treatment for up to 18 months in Part A, and include additional MRI scans to comprehensively evaluate PN, as well as adding more detailed cutaneous neurofibroma (CN) measurements, including tumor height and volume.

Pasithea has completed enrollment and multi-cycle dosing of the initial 4mg, 8mg, 12mg and 18mg cohorts, and enrolled the 24mg cohort and an intermediate 15mg cohort.

"We believe increasing the breadth and depth of Part A of the NF1 study will help inform dose selection for Part B and our future registrational studies," said Dr. Kartik Krishnan, Chief Medical Officer, Pasithea. "I am pleased that we rapidly enrolled and dosed an additional 6 patients and that the amendments will allow us to provide more comprehensive data in 2026."

This multicenter, phase 1/1b, open-label study is divided into two parts: a dose-escalation phase (part A) and an expansion cohort phase (part B). To date, the dose-escalation phase has enrolled and dosed 18 patients with NF1.

About NF1- PN
Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

(Press release, Pasithea Therapeutics, JUN 16, 2026, View Source [SID1234668758])

On June 16, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, reported that the United States Patent and Trademark Office ("USPTO") has issued a new patent broadly protecting the Company’s proprietary manufacturing process for pelareorep.

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The newly issued patent covers key aspects of the methods used to manufacture pelareorep and is expected to provide intellectual property protection into 2044. The patent is designed to protect the Company’s ability to consistently produce pelareorep at commercial scale and represents a significant addition to Oncolytics’ growing intellectual property portfolio.

The Company also announced that a previously filed method-of-use patent application directed at pelareorep’s use as an immunotherapy remains under review and, if issued, is expected to provide protection into the year 2046. In addition, Oncolytics plans to file further patent applications this year that are designed to expand and strengthen the pelareorep intellectual property estate across additional therapeutic applications, treatment settings, and combination approaches.

"Building a strong intellectual property estate around pelareorep is an important part of our strategy as we advance the program toward potential registration and commercialization," said Jared Kelly, Chief Executive Officer of Oncolytics. "This newly issued patent strengthens our protection around the manufacturing of pelareorep and supports our ability to produce the product at commercial scale. Combined with our previously filed method-of-use patent application and additional planned filings, we continue to build a durable patent portfolio designed to support the long-term value of pelareorep. Checking this box represents another important milestone as we execute on our strategy and move pelareorep into its next phase of development."

The Company’s intellectual property strategy is focused on protecting pelareorep through a combination of manufacturing, method-of-use, formulation, and combination therapy patents designed to support the continued development and commercialization of pelareorep across multiple oncology indications.

(Press release, Oncolytics Biotech, JUN 16, 2026, View Source [SID1234668757])