On June 2, 2026 Evogene Ltd. ("Evogene") (Nasdaq: EVGN) (TASE: EVGN), a pioneering computational chemistry company specializing in generative design of small molecules for the pharmaceutical and agricultural industries, reported the successful completion of the first-in-human (FIH) Phase 1 clinical study of BMC128, a rationally-designed live bacterial product developed by its subsidiary, Biomica Ltd., in combination with Nivolumab in patients with advanced solid tumors, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).

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The open-label, single-arm Phase 1 study enrolled 11 patients, with advanced solid tumors who had previously progressed following anti-PD-1 immunotherapy and was designed to evaluate the safety and tolerability of BMC128 in combination with Nivolumab. The treatment regimen included a two-week induction phase with BMC128 monotherapy, followed by 16 weeks of combination treatment with BMC128 and Nivolumab. Patients demonstrating clinical benefit were eligible to continue Nivolumab monotherapy for up to two years or until disease progression.

The study successfully met its primary endpoint, demonstrating favorable safety and tolerability, with no dose-limiting toxicities observed.

Preliminary clinical findings demonstrated early signs of anti-tumor activity. Five of the eleven treated patients achieved stable disease beyond the 16-week combination treatment period. Two patients remained on study through the full two-year follow-up period during Nivolumab maintenance therapy, while one patient achieved a partial response.

In addition to clinical observations, translational analyses demonstrated biological signals consistent with the proposed mechanism of action of BMC128. Responding patients showed increased microbiome diversity, evidence of immune activation, and modulation of immune suppression-associated signatures.

Ofer Haviv, President and CEO of Evogene and Biomica, commented:
"Completion of this first-in-human study represents an important milestone for the BMC128 development program and further supports the potential of microbiome-based approaches in immuno-oncology. We are encouraged not only by the favorable safety and tolerability profile observed in the study, but mainly by the preliminary signals of clinical activity and the translational data supporting the proposed mechanism of action of BMC128. We believe these findings support the continued clinical development of BMC128 by our licensing partner, Lishan Biotech."

Earlier this year, Evogene, through its subsidiary Biomica, entered into a licensing agreement with Lishan Biotech for the continued clinical development and commercialization of BMC128, now designated LS-LBP-002.

Dr. Weijie Chen, President and CEO of Lishan Biotech, added: "We are highly encouraged by the favorable safety profile and preliminary efficacy signals results generated in this Phase 1 study. These results not only provide important support for the continued advancement of LS-LBP-002, formerly BMC128, but also strengthen our confidence in the rationale of rationally designed live bacterial products combined with immune checkpoint inhibitors.

Based on this positive data, we are accelerating our planning for the next-stage clinical development. We look forward to further evaluating the therapeutic potential of this novel microbiome-based approach and bringing this promising candidate closer to patients in need."

About BMC128

BMC128 is a rationally designed live bacterial therapeutic candidate developed to facilitate anti-tumor immune responses in patients receiving immune checkpoint inhibitors. The product consists of a defined consortium of bacterial strains selected based on Evogene’s computational microbiome discovery platform and preclinical validation studies.

Under the licensing agreement with Lishan Biotech, BMC128 is being further developed under the designation LS-LBP-002.

(Press release, Evogene, JUN 2, 2026, View Source [SID1234666382])

On June 2, 2026 AbbVie (NYSE: ABBV) reported it will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on Tuesday, June 9, 2026. Management will participate in a fireside chat at 9:40 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

(Press release, AbbVie, JUN 2, 2026, View Source [SID1234666381])

On June 2, 2026 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, and Vanderbilt Health reported data from a Phase 2a clinical trial of ifetroban to prevent metastasis in high-risk solid tumors. The study’s primary safety endpoint was achieved, along with favorable trends in decreased metastasis recurrence and metastasis-free survival. A safe and effective medication that reduces distant metastatic recurrence could transform cancer management and improve the lives of millions of cancer survivors and their families.

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The randomized, double-blind, placebo-controlled Phase 2a trial evaluated the safety of ifetroban, an investigational thromboxane A2 receptor antagonist, in patients with solid tumors at high risk of early metastatic recurrence. Cancer types included breast, lung, pancreatic, soft tissue, bladder, and renal cancers.

The study met its primary endpoint, demonstrating that ifetroban was safe and well-tolerated in this patient population. Rates for adverse events related to treatment were similar between placebo and ifetroban. No serious adverse events (> grade 3) in either group were identified as being related to study treatment. Treatment discontinuation rates were not statistically different between placebo and ifetroban.

Although primarily a safety study and intentionally not powered for efficacy, the study compared the percentage of patients with distant metastatic recurrence 12 months after completion of therapy in both groups (10 placebo-treated and 18 ifetroban-treated participants) as a prespecified secondary endpoint. While 50% of participants experienced distant metastatic recurrence in the placebo arm, only 17% of participants experienced distant metastatic recurrence in the ifetroban arm (p=0.091). Three deaths due to distant metastatic disease occurred in the placebo arm, and none occurred in the ifetroban arm (p=0.037).

Though metastasis is a primary driver of cancer lethality, most current therapies act on tumor cells directly. Approaches targeting the mechanisms underlying the metastatic process are lacking. Even during clinical remission, microscopic metastases can remain present, leaving many patients at serious risk for metastatic recurrence. The premise of this novel therapy is that antagonizing the thromboxane A2 receptor and blocking platelet activation and aggregation lessens tumor cells’ ability to migrate, spread, cluster, invade distal organs, and evade immune detection.

This was the first trial evaluating the effects of ifetroban in people with solid tumors with high risk for early recurrence, defined as ≥ 50% chance of recurrence within 5 years of diagnosis. The intervention was given after all cancer-related therapies and surgical procedures had been completed; participants received the intervention for 12 months and were then followed for an additional 12 months. Among 29 participants, 10 received placebo and 19 received ifetroban.

"A therapeutic intervention aimed at metastasis prevention for cancer patients with high risk of recurrence that is given during the period of "watchful waiting" could be groundbreaking if proven beneficial in larger scale investigations," said Dr. Ben Ho Park of the Vanderbilt-Ingram Cancer Center. "We look forward to pursuing those pivotal studies as we relentlessly look for treatments to benefit patients living with cancer."

This clinical trial translated robust in silico and preclinical data to humans, confirming safety of ifetroban in patients with solid tumors and preliminarily suggesting that ifetroban may target biologic mechanisms involved in distant metastatic recurrence. A phenome-wide association study (PheWAS) was conducted by Vanderbilt Health investigators using the BioVU biorepository, which linked a naturally occurring genetic variant in the thromboxane receptor gene (TBXA2R) to an increased risk of metastatic disease across multiple cancer types.

Preclinical studies subsequently published in Molecular Cancer Therapeutics demonstrated that ifetroban reduced metastasis in several animal models without affecting tumor growth, and that the drug’s effects appeared to involve strengthening of the vascular endothelial barrier and inhibiting the ability of tumor cells to migrate across blood vessel walls.

"The favorable safety profile of ifetroban in this patient population, combined with the efficacy signals observed in this study, supports continued investigation of ifetroban as a candidate for metastasis prevention," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals. "The contributions of the Vanderbilt Health team have been essential to advancing this program."

Results of this Phase 2a clinical trial will be used to guide the further clinical development verifying efficacy and further demonstrating safety.

About Ifetroban

Ifetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. It exhibits high affinity for TPr on many cell types including platelets, cardiomyocytes, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. Cumberland is also evaluating ifetroban in Phase 2 clinical programs for patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. Ifetroban has a favorable safety profile as evidenced by multiple completed clinical trials collectively enrolling over 1,400 people.

(Press release, Cumberland Pharmaceuticals, JUN 2, 2026, View Source [SID1234666380])

On June 2, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a liquid biopsy company focused on innovative diagnostics for cancer, and Neovia Oncology LLC, a Delaware based pharmaceutical company dedicated to developing novel oncology therapies, reported the signing of a strategic partnership agreement to collaborate on Neovia’s upcoming studies treating patients with advanced multiple drug resistant solid tumors who are entering late lines of therapy.

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The collaboration is expected to generate translational and biomarker data designed to improve patient stratification and deepen understanding of treatment response dynamics in advanced cancers.

In addition to its development as a systemic therapy, Neovia is also evaluating the broader platform potential of NEV-801 in next-generation oncology applications, including antibody-drug conjugate (ADC) strategies.

"We selected Creatv Bio because of their strong scientific capabilities and extensive experience supporting biomarker research across multiple solid tumor types," said Trevor Blake, Founder and CEO of Neovia Oncology. "By integrating advanced liquid biopsy technologies into our clinical development program, we hope to gain deeper insights into patient response patterns and resistance biology as we advance NEV-801."

Creatv’s LifeTracDx blood test isolates Cancer Associated Macrophage-Like Cells (CAMLs) and Circulating Tumor Cells (CTCs) using Creatv’s CellSieveTM microfilters to develop companion diagnostics to monitor drug targets and provide information on patient treatment response.

Dr. Cha-Mei Tang, President and CEO of Creatv Bio added, "Our partnership with Neovia Oncology LLC has the potential to advance the future of cancer diagnosis and treatment, thus saving and improving the lives of cancer patients."

(Press release, Neovia Oncology, JUN 2, 2026, View Source [SID1234666379])

On June 2, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago, USA, the first-in-human study results of the novel B7-H3 ADC SKB500 in patients with advanced solid tumors were presented as a rapid oral report by Professor Liu Haifeng from Jilin Provincial Cancer Hospital (Abstract #3011|Molecularly Targeted Agents and Tumor Biology).

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SKB500 utilizes an antibody with high affinity, high hydrophilicity, and enhanced endocytosis, and has been engineered to silence Fc effector function in the constant region. Moreover, the antibody is conjugated to a payload with moderate toxicity via a cleavable hydrophilic AAA linker, with a drug-to-antibody ratio (DAR) of approximately 8.

The study was divided into three stages: dose escalation, dose expansion, and indication expansion, enrolling a total of 192 patients, including those with small cell lung cancer (SCLC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), neuroendocrine carcinoma (NEC), and other tumors. Patients received SKB500 at doses ranging from 2 to 18 mg/kg every three weeks (Q3W), with dose expansion and indication expansion conducted at 12 mg/kg and 16 mg/kg.

As of March 31, 2026, efficacy data showed:

Antitumor activities were observed across multiple solid tumor types, including SCLC, ESCC, HNSCC, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and nasopharyngeal carcinoma (NPC). Among 124 patients treated at 12 mg/kg with at least 6 weeks of follow-up, the objective response rate (ORR) was 42.7%, and the disease control rate (DCR) was 83.9%.
Among the treated SCLC patients (n=40), the ORR was 65.0% (95% CI: 48.3, 79.4), median progression-free survival (mPFS) was 7.2 months (95% CI: 4.3, NE), DCR was 95.0%, and mDOR was 5.8 months.
Among the treated ESCC patients (n=37), the ORR was 54.1%.
In terms of safety, compared to the 16 mg/kg group, the 12 mg/kg group demonstrated a more favorable safety profile, characterized by a lower incidence of grade ≥3 treatment-related adverse events (TRAEs) and treatment-related serious adverse events (TRSAEs), as well as a low rate of permanent discontinuation. In the 12 mg/kg group, the incidence of grade ≥3 TRAEs was 32.3%, most commonly hematologic events.

The study demonstrates that SKB500 exhibits broad-spectrum antitumor activity, with responses observed in multiple treated advanced solid tumors including SCLC, ESCC, HNSCC, and PDAC, with notable efficacy in SCLC patients. At the 12 mg/kg group, SKB500 showed a favorable safety profile, where there was a low incidence of permanent discontinuation and no treatment-related deaths.

Professor Liu Haifeng, Principal Investigator from Jilin Provincial Cancer Hospital, said: "The positive results from this first-in-human study of SKB500 not only preliminarily confirm its favorable efficacy and manageable safety profile as a novel B7-H3 ADC, but also suggest its therapeutic potential in multiple solid tumors—offering particular hope for SCLC, a disease that is highly aggressive and has limited later-line treatment options. These findings lay a solid foundation for further clinical development. We look forward to further validating its clinical value in subsequent trials."

About SKB500

SKB500 is a novel B7-H3-targeted ADC independently developed by the company using its OptiDC platform technology, featuring a site-specific cleavable linker and a potent topoisomerase I inhibitor. In the Phase I clinical study, SKB500 demonstrated robust efficacy and manageable safety profiles across multiple advanced solid tumors. Currently, a Phase II exploratory study of SKB500 in combination with immunotherapy with or without chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is ongoing in China.

(Press release, Kelun, JUN 2, 2026, View Source [SID1234666378])