On July 15, 2026 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company addressing drug resistance in cancer, reported compelling interim safety data from its ongoing Phase 1 clinical trial evaluating ENV-105 (carotuximab) in combination with osimertinib (AstraZeneca’s Tagrisso) in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). The data represent a pivotal milestone in Kairos Pharma’s lead program: resensitizing patients who have acquired resistance to osimertinib, the global standard-of-care for EGFR-mutated NSCLC. With no serious adverse events (Grade 3 or higher) observed across 13 treated patients to date from ENV-105 treatment, the safety profile supports continued progression toward an early efficacy readout.

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Non-small cell lung cancer is the dominant form of lung cancer, accounting for approximately 85% of all lung cancer diagnoses globally. Within NSCLC, EGFR-mutated patients represent the most commercially important and genetically actionable subpopulation. The EGFR-NSCLC market alone is valued at approximately $10 billion across leading current markets, growing at a CAGR of 10.5%, projected to be over $13 billion by 2030.1-3 Osimertinib (Tagrisso) is the gold-standard, first-line therapy for this patient population with about $6 billion in sales annually.4,5 Despite osimertinib’s initial efficacy, resistance to the drug is inevitable. Once a patient progresses on osimertinib, therapeutic options are limited with a significant clinical setback with inferior survival outcomes. Currently, there is no FDA-approved agent specifically designed to reverse or overcome osimertinib resistance and restore drug sensitivity.

Kairos Pharma’s scientific thesis is grounded in a precision oncology insight of restoring sensitivity to standard of care cancer therapies. CD105 (endoglin) is pathologically elevated in patients who develop osimertinib resistance, and its overexpression drives one of the core resistance signaling pathways.6, 7 ENV-105 (carotuximab) is a first-in-class CD105 antibody that blocks the signaling of this overexpressed protein, mechanistically dismantling the resistance phenotype and creating the biological conditions for osimertinib sensitivity. This strategy support extending progression-free survival, preserving quality of life, and fundamentally increasing the clinical utility of the world’s most prescribed EGFR-targeted therapy. If successful, ENV-105 would not compete with osimertinib — it would extend its commercial life across the entire EGFR-mutated patient population.

"Our goal is not simply to complete a Phase 1 trial; it is to deliver a resensitization solution that changes the post-progression treatment paradigm and positions Kairos as the essential complement to the EGFR-targeted therapy market with this clean safety profile now confirmed across 13 patients" said Dr. John Yu, Chief Executive Officer of Kairos Pharma.

The scientific rationale for targeting CD105 is well-established: CD105 is a validated driver of resistance and disease relapse across multiple cancer types, including EGFR-driven NSCLC, and pre-clinical models have already confirmed ENV-105’s capacity to sensitize tumors to both radiation and hormone therapy. Critically, ENV-105’s clinical validation extends beyond lung cancer with an ongoing Phase 2 trial for castrate-resistant prostate cancer, ENV-105 delivered median progression-free survival exceeding 13 months, a significant improvement over standard of care. We believe that this demonstrated that the CD105 suppression mechanism translates into durable clinical benefit across fundamentally different tumor types and resistance contexts.

"ENV-105 continues to be extremely well tolerated, now across two very different indications," said Dr. Neil Bhowmick, Chief Science Officer of Kairos Pharma. "As we continue to showcase ENV-105’s potential for targeting drug resistance, this data is another important milestone in achieving our goal to ultimately provide better patient care over a longer term."

Interim Phase 1 Safety Data: Clinical Highlights

The interim safety analysis of the Phase 1 trial evaluating ENV-105 + osimertinib in EGFR-mutated advanced NSCLC patients demonstrates a clean early safety profile in the 13 patients treated with combination therapy. The trial is intended to assess safety, tolerability, and recommended Phase 2 dose, with adverse events evaluated under Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and dose-limiting toxicities monitored during the initial treatment cycles. All side effects were manageable with standard supportive care.

(Press release, Kairos Pharma, JUL 15, 2026, View Source [SID1234669231])

On July 15, 2026 BPGbio, a clinical-stage biopharmaceutical company advancing mitochondrial-targeted therapeutics for patients, reported encouraging preliminary clinical findings from its ongoing Phase 2 study evaluating BPM31510, an investigational mitochondrial therapy, in combination with standard-of-care radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed glioblastoma multiforme (GBM) patients. The data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The multi-center Phase 2 study (NCT04752813) is evaluating BPM31510, a lipid nano dispersion of oxidized CoQ10 administered with vitamin K1, as a neo-adjuvant and concurrent therapy alongside RT and TMZ in newly diagnosed GBM patients who have not received prior treatment.

Among patients evaluable per protocol (N=39), preliminary findings demonstrated a strong median overall survival (OS) of 19.3 months led by nearly 2X median OS compared to historical controls for the hardest-to-treat subgroup. Specifically:

Unmethylated subgroup: In 24 patients with MGMT unmethylated tumors, a group associated with poor prognosis and efficacy to standard of care—BPGbio observed a preliminary median OS of 29.3 months, nearly doubling the historical control baseline of 12.7-15.5 months.
Methylated subgroup: The median OS for the MGMT methylated patient cohort has not yet been reached due to high ongoing survival rates.
Findings remain preliminary, subject to final readout audit and are still being collected and analyzed.
The study also demonstrated that BPM31510 was generally well tolerated in combination with standard chemoradiation, with no new drug-related serious adverse events (SAEs) observed in treatment-naïve patients in the frontline setting.

"As the data continue to mature, we are increasingly encouraged by the preliminary findings emerging from both cohorts, particularly the overall survival trends observed in the cohort with MGMT unmethylated glioblastoma," said Niven R. Narain, Ph.D., President and CEO of BPGbio. "These findings further reinforce our belief that targeting mitochondrial dysfunction and altered tumor metabolism may represent an important new therapeutic approach for aggressive solid tumors such as GBM. We look forward to advancing the program toward topline and final data readout."

BPM31510 is designed to target the tumor microenvironment and alter the mitochondrial metabolic machinery to modulate oxidative phosphorylation reactivation and ROS production, thereby restoring the apoptotic function in tumors. In cancer, altered mitochondrial metabolism supports tumor growth, therapeutic resistance and adaptation to oxidative stress. BPM31510 was designed to address these metabolic vulnerabilities while supporting efficient metabolism in non-tumorigenic tissues.

The Phase 2 study has completed enrollment, with 51 patients enrolled across leading U.S. cancer centers. BPGbio anticipates topline data from the study in late fall 2026.

The ASCO (Free ASCO Whitepaper) presentation, titled "Trial in Progress: Update on a Phase 2 Study of BPM31510 (a lipid nanodispersion of oxidized CoQ10) with Vitamin K in Combination with Standard of Care RT and TMZ in Glioblastoma (GBM) Patients Without Prior Therapy" (Abstract TPS2101), was presented by study principal investigator Seema Nagpal, M.D., Professor of Neurology and Neurological Sciences at Stanford University School of Medicine. The poster can be found here.

BPGbio anticipates presenting more advanced data from the Phase 2 trial at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Meeting in Madrid, Spain this Fall.

(Press release, BPGbio, JUL 15, 2026, View Source [SID1234669247])

On July 15, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV)( FSE: 7JO0), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, reported a non-brokered private placement offering (the "Offering") of up to $1.5 million.

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Pursuant to the Offering, Rakovina will issue up to 15 million equity units ("Units") at an offering price of $0.10 per Unit, with each Unit consisting of one common share and one-half of one common share purchase warrant (a "Warrant"). Each whole Warrant will entitle the holder to acquire one additional common share at an exercise price of $0.20 exercisable for a period of 24 months from issuance.

Proceeds from the Offering will be used to advance Rakovina’s pipeline, with a primary focus on in vivo ADME and efficacy testing for the kt-5000AI dual ATR/mTOR inhibitor program and continued AI-driven lead optimization through the Company’s collaboration with Variational AI. Funds will also support advancement of the kt-3000 LNP formulation program through in vitro and in vivo characterization, ongoing kt-2000AI compound development, and the continued expansion of the Company’s AI-enabled drug discovery collaborations. Remaining proceeds will be used for general working capital purposes.

The Units will be sold on a non-brokered "private placement" basis in accordance with applicable Canadian securities laws and under applicable exemptions from prospectus and registration requirements and the securities will be subject to resale restrictions for a period of four months plus one day from the date of issue.

(Press release, Rakovina Therapeutics, JUL 15, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-announces-1-5-million-private-placement [SID1234669272])

On July 14, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that the Australian Patent Office has allowed Patent Application No. 2021290439 entitled "Treatment of Advanced Metastatic Cancer."

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The patent complements Can-Fite’s rapidly advancing oncology pipeline. Namodenoson is currently being evaluated in a pivotal Phase 3 study for advanced hepatocellular carcinoma following FDA and EMA protocol agreement. In pancreatic cancer, the Company recently completed a Phase 2a clinical study demonstrating an excellent safety profile together with encouraging survival outcomes and durable disease stabilization and is planning a Phase 2b study evaluating Namodenoson in combination with gemcitabine.

"This patent allowance further strengthens our global intellectual property portfolio surrounding Namodenoson and reinforces the long-term value of our oncology franchise," said Pnina Fishman, Ph.D., Chairperson and Chief Scientific Officer of Can-Fite BioPharma. "Importantly, the patent supports two of our most advanced oncology programs—hepatocellular carcinoma and pancreatic cancer—and extends protection for our innovative therapeutic approach in a major international market."

Namodenoson selectively targets the A3 adenosine receptor (A3AR), which is highly expressed in inflammatory and cancer cells. Activation of A3AR has been shown to induce apoptosis of tumor cells while sparing normal tissues, contributing to the compound’s favorable safety profile demonstrated across clinical studies.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and enroll patients for a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety of the drug.

(Press release, Can-Fite BioPharma, JUL 14, 2026, View Source [SID1234669201])

On July 14, 2026 Insilico Medicine ("Insilico"; HKEX: 3696), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, reported a multi-target strategic alliance with Bora Pharmaceuticals Co., Ltd. ("Bora"; TWSE: 6472; OTCQX: BORAY), a global leader in pharmaceutical manufacturing.

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The proposed alliance will be governed by definitive agreements to be discussed and executed by Insilico and Bora and is designed to combine Insilico’s proprietary Pharma.AI platform, spanning target discovery, generative chemistry, and molecule optimization, with Bora’s global development, manufacturing, quality, and commercialization capabilities. By linking AI-enabled discovery with automation-driven development, manufacturing, and quality execution, Insilico and Bora aim to pioneer a next-generation drug innovation model that connects novel molecule design with the capabilities required to develop, manufacture, and deliver medicines to patients with unmet medical needs.

The alliance lays the foundation for a broad, multi-target collaboration framework, subject to the parties’ further discussion and execution of definitive agreements. If fully implemented, the potential value of the proposed collaboration could exceed US$2.5 billion. Insilico expects to support Bora in strengthening AI capabilities across its global workforce and enhancing AI literacy across the organization. The partnership is also expected to apply Insilico’s AI capabilities to improve efficiency across manufacturing, supply chain, distribution, and corporate operations. As the collaboration progresses, Bora and Insilico expect to further refine its scope, scale, and operating framework.

As part of the alliance, Insilico aims to accelerate Bora’s transition toward more AI-driven and automation-driven drug discovery and development capabilities by providing comprehensive research and development strategies and end-to-end AI solutions across global discovery and development workflows. Over time, the alliance will further explore opportunities to apply AI and automation-driven approaches across development planning, process optimization, pharmaceutical development, manufacturing readiness, and quality systems.

The proposed alliance reflects a shared vision that the next generation of biopharmaceutical innovation will be increasingly AI-native, data-rich, and automation-driven. In this new model, value will be created not only through the discovery and design of novel molecules, but also through smarter, more efficient translation of those molecules into high-quality development programs and, ultimately, medicines for patients. Insilico brings an AI-native discovery engine with demonstrated productivity across multiple therapeutic areas, while Bora brings deep experience in drug development, global manufacturing, quality systems, supply chain execution, and commercialization.

"Insilico Medicine has established itself as one of the world’s leading AI drug discovery companies by demonstrating that generative AI can identify novel targets, design novel molecules, and advance drug candidates into clinical development," said Bobby Sheng, founder, Chairman of Bora Group and CEO of Bora Pharmaceuticals. "This strategic alliance marks an important step in Bora’s evolution from a leading pharmaceutical development and manufacturing partner into a broader drug innovation ecosystem. By combining Insilico’s AI-native capabilities with Bora’s global expertise in formulation, CMC, regulatory development, scale-up, quality, commercial manufacturing, supply chain, and commercialization, we have an opportunity to create a truly integrated pathway from discovery to commercialization.

"AI is already transforming drug discovery, but its full potential will only be realized when that transformation extends across the entire development and manufacturing value chain. This is not simply about adding AI to existing processes; it is about reimagining how pharmaceutical products are developed, manufactured, and brought to patients. Together, we aim to build a scalable and repeatable model that can advance promising drug candidates more efficiently, positioning Bora at the forefront of AI-enabled pharmaceutical development and manufacturing, and establish a long-term growth platform through the development and commercialization of high-value proprietary assets."

"We are thrilled to partner with Bora, a visionary leader with world-class development and manufacturing capabilities and a strong commitment to AI-driven innovation," said Dr. Alex Zhavoronkov, founder, co-CEO, and CBO of Insilico Medicine. "Building on our collaborations with Takeda and SK Biopharmaceuticals in Asia-Pacific, this alliance with Bora further demonstrates Insilico’s commitment to partnering with leading biopharmaceutical innovators across the region. Insilico has built a powerful AI-native engine for target discovery, generative chemistry, and molecule optimization. Together with Bora, we aim to connect that discovery engine with the capabilities required to advance high-quality drug candidates through development, manufacturing, and potential commercialization, while also supporting Bora’s broader AI transformation. This alliance represents an important step toward demonstrating how AI-discovered medicines can be developed faster, more efficiently, and with greater scalability."

As an AI-native biotechnology company, Insilico is redefining the efficiency of preclinical drug development through its advanced AI and automation platform. While traditional early-stage drug discovery typically takes 2.5 to 4 years, Insilico has consistently reached preclinical candidate ("PCC") nomination in an average of just 12 to 18 months. Since 2021, the company has nominated 31 PCCs, 13 of which have received IND approval or clearance – a track record of speed and productivity that this alliance aims to pair with Bora’s development and manufacturing scale.

While expanding the practical applications of its technology in drug discovery and life science research, Insilico is also continuously enhancing the performance of its AI platform. Drawing on extensive experience and datasets from its training platform, the company has distilled thousands of benchmarks and integrated them into MMAI Gym. Serving as both a "trainer and benchmark" for scientific AI, MMAI Gym enables organizations to train models for domain-specific reasoning while rigorously evaluating their performance on real-world tasks, advancing the path toward pharma superintelligence. To date, Human Longevity and Liquid AI have collaborated with Insilico, joining as partners of MMAI Gym.

(Press release, Insilico Medicine, JUL 14, 2026, View Source [SID1234669216])