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Kairos Pharma Announces Participation and Presentation in the H.C. Wainwright 27th Annual Global Investment Conference September 8-10, 2025

On July 16, 2025 Kairos Pharma, Ltd. (NYSE American:KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported participation and presentation at the H.C. Wainwright 27th Annual Global Investment Conference, taking place September 8–10, 2025, at the Lotte New York Palace Hotel in New York City (Press release, Kairos Pharma, JUL 16, 2025, View Source [SID1234654418]). Kairos Pharma will participate in on-on-one meetings and present at the meeting which will be available virtually and hosted on the kairospharma.com website.

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John Yu, MD, CEO and Chairman, will be hosting one-on-one meetings during the meeting September 8-10. To register for one-on-one meetings with management at The Lotte New York Palace Hotel in New York City.

SNB-101 Earns Government Backing as Promising Therapy for Small Cell Lung Cancer

On July 16, 2025 SN BioScience reported that its anticancer candidate SNB-101 has been selected as a clinical-stage project under the 2025 Korea Drug Development Project, a government-initiated program led by the Korea Drug Development Fund (KDDF) (Press release, SN BioScience, JUL 16, 2025, View Source [SID1234654417]). The program includes two years of research support, aiding the company’s advancement of SNB-101 into global Phase 1b/2 trials.

The Korea Drug Development Fund (KDDF) is a government agency funded by three ministries. It aims to actively fund and provide necessary support for drug development in academia and the pharmaceutical industry.

As Korea’s most authoritative national drug development platform, the KDDF is dedicated to advancing innovative drug development projects, spanning the entire process from early discovery to clinical stages.

SNB-101 is a polymeric nanoparticle-based nanoformulation of SN-38, the potent active metabolite of irinotecan, a topoisomerase I inhibitor in the Camptothecin class. Utilizing its proprietary dual nanomicelle platform, the drug is designed to maximize tumor-specific targeting by leveraging the Enhanced Permeability and Retention (EPR) effect, thereby enhancing therapeutic efficacy while minimizing toxicity to healthy tissues.

SNB-101 has already garnered international recognition through multiple regulatory designations as a next-generation anticancer therapy. The U.S. FDA has granted SNB-101 Orphan Drug Designation for both small cell lung cancer (SCLC) and pancreatic cancer, and has also granted Fast Track Designation for SCLC — a regulatory green light to accelerate its development timeline.

SN BioScience is set to launch a multinational Phase 1b/2 clinical trial for patients with extensive-stage small cell lung cancer (ES-SCLC), spanning key sites across South Korea, the United States, and Europe. The study will focus on dose optimization, safety, and efficacy, with particular emphasis on enrolling a racially and ethnically diverse patient population to support early commercialization efforts.

Given the aggressive nature and poor prognosis of this rare cancer, SNB-101 is gaining attention as a potential second- or third-line treatment for patients who have failed existing therapies. Furthermore, the company is exploring combination strategies with immunotherapies to position SNB-101 as a potential first- or second-line standard of care in the future.

"SNB-101 represents our commitment to overcoming the limitations of conventional cancer therapies," said Young-Hwan Park, CEO of SN BioScience. "This national grant will accelerate our global clinical development and solidify SNB-101’s position as a next-generation anticancer therapy."

TPEx-Listed HanchorBio Advances Global Impact of HCB101 Immunotherapy

On July 16, 2025 HanchorBio Inc. (TPEx: 7827.TWO), a pioneer of immunotherapy biologics, reported its official listing on the Taipei Exchange (TPEx) Emerging Stock Board under the ticker symbol 7827.TWO and the name Hanchor-KY (Press release, Hanchor Bio, JUL 16, 2025, View Source [SID1234654416]). The company enters the public market with over USD 80 million in equity financing, backed by cumulative investments from leading global institutional investors, including Vivo Capital, Panacea Venture, and Affinity Capital. Effective on June 20, 2025, the listing marks a significant step forward for the company as momentum builds around its best-in-class CD47-targeting immunotherapy, HCB101.

As HanchorBio actively fundraises, interested parties may contact: [email protected]

"This IPO is more than a financial milestone — it’s a defining moment for all of us at HanchorBio," said Scott Liu, PhD, Co-Founder, Chairman, and CEO of HanchorBio. "When we started this journey just a few years ago, our vision was bold: to build a next-generation immunotherapy company with global impact. Today, we are one step closer to realizing that vision with a differentiated platform; an advanced pipeline with more than six first-in-class, multifunctional fusion proteins; and encouraging clinical results. I’m incredibly grateful to our dedicated team, Board of Directors, world-class scientific advisors, and the supportive investors who have believed in us from the beginning. We believe Taiwan is uniquely positioned to nurture the next set of global leaders in precision immunotherapy, and we are proud to contribute to this transformation."

Harnessing the potential of immunotherapy

Immunotherapy for cancer treatment holds significant promise, and the global market specifically for CD47-targeting immunotherapies like HCB101 is particularly lucrative — it is projected to exceed US$40 billion by 2035, growing at a CAGR of 18%, according to Frost and Sullivan.

HanchorBio’s listing also reflects the growing role Taiwan is playing as a strategic center for biotech innovation. According to BioSpectrum Asia, Taiwan’s biotech sector is steadily expanding through coordinated efforts between government and industry.

The company’s public listing offers investors exposure to:

A validated clinical asset (HCB101) with global regulatory clearance
A next-generation biologics platform (FBDB) with broad licensing and development potential
Strategic operations across the U.S., mainland China, and Taiwan
A seasoned leadership team with over 30 IND submissions and 10 NDA/BLA filings and approvals
Growing momentum of HCB101

HanchorBio’s leading treatment, HCB101, has reached major milestones recently. It began Phase 2 clinical trials in March 2025, with participants from Taiwan, the United States, and China. In late May, the company also shared interim results from its ongoing Phase 1a dose-escalation trial (NCT05892718) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The key findings included:

Favorable safety and tolerability across escalating dose cohorts
Plasma exposure increased in a greater-than-dose-proportional manner and with increased half-life at higher doses
High-level CD47 receptor occupancy in peripheral immune cells
Early clinical signs of anti-tumor activity:
Six patients in the low-dose cohorts achieved stable disease (SD) at the best response, including one ovarian cancer patient (1.28 mg/kg) who maintained disease control for over 32 weeks.
Two patients in the higher-dose cohorts achieved confirmed partial responses (PRs):
A head and neck squamous cell carcinoma (HNSCC) patient at 5.12 mg/kg experienced a 27% tumor reduction in the sum of diameters (SOD) at Week 8, then increasing to 42% by Week 16.
A patient with Non-Hodgkin Lymphoma (NHL) at 8 mg/kg achieved a PR confirmed by PET imaging at Week 8.

SandboxAQ and iOncologi Partner to Accelerate Brain Cancer Treatment with AI-driven Drug Discovery For Glioblastoma

On July 16, 2025 SandboxAQ and iOncologi reported a strategic collaboration to jointly develop, validate, and commercialize a novel high-fidelity mRNA vaccine for glioblastoma, the most common and aggressive malignant brain tumor in adults (Press release, iOncologi, JUL 16, 2025, View Source [SID1234654415]). The joint effort combines SandboxAQ’s proven software and biologics technology for drug candidate identification and lead optimization with iOncologi’s deep tech immunotherapy design and clinical expertise to overcome longstanding barriers in brain cancer treatment.

Because treatment options are limited, people diagnosed with glioblastoma usually survive less than two years. This aggressive cancer accounts for about 15% of all primary brain tumors, about 300,000 new cases and more than 200,000 deaths worldwide each year, according to the World Health Organization.

"Glioblastoma’s rapid progression and high mortality rate make it one of the most devastating cancers in the world," said Jack Hidary, CEO of SandboxAQ. "Our collaboration with iOncologi aims to create a new and effective treatment for this challenging condition, pairing the most comprehensive oncology datasets with advanced quantitative AI tools and simulation techniques, greatly accelerating the drug discovery process."

The joint program aims to deliver a lead therapeutic candidate into the clinic within 18 months by combining SandboxAQ’s AQBioSim platform for drug discovery and optimization, with iOncologi’s leadership in immunotherapy design and clinical execution. iOncologi specializes in precision immunotherapies that reprogram and redirect the immune system to target tumors previously considered untreatable, particularly those shielded by the blood-brain barrier or cloaked in immune tolerance.

"iOncologi is reimagining cancer immunotherapy by integrating immune intelligence, mRNA engineering, and drug delivery platforms into universal and adaptable, patient-specific treatment models," said Dr. Edgardo Rodriguez-Lebron, CEO of iOncologi. "By combining this with SandboxAQ’s ability to model and rapidly optimize molecules across vast chemical and biological spaces, we are well-positioned to advance a truly transformative therapeutic for glioblastoma, and eventually for other treatment-resistant solid tumors."

SandboxAQ’s AQBioSim platform uses Large Quantitative Models (LQMs) grounded in physics and chemistry to rapidly identify potential drug candidates, simulate molecular behavior and design new potential drug molecules, in the same way as other generative models might output text or images. SandboxAQ’s generative chemistry AI model has been shown to design new molecules with better binding characteristics than the next best technologies, such as large-scale virtual screening, and it does this 100 times faster and at lower cost.

"SandboxAQ’s Large Quantitative Models and AI simulation techniques have proven their ability to rapidly identify and design molecules that address some of the most challenging diseases including Alzheimer’s and Parkinson’s," said Nadia Harhen, General Manager of AI Simulation and head of the AQBioSim division at SandboxAQ. "By adapting the technology stack to oncology, we believe we can make a significant impact where traditional approaches and other advanced technologies have failed."

In June, SandboxAQ also announced a collaboration with Stand Up To Cancer (SU2C) to support SU2C-funded cancer research projects. Leveraging LQMs, the initiative aims to accelerate the development of new treatments, including supporting efforts to detect hard-to-diagnose and treat cancers, and leverage predictive modeling to optimize treatment response and monitor potential recurrence.

Genetic Leap receives FDA IND clearance for first-in-class, oral natural IL-2 modulator

On July 16, 2025 Genetic Leap, a clinical stage, AI-native biotech pioneering RNA genetic therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for GL-IL2-138, the company’s small-molecule modulator of natural interleukin-2 (IL-2) (Press release, Genetic Leap, JUL 16, 2025, View Source [SID1234654414]).

IL-2 is a pleiotropic cytokine that regulates the careful homeostatic balance between immune tolerance and activation. The tremendous potential of IL-2 to address multiple major diseases is universally recognized. Recombinant IL-2 protein (rIL-2) was the first FDA-approved immunotherapy proven effective against cancer at high dose, though toxicity has historically limited its use. And low dose rIL-2 is clinically effective in autoimmune and neurodegeneration diseases. But numerous attempts by pharma companies to remove toxicity from rIL-2 muteins have flopped, earning IL-2 its reputation as an impossible target.

Genetic Leap addressed this herculean challenge by developing a small molecule drug that binds endogenous IL-2 mRNA to drive controlled, systemic production of natural IL-2 protein by immune cells, which has many advantages over rIL-2 including:

Superior potency and durability

Oral dosing with high tolerability

Broad "pipeline-in-a-pill" potential across oncology, immunology (I&I), and neurodegeneration
"We created the Genetic Leap AI platform to deliver breakthroughs like GL-IL2-138," said Dr. Bertrand Adanve, Founder and CEO of Genetic Leap. "Innovative medicine that defies known scientific limitations, like a sci-fi drug made real. GL-IL2-138 is like combining Humira (leading autoimmune biologic) and Keytruda (leading cancer biologic) into one oral pill without the downsides and applicable to even more diseases. GL-IL2-138 is poised to be a giant leap for human health, and Genetic Leap is the company making it happen."

The drug will now be tested in a randomized, double-blind, placebo-controlled phase 1 clinical trial to evaluate its tolerability, pharmacokinetics and pharmacodynamics in humans.