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Co-PSMA trial: Recruitment successfully completed

On July 17, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that the Co-PSMA (NCT06907641)1 Investigator-Initiated Trial (IIT) led by Prof Louise Emmett at St Vincent’s Hospital Sydney has now completed study enrolment, with all participants having been imaged (Press release, Clarity Pharmaceuticals, JUL 17, 2025, View Source [SID1234654402]).

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The study is evaluating the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in comparison to standard-of-care (SOC) 68Ga-PSMA-11 for the detection of prostate cancer recurrence in patients with low prostate-specific antigen (PSA) who are candidates for curative salvage therapy.

Co-PSMA (Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy) is a prospective, Phase II imaging trial in 50 patients in biochemical recurrence (BCR) of prostate cancer. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA between 0.2 and 0.75 ng/mL. The primary objective of the trial is to compare the detection rate of sites of prostate cancer recurrence, as determined by number of lesions per patient, between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 PET/CT.

The diagnostic capabilities of 64Cu-SAR-bisPSMA compared to SOC diagnostic imaging have been demonstrated in two prospective clinical trials, PROPELLER2 and COBRA3. Following the positive results of these trials, Clarity is conducting two Phase III registrational trials, CLARIFY4 and AMPLIFY5, in the pre-prostatectomy and BCR settings, respectively. The CLARIFY trial is recruiting patients at St Vincent’s Hospital Sydney and this site will also open recruitment for the AMPLIFY trial shortly with Prof Emmett as the principal investigator.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "We are excited about this important milestone in the Co-PSMA trial and the development program of 64Cu-SAR-bisPSMA. With mounting data of the benefits that 64Cu-SAR-bisPSMA could offer compared to SOC diagnostic imaging, demonstrated in the PROPELLER and COBRA trials, we eagerly anticipate the results from this head-to-head trial against 68Ga-PSMA-11.

"The high volume of patients imaged in recent months at a single site reflects the high unmet need for more effective diagnostic tools for men with rising PSA following radical prostatectomy. Visualising cancer early in these patients is crucial for physicians to determine the optimal course of treatment before the cancer spreads, leading to improved outcomes, including the potential for cure. We are very pleased to be able to support Prof Emmett, a world-renowned thought leader in the theranostics space, through the Co-PSMA trial in our own city of Sydney. We are honoured to continue working together on our pipeline of Targeted Copper Theranostics (TCTs) at St Vincents Hospital Sydney, as it is already actively recruiting patients for the CLARIFY trial and preparing to open enrolment for the AMPLIFY trial shortly."

Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the Co-PSMA trial, commented, "We are pleased to have reached our enrolment target for the Co-PSMA trial. Imaging prostate cancer patients has evolved significantly in recent years, particularly with the development of the current-generation PSMA targeted products. The approved PSMA PET products have high specificity, however, due to their low sensitivity, especially in patients with low PSA, a considerable proportion of patients have no detectable disease on the scans while their PSA continues to rise, indicating recurrence of their cancer. With no clear visualisation of where the cancer is located, planning effective treatments is challenging. Early intervention is essential in order to achieve cure in BCR, and the need for more sensitive diagnostics remains. This unmet need is what led us to design the Co-PSMA study.

"The data generated thus far on 64Cu-SAR-bisPSMA in the PROPELLER and COBRA trials are very encouraging. The high lesion uptake and retention of the product over time provides better visualisation on same-day imaging compared to SOC imaging. Furthermore, the delayed imaging, enabled by the longer half-life of copper-64 compared to gallium-68 and fluorine-18, increases image contrast, helping to identify smaller lesions and allowing more flexible scheduling of patients. If the Co-PSMA trial confirms that 64Cu-SAR-bisPSMA can detect more lesions than 68Ga-PSMA-11 in this patient group with such low PSA, this may improve image-guided therapy, potentially avoiding complications and improving outcomes. We look forward to reporting the trial results in the coming months."

About SAR-bisPSMA

SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide6. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease.

BriaCell Therapeutics Announces Closing of $15 million Public Offering

On July 16, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the closing of its best-efforts public offering of 12,000,000 units (Press release, BriaCell Therapeutics, JUL 16, 2025, View Source [SID1234655033]). Each unit consists of one common share (or one pre-funded warrant ("Pre-Funded Warrant") in lieu thereof) and one warrant (the "Warrants"). Each unit was sold to the public at a price of $1.25 per unit (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of $15 million, before deducting placement agent fees and offering expenses. Each Pre-Funded Warrant is exercisable to purchase one common share at an exercise price of $0.001 until such time as the Pre-Funded Warrant is exercised in full and each Warrant is immediately exercisable, and entitles the holder thereof to purchase one common share at an exercise price of $1.50 per share for a period of five years from the date of issuance. The common shares (or Pre-Funded Warrants) and Warrants were purchased together in the offering but were issued separately.

No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the securities in connection with the offering. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity acted as the sole placement agent for the offering.

A registration statement on Form S-1 (File No. 333-288562) relating to the securities was filed with the Securities and Exchange Commission ("SEC") and became effective on July 15, 2025. This offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, 17 State Street, 41 st Floor, New York, New York 10004. The final prospectus has been filed with the SEC and is available on the SEC’s website located at View Source .

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.

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.