On July 17, 2025 Syntara Limited (ASX:SNT), a clinical-stage drug development company, reported initiation of AZALOX, a Phase 1b/2 multi-centre study evaluating amsulostat (SNT-5505) in combination with 5-Azacitidine for the treatment of high-risk Myelodysplastic Neoplasms (MDS) and Chronic Myelomonocytic Leukemia (CMML) (Press release, Syntara, JUL 17, 2025, View Source;v=4a466cc3f899e00730cfbfcd5ab8940c41f474b6 [SID1234654426]).

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The study commenced at University Medicine Mannheim (UMM), Germany, the first of nine planned centres expected to enrol patients under the German MDS Study Group. Led by Professor Susanne Saußele and her team, the trial will focus on patients with significant disease severity who are transfusion dependent.

The initial Phase 1b portion of the AZALOX trial will determine the safety profile and recommended dose of amsulostat alongside 5-Azacitidine. The Phase 2 component will then further evaluate safety and efficacy of the selected dose across 30 patients.

Patients eligible for the trial include those with confirmed high-risk MDS or CMML, who are either treatment-naïve or have undergone limited prior treatment with hypomethylating agents.

The trial is financially supported by German Cancer Aid (Deutsche Krebshilfe, DKH), with Heidelberg University sponsoring the study in collaboration with the Coordination Centre for Clinical Studies (KKS) Heidelberg.

Professor Saußele commented: "Our preclinical data suggest that with this combination therapy, we can reactivate the production of red blood cells. With this, we aim to eliminate the need for blood transfusions in the long term and reduce the risk of transformation to acute myeloid leukemia."

Syntara CEO, Gary Phillips stated: "We are delighted to be working with the German MDS Study Group as they initiate the AZALOX study. This represents an important milestone for amsulostat, leveraging the positive results in myelofibrosis and expanding to a second blood cancer indication. The AZALOX trial builds on promising preclinical data, potentially providing a new treatment option for patients suffering from MDS and CMML."

As previously reported on Form 8-K filed on June 5, 2025 in regard to the exclusive license agreement (the "Agreement") between HCW Biologics Inc. (the "Company") and WY Biotech Co., Ltd. ("WY Biotech"), on May 29, 2025, WY Biotech notified the Company that it completed its due diligence to study the technical report delivered by the Company and elected to continue with the Agreement (Press release, HCW Biologics, JUL 18, 2025, View Source [SID1234654442]). As a result, WY Biotech is financially obligated to the Company, as detailed in the Agreement, as amended, including the obligation to pay a $7.0 million in upfront license fee. In order to accommodate WY Biotech’s timing in finalizing agreements with its CDMO and investors, as of July 13, 2025, the Company and WY Biotech agreed to extend the date for payment such that WY Biotech will provide confirmation of wiring of the $7.0 million license fee on or before September 30, 2025. The foregoing summary of certain terms of the Agreement and the referenced amendment does not purport to be complete.

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On July 17, 2025 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported the publication of preclinical data from its second generation ateganosine prodrugs platform in Nucleic Acids Research (NAR), a leading open-access peer-reviewed scientific journal (Press release, MAIA Biotechnology, JUL 17, 2025, View Source [SID1234654433]). The study, titled "Novel Telomere-Targeting Dual-Pharmacophore Dinucleotide Prodrugs for Anticancer Therapy," details MAIA’s lead ateganosine (THIO)-derived second-generation prodrugs as promising new molecules in its strategy for enhancing cancer treatment and overcoming drug resistance. The manuscript with the data was published on June 26, 2025, in Volume 53, Issue 12 of the NAR journal.

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In January 2023, MAIA nominated one lead new molecular entity candidate (designated as MAIA-2021-20) and one back-up new molecular entity candidate (MAIA-2022-12) for further advancement into preclinical GLP-toxicity and other studies. More than 80 ateganosine-like compounds have been developed as part of MAIA’s second-generation telomere targeting program.

In the featured study, MAIA designed and synthesized divalent dinucleotide prodrugs comprised of two nucleosides. The lead THIO-containing compounds, with two THIO pharmacophores, demonstrated the strongest anticancer efficacy in vivo and induced the strongest host immune-memory responses in vivo.

"The reported study data has shown that the sequential combination of MAIA-2022-12 or MAIA-2021-20 with an immune checkpoint inhibitor demonstrated a significantly lower 50% inhibitory concentration with superior anticancer efficacy compared with the corresponding monotherapies. The results suggest that MAIA-2022-12 and MAIA-2021-20 are promising candidates for future preclinical and clinical studies," said MAIA Chairman and CEO Vlad Vitoc, M.D. "We are working now to advance at least one of the candidates into human clinical trials upon completion of required GLP-toxicity and other evaluations."

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On July 17, 2025 Ajax Therapeutics, Inc. and Schrödinger, Inc. (Nasdaq: SDGR) reported an expansion of their exclusive research collaboration to include a new Janus kinase (JAK) target (Press release, Ajax Therapeutics, JUL 17, 2025, View Source [SID1234654434]). The partnership was established in 2019 with a goal of leveraging Schrödinger’s advanced computational platform and Ajax’s structural biology insights to develop a pipeline of novel molecules, with a focus on JAK inhibitors. Ajax’s lead candidate from the collaboration, AJ1-11095, is a potential first-in-class Type II JAK2 inhibitor currently being evaluated in a Phase 1 clinical study for the treatment of myelofibrosis.

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"We’re excited to expand our longstanding research collaboration with Schrödinger," stated Martin Vogelbaum, chief executive officer of Ajax Therapeutics. "Given our teams’ history of success in creating more selective and potent JAK2 inhibitors, we expect to take a similar approach to this new JAK target with the goal of generating a new class of inhibitors that extend beyond oncology indications to include inflammatory and autoimmune disorders."

"Our collaboration with Ajax and the progress of AJ1-11095 demonstrates the power of combining our world-leading computational platform at scale with Ajax’s novel structural biology insights," stated Ramy Farid, Ph.D., chief executive officer of Schrödinger. "We are really pleased with the progress our teams have made over the course of this partnership, and we look forward to working with the Ajax team on this new JAK family target."

Abnormal JAK signaling is a key driver in myeloproliferative neoplasms, including myelofibrosis, as well as in inflammatory and autoimmune diseases. In collaboration with Schrödinger, Ajax is leveraging advanced computational methods and structural biology insights to develop next-generation inhibitors with the potential for greater selectivity and deeper, more durable responses compared to existing JAK inhibitors.

Under the terms of the amended agreement, Ajax and Schrödinger will collaborate on the discovery of the development candidate, and Ajax will be responsible for clinical development and commercialization. Schrödinger is eligible to receive discovery and development milestones similar to the terms of the original agreement. Schrödinger is also eligible to receive sales milestones and single-digit royalties on net sales of any products emerging from the additional target.

In 2024, Ajax completed an oversubscribed $95 million Series C financing, in which Schrödinger participated as a continuing investor. Schrödinger was a co-founder of Ajax and maintains an equity stake in the company.

About AJ1-11095

AJ1-11095 was designed using structure-based drug design and computational methods at scale to selectively bind the Type II conformation of the JAK2 kinase to provide greater efficacy with disease modification compared to all currently approved JAK2 inhibitors, including ruxolitinib, which bind the Type I conformation of JAK2. AJ1-11095 has been shown in preclinical studies to reverse marrow fibrosis, reduce mutant allele burden, and maintain efficacy against MPN cells that become resistant to chronic Type I JAK2 inhibition. AJ1-11095 is currently in a Phase I study for patients with MF who have been failed by a Type1 JAK2 inhibitor. Further details about the study can be found at www.clinicaltrials.gov.

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.