On July 17, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that it will host a virtual R&D Day at 1:30 PM PT on Thursday, July 24, 2025 (Press release, Janux Therapeutics, JUL 17, 2025, View Source [SID1234654435]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The event will include a presentation from management highlighting product candidates identified from its preclinical pipeline to move into clinical trials. These previously undisclosed preclinical programs utilize Janux’s expertise and platform technologies to potentially address significant unmet medical needs.

Event Information

To join the webcast, please visit this link, or the Events & Presentations page of the Investors section on the Company’s website at View Source A replay of the webcast will be archived and available following the event.

Participant Dial-In Numbers:
USA / International +1 (646) 307-1963
USA – Toll-Free (800) 715-9871
Conference ID 9235403

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with metastatic castration-resistant prostate cancer. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 One Biosciences ("One Biosciences" or the "Company"), a precision oncology techbio company pioneering clinical grade single-cell tumor transcriptomic profiling, reported a €15 million Series A financing led by Redmile Group and Blast, with participation from Galion.exe, Invus, Adamed Technology, Sofinnova Partners, Polytechnique Ventures, and Kima Ventures (Press release, One Biosciences, JUL 17, 2025, View Source [SID1234654432]). This round brings One Biosciences’ total funding, to date, to over €20 million including Home Biosciences’ seed financing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

One Biosciences technology creates detailed functional profiles of patient tumors, unlocking insights that may drive better clinical decision-making, patient selection, therapy development, and potentially optimizing clinical trials. Proceeds from the financing will accelerate the clinical development of One Biosciences’ flagship OneMap platform and support the scaling of strategic partnerships with pharmaceutical and biotech companies.

Hedi Ben Brahim, CEO of One Biosciences, said: "This funding enables us to translate our breakthrough single-cell technology into real-time insights that could directly inform physician decision-making, improve patient care, and accelerate drug development. The extraordinary support we have received from this group of leading global investors reinforces our conviction and fast-tracks our route to market."

Dr. Céline Vallot, Co-Founder of One Biosciences and group leader at Curie Institute, commented: "This investment coupled with our established capacity to train our AI algorithms with proprietary single-cell patient datasets will further substantiate our ability to predict the response to most classes of oncology therapeutics from clinical grade specimens."

Dr Mehdi Touat, Assistant Professor, Assistance Publique – Hôpitaux de Paris AP-HP, Pitié-Salpêtrière and Paris Brain Institute, said: "Widespread use of next generation sequencing (NGS) profiling has led to substantial advances in cancer care but the clinical benefit remains limited to small patient subsets. We believe clinical grade single cell profiling has the potential to catalyze the next generation of diagnostic and therapeutic advances ".

On July 17, 2025 Johnson & Johnson (NYSE: JNJ) reported that the U.S. Food and Drug Administration (FDA) granted Priority Review to the New Drug Application (NDA) filed for TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors (Press release, Johnson & Johnson, JUL 17, 2025, View Source;johnson-receives-us-fda-priority-review-for-tar-200-nda-in-high-risk-non-muscle-invasive-bladder-cancer-302507112.html [SID1234654431]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"TAR-200 represents an innovation in drug delivery that has not been seen in decades," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "The FDA Priority Review for TAR-200 underscores our mission to fundamentally change the way urologists treat certain types of bladder cancer."

The regulatory submission is supported by data from the Phase 2b SunRISe-1 study, which demonstrated an 82.4 percent complete response (CR) rate with 52.9 percent of patients remaining cancer-free at least one year or more after achievement of a CR (95 percent confidence interval [CI], 72.6-89.8). The majority of adverse reactions were mild and moderate. The most common adverse reactions (≥10 percent) included pollakiuria, dysuria, urinary tract infection, micturition urgency, hematuria, cystitis noninfective, and urinary tract pain. No systemic adverse reactions were reported. The findings were presented during a plenary session at the April 2025 American Urological Association Annual Meeting.1

Despite advancements, there has been little change in the standard of care for patients with HR-NMIBC for over 40 years, and patients have limited treatment options if initial BCG therapy does not work. TAR-200 is the first and only intravesical drug releasing system (iDRS) designed to provide sustained local delivery of a cancer treatment into the bladder. TAR-200 remains in the bladder for three weeks per treatment cycle.1 A healthcare professional places it into the bladder using a co-packaged urinary placement catheter in an outpatient setting in less than five minutes. There is no need for general anesthesia, further monitoring, or other restrictions immediately post-insertion within the healthcare provider’s office.

About TAR-200
TAR-200 is an investigational intravesical gemcitabine releasing system. In January 2025, Johnson & Johnson announced the initiation of a new drug application with the FDA for TAR-200 under the Real-Time Oncology Review (RTOR) program. In December 2023, the FDA granted Breakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG-unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with NMIBC in SunRISe-1, SunRISe-3 and SunRISe-5 and muscle-invasive bladder cancer (MIBC) in SunRISe-4.

About SunRISe-1, Cohort 2
SunRISe-1 (NCT04640623), Cohort 2, is a single arm, open-label Phase 2b clinical study evaluating the safety and efficacy of TAR-200 monotherapy for BCG-unresponsive HR-NMIBC patients with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for, or elected not to undergo, radical cystectomy. The primary endpoint for Cohort 2 is complete response (CR) rate at any time point, and secondary endpoints include duration of response (DOR), safety, overall survival and quality of life.

About High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)
High-risk non-muscle invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to muscle invasive bladder cancer compared to low-risk NMIBC.2,3 HR-NMIBC is characterized by a high-grade, large tumor size, presence of multiple tumors, and carcinoma in situ (CIS). HR-NMIBC with CIS makes up approximately 10 percent of patients with NMIBC.4 Bacillus Calmette-Guérin (BCG), is an intravesical medication administered directly into the bladder that patients have to hold for a few hours.5,6 BCG is a weakened form of the bacteria found in tuberculosis treatment, and though effective, some patients become unresponsive to it and experience tolerability challenges.7 Radical cystectomy is currently recommended for HR-NMIBC patients who fail BCG therapy; it is a life-altering surgery with a high degree of morbidity and impact on life, and has a post-surgery mortality rate of three to eight percent.8,9 Given that HR-NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.