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.

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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]).

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"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.

On July 17, 2025 10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, and the A*STAR Genome Institute of Singapore (A*STAR GIS), reported a research collaboration for the Target Inference from Spatialomics & Histology Using Multimodal AI & Phenotypes (TISHUMAP) project (Press release, A*STAR, JUL 17, 2025, View Source [SID1234654430]). This initiative will leverage 10x Genomics’ Xenium platform and advanced artificial intelligence (AI) to analyze thousands of tissue samples with the goal of accelerating drug target discovery and enabling precision medicine for cancer and inflammatory diseases.

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As part of the TISHUMAP study, A*STAR GIS and 10x Genomics will analyze up to 2,500 formalin-fixed paraffin-embedded (FFPE) clinical tissue samples, including those from gastric, liver and colorectal cancers. Unlike traditional methods that require tissues to be broken down, 10x Genomics’ Xenium platform uniquely enables researchers to visualize gene activity directly within individual cells in intact tissues. This approach generates a comprehensive and precise molecular-level map, clearly illustrating how cells are positioned, interact and function within their natural biological context. When combined with advanced AI, this powerful capability allows researchers to detect critical patterns across large datasets swiftly, significantly advancing the identification of novel biomarkers and drug targets. The goal is to pave the way for the development of new diagnostics and, in the future, personalized treatment plans for patients.

"We are excited to partner with 10x Genomics on TISHUMAP, a transformative initiative in large-scale spatial omics for drug target discovery," said Dr. Shyam Prabhakar, Associate Director, Spatial and Single Cell Systems at A*STAR GIS. "TISHUMAP builds on A*STAR GIS’ leading role in translational genomics in Asia and 10x Genomics’ commitment to advancing human health through spatial and single cell innovations. Together, we are building the foundation for new diagnostics and more effective therapies for various cancers and precancerous conditions."

This collaboration spans both data generation and analysis stages, including tailored gene panels designed for specific research questions and intelligent software pipelines for efficient management of large datasets. A*STAR GIS and 10x Genomics will work together to streamline lab workflows and build advanced tools that simplify how scientists prepare samples, capture images, and analyze spatial biology data. They’ll also co-develop custom gene panels and smart software pipelines designed to handle the massive datasets generated by this cutting-edge research.

"With Xenium, we are uncovering how biology works at subcellular resolution, revealing the underlying mechanisms of health and disease. By delivering accessible and transformative spatial biology, Xenium empowers scientists everywhere to ask bigger questions and unlock discoveries that were previously out of reach," said Serge Saxonov, CEO of 10x Genomics. "Spatial biology and advanced AI is the future of precision medicine. We are proud to partner with A*STAR GIS to accelerate the development of new diagnostics and therapies."

On July 17, 2025 Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a majority-owned subsidiary of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), reported the closing of its "reasonable best-efforts" public offering of 6,818,182 shares of common stock of the Company and warrants to purchase shares of common stock at a public offering price of $1.32 per share (Press release, Citius Oncology, JUL 17, 2025, View Source [SID1234654429]). The warrants have an exercise price of $1.32 per share, are immediately exercisable upon issuance, and expire five years from the date of issuance. Gross proceeds from the offering, before deducting placement agent fees and other estimated offering expenses, are approximately $9.0 million.

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Maxim Group LLC acted as sole placement agent in connection with the offering.

The Company intends to use the net proceeds from the offering primarily to support the commercialization of LYMPHIR, including milestone, royalty, or other payments pursuant to existing license agreements, as well as for working capital and general corporate purposes.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-288656), as amended, which was filed with the U.S. Securities and Exchange Commission ("SEC") on July 14, 2025, and was declared effective by the SEC on July 16, 2025. A final prospectus relating to the offering was filed with the SEC and may be obtained on the SEC’s website at View Source The offering was made only by means of a prospectus forming part of the effective registration statement. Electronic copies of the final prospectus relating to this offering may also be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, New York 10022, Attention: Syndicate Department, by telephone at (212) 895-3745 or by email at [email protected].

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

On July 17, 2025 Daiichi Sankyo reported that ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer (Press release, Daiichi Sankyo, JUL 17, 2025, View Source [SID1234654428]).

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The U.S. Food and Drug Administration (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

The FDA granted this BTD based on data from the DESTINY-Breast09 phase 3 trial presented during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting.

"This Breakthrough Therapy Designation provides further recognition of the potential benefit of ENHERTU in combination with pertuzumab in the first-line setting of HER2 positive metastatic breast cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "If approved, ENHERTU will continue to redefine the treatment of metastatic breast cancer as these latest results from DESTINY-Breast09 demonstrate a median progression-free survival of more than three years when using ENHERTU plus pertuzumab in this disease setting, which is an improvement over the current standard of care that has been in place for more than a decade."

ENHERTU has received nine BTDs, including five BTDs for metastatic breast cancer. In addition to the new BTD, the four previous BTDs for breast cancer were for second-line HER2 positive metastatic breast cancer, later-line HER2 positive metastatic breast cancer, later-line HER2 low metastatic breast cancer and HER2 low or HER2 ultralow metastatic breast cancer. ENHERTU also received four additional BTDs for HER2 positive (IHC 3+) metastatic solid tumors, HER2 positive metastatic colorectal cancer, HER2 (ERBB2) mutant metastatic non-small cell lung cancer (NSCLC) and HER2 positive metastatic gastric cancer.

The latest BTD for ENHERTU represents the thirteenth BTD across the oncology portfolio of Daiichi Sankyo.

About DESTINY-Breast09

DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a first-line treatment in patients with HER2 positive metastatic breast cancer.

Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is progression-free survival (PFS) as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov

About HER2 Positive Metastatic Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or progress to metastatic disease are expected to live five years following diagnosis.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 Approximately one in five cases of breast cancer are considered HER2 positive.

HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.6 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.4,7,8,9 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 70 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other anti-cancer therapies across multiple HER2 targetable cancers.