On September 24, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported the initiation of the Phase 2 monotherapy, dose-optimization trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46-expressing cancer lesions in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, FibroGen, SEP 24, 2025, View Source [SID1234656192]). The trial will also assess the diagnostic and predictive performance of FG-3180, a companion PET imaging agent, which shares the same CD46-targeted antibody used in FG-3246. The ability of FG-3180 to identify mCRPC lesions and predict response to FG-3246 will be evaluated.

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"With the transformation of FibroGen to a U.S.-focused organization now complete and a robust cash runway into 2028, we are excited to advance our FG-3246 program and initiate the Phase 2 monotherapy trial with the activation of the University of California San Francisco (UCSF) site," said Thane Wettig, Chief Executive Officer of FibroGen. "FG-3246 demonstrated compelling clinical activity in patients that were heavily pre-treated, with a competitive radiographic progression free survival benefit in the Phase 1 monotherapy study. We are confident that the dosing regimen of FG-3246, use of prophylactic G-CSF, and the enrollment of patients in earlier lines of treatment of mCRPC set us up to further demonstrate the potential of this program. We anticipate results from the interim analysis of our Phase 2 study in the second half of 2026. We also look forward to reporting the results from the ongoing investigator-sponsored study of FG-3246 in combination with enzalutamide in the fourth quarter of this year."

The Phase 2 monotherapy trial (NCT06842498) is a randomized, open label, dose optimization trial designed to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246 for the treatment of patients with mCRPC who have progressed following ARSI treatment and who have not received chemotherapy for their mCRPC. The trial is scheduled to enroll 75 patients who will be randomized 1:1:1 to receive either 1.8, 2.4 or 2.7 mg/kg AJBW of FG-3246. The primary endpoint of the trial is the determination of the optimal dose for the Phase 3 trial based on efficacy, safety, and PK parameters. Secondary endpoints include radiographic progression free survival (rPFS), prostate-specific antigen (PSA) 50 response, and PSA90 response. An interim analysis is planned once 12 patients enrolled in each of the three dose arms have completed 12 weeks on study or discontinued and is anticipated in the second half of 2026. An exploratory sub-study will evaluate FG-3180, a companion PET imaging agent, as a diagnostic radiopharmaceutical. All patients deemed eligible for participation in the Phase 2 trial will participate in the sub-study evaluating FG-3180 prior to randomization.

In addition, topline results from the ongoing investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC are expected in the fourth quarter of 2025.

About FG-3246
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies.

FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The Phase 2 monotherapy dose optimization trial for FG-3246 in mCRPC was initiated in the third quarter of 2025, with interim results expected in the second half of 2026. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Prostate cancer is the second most common malignancy in men, contributing significantly to male mortality rates. Approximately 13% of men will be diagnosed with prostate cancer at some point during their lifetime. There are about 65,000 drug treatable mCRPC cases in the U.S. annually and 5-year survival in mCRPC is approximately 30%.

On September 24, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) on August 29 for the anti-cancer agent/humanized anti-VEGF*1 monoclonal antibody Avastin for Intravenous Infusion 100mg/4mL, 400mg/16mL [generic name: bevacizumab (genetical recombination)] for neurofibromatosis type 2 (NF2), a new indication for Avastin (Press release, Chugai, SEP 24, 2025, View Source [SID1234656190]).

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This filing is based on the results from a Japanese phase II BeatNF2 study initiated by investigators, which evaluated the efficacy and safety of Avastin for NF2.

About BeatNF2 study
BeatNF2 study (jRCT2080224914) is an investigator-initiated, Japanese Phase II, multicenter, placebo-controlled, double-blind, randomized study that evaluated the efficacy and safety of Avastin for NF2, a rare hereditary disease. The study enrolled 62 patients who were divided into an Avastin treatment group and a placebo group to compare the improvement in hearing at 24 weeks after treatment initiation. After 24 weeks and up to 48 weeks, both groups received Avastin. The primary endpoint was "the proportion of patients with improved hearing at 24 weeks after treatment initiation compared to baseline, based on the evaluation using maximum speech discrimination score*2." Secondary endpoints included maximum speech discrimination score at weeks 12, 36, and 48, tumor volume, pure tone audiometry, auditory steady-state response, NF2 severity score, and the efficacy of retreatment in patients who experienced hearing deterioration following initial improvement.

*1 VEGF：Vascular Endothelial Growth Factor
*2 Maximum speech discrimination score is an indicator of speech comprehension ability. It refers to the percentage of correct answers in a monosyllabic word recognition test at the volume level that yields the highest accuracy while adjusting sound intensity. The higher this value, the better one’s ability to accurately understand speech when sounds are audible. It also serves as a measure for evaluating the effectiveness of hearing aids.

About neurofibromatosis type 2 (NF2)1
NF2 is an autosomal dominant hereditary disease characterized by bilateral acoustic nerve tumors (vestibular schwannomas). Symptoms commonly associated with acoustic schwannomas include hearing loss, dizziness, unsteadiness, and tinnitus. Additionally, symptoms related to other manifestations such as spinal nerve schwannomas may include numbness in the limbs, reduced sensation, and weakness.
For acoustic neuroma, observation, surgery, and radiation therapy are performed. While it is a benign tumor that sometimes shows little growth, in cases where symptoms develop or tumor growth is evident, surgical removal may be performed, which can affect the long-term prognosis. Preservation of hearing through surgery is difficult, and there is a risk of postoperative neurological complications.
According to overseas reports, the incidence rate is a rare 1 in 25,000-60,000 people, and in Japan, approximately 800 people submitted clinical registry data between 2009-2013. Most cases are diagnosed in patients between 10 and 29 years of age.

About Avastin
Avastin is an antibody drug that specifically binds to VEGF2, which plays an important role in angiogenesis necessary for tumor growth and metastasis, and inhibits its action. Since its launch in Japan in June 2007, it has been positioned as one of the standard treatments in treatment guidelines for various types of cancer. It has been approved for seven indications (unresectable advanced or recurrent colorectal cancer, unresectable advanced or recurrent non-small cell lung cancer excluding squamous cell carcinoma, inoperable or recurrent breast cancer, malignant glioma, ovarian cancer, advanced or recurrent cervical cancer, and unresectable hepatocellular carcinoma).

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On September 24, 2025 Artios Pharma Limited ("Artios"), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response ("DDR") in cancer, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its ATR inhibitor, alnodesertib, in combination with a low dose of chemotherapeutic agent irinotecan, for the treatment of adult patients with ATM-negative metastatic colorectal cancer (mCRC) in the third-line setting (Press release, Artios Pharma, SEP 24, 2025, View Source [SID1234656187]).

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"The Fast Track designation for alnodesertib underscores its first-in-class potential for third-line mCRC patients with ATM-negative tumors," said Mike Andriole, Chief Executive Officer of Artios. "Approximately 3,000 patients with ATM-negative third-line mCRC succumb to this disease annually in the United States, with no treatment options that specifically address this protein deficiency. Alnodesertib has the potential to be the first treatment specifically for this invariably lethal disease. Additionally, we are encouraged by the durable responses this program has demonstrated across other tumor types, highlighting its ability to target replication stress across a range of solid tumors."

The designation is supported by encouraging results from the ongoing STELLA Phase 1/2a study, which is evaluating alnodesertib in combination with a low dose of irinotecan. Beyond third-line mCRC, clinical responses were observed in seven additional solid tumor types with ATM deficiency. The combination of alnodesertib plus low-dose irinotecan has a favorable safety profile to date, has been well tolerated, and has been shown to be suitable for long-term dosing.

"Patients with third-line colorectal cancer face a dismal prognosis, with current standards of care for third-line mCRC delivering response rates in the single digits. In our studies to date, alnodesertib has demonstrated compelling clinical activity in ATM-negative patients with mCRC as well as in other heavily pretreated cancer types with high endogenous replication stress," said Ian Smith, Chief Medical Officer of Artios. "These results, together with activity across other solid tumors, highlight alnodesertib’s potential to deliver meaningful benefit where treatment options are limited. The FDA’s Fast Track designation recognizes both the strength of our early clinical data and the urgent need for new therapies, while also providing the opportunity for enhanced interactions with the Agency."

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with Fast Track designation are eligible for priority review and accelerated approval if relevant criteria are met. The Fast Track designation for alnodesertib was granted based on early Phase 1/2 clinical studies that are currently ongoing in the United States. The designation will enable Artios to interact early and more frequently with the FDA to discuss alnodesertib’s development path.

About Alnodesertib

Alnodesertib, formerly known as ART0380, is a potential first-in-class, orally administered, selective small molecule inhibitor of ataxia-telangiectasia and Rad3-related protein (ATR). Artios’ differentiated approach combines alnodesertib with a low dose of the chemotherapy irinotecan, targeting cancers with high endogenous replication stress, such as those with ATM protein deficiency.

On September 23, 2025 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho Pharmaceutical"), reported a collaboration agreement with Guardant Health, Inc. (hereinafter "Guardant Health") to discover new biomarker signatures by leveraging Guardant Health’s "GuardantINFORMTM" platform for multimodal analysis of real-world data (Press release, Taiho, SEP 24, 2025, View Source [SID1234656173]).

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This collaboration aims to discover new biomarker signatures with clinical and biological significance for addressing unmet needs in early-stage recurrent cancer, where the presence of microscopic cancer cells remaining in the body after surgery is a cause of recurrence. This collaboration leverages unique multimodal and longitudinal cohorts within GuardantINFORM, including those with minimal residual disease (MRD) testing.

This initiative is expected to support the development of treatments for patients at high risk of recurrence and lead to new and clinically relevant approaches enabling medical interventions at an early stage of cancer. The collaboration has an overarching goal of driving significant progress in overcoming cancer.

Taiho Pharmaceutical has a strong track record of developing multiple investigational and approved drugs in Japan, the US, and Europe by utilizing its proprietary "Cysteinomix drug discovery" which enables the creation of drugs that bind specifically and strongly to drug targets. By further analyzing the novel gene signatures identified through this collaboration and integrating these insights with the Cysteinomix drug discovery platform, we anticipate substantial potential to develop precise and effective treatment approaches for new drug targets that were previously difficult to discover.

Takeshi Sagara, Taiho Pharmaceutical’s Executive Director, Clinical Development and Medical Affairs, Discovery & Preclinical Research, said, "We believe that future anticancer drug discovery focusing on research and development not only for advanced cancer but also for early-stage recurrent cancer, with an eye on the patient’s journey, will lead to long-term survival and ultimately the overcoming of cancer. Through our collaboration with Guardant Health, we aim to identify and develop biomarker signatures, that arise in early-stage recurrence and contribute to the creation of next-generation treatment methods."

About Cysteinomix Drug Discovery
Cysteinomix drug discovery is Taiho Pharmaceutical’s original drug discovery technology designed to continuously generate covalent drugs targeting a variety of proteins that contain cysteine. Covalent drugs are pharmaceuticals that irreversibly control the function of target proteins by forming covalent bonds with them. These drugs consist of a ligand that binds to a protein pocket and a reactive group that forms a covalent bond with a specific amino acid. The Cysteinomix drug discovery platform is composed of a target protein database, a covalent compound library, and various compound evaluation systems, among other components. To date, this platform has successfully led to the creation of several pipelines.

On September 23, 2025 Manas AI, a full-stack, AI native drug discovery and development company, reported the closing of a $26M Seed Extension and the addition of its new Co-Founder and Chief Technology Officer, Ujjwal Singh (Press release, Manas AI, SEP 23, 2025, View Source [SID1234656927]).

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Manas AI was founded to overcome the critical inefficiencies of traditional drug development. By uniting world-class biomedical expertise and next generation AI capabilities, the company is pioneering a new paradigm of faster, cheaper, and more precise medicines.

Manas AI will utilize the new funding to accelerate the development of its drug discovery foundational models and advance its current therapeutic campaigns. Manas AI will also utilize funds to continue to expand its team of premier interdisciplinary individuals, with new additions headed by Ujjwal Singh.

Singh joins Manas AI having most recently served as Chief Technology and Product Officer at Multiverse. He previously held the role of Head of Workplace at Meta, following a distinguished tenure at Google where he drove significant product innovation. At Google, Singh was a Partner at the internal incubator, Area 120, and as Senior Director of Engineering, he founded and launched Google Hangouts. He also spearheaded the engineering efforts that expanded YouTube into dedicated platforms like YouTube Kids, Music, and Gaming.

"We are incredibly excited to welcome Ujjwal Singh as both a Co-Founder and Chief Technology Officer", said Dr. Siddhartha Mukherjee, CEO and Co-Founder of Manas AI. "Ujjwal’s extensive AI and productization background perfectly complement the AI-native, scalable design of Manas’ vision. Ujjwal will not only make an impact on our cutting-edge AI capabilities but also as an experienced and visionary leader in the Co-Founder role."

"Manas AI’s mission to usher in a new era of medicine—one defined by accelerated discovery and highly targeted therapies—deeply resonates with me," said Singh. "Together with Reid Hoffman, Dr. Siddhartha Mukherjee, and the rest of the remarkable leadership team, I believe we can build a truly meaningful company that harnesses and deploys the most impactful aspects of the AI revolution we are witnessing."

"It is excellent to work with Ujjwal again. Ujjwal is an amazing technologist, who brings the experience of many scale AI projects to Manas’ mission to transform the drug discovery process," said Reid Hoffman, Co-Founder of Manas AI, Inflection AI, and LinkedIn.

Manas AI’s Seed Extension follows a $24.6M Seed Round announced in January of this year led by General Catalyst and Reid Hoffman. The seed extension also includes The General Partnership, Wisdom Ventures, Blitzscaling Ventures, Westbound Equity Partners, Mosaic Ventures, and a number of individuals.