On August 11, 2025 FoRx Therapeutics, a clinical-stage biotechnology company developing precision anti-cancer therapeutics, reported the dosing of the first patient in a first-in-human clinical study of FORX-428, a novel PARG inhibitor designed to target and disrupt the DNA Damage Response (DDR) in advanced solid tumors (Press release, FoRx Therapeutics, AUG 11, 2025, View Source [SID1234655067]).

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The discovery that distinct genetic subsets of cancer are exceptionally vulnerable to drugs that interfere with the DDR led to the approval of PARP inhibitors more than 10 years ago, transforming cancer treatment. By pursuing a next-generation DDR target, called PARG, FoRx is seeking to further advance this strategy. PARG inhibition holds tremendous promise as a treatment option for patients whose cancers do not or no longer respond to PARP inhibitors.

Tarig Bashir, CEO of FoRx Therapeutics, said: "FoRx is built on the disruptive potential of PARG inhibition as a therapeutic strategy. FORX-428 has demonstrated exquisite anti-tumor efficacy in multiple preclinical in vivo tumor models, suggesting best-in-class potential. The entry of FORX-428 into clinical development is a major milestone in our mission to redefine cancer therapy by offering better treatment options for patients."

An initial data readout from the trial is expected by mid-2026. The open-label study, initially taking place in the United States, is evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors who have exhausted standard-of-care options.

Manish R. Sharma, MD, Co-Director of Clinical Research at START Midwest and Principal Investigator on the trial said: "We are excited to have dosed the first patient with cancer in collaboration with FoRx Therapeutics. There is an unmet need to develop new therapies for advanced cancer patients with distinct DNA damage repair deficiencies or high replication stress. The PARG inhibitor, FORX-428, has a novel mechanism of action, and preclinical studies have shown it had impressive activity in cancers resistant to chemotherapy and PARP inhibitors."

FORX-428 received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) on June 13, the first patient first visit (FPFV) was on July 22 and the first patient was dosed on August 6.

Jens Wuerthner, MD, PhD, Chief Medical Officer of FoRx Therapeutics, said: "The efficient pace from IND clearance to dosing the first patient is a testament to the dedication and coordination of our clinical, regulatory, operational, and research teams, including the team at START Midwest. We are thrilled to have begun investigating FORX-428 in patients with advanced cancer and believe this compound could be a significant advancement in solid tumor therapy."

FORX-428 is a proprietary, orally available small molecule drug designed to inhibit poly (ADP-ribose) glycohydrolase (PARG) to cause tumor cell death. PARG is a key DNA repair enzyme necessary for the survival of certain genetically defined cancers, harboring specific DDR deficiencies or high replication stress. Preclinical studies demonstrated FORX-428 had robust anti-tumor activity across multiple solid tumor types underscoring the novel compound’s outstanding potential in both monotherapy and combination settings. Importantly, FORX-428 was well tolerated, demonstrating drug-like pharmacology and a favorable safety profile.

On August 11, 2025 Tahoe Therapeutics reported $30 million in new funding to build the definitive foundational dataset for training Virtual Cell Models (Press release, Tahoe Therapeutics, AUG 11, 2025, View Source [SID1234655088]). With this, the team will generate one billion single-cell datapoints, mapping one million drug-patient interactions, a scale previously impossible. The dataset will support the discovery of new precision medicines for cancer and beyond. Tahoe will also select a single partner to share the data and accelerate translation to clinical outcomes.

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The round was led by Amplify Partners, joined by a distinguished group of investors including Databricks Ventures, Wing Venture Capital, General Catalyst, Civilization Ventures, Conviction, Mubadala Capital Ventures, and AIX Ventures.

The raise follows the release of Tahoe‑100M, the world’s first gigascale perturbative single-cell dataset, which has become foundational for teams building virtual cell models, ranging from major AI labs to focused research institutions. Open-sourced just a few months ago, Tahoe-100M has been downloaded nearly 100,000 times. The dataset and the models trained on it have already led to the discovery of promising new therapeutic candidates for major cancer subtypes as well as novel targets across multiple modalities.

Tahoe is now expanding on that foundation: the company plans to generate one billion single-cell datapoints, mapping how tens of thousands of drug molecules interact with human biology. This new dataset will expand the boundaries of biological foundation models, aiming to reduce clinical trial failure rates and accelerate the development of precision medicines.

"Building Tahoe-100M required us to invent new ways to generate single-cell data," said Nima Alidoust, co-founder and CEO of Tahoe Therapeutics. "Now, we’re applying that superpower to go 10x further. This next phase is about using these massive datasets to bring about the GPT moment for AI models of human cells, translating insights to clinical readouts, and developing new medicines with much lower clinical failure rates."

With the new capital, Tahoe is advancing its own therapeutic programs toward the clinic, while also launching a new model of strategic collaboration. The company will select a single partner, a pharmaceutical or AI company with complementary strengths, to access the forthcoming dataset. Together, the goal is to develop the first medicines powered by virtual cell models, combining Tahoe’s data with the partner’s clinical or modeling expertise.

"While structural models have accelerated molecular design, they rarely translate to clinical success — a problem that remains one of the biggest challenges in drug development," said Sunil Dhaliwal, General Partner at Amplify Partners. "Tahoe Therapeutics is uniquely positioned to move the industry past this bottleneck by generating massive drug-patient datasets and training high-dimensional, cell-based AI models. We’re proud to back this exceptional team as they combine biology and computation to accelerate clinical impact."

Tahoe founders, Nima Alidoust, Johnny Yu, Hani Goodzari, and Kevan Shokat hold deep experience in single-cell genomics, ML, and drug discovery. The company’s platform makes large-scale, single-cell drug screening across diverse patient contexts not only possible, but scalable. Built on scientific breakthroughs at UCSF, Tahoe is creating the raw materials needed to train disease-relevant foundation models of human cells and chart a new course for precision medicine.

On August 11, 2025 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE natural killer (NK) cell engager platform, reported initiation of dosing in Cohort 3 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies (Press release, GT Biopharma, AUG 11, 2025, View Source [SID1234655068]).

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The Phase 1 dose escalation trial is evaluating GTB-3650, GT Biopharma’s second-generation TriKE, for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies. Cohorts 1 and 2 have now both been successfully completed and following the formal safety reviews, no safety or tolerability issues have been observed. This has allowed initiation of dosing in Cohort 3, with the first patient now having completed the first week of cycle 1.

Patients from Cohort 1 and Cohort 2 have shown encouraging early results indicative of GTB-3650’s ability to activate endogenous NK cells and induce NK cell expansion. Data from multiple blood biomarker assays from the first four patients show heightened immune activity. GT Biopharma plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts.

The trial plans to evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) and GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off (defining a treatment cycle), for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. More details can be found on clinicaltrials.gov with the identifier: NCT06594445.

On August 11, 2025 I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported that enrollment in the planned Phase 1b dose expansion cohorts evaluating givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, in combination with nivolumab and mFOLFOX6, has been completed ahead of expectations (Press release, I-Mab Biopharma, AUG 11, 2025, View Source [SID1234655069]).

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The Phase 1b study (NCT04900818) is evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig, a potential best-in-class, Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, used in combination with nivolumab and mFOLFOX6, as first line therapy (1L) in patients with CLDN18.2-positive gastric cancers (≥1+ intensity in ≥1% of cells). The primary endpoint is safety. The study enrolled only patients in the U.S. The dose expansion cohorts of the study enrolled a total of 40 patients across two doses (8 mg/kg and 12 mg/kg).

"Our optimism in givastomig has been bolstered by the accelerated pace of enrollment in the Phase 1b trial and the ongoing enthusiasm of the study’s investigators. These observations highlight the unmet need for improved gastric cancer therapy, the oncology community’s growing interest in Claudin 18.2-directed therapies and its awareness of the givastomig clinical program. I am encouraged by the Phase 1b dose escalation data, and hopeful that givastomig can become a new treatment option for patients with Claudin 18.2-positive gastric cancers," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "I especially want to thank the patients, their families, investigators and study sites for their continued support for this program."

Data from the dose escalation cohorts of the study were presented on July 2, 2025 in a Mini Oral presentation at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI) 2025 in Barcelona, Spain, accessible here. The data showed that givastomig in combination with immunochemotherapy achieved an 83% (10/12) objective response rate (ORR) at the doses (8 mg/kg and 12 mg/kg) selected for dose expansion. Response onset was rapid, durable and deepened over time, with favorable overall safety. I-Mab hosted a virtual investor event on July 8, 2025 reviewing the Phase 1b dose escalation data (accessible for viewing here).

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation (n=17) and dose expansion (n=40) cohorts. The study builds on positive Phase 1 monotherapy data.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

On August 11, 2025 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs, reported financial results for the second quarter ended June 30, 2025.

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Said Brendan O’Grady, Chief Executive Officer, "The second quarter business and financial results demonstrate continued progress executing our 2025 transformation priorities intended to create sustainable near-term growth and increased long-term value. As part of our transformation process, we are taking steps to streamline our operations to secure additional operating expense savings. We started this process with the divestment of Assertio Therapeutics as communicated last quarter. Pursuant to this effort, we are also consolidating products from previously acquired subsidiaries to further optimize our cost structure.

"Based on strong commercial execution in our core growth assets, Rolvedon achieved the highest level of customer demand since we acquired the product and Sympazan continues to see growth in both prescribers and prescription demand. The remainder of our portfolio is tracking to our expectations. In addition, balance sheet cash and investments increased to more than $98 million as a result of our focus and continued business performance."

(Press release, Assertio Holdings, AUG 11, 2025, View Source [SID1234661832])