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 IO Biotech (Nasdaq: IOBT) reported topline results from the pivotal Phase 3 trial of its investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine, Cylembio (imsapepimut and etimupepimut, adjuvanted) (Press release, IO Biotech, AUG 11, 2025, View Source [SID1234655070]). The trial evaluated Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), vs. pembrolizumab alone as a first-line treatment in 407 patients with unresectable or metastatic (advanced) melanoma. In the study, Cylembio plus pembrolizumab demonstrated clinical improvement in progression free survival compared to pembrolizumab alone, but statistical significance was narrowly missed on the primary endpoint.

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"In this study, we observed a highly encouraging improvement in progression free survival and consistent trend in overall survival in patients treated with Cylembio," said Mai-Britt Zocca, PhD, president and chief executive officer of IO Biotech. "The magnitude and durability of clinical effect observed consistently across subgroups supports our confidence in Cylembio and its potential as a treatment for advanced melanoma patients. We look forward to engaging with the FDA to determine a potential path to approval based on these data."

The randomized, open-label study enrolled 407 patients across more than 100 sites worldwide. Patients received either Cylembio in combination with pembrolizumab (n=203) or pembrolizumab alone (n=204). The primary endpoint was PFS as assessed by a blinded independent review committee per RECIST v1.1. The early and sustained separation of PFS curves demonstrated an improvement with a hazard ratio of 0.77 [95% CI: 0.58-1.00; p=0.056; threshold for significance p≤0.045]. Based on an intent-to-treat analysis, patients in the study treated with Cylembio in combination with pembrolizumab achieved 19.4 months of median progression free survival compared to 11.0 months in patients treated with pembrolizumab alone.

Although not yet mature, a trend toward an improvement in overall survival was also observed [HR 0.79 (95% CI: 0.57-1.10)]; the company expects OS to mature over the next six to nine months.

Improvement in PFS was achieved across virtually all subgroups, including those with poor prognostic factors, with a profound effect in patients with PD-L1 negative tumors treated with Cylembio plus pembrolizumab (n=67) compared to patients treated with pembrolizumab monotherapy (n=63), HR: 0.54 (CI 0.35-0.85) (nominal p=0.006), with mPFS of 16.6 months vs. 3.0 months, respectively. Additionally, in a post hoc analysis of patients enrolled in this study without prior anti-PD-1 treatment (n=371), patients treated with Cylembio plus pembrolizumab achieved improvement in PFS compared to patients treated with pembrolizumab monotherapy, HR: 0.74 (CI 0.56-0.98) (nominal p=0.037), with mPFS of 24.8 months vs. 11.0 months, respectively.

The combination was well tolerated, with no new safety signals observed. Injection site reactions, which were transient and resolved on treatment, were the most commonly reported adverse events in the combination arm, with 56% of patients receiving Cylembio plus pembrolizumab reporting an event.

"In this study, patients treated with Cylembio in combination with pembrolizumab have achieved the longest median PFS ever observed in a Phase 3 clinical study in advanced melanoma, and in the PD-L1 negative population, patients achieved a remarkable 16.6 months of median PFS, compared to 3.0 months in patients treated with pembrolizumab alone," said Omid Hamid, MD, Director, Clinical Research and Immunotherapy at The Angeles Clinic and Research Institute, A Cedars Sinai Affiliate. "The significant benefit seen across patients with poor prognostic factors, including PD-L1 negative patients, cannot be overlooked. Given the notable safety profile and the strong clinical effect observed with Cylembio, as well as the unmet need in advanced melanoma patients, Cylembio, if approved, has the potential to become a new standard of care for patients with advanced melanoma."

"These data show the potential of a therapeutic cancer vaccine in patients with metastatic melanoma," said Jessica Hassel, MD, Professor at the Department of Dermatology and National Center for Tumor Diseases at the University Hospital Heidelberg, Germany, and lead enrolling investigator for the Phase 3 trial. "We were thrilled to play such an important part in this study and to have had the ability to offer our patients an investigational therapy that potentially offers improvements in PFS while not adding significant systemic toxicity."

"Delaying progression and improving survival is the ultimate treatment goal for patients and although overall survival is not yet mature, the trend we are seeing in OS with separation of the curves is encouraging, with a consistent PFS clinical improvement and OS trend favoring the combination arm across virtually all subgroups, with no new safety signals or significant additional systemic toxicity," said Qasim Ahmad, MD, chief medical officer of IO Biotech. "We are deeply grateful to the patients for their participation in this study, as well as to investigators and study coordinators whose dedication and collaboration brings us one step closer to delivering a new treatment option to patients in need."

"Since reporting the positive outcome of our Phase 1/2 study (MM1636) in a similar patient population, we have been eagerly awaiting these results supporting the activity of Cylembio combined with an anti-PD-1 in patients with advanced melanoma," said Inge Marie Svane, MD, PhD, Professor, Director of the National Center for Cancer Immune Therapy (CCIT) at the Copenhagen University Hospital, Herlev and Principal Investigator in the Phase 3 trial. "These data provide evidence that a therapeutic cancer vaccine can improve progression free survival in patients with metastatic disease."

Based on these results, IO Biotech plans to meet with the United States (US) Food and Drug Administration (FDA) this fall to discuss the totality of data and determine next steps for submission of a Biologics License Application (BLA) for the treatment of advanced melanoma. Additionally, the company plans to present more detailed results from the IOB-013 study at an upcoming medical meeting.

Conference Call and Webcast Information

IO Biotech management will hold a conference call and webcast today at 8:30 a.m. ET to discuss these clinical data results. Participants can register for the live webcast here. The live webcast and replay will be available through IO Biotech’s website here.

About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial

IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) was an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.

About Cylembio

Cylembio (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 clinical trials is now complete.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio.

Cylembio is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada).

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])