On September 30, 2025 CatalYm reported that the first patient has been dosed in the randomized Phase 2b GDFATHER-NSCLC-01 trial (NCT07098988) (Press release, Catalym, SEP 30, 2025, View Source [SID1234656364]). The trial investigates the efficacy and safety of the company’s anti-GDF-15 antibody visugromab, in combination with standard-of-care chemoimmunotherapy, compared to placebo plus chemoimmunotherapy, as a first-line treatment for patients with newly diagnosed metastatic non-squamous non-small cell lung cancer (NSQ mNSCLC).

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!

Visugromab is a humanized, monoclonal antibody designed to neutralize Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine that plays a central role in immune suppression and anti-PD-(L)-1 resistance. CatalYm demonstrated visugromab’s therapeutic potential in the exploratory Phase 1/2a GDFATHER trial (NCT04725474), where the combination of visugromab and an anti-PD-1 inhibitor led to deep and durable responses across multiple solid tumor types while maintaining a favorable safety profile. Visugromab also showed potential to mitigate cancer cachexia, enhancing patients’ quality of life and treatment tolerability, which could extend therapy duration. Results from an additional blinded, exploratory phase 2 trial of nivolumab and visugromab or placebo as neoadjuvant treatment in patients with muscle-invasive bladder cancer will be announced at ESMO (Free ESMO Whitepaper) 2025.

"Our clinical trials have clearly shown visugromab’s impact for solid tumor patients in multiple settings," said Scott Clarke, Chief Executive Officer at CatalYm. "Given the strong anti-tumor effect with long durability, we believe that visugromab is uniquely positioned to demonstrate compelling efficacy as part of a first-line treatment regimen. We will explore the full potential of GDF-15 neutralization through our targeted Phase 2b development program across different tumor types, treatment settings and associated conditions like cancer cachexia."

The randomized, blinded, placebo-controlled Phase 2b GDFATHER-NSCLC-01 (GDF-15 Antibody-mediaTed Human Effector Cell Relocation) trial will enroll approximately 107 patients across multiple sites in the US, EU and Switzerland. The trial consists of an initial non-randomized safety run-in, followed by a randomized part. The primary endpoint of the trial is objective response rate (ORR). Key secondary endpoints include duration of response (DOR), complete and partial response rates (CR and PR), progression-free survival (PFS), overall survival (OS), body weight trends as well as safety and tolerability parameters.

"Joining CatalYm at this pivotal stage, I am encouraged by the clear scientific rationale supporting visugromab’s mechanism of action. GDF-15 plays a critical role in shielding tumors from immune attack, limiting the effectiveness of current immunotherapies. This mechanism is particularly relevant in first-line metastatic NCSLC, where many patients fail to respond or relapse early on immunotherapy. This trial marks an important step in evaluating visugromab’s potential to overcome this resistance and improve outcomes in a setting with limited options," said Sujata Rao, MD, Chief Medical Officer at CatalYm.

About NSCLC

Lung cancers remain the leading cause of cancer-related mortality globally and non-small cell lung cancers (NSCLCs) account for approximately 87% of the 210,000 annual lung cancer diagnoses in the US1. Five-year survival rates in the US for non-squamous NSCLC are low: 12.8% for adenocarcinoma and 5.1% for large-cell carcinoma2. 70-85% of NSCLC patients either exhibit primary resistance to PD-1 blockade or develop acquired resistance to immunotherapy3, emphasizing the need for innovative approaches to overcome immunotherapy resistance.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

On September 30, 2025 Toragen, Inc., a clinical-stage biotechnology company developing a first-in-class, oral small molecule HPV E5 protein inhibitor targeting cancers caused by the human papillomavirus ("HPV"), reported the successful completion of a $12 million convertible note financing (Press release, Toragen, SEP 30, 2025, View Source [SID1234656363]).

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 financing was led by Steven Lebow, who will join Toragen’s Board of Directors along with his designee, Dr. Scott Rasgon. GenHenn Capital also participated with a significant investment and will be represented on the Board by Bill Hagaman, COO of GenHenn Capital. In addition, Cathleen May, PhD, will assume the Board seat of the late Paul Engler, representing the Paul F. and Virginia J. Engler Foundation.

"This financing enables us to advance the next critical steps in developing TGN-S15, our lead candidate, and prepare for our upcoming clinical trial," said Sandra Coufal, MD, CEO of Toragen. "We are grateful for the support of our investors and are excited to welcome four distinguished new members to our Board who bring deep expertise and commitment to our mission of developing an effective treatment for HPV-driven cancers."

The majority of proceeds from this financing will support CMC and IND-enabling studies for TGN-S15.

About Steven E. Lebow

Steven Lebow is widely recognized in the investment banking community for his 21-year tenure as Managing Director at Donaldson, Lufkin & Jenrette (DLJ), where he led the Retail Investment Banking Group and advised clients across the U.S., Europe, and Latin America.

He has been an early investor in companies including Costco, Starbucks, PetSmart, Dick’s Sporting Goods, and Ulta Beauty, generating returns between 100x and 600x and helping drive their combined market capitalization above $600 billion. In recognition of his achievements, Steven was inducted into the DLJ "Hall of Fame" in 1995.

He later co-founded Global Retail Partners, a venture capital firm that became GRP Partners, and has continued to be a prominent figure in finance and investment. Steven earned his BA in Economics and Political Science, magna cum laude and Phi Beta Kappa, from UCLA and an MBA from the Wharton School at the University of Pennsylvania, where he was awarded the Exxon Fellowship.

On September 30, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy and safety of IBTROZI (taletrectinib), a next-generation ROS1 inhibitor, versus placebo for the adjuvant treatment of patients with resected ROS1-positive (ROS1+) early-stage non-small cell lung cancer (NSCLC) (Press release, Nuvation Bio, SEP 30, 2025, View Source [SID1234656362]).

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!

"While surgical resection is a standard treatment for early-stage non-small cell lung cancer, many patients will unfortunately have a recurrence of their cancer after surgery. Patients with ROS1 fusion-positive cancers need new options in the adjuvant setting beyond chemotherapy, especially as we have seen improved outcomes with targeted therapies in other driver-positive cancers," said Alexander Drilon, M.D., Chief, Early Drug Development, Memorial Sloan Kettering Cancer Center and trial investigator. "With its well-characterized, manageable safety profile and demonstrated efficacy in advanced disease, taletrectinib, I believe, holds promise to help prevent disease recurrence following resection of ROS1 fusion-positive tumors. I look forward to learning more about the potential of taletrectinib in this setting as the trial advances."

Following alignment with the U.S. Food and Drug Administration on study design, TRUST-IV will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China with ROS1+ stage IB, II or IIIA NSCLC who have received surgery for their disease. Patients must not have received adjuvant anticancer therapy except standard postoperative platinum-based doublet chemotherapy. Patients will be randomized 2:1 to receive either taletrectinib or placebo daily. The primary endpoint is disease-free survival as determined by investigator. Primary completion date is estimated to be in 2033.

"Based on the proven efficacy and safety data supporting IBTROZI’s use and approval in advanced ROS1-positive non-small cell lung cancer, we are excited to explore its potential in earlier-stage disease, where targeted therapies are lacking," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "The initiation of this trial, with our first patient in the U.S. now enrolled, marks important momentum with our pipeline as we aim to help more patients with lung cancer stay ahead of their disease."

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 20-30% of patients newly diagnosed with ROS1+ NSCLC have early-stage disease amenable to surgical resection.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, following Priority Review and Breakthrough Therapy Designations for both first- and second-line treatment, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at IBTROZI.com.

Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZITM (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.​

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). ​

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%). ​

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity. ​
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.

On September 30, 2025 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based, biopharmaceutical company reported having signed a license agreement for SunRock Biopharma’s SRB21, an HER3/HER2 antibody (Press release, Debiopharm, SEP 30, 2025, View Source [SID1234656361]). SunRock Biopharma is a Galician company supported by the regional government, Xunta de Galicia, through Xesgalicia, devoted to the development of antibodies against highly invasive tumors with an urgent clinical need in oncology. Debiopharm has exercised its option to license SunRock Biopharma’s bispecific antibody, which targets both HER2 and HER3 human epidermal growth factor receptors. This agreement, initially announced in 2023, will combine this antibody with Debiopharm’s proprietary MultiLINK Linker Technology to develop a new antibody-drug conjugate (ADC) under the name Debio 2512.

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!

Debiopharm will leverage their "Trifecta" approach with this bispecific antibody to create a fit-for-purpose ADC using proprietary linkers and smart payload selection. Bispecific ADCs target multiple antigens simultaneously potentially offering higher efficacy and specificity while reducing off-target effects and overcoming resistance mechanisms. This dual-targeting strategy may allow for more potent delivery of cytotoxic payloads directly to cancer cells while sparing healthy tissues, offering breakthrough options for patients with resistant cancer types.

"Bi-specific ADCs hold significant promise as the next generation of cancer therapies," mentioned Bertrand Ducrey, CEO of Debiopharm. "We’re excited to confirm this licensing option as it allows us to apply our MultilinkTM Linker Technology to a dual-targeted design that could pave the way for breakthrough therapies in HER-driven cancers."

HER2-driven cancers are widely recognized as more aggressive forms of disease, marked by faster growth, earlier relapse, and a higher likelihood of treatment resistance.1 While recent therapies have provided meaningful advances, many patients ultimately develop resistance and metastasis, limiting the durability of response and long-term survival benefits. A bi-specific antibody targeting HER3 and HER2 represents a highly promising advancement for ADC development. By targeting simultaneously HER2 and HER3, this approach has the potential to overcome resistance mechanisms that limit current HER2-directed therapies.

"The licensing of SRB21 represents a significant milestone for SunRock Biopharma and a strong validation of our bi-specific antibodies platform," said Laureano Simón, CEO of SunRock Biopharma. "Through our collaboration with Debiopharm, we aim to accelerate the development of next-generation bi-specific ADCs, tailored to offer new hope to patients with HER2-resistant tumors."

"Patients fighting HER2-driven cancers require treatment approaches that can safely and effectively target and outsmart resistant or recurrent disease," explained Frederic Levy, CSO at Debiopharm. "The development of bi-specific ADCs targeting HER3 and HER2 in conjunction with our "Trifecta" approach represents a highly promising advancement in hard-to-treat cancers."

On September 30, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the publication of a peer-reviewed manuscript in the Journal of Clinical Oncology – Precision Oncology (JCO PO) (Press release, Natera, SEP 30, 2025, View Source [SID1234656360]). The paper features results from a multi-institutional study evaluating circulating tumor DNA (ctDNA) as a prognostic biomarker for patients with germ cell tumors (GCT), including testicular cancer.

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!

Testicular cancer represents approximately 95% of all GCTs1 and is the most common malignancy in men aged 15-35.2 Serum tumor markers (STM) play a central role in the management of testicular cancer, but their utility is limited since they can be normal or falsely elevated in a substantial proportion of patients. While early stages can be cured with surgery alone or with the addition of chemotherapy and/or radiotherapy, a subset of patients may receive chemotherapy that may not be necessary. Having reliable biomarkers to stratify recurrence risk and guide these decisions is a critical challenge in advancing care for this patient population.

This multicenter, retrospective study analyzed 324 plasma samples from 74 patients with testicular cancer, across stages I-III. Signatera was used to assess ctDNA levels before, during and after treatment. Results demonstrated that Signatera-positivity was significantly associated with shorter event-free survival (EFS) in both post-surgical and surveillance settings. By comparison, conventional STMs did not consistently correlate with outcomes. When assessed together during surveillance, ctDNA outperformed STMs in predicting EFS. Key findings include:

The Signatera-based ctDNA-positivity rate pre-surgery was 91.6% for stage I, and 100% for both stage II and III.
Post-surgery (<12 weeks), Signatera-positive patients had a significantly shorter EFS compared to Signatera-negative patients (EFS HR: 5.11, p=0.019). In contrast, patients with elevated STMs showed no significant difference in EFS compared to those with normal STM levels (EFS HR: 2.97, p=0.149).
In the surveillance setting, Signatera-positive patients experienced a significantly shorter EFS compared to Signatera-negative patients (HR: 12.45, p<0.0001). This was not reflected in patients stratified by STM levels (HR: 1.74, p=0.194).
"These findings demonstrate that ctDNA can identify which patients with testicular cancer are at high risk of recurrence or progression," said Nabil Adra, M.D., associate professor of medicine at Indiana University and principal investigator of the study. "This study gives us new key evidence on the potential of ctDNA to meaningfully improve how we monitor and manage this disease."

"Testicular cancer is the most common cancer in young men," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "Serum tumor biomarkers are widely used but often leave gaps in decision-making. These results, which represent the largest published study of ctDNA in testicular cancer to date, highlight the unique value of Signatera to reliably detect molecular residual disease and predict clinical outcomes."