SNV1521 / Synnovation Therap - LARVOL DELTA

First in Human Study of SNV1521 With a RAS Inhibitor for People With Advanced Pancreatic Cancer (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Synnovation Therapeutics, Inc.

First-in-human • New P1 trial • Oncology • Pancreatic Cancer • Solid Tumor

Itareparib: A potent, selective and non-trapper PARP1 inhibitor for combination therapy with DNA damaging agents in solid tumors (AACR 2026) - "Multiple first generation non-selective, trapping PARP1/2 inhibitors have been successful as single agent cancer treatments in homologous recombination (HR)-deficient malignancies; on the other hand, first-generation PARPi such as olaparib (a strong PARP1 trapper), or veliparib (a PARP1 trapper with medium potency), have not been successful in combination with chemotherapy due to a poor therapeutic window. Recently, second generation trapper PARP1-selective inhibitors (e.g. saruparib, M9466, SNV1521 and palacaparib) have entered clinical development, based on preclinical evidence that PARP2 inhibition is associated with anemia and dispensable for anti-tumor efficacy...Indeed, all these inhibitors trap PARP1 on DNA lesions, causing hematological adverse effects that are overlapping with those caused by chemotherapy agents such as temozolomide (TMZ) and topoisomerase I inhibitors (TOP1i), thus limiting their combination potential. We used biochemical and cellular assays to..."

Combination therapy • Brain Cancer • Glioma • High Grade Glioma • Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • PARP2 • SLFN11

SNV1521-101: SNV1521 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=400 | Recruiting | Sponsor: Synnovation Therapeutics, Inc. | N=200 ➔ 400 | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Prostate Cancer • Solid Tumor

The potent and selective PARP1 inhibitor and trapper SNV1521 exhibits combination activity with targeted and chemotherapeutics (AACR 2025) - "When comparing with the target efficacious concentration using a BRCA2-deficient cell line versus the NOEL for suppression of heme progenitors, SNV1521 showed an expanded margin versus either olaparib or saruparib...In a PDX model of breast cancer, the combination of topotecan with SNV1521 showed deeper tumor regression than either agent alone. Moreover, this activity showed durable anti-tumor activity after cessation of dosing. In summary, these data support the continued clinical development of SNV1521 as monotherapy and also in combination with drugs that are mechanistically synergistic but cannot be effectively combined with less selective PARP1 inhibitors because of overlapping toxicities."

Breast Cancer • Oncology • Solid Tumor • BRCA • BRCA2 • PARP2

First results from a phase I trial of SNV1521, a next generation, CNS-penetrant, PARP1-selective inhibitor in patients (pts) with molecularly selected advanced solid tumors (ESMO 2025) - P1 | "Conclusions SNV1521 is well tolerated and has a differentiated PK profile with prolonged t½ and wider therapeutic window compared to other PARPi. Encouraging anti-tumor activity and minimal hematologic toxicities support further development."

Clinical • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • BRCA1 • BRCA2 • CDK12 • CHEK1 • CHEK2 • MUC16 • PALB2 • PARP2 • RAD51

PARP1 & Pol theta (ApexOnco OncologyPipeline) - "Synnovation’s SNV1521 did at least show this, yielding grade 3+ treatment-related adverse events in just two of 58 patients treated...But there were just three confirmed partial partial responses (in breast and prostate cancers) among 27 evaluable subjects treated with SNV1512. There were all in PARP inhibitor-naive tumours; the situation was complicated by the fact that at least three other PARP-naive patients experienced significant disease progression."

P1 data • Platinum resistant • Breast Cancer • Fallopian Tube Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer

Synnovation to Present SNV1521 (PARP1) Phase 1 Study Results at the European Medical Oncology (ESMO) Congress 2025… (Businesswire) - "Patricia LoRusso, D.O, Ph.D, Associate Center Director for Innovative Medicine at Yale Cancer Center, will present the initial results on Friday, October 17, 2025."

P1 data • Solid Tumor

Synnovation…Announces Clinical Collaboration with DualityBio to Evaluate the Combination of SNV1521 with Duality’s HER3 ADC, DB-1310 (Businesswire) - "...'This collaboration provides an exciting opportunity to evaluate the combination of two potentially best-in-class therapies...with the aim of demonstrating synergistic efficacy and improving patient outcomes'."

Licensing / partnership • Solid Tumor

SNV1521-101: SNV1521 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Synnovation Therapeutics, Inc. | N=76 ➔ 200

Enrollment change • Oncology • Prostate Cancer • Solid Tumor

SNV1521-101: SNV1521 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Synnovation Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Synnovation Therapeutics Announces First Patient Dosed in Phase I Trial with SNV1521, a PARP1 Selective Inhibitor for the Treatment of Solid Tumors (Businesswire) - "Synnovation Therapeutics...announced that the first patient has been dosed in a Phase I trial evaluating SNV1521 in patients with solid tumors. SNV1521 is a potentially best-in-class, potent, highly selective and CNS penetrant PARP1 inhibitor."

Trial status • Oncology • Solid Tumor

SNV1521 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: Synnovation Therapeutics, Inc.

Metastases • New P1 trial • Oncology • Solid Tumor

Synnovation Therapeutics Launches with $102 Million to Advance Clinical-Stage Pipeline of Precision Therapies Targeting Highly Validated Disease Pathways (Businesswire) - "Synnovation Therapeutics...launched today with a $102 million Series A. The financing was led by Third Rock Ventures with participation from Nextech, Lilly Asia Ventures, Sirona Capital and Cormorant Asset Management....Proceeds will fund the advancement of the company’s clinical and preclinical pipeline, including SNV1521 and SNV4818, as well as additional programs....The company is initiating a Phase I study and anticipates dosing its first patient in the coming weeks."

Financing • New P1 trial • Oncology