SB 11285 / Sino Biopharm - LARVOL DELTA

Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=61 | Completed | Sponsor: invoX Pharma Limited | Active, not recruiting ➔ Completed | N=146 ➔ 61 | Trial completion date: Dec 2024 ➔ Jul 2024 | Trial primary completion date: Dec 2024 ➔ Jul 2024

Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • BRAF

Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=146 | Active, not recruiting | Sponsor: invoX Pharma Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2027 ➔ Dec 2024 | Trial primary completion date: Mar 2027 ➔ Dec 2024

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • BRAF

Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=146 | Recruiting | Sponsor: invoX Pharma Limited | Phase classification: P1a/1b ➔ P1 | Trial completion date: Oct 2025 ➔ Mar 2027 | Trial primary completion date: Oct 2023 ➔ Mar 2027

Combination therapy • Metastases • Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • BRAF

Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=146 | Recruiting | Sponsor: F-star Therapeutics, Inc. | N=110 ➔ 146 | Trial completion date: May 2022 ➔ Oct 2025 | Trial primary completion date: Dec 2021 ➔ Oct 2023

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • BRAF

F-star Therapeutics Reports Full-Year 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Anticipated Program Milestones: In 2022: A clinical efficacy readout of FS118 in PD-1 acquired resistance head and neck cancer patients who have failed checkpoint therapies. Clinical update on FS222 Phase 1 trial. Program update on the Phase 1 trial of FS120. FS120 trial part B initiation, in combination with Merck’s pembrolizumab...R&D expense was $28.8M for the year ended December 31, 2021, compared to $14.1M for the 2020 year-end. The increase in R&D expense was due primarily to the expansion of our FS118 clinical trial into acquired resistance head & neck patients, as well as our CPI naïve trial in NSCLC and DLBCL, a full year of spend on the mono and combo SB11285 clinical trial, and continued progression of our FS120 and FS222 clinical programs."

Clinical • Clinical data • Commercial • Diffuse Large B Cell Lymphoma • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

F-star Therapeutics to Host Virtual R&D Day on December 6, 2021 (GlobeNewswire) - "Following a discussion of F-star’s R&D platform, Louis Kayitalire, M.D., Chief Medical Officer, will present on the vast potential of the company's clinical pipeline of tetravalent mAb2 bispecifics, each of which is directed against some of the most exciting targets in immuno-oncology drug development, including LAG-3 and CD137 (4-1BB)."

Clinical • Breast Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] A phase I/Ib dose-escalation study of intravenously administered SB 11285 alone and in combination with nivolumab in patients with advanced solid tumours (ESMO 2020) - P1a/1b | "Funding: Spring Bank Pharmaceuticals. Clinical trial identification: NCT04096638."

Clinical • Combination therapy • IO Biomarker • P1 data • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • STING

[VIRTUAL] A Phase 1/1b Dose-escalation Study of Intravenously Administered SB 11285 Alone and in Combination with Atezolizumab in Patients with Advanced Solid Tumors (SITC 2020) - No abstract available

Clinical • Combination therapy • P1 data • Oncology • Solid Tumor

[VIRTUAL] A phase Ia/Ib dose-escalation study of intravenously administered SB 11285 alone and in combination with nivolumab in patients with advanced solid tumors. (ASCO 2020) - P1a/1b | "The trial is being conducted at multiple sites in the U.S . Research Funding: Spring Bank Pharmaceuticals, Inc."

Clinical • Combination therapy • IO Biomarker • P1 data • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • STING

F-star Therapeutics is Granted Composition of Matter Patent for its Novel Second Generation STING Agonist, SB 11285 (GlobeNewswire) - “F-star Therapeutics, Inc…announced that the United States Patent and Trademark Office (USPTO) has granted the Company a patent (U.S. Patent No. 11,033,569) protecting the composition of matter of F-star’s SB 11285, a second generation STING agonist. The patent protection is expected to continue to July 2037, not including any potential patent term extensions.”

Patent • Oncology

F-star Therapeutics Provides Interim Update on SB 11285 First-In-Human Dose-Escalation Study in Patients with Advanced Solid Tumors (GlobeNewswire) - P1, N=110; NCT04096638; Sponsor: F-star Therapeutics; “F-star Therapeutics…is providing an interim update on the first-in-human dose-escalation study of SB 11285, a second generation STING agonist. The ongoing multicenter clinical trial [NCT04096638] is evaluating the safety and efficacy of intravenously (IV) administered SB 11285 alone and in combination with the anti-PD-L1 monoclonal antibody, atezolizumab, in patients with advanced solid tumors. SB 11285 was well tolerated both alone and in combination with atezolizumab across all dose levels tested to-date, including five dose levels as monotherapy and three dose levels as a combination. Initial analysis showed that pharmacokinetics (PK) were in line with the predicted profile for rapid cellular uptake, a characteristic of second generation STING agonists. A further clinical update will be shared in 2022.”

Media quote • P1 data • Oncology • Solid Tumor

F-star Therapeutics Reports First Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "FS118: The phase 2 proof-of-concept trial of FS118 is proceeding on plan and the Company plans to provide an update on progress in the first half of 2022...FS222: The ongoing phase 1 clinical trial is proceeding on plan and the Company plans to provide an update on progress before the end of 2021...SB 11285: The Company plans to provide an update on the progress of SB 11285 in the phase 1 clinical trial in mid-2021."

Trial status • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

SB 11285: Expiry of patents related to composition-of-matter, method of use to treat cancer in US, Australia, Canada, China, EU, Japan, South Korea in 2037 (F-star therapeutics) - Annual Report 2020

Patent • Oncology

Study Published in Nature Shows F-Star’s STING Agonist SB 11285 Enhances Preclinical Efficacy of Radiation Therapy (GlobeNewswire) - "F-star Therapeutics, Inc...announced the publication of a new study, conducted by Yale University and F-star, of its second generation STING agonist, SB 11285, in the current issue of Nature Communications. The study entitled 'STING enhances cell death through regulation of reactive oxygen species and DNA damage' demonstrates that systemic administration of a STING agonist in combination with radiation in a preclinical model enhances local control in Head and Neck Squamous Cell Carcinoma (HNSCC) and suggests that STING expression in the tumor is required for maximal therapeutic benefit."

Preclinical • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Evaluating Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=110; Not yet recruiting; Sponsor: Spring Bank Pharmaceuticals, Inc.

Clinical • Combination therapy • New P1 trial • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • BRAF

Evaluating Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=110; Recruiting; Sponsor: Spring Bank Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting; Trial completion date: Nov 2020 ➔ May 2022; Trial primary completion date: Sep 2020 ➔ Dec 2021

Clinical • Combination therapy • Enrollment open • Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • BRAF

F-star Therapeutics Reports Full-Year 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - "The European Patent Office (EPO) granted a patent in January 2021 with claims protecting the composition of matter of F-star’s FS118 molecule. The expiry date of the patent, not including any potential extensions to the standard 20-year term of protection, is expected to be June 2037...Mid- 2021, FS120: Update on accelerated dose titration; Mid- 2021, SB 11285, Update of Phase 1a/b including combination dosing with Tecentriq; Q4 2021, FS222, Update on accelerated dose titration and initiation of PK/PD expansion cohorts; H1 2022, FS118, Phase II ( PoC) early efficacy analysis."

Enrollment status • P1 data • P2 data • Patent • Head and Neck Cancer • Hematological Malignancies • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

SB 11285 + Tecentriq: Data from P1a/1b trial (NCT04096638) for solid tumors in Q2 2021 (Spring Bank) - Investor Presentation

P1 data • Oncology • Solid Tumor

Spring Bank Announces Poster Presentation at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Spring Bank Pharmaceuticals, Inc...announced an upcoming trial-in-progress poster presentation for SB 11285 at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2020), to be held virtually from November 9-14, 2020. SB 11285 is Spring Bank’s intravenously (IV)-administered STING agonist product candidate that is currently being evaluated in a Phase 1a/1b clinical trial as a monotherapy and in combination with Roche’s PD-L1 checkpoint inhibitor (Tecentriq^®). This poster presentation will include an update on the progress of the IV SB 11285 Phase 1a/1b trial."

Trial status • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] A Phase 1/1b Dose-escalation Study of Intravenously Administered SB 11285 Alone and in Combination with Atezolizumab in Patients with Advanced Solid Tumors (SITC 2020) - No abstract available

Clinical • Combination therapy • P1 data • Oncology • Solid Tumor

[VIRTUAL] A Phase 1a/1b Dose-escalation Study of Intravenously Administered SB 11285 Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors (ITOC-I 2020) - P1a/1b | "In addition, the biological effects of SB 11285 will be evaluated by changes in immune cell types and activation state, serum cytokines, and gene expression patterns indicative of activation of the immune compartment. The trial is being conducted at multiple sites in the U.S."

Clinical • Combination therapy • IO Biomarker • P1 data • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD8 • STING • TNFA

Spring Bank Pharmaceuticals and F-star Therapeutics Agree to Combine to Pursue Mission of Creating Next Generation Immunotherapies (GlobeNewswire) - "The combined company plans to advance its pipeline through multiple clinical trials, including the following anticipated near-term milestones that offer significant potential value creation for Spring Bank’s stockholders: (i) Update on SB 11285 monotherapy cohorts (2020 Q4); (ii) Update on accelerated dose titration from the FS120 Phase 1 trial (2021 Q2); (iii) Initial read out from the SB 11285-atezolizumab combination cohort (2021 H1); (iv) Initiation of FS120 PD-1 combination trial (2022 Q2)."

Clinical data • New trial • P1 data • Oncology

Spring Bank Pharmaceuticals and F-star Therapeutics Agree to Combine to Pursue Mission of Creating Next Generation Immunotherapies (GlobeNewswire) - "Spring Bank Pharmaceuticals...and F-star Therapeutics, Limited...announced that the companies have entered into a definitive share exchange agreement pursuant to which Spring Bank will, subject to stockholder approval, acquire all of the outstanding share capital of F-star in exchange for newly issued shares of Spring Bank in an all-stock transaction. The combined company, operating under the name F-star Therapeutics, Inc., will advance its immuno-oncology pipeline of multiple tetravalent bispecific antibody programs, as well as Spring Bank’s STING (STimulator of INterferon Gene) agonist, SB 11285, currently in a Phase 1/2 clinical trial."

M&A • Oncology

Spring Bank announces poster presentation at the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting (GlobeNewswire) - "Spring Bank Pharmaceuticals, Inc…announced that a trial in progress poster will be presented for the Phase 1a/1b trial of the company’s intravenously-administered STING agonist candidate, SB 11285, at the American Society of Clinical Oncology (ASCO) Annual Meeting, which will be conducted virtually from May 29-June 2, 2020."

P1 data • Oncology • Solid Tumor

Spring Bank advances IV SB 11285 clinical program (GlobeNewswire) - "Spring Bank Pharmaceuticals, Inc…announced that its Phase 1a/1b clinical trial of the company’s intravenously (IV)-administered STING agonist, SB 11285, continues to advance to an escalated monotherapy dosing level and the first cohort in which patients in the trial will receive the co-administration of the IV STING agonist and a checkpoint inhibitor…The Safety Review Committee for this clinical trial has recommended dose escalation to monotherapy dose level 3 and concurrent opening and dosing of combination dose level 1 with Roche’s PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®). To date, no dose limiting toxicities (DLTs) or drug-related serious adverse events (SAEs) have been observed."

Clinical protocol • Enrollment status • Oncology • Solid Tumor