axitinib intradermal (AIV001) / AiViva BioPharma - LARVOL DELTA

AiViva Biopharma Receives FDA Clearance to Administer AIV001 in Facial Skin by Intradermal Injection for Nonmelanoma Skin Cancer (GlobeNewswire) - "AiViva Biopharma Inc...announced the receipt of FDA clearance for testing AIV001 (axitinib) by intradermal injection with their formulation in facial skin....This FDA clearance was supported by AiViva’s submission of safety data on non-facial skin tolerability and efficacy, and systemic exposure from 67 subjects treated with AIV001 in BCC and in scar management."

FDA approval • Non-melanoma Skin Cancer

Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=26 | Completed | Sponsor: AiViva BioPharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Nodular Basal Cell Carcinoma

AiViva Biopharma Completes Phase 1/2 Clinical Trial of AIV001 Administration in Patients with Nonmelanoma Skin Cancer (GlobeNewswire) - P1/2 | N=26 | NCT04470726 | Sponsor: AiViva BioPharma, Inc. | "AiViva Biopharma Inc...announced completion of their first trial administering AIV001 (axitinib) to patients diagnosed with basal cell carcinoma (BCC) tumors. AIV001 is AiViva’s novel intradermally administered product designed for local, prolonged treatment effect for dermatological conditions...The phase 1/2 multicenter, open-label clinical trial evaluated AIV001 in patients with superficial, nodular or mixed BCC tumors. The study enrolled a total of 26 subjects who were studied in four ascending dose cohorts...'We are excited to have completed this safety study that is demonstrating excellent skin tolerability and a dose response.'"

Enrollment closed • P1/2 data • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=26 | Active, not recruiting | Sponsor: AiViva BioPharma, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2023 ➔ Jun 2023 | Trial primary completion date: Dec 2022 ➔ Jun 2023

Biopsy • Enrollment closed • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Nodular Basal Cell Carcinoma

Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: AiViva BioPharma, Inc. | Recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ Dec 2022 | Trial primary completion date: Jul 2023 ➔ Dec 2022

Trial completion • Trial completion date • Trial primary completion date • Fibrosis

Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: AiViva BioPharma, Inc. | N=18 ➔ 24

Enrollment change • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Nodular Basal Cell Carcinoma

Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: AiViva BioPharma, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2022 ➔ Oct 2023 | Trial primary completion date: Sep 2022 ➔ Jul 2023

Enrollment open • Trial completion date • Trial primary completion date • Fibrosis

Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: AiViva BioPharma, Inc. | Trial primary completion date: Jul 2021 ➔ Dec 2022 | Trial completion date: Jul 2021 ➔ Mar 2023

Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Nodular Basal Cell Carcinoma

A Safety and Efficacy Study to Evaluate Rosacea (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: AiViva BioPharma, Inc. | N=24 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Dermatology • Rosacea

Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: AiViva BioPharma, Inc.

New P1 trial • Fibrosis

A Safety and Efficacy Study to Evaluate Rosacea (clinicaltrials.gov) - P1/2; N=24; Not yet recruiting; Sponsor: AiViva BioPharma, Inc.; Trial completion date: Mar 2022 ➔ Aug 2022; Trial primary completion date: Dec 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Dermatology • Rosacea

Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma (clinicaltrials.gov) - P1/2; N=18; Recruiting; Sponsor: AiViva BioPharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Nodular Basal Cell Carcinoma

AiViva Biopharma Initiates Phase 1/2 Clinical Trial of AIV001 for Nonmelanoma Skin Cancer (GlobeNewswire) - “AiViva Biopharma Inc…announced that it has begun dosing patients diagnosed with superficial or nodular basal cell carcinoma (BCC) with AIV001….The study is expected to enroll a total of 18 subjects who will be studied in two ascending dose cohorts.”

Trial status • Basal Cell Carcinoma • Oncology

Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma (clinicaltrials.gov) - P1/2; N=18; Not yet recruiting; Sponsor: AiViva BioPharma, Inc.

Clinical • New P1/2 trial • Basal Cell Carcinoma • Oncology