CORVax12 / OncoSec - LARVOL DELTA

CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - P1 | N=16 | Terminated | Sponsor: Providence Health & Services | Completed ➔ Terminated; Study was ended prematurely due to lack of efficacy. As per FDA guidance, our site continued to follow enrolled subjects through the 180 day safety visit.

Biomarker • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Providence Health & Services | Active, not recruiting ➔ Completed | N=36 ➔ 16

Biomarker • Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

NCI-2018-02901: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat (clinicaltrials.gov) - P2 | N=14 | Terminated | Sponsor: Chase Heaton, MD | Trial completion date: May 2024 ➔ Jul 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: May 2024 ➔ Jul 2022; Treatment Ineffective

Trial completion date • Trial primary completion date • Trial termination • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

NCI-2018-02901: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat (clinicaltrials.gov) - P2 | N=14 | Active, not recruiting | Sponsor: Chase Heaton, MD | Recruiting ➔ Active, not recruiting | N=96 ➔ 14

Enrollment change • Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Evaluation of the long-term anti-Spike immune response following a novel coronavirus vaccine (CORVax): electroporation of SARS-CoV-2 Spike plasmid DNA plus IL12 plasmid DNA (IMMUNOLOGY 2022) - "At one year following vaccination the anti-Spike IgG titers were higher in mice that received CORVax plus IL-12, however the rate at which the titers waned from their initial peak was comparable whether the mice received IL-12 or not. Additional studies are ongoing to determine whether the addition of IL-12 will enhance an anti-Spike memory response."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL12A

NCI-2018-02901: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Chase Heaton, MD | Active, not recruiting ➔ Recruiting | N=14 ➔ 96

Enrollment change • Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Providence Health & Services | Trial completion date: May 2022 ➔ Dec 2022 | Trial primary completion date: Jul 2021 ➔ Jul 2022

Biomarker • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - P1; N=36; Active, not recruiting; Sponsor: Providence Health & Services; Recruiting ➔ Active, not recruiting

Biomarker • Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

OncoSec Announces First Subjects Dosed in Phase 1 Trial of CORVax12, OncoSec's COVID-19 Vaccine Candidate Combining Interleukin-12 (IL-12) with an Enhanced SARS-CoV-2 Spike Protein (PRNewswire) - "OncoSec Medical Incorporated...announced that it has dosed several subjects in its Phase 1 clinical trial of CORVax12...This trial...will address safety and anti-viral immunological responses with the combination of a DNA-encodable stabilized SARS-CoV-2 spike glycoprotein and OnocSec's cancer immunotherapy candidate, TAVO...Additionally, preliminary preclinical data has demonstrated that CORVax12 administered into tumor tissue not only yields a productive anti-viral response, but also a strong anti-tumor response....Thus, CORVax12 has the potential to effectively combine OncoSec's powerful oncology platform with a strong vaccination."

Trial status • Infectious Disease • Novel Coronavirus Disease

CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Providence Health & Services; Not yet recruiting ➔ Recruiting

Biomarker • Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Vaxil Announces Close of Second and Final Tranche of Previously Announced Non-Brokered Private Placement for Gross Proceeds of $264,100 (Streetinsider.com) - "VAXIL BIO LTD....announces that the Company completed the second and final tranche of its previously announced non-brokered private placement (see press release dated November 9, 2020) for gross proceeds of $264,100...Net proceeds from the Second Tranche Private Placement, together with net proceeds from the first tranche...are presently expected to be used to further expand and expedite pre-clinical and manufacturing development of CorVax™..."

Financing

Form 10-Q ONCOSEC MEDICAL Inc For: Oct 31 (Streetinsider.com) - "Providence investigators filed an Investigator-Initiated Investigational New Drug ('IND') Application with the United States Food and Drug Administration ('FDA') and have designed a clinical trial protocol that will evaluate the vaccination of healthy adult volunteers utilizing CORVax12...The Company announced that the IND was accepted by the FDA on October 29, 2020 and the first patient is expected to be dosed in December of 2020 at Providence. The trial will also include extensive immune monitoring."

IND • Trial initiation date

CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Providence Health & Services

Biomarker • Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

OncoSec Announces FDA Clearance of IND Application for Initiation of Phase 1 Clinical Trial of its CORVax12 Vaccine Candidate for COVID-19 (Yahoo Finance) - "OncoSec Medical Incorporated...today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for a first-in-human Phase 1 trial for CORVax12....Providence will conduct a Phase 1, open-label study to evaluate the safety and immunogenicity of a plasmid encoding the SARS-CoV-2 spike protein alone or in combination with IL-12 (CORVax12, SARS-CoV-2 S glycoprotein plasmid DNA in combination with IL-12 plasmid) in up to 36 healthy volunteers. CORVax12 will be given as a prime and booster dose four weeks apart."

IND • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Utilising an interleukin-12 plasmid: A novel Covid-19 vaccine (Drug Target Review) - "...CORVax12, has been developed by researchers in the US....Upon gaining US Food and Drug Administration (FDA) approval, OncoSec’s CORVax12 vaccine will be studied by Providence Cancer Institute in a first-in-human Phase I clinical trial....Fox hopes that by the end of May, the FDA will grant approval for the vaccine’s Investigational New Drug (IND) application....The study will consist of two groups; in the first, patients will be injected and electroporated with a plasmid encoding for the stabilised S protein and in the second, patients will be injected and electroporated with both the stabilised S protein plasmid as well as the IL-12 plasmid."

IND • New P1 trial • Infectious Disease • Novel Coronavirus Disease