SAN DIEGO and PENNINGTON, N.J., June 28, 2018 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, provided an update of key value-creating milestones for the second half of 2018 and a review of its year-to-date accomplishments.
"We believe we can unlock the larger checkpoint market across multiple cancer types by turning 'cold tumors' to 'hot tumors' with our intratumoral IL-12 immunotherapy or 'TAVO.' Our data have demonstrated TAVO's ability to do so by recruiting more tumor infiltrating lymphocytes (TILs) into the tumors. In doing so, TAVO can pave the way for checkpoints to be effective in the largest, but still unresponsive, segment of the checkpoint market," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec.
ANTICIPATED 2018 MILESTONES
OncoSec anticipates to achieve the following clinical and operational milestones during the second half of 2018:
Clinical Milestones for TAVO
TAVO for Metastatic Melanoma
- Complete enrollment of 23 patients in Stage 1 of PISCES/KEYNOTE-695 in the third quarter
- Provide topline data update from Stage 1 PISCES/KEYNOTE-695
- Meet with European regulatory authorities to seek the classification of TAVO as an Advanced-Therapy Medicinal Product (ATMP)
- Submit for publication the complete results from the TAVO monotherapy (OMS-100) and TAVO / KEYTRUDA® combination (OMS-102) studies to peer-reviewed medical journals
- Present final TAVO monotherapy data (OMS-100) at a medical meeting
- Initiate a Phase 2 neoadjuvant clinical trial of TAVO in combination with standard of care Opdivo® (nivolumab) in operable melanoma
TAVO for Triple Negative Breast Cancer (TNBC)
- Initiate KEYNOTE-890, a Phase 2 study of TAVO in combination with KEYTRUDA® in TNBC patients who have progressed on more than one line of prior therapy
- Complete patient enrollment and provide topline data update from TAVO monotherapy (OMS-140) in late-stage TNBC
TAVO for Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Initiate a Phase 2 investigator-sponsored clinical study of TAVO in combination with standard of care KEYTRUDA® (pembrolizumab) and another immunotherapy in the recurrent and/or metastatic SCCHN
New Product Candidate
Expanding Clinical Pipeline beyond TAVO
- Conduct pre-IND (Investigational New Drug) meeting with FDA for our new proprietary product candidate by adding additional immune stimulating targets to complement our IL-12 foundation
Commercially Ready Generator
- Prepare to replace the MedPulserTM generator, currently being used in clinical trials, with the new commercially ready generator, GenPulseTM generator
- Advance ongoing discussions with several global biopharmaceutical companies in order to achieve transformational collaborations for our cancer immunotherapy platform
FIRST HALF 2018 HIGHLIGHTS
OncoSec achieved important clinical, operational and business-development milestones during the first half of 2018, highlighted by the following accomplishments:
- Presented on PISCES/KEYNOTE-695 Phase 2b Registration-Directed Clinical Trial in Combination with Merck's KEYTRUDA® (pembrolizumab) for Metastatic Melanoma at the ASCO 2018 Annual Meeting
On June 4, 2018, OncoSec announced the presentation of a Trials-in-Progress poster at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The poster detailed OncoSec's global, multi-center, registration-directed open-label Phase 2b clinical trial, assessing the Company's investigational therapy, (intratumoral pIL-12 [tavokinogene telseplasmid] delivered with electroporation) ("TAVO" or "ImmunoPulse® IL-12"), and the approved anti-PD-1 therapy pembrolizumab, in patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy.
- Announced Expanded Relationship with Merck; Clinical Collaboration to Evaluate Combination of TAVO and KEYTRUDA® (pembrolizumab) for TNBC
On May 8, 2018, OncoSec entered into a second clinical trial collaboration and supply agreement with Merck to evaluate the combination of OncoSec's TAVO with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase2 clinical trial. The planned clinical trial will evaluate the safety and efficacy of the combination in patients with inoperable locally advanced or metastatic TNBC who have previously failed at least one systemic chemotherapy or immunotherapy.
- Hosted Research Reception at AACR Annual Meeting 2018
On April 15, 2018, OncoSec held a research reception at the AACR Annual Meeting 2018. The Research Reception was organized to provide industry experts gathered at AACR with a comprehensive overview of OncoSec's ongoing and anticipated clinical programs involving TAVO (ImmunoPulse® IL-12) in metastatic melanoma and TNBC, including an overview of a poster presented at AACR regarding a Phase 1 pilot study of TAVO in TNBC.
- Announced Strategic Relocation of Office and Laboratories
On March 20, 2018, OncoSec announced a strategic relocation of its office and lab in San Diego that is expected to provide immediate and significant cost-savings of approximately $65,000 per month.
- Announced Publication In Nature Gene Therapy Demonstrating Efficacy Of IL-12 Intratumoral Gene Electrotransfer
On March 12, 2018, OncoSec announced that its manuscript, "Improving therapeutic efficacy of IL-12 intratumoral gene electrotransfer," was published in Nature Gene Therapy. The research, led by a team of OncoSec scientists, evolves the company's current clinical EP platform to improve the therapeutic efficacy of IL-12 intratumoral gene electrotransfer through novel plasmid design and modified parameters. Findings demonstrated that modifications to the electroporation parameters, including lowering the electric field strength (low voltage) combined with a longer pulse length, significantly increase the transfection efficiency of intratumoral electroporation.
- Closed $23.0 Million Public Offering of Common Stock
On February 6, 2018, OncoSec announced the closing of its underwritten public offering of 15,333,334 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase 2,000,000 additional shares, at the public offering price of $1.50 per share. The gross proceeds from the offering, including the exercise of the option to purchase additional shares, were approximately $23 million, before deducting underwriting discounts and commissions and estimated offering expenses paid by OncoSec.
- Appointed Veteran Biopharma Executive Gregory T. Mayes to Board of Directors
On January 16, 2018, OncoSec announced the appointment of Gregory T. Mayes to its board of directors. Mr. Mayes is President, Chief Executive Officer and Founder of Engage Therapeutics, and brings more than 20 years of experience as a biopharmaceutical executive with an extensive network in the life sciences field to OncoSec.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "can," "may," "will," "suggest," "look forward to," "potential," "understand," and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management's current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec's filings with the Securities and Exchange Commission.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
Stern Investor Relations
Phone: (212) 362-1200
Janine McCargo / David Schemelia
Tiberend Strategic Advisors, Inc.
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SOURCE OncoSec Medical Incorporated