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
Business Development
- 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.
CONTACT
Investor Relations:
Stern Investor Relations
Will O'Connor
Phone: (212) 362-1200
will@sternir.com
Media Relations:
Janine McCargo / David Schemelia
Tiberend Strategic Advisors, Inc.
Phone: 212-827-0020
jmccargo@tiberend.com
dschemelia@tiberend.com
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SOURCE OncoSec Medical Incorporated