On February 1, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that it provided a clinical data update regarding KEYNOTE-695, as well as progress of its ongoing clinical development efforts and its outlook for 2019 (Press release, OncoSec Medical, FEB 1, 2019, View Source [SID1234533013]).
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KEYNOTE-695 (TAVO + KEYTRUDA (pembrolizumab) for metastatic/recurrent melanoma)
With one fifth of patients in the study now evaluated, the observed preliminary response rate is approximately 24% (5/21) with enrollment ongoing
The observed preliminary ORR of approximately 24% is encouraging given the primary endpoint of KEYNOTE-695 is a 20% ORR
As of December 15, 2018, 21 patients have been treated and evaluated for tumor response by RECIST v1.1
Five of these 21 patients have experienced objective tumor responses, of which four were partial responses and one was a complete response
Responses have been determined at approximately three months and subsequently confirmed at approximately six months by either the investigator or by blinded independent review at the first assessment timepoint
Currently, all five responding patients continue to be treated with KEYTRUDA; two patients are no longer being treated with TAVO due to regression of all TAVO accessible lesions
Durable responses have been observed, with all responding patients still on study from 6 to 10 months
Responding patients demonstrate regression of both distant internal (or visceral) lesions and lesions not treated with TAVO
All patients entered KEYNOTE-695 with late-stage, progressive metastatic melanoma and had large, bulky established tumors
All patients unequivocally failed prior treatment with either KEYTRUDA or OPDIVO according to their approved labels
33 patients have been enrolled in the study and approximately 100 patients are planned to be enrolled
Safety profile mirrors earlier TAVO studies; nearly exclusively Grade 1 or 2 adverse events; safety profile is a key strength
Enrollment is ongoing at sites in the U.S, Canada and Australia
Filing for E.U. Advanced Therapy Classification will occur later this year
Study enrollment completion is anticipated in 2019, with a potential filing for accelerated approval in the U.S. in 2020 and a potential application for conditional approval in Europe shortly thereafter
OMS-150 Cervical Cancer Study (TAVO and commercially available KEYTRUDA for recurrent/persistent cervical cancer)
Registration-enabled study of TAVO in recurrent/persistent cervical cancer to be conducted in collaboration with the Gynecologic Oncology Group (GOG), a world-renowned non-profit organization conducting clinical research for the prevention and treatment of all gynecologic cancers, including cervical cancer
Single-arm study of TAVO and KEYTRUDA by prescription, expected to enroll 80 or more patients, powered to detect a response meaningfully higher than seen with KEYTRUDA monotherapy of 14% ORR
Along with GOG, study preparations are underway with first site initiation and patient enrollment expected to begin in the U.S. in the first half of 2019, with potential expansion into other countries
Anticipated U.S. regulatory filing in 2021
With only two drugs approved in the past 30 years, there is a significant need for better treatment options for advanced cervical cancer
A press release announcing this collaboration can be found here
KEYNOTE-890 (TAVO + KEYTRUDA for triple negative breast cancer (TNBC))
Study enrolling as expected with eight of 25 patients currently enrolled in the study
Anticipated study enrollment completion in 2019
Plan to report preliminary data later this year
New Product Candidate
Based upon immunological findings made from previously treated TAVO patients, OncoSec’s research laboratory has designed a new, second product candidate targeting not only IL-12, but also other important, immunologically relevant targets
IND filing for this new product candidate expected in 2H 2019
Details regarding this new product candidate, including pre-clinical data, will be presented at a major medical meeting this year
Expanding TAVO to Interior Lesions with new Visceral Lesions Applicator (VLA)
Significant opportunities exist with OncoSec’s current technology, which allows physicians to treat accessible lesions up to a depth of 15 millimeters
TAVO’s mechanism of action is likely to be relevant in nearly all solid tumors
Considering the therapeutic benefit and associated market impact, expansion is planned beyond accessible lesions, with the development of a new applicator able to access internal, or visceral, lesions
OncoSec’s engineering and research groups have successfully miniaturized the new visceral applicator or VLA, achieving the requisite energy parameters and therapeutic effect in multiple tumor models
VLA can be used with both the current clinical generator and planned next generation generator, allowing for a minimally invasive, safe and effective delivery of local IL-12 and other important, immunologically relevant targets into visceral tumors
"2018 was a busy and productive year for OncoSec, and as we enter 2019, we are well-positioned to continue advancing our lead program, TAVO, towards registration in multiple tumor settings in the United States beginning as early as 2020," said Daniel O’Connor, OncoSec’s Chief Executive Officer. "Our focus in 2019 will be moving TAVO towards registration in our current indication of PD-1 refractory, late-stage melanoma, progressing our recently announced registration-enabled clinical study in cervical cancer, expanding our ability to target tumors affecting internal organs, advancing a new, second pipeline candidate for which we expect to file an IND in 2019, and completing KEYNOTE-890, our combination study with TAVO + KEYTRUDA in TNBC. We believe that executing on this plan will extend the long-term valuation of our company and, most importantly, bring meaningful new treatments to patients and clinicians who very much need them."
Anticipated 2019 Milestones
Receive Advanced Therapy Medicinal Product (ATMP) Classification in Europe by EMA’s committee for Advanced Therapies for melanoma in 1H 2019
Initiate European trial sites in KEYNOTE-695 this year
Complete enrollment in KEYNOTE-695 2H 2019
Dose first patient in OMS-150 cervical cancer study in 1H 2019
Provide preliminary data update for the KEYNOTE-890 TNBC study in 2H 2019
Present New Product Candidate at a major medical meeting this year
File IND for New Product Candidate in 2H 2019
Conference Call and Webcast Information
OncoSec will host a conference call and live audio webcast today at 9:00 a.m. ET. To access the live conference call, please dial (844) 562-3893 (domestic) or (409) 220-9946 (international) at least five minutes prior to the start time, and refer to conference ID 4067388.
An accompanying presentation will be referenced during the conference call and can be accessed under "Events and Presentations" in the Investors section of OncoSec’s website at ir.oncosec.com. A replay will be available shortly after the conference call and can be accessed for 30 days following the call.