As of last check, OncoSec Medical Incorporated (ONCS) shares rose 24.01% to trade at $3.46 in after-hours trading. OncoSec stock dropped -2.45% on Tuesday to close at $2.79. Volume of ONCS stock remained at 3.43 million shares, exceeding the average daily volume of 0.26 million shares over the past 50 days. Following the signing of a collaboration agreement, ONCS stock rose.

Why did that collaboration take place?

A biotechnology company called OncoSec is developing intratumoral immunotherapy based on cytokines to attack cancer cells. One of ONCS’ leads immunotherapy investigational product candidates, TAVO, delivers naturally occurring interleukin-12 (IL-12), an immune-stimulating protein, intratumorally. Using ONCS technology, which involves electroporation, tumor microenvironments are specifically targeted, allowing the immune system to target and eliminate tumor cells throughout the body.

OncoSec today announced the signing of a Clinical Trial Collaborative and Supply Agreement between ONCS and Merck.

  • ONCS and Merck will conduct an evaluation of ONCS’ DNA-plasmid interleukin-12 TAVO and Merck’s anti-PD-1 drug, KEYTRUDA.
  • ONCS has teamed up with Merck for KEYNOTE-C87 for a global Phase 3 randomized clinical trial.
  • Patients with metastatic melanoma who are refractory to immunotherapies will be randomized into a clinical trial to see how well TAVO combined with KEYTRUDA performs compare to standard of care at late stages of the disease.
  • It was granted Fast Track designation from the US Food and Drug Administration (FDA), as a potentially first-in-class intratumoral anti-cancer gene therapy that expresses IL-12 after progression on KEYTRUDA or OPDIVO.
  • In addition to helping ONCS to support accelerated US FDA approval, this study will also serve as pivotal for a full license to be obtained.
  • ONCS will provide the investigational drug, TAVO, under the terms of the agreement.
  • Costs will be covered by ONCS for third parties, with each party responsible for its own internal costs.
  • It is necessary for patients to have unresectable, metastatic melanoma with a history of checkpoint therapy refractory to treatment.
  • A total of 400 patients are expected to be enrolled in the study, which will be conducted in the US, Canada, the European Union, and Australia.

What ONCS is trying to achieve?

The goal of OncoSec (ONCS) entering into this collaboration and supply agreement with Merck is to bring TAVO to patients with metastatic melanoma who have not responded to checkpoint inhibitor therapy or who have developed progressive disease without other therapeutic options. The Phase 3 collaboration represents a significant milestone for ONCS, advancing TAVO from the clinic towards potential approval globally, while building on the clinical collaboration and supply agreement it signed with Merck in 2017.



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