On October 10, 2017 Quadriga Biosciences, a privately held, pharmaceutical company focused on developing novel, proprietary amino acid mimics for the treatment of cancer, reported that the Company has been awarded a Phase II Small Business Innovation Research Grant (SBIR) of $2 million from the National Institutes of Health (NIH) to support the development of its compounds for the treatment of glioblastoma multiforme (GBM), an extremely deadly form of brain cancer for which no long term effective treatment options are available (Press release, Quadriga BioSciences, OCT 10, 2017, View Source [SID1234527723]).

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"We appreciate the NIH’s continued recognition of our science and the importance of the development of our lead molecules for the treatment of GBM," said Dr. Gordon Ringold, Chief Executive Office of Quadriga Biosciences. "GBM is the most malignant form of brain cancer and new therapeutic approaches will be required to significantly impact the progression of this disease. Given the high unmet medical need, we are excited about the opportunity to advance our lead compound through preclinical development over the ensuing months and be in a position to initiate clinical trials by late next year."

On October 10, 2017 OncoSec Medical Incorporated ("OncoSec" or the "Company") (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that it has initiated its phase 2b registration directed trial, PISCES/KEYNOTE-695 (Press release, OncoSec Medical, OCT 10, 2017, View Source [SID1234520867]). The PISCES/KEYNOTE-695 study is a global, multicenter phase 2b trial of OncoSec’s investigational therapy, ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), combined with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck (known as MSD outside the US and Canada), in patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy.

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"Patients with metastatic melanoma who are progressing or have progressed on anti-PD-1 therapy have limited treatment options. We believe the combination of ImmunoPulse IL-12 and pembrolizumab offers a potentially transformative approach for these patients given the absence of approved therapies," said Punit Dhillon, CEO and President at OncoSec. "The advancement of the PISCES trial marks an important milestone for the Company."

The phase 2b, Simon 2-stage multicenter study of intratumoral tavo with electroporation in combination with intravenous KEYTRUDA will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

"ImmunoPulse IL-12 and pembrolizumab are immunotherapies designed to modulate the patient’s own immune response to fight cancer," said Sharron Gargosky Ph.D., Chief Clinical and Regulatory Officer at OncoSec. "We are pleased with the progress of the ongoing PISCES trial, which has benefitted from our clinical trial collaboration and supply agreement with Merck."

The collaboration agreement, which was announced in May 2017, is between OncoSec Medical Incorporated and Merck, through a subsidiary. Under the agreement, OncoSec will sponsor and fund the study and Merck will provide KEYTRUDA.

To learn more about the trial, visit www.oncosec.com. Additional details can also be found at www.clinicaltrials.gov via NCT03132675.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

ImmunoPulse is a registered trademark of OncoSec Medical Incorporated, San Diego, CA, USA.

About Metastatic Melanoma1

Melanoma is a type of skin cancer that begins in skin cells called melanocytes. As the cancer progresses, melanoma becomes more difficult to treat once it spreads beyond the skin, such as the lymphatic system (metastatic disease). Given its occurrence young individuals, the potential years of life lost to melanoma can be higher when compared with other cancers. Although melanoma is a rare form of skin cancer, it accounts for over 75% of skin cancer deaths. The American Cancer Society estimates that approximately 87,000 new melanoma cases and 10,000 deaths from the disease will occur in the United States in 2017. Additionally, the World Health Organization estimates that approximately 132,000 new cases of melanoma are diagnosed around the world every year.

1 American Cancer Society (View Source); World Health Organization (View Source)

About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)

PISCES is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

On October 10, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") and Seattle Genetics Inc., Inc., (NASDAQ: SGEN) reported dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy (Press release, Astellas, OCT 10, 2017, View Source [SID1234520836]). The EV-201 study will assess the antitumor activity and safety of enfortumab vedotin to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations.

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"Locally advanced or metastatic urothelial cancers are often aggressive and treatment-resistant. Treatment options are limited for those many patients who do not respond to chemotherapy and checkpoint inhibitors, or CPIs. In addition, there are no FDA-approved therapies for patients who progress following CPI treatment," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "Initiation of this pivotal phase 2 trial of enfortumab vedotin is a significant advance toward our goal of providing a new treatment option for patients with locally advanced or metastatic urothelial cancer."

The primary endpoint of the single-arm, open-label trial is confirmed objective response rate (ORR), per independent review. Secondary endpoints include assessments of overall survival, progression free-survival, safety and tolerability. The study will enroll approximately 120 patients at multiple centers globally, and enfortumab vedotin will be administered three of every four weeks for the duration of treatment.

"The initiation of the EV-201 clinical trial demonstrates our continued commitment to patients living with locally advanced or metastatic urothelial cancer," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "Our decision to move forward with this registrational trial is based on the results of our ongoing Phase 1 study, and we look forward to future clinical development milestones for enfortumab vedotin."

The companies also plan to initiate a combination trial of enfortumab vedotin with CPI therapy in late 2017.

For more information about the phase 2 pivotal trial, including enrolling centers, please visit www.clinicaltrials.gov.

About Urothelial Cancer

Urothelial cancer is most commonly found in the bladder (90 percent). According to the American Cancer Society, approximately 79,000 people in the U.S. will be diagnosed with bladder cancer during 2017 and almost 17,000 will die from the disease. Outcomes are poor for patients diagnosed with metastatic disease, with a five-year survival rate of five percent.

About Enfortumab Vedotin

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary, industry-leading linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Agensys (an affiliate of Astellas), which is expressed on many solid tumors. Nectin-4 is highly expressed in urothelial cancers, particularly in bladder cancer. Preclinical data demonstrate that enfortumab vedotin binds to Nectin-4 on cancer cells and releases the cell-killing agent into these target cells upon internalization.