On December 12, 2018 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative commercial stage biopharmaceutical company, reported that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ZEJULA (niraparib, or ZL-2306) as a Category 1 drug for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal ovarian cancer who are in a complete or partial response to platinum-based chemotherapy (Press release, Zai Laboratory, DEC 12, 2018, View Source [SID1234532051]). ZEJULA is a potent and highly selective PARP1/2 inhibitor that does not require BRCA mutation or other biomarker testing prior to administration.

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"The NMPA’s acceptance of our NDA submission for ZEJULA represents a major milestone for Zai Lab as this is our first ever NDA submission in Mainland China," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "ZEJULA will offer an important, new treatment option to more than 50,000 Chinese patients who suffer from ovarian cancer every year and we are grateful that NMPA recognizes this critical medical need and the promise of ZEJULA. Zai is a leader in the field of innovative oncology treatments in China and we have a deep and highly-differentiated pipeline, including three U.S. FDA-approved products and four other assets in late stage clinical development. As a result, we expect additional regulatory submissions in the coming years as we continue to advance our pipeline."

Dr. Yong-Jiang Hei, Chief Medical Officer for Oncology of Zai Lab said, "We believe ZEJULA is a best-in-class PARP inhibitor due to its compelling efficacy, once-daily dosing and superior pharmacokinetic properties including its ability to cross the blood brain barrier. The NDA submission based on the Category 1 designation of ZEJULA is a result of China-based clinical trials and manufacturing conducted by Zai Lab. We plan to expand our development efforts in collaboration with our partner Tesaro across several additional indications including, but not limited to, first-line maintenance treatment of ovarian cancer, lung cancer and gastric cancer."

William Liang, Chief Commercial Officer noted, "The Zai Lab commercial team is very excited about the attractive profile of ZEJULA and plans to leverage ZEJULA’s recent Hong Kong approval and commercial launch to prepare for the launch in China. If approved, we believe ZEJULA will provide a differentiated treatment option to benefit more ovarian cancer patients. We also intend to closely collaborate with local authorities and NGOs to develop patient assistant programs to increase access to more women who could benefit from this treatment. Zai Lab is committed to making a meaningful impact on the way cancer is treated in China and will continue to develop and bring new innovative oncology treatment options to patients in need."

About Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers in China with approximately 51,000 newly diagnosed cases and 23,000 deaths in China in 2014. The 5-year overall survival rate of ovarian cancer patients is 46% across all stages, but only 29% in patients are diagnosed with distant metastatic disease. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. Effective treatment options for patients with platinum-sensitive recurrent ovarian cancer remain limited. New agents that prolong the duration of response following platinum-based treatment and delay the inevitable relapse of ovarian cancer will benefit patients with ovarian cancer in China.

About ZEJULA

ZEJULA (niraparib, ZL-2306) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2inhibitor. It was approved in March 2017 by the FDA in the United States and in November 2017 by the EMA in the European Union under the trade name ZEJULA as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Based on the approval status in the United States and European Union by our partner, Tesaro, Zai Lab has obtained the approval for marketing ZEJULA in Hong Kong in October 2018.

On December 12, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing novel cancer immunotherapies, reported an update regarding tumor responses in its KEYNOTE-695 global, multicenter Phase 2b, open-label trial of intratumoral delivery of TAVO (tavokinogene telseplasmid / IL-12) with intravenous KEYTRUDA (pembrolizumab) in patients with unresectable, advanced melanoma (Press release, OncoSec Medical, DEC 12, 2018, View Source [SID1234532030]). The Company previously reported at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 33rd Annual Meeting (SITC) (Free SITC Whitepaper) that, of the first nine patients to complete 12 weeks of treatment and reach initial tumor evaluation (by RECIST v1.1), two patients had a partial response. The Company now reports that both responses have been confirmed by blinded independent review at the first assessment timepoint. Further, in both cases, response duration has now reached six months. Importantly, one of these previously assessed partial responses has now become a complete response per investigator assessment at the six-month tumor evaluation timepoint. Enrollment is ongoing and the Company expects to complete the study next year.

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"Complete responses in this patient population are rare. One of the first partial responses to be observed in this study now being assessed by the investigator at six months as a complete response is exciting. Durable responses reaching the six-month mark demonstrate that the benefits of TAVO are clinically meaningful," said Daniel J. O’Connor, President and CEO of OncoSec. "The evidence of the potential of TAVO in conjunction with PD-1 inhibition to improve outcomes in this patient population is mounting and we look forward to providing updates as necessary regarding the progress of this trial."

KEYNOTE-695 enrollment criteria with respect to anti-PD-1 checkpoint failure is highly restrictive. In order to be considered an anti-PD-1 checkpoint failure, all patients must have Stage III/IV metastatic melanoma progressive disease after at least four prior cycles of either KEYTRUDA or OPDIVO. Literature suggests that retreatment with a PD-1 therapy following failure of a PD-1 therapy offers approximately a 5% response rate1. Disease progression is determined according to RECIST v1.1, measured by radiologic assessment, with confirmation of progression by second assessment.

"It’s becoming clear that TAVO can reverse PD-1 resistance in refractory metastatic melanoma patients. This is important because the majority of melanoma patients do not respond to PD-1 treatment," said Adil Daud, MD, HS Clinical Professor, Department of Medicine (Hematology/Oncology), UCSF; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center and Lead Principle Investigator of KEYNOTE-695. "Patients in KEYNOTE-695 have unequivocally failed all approved anti-PD-1 therapies. The tumor responses seen in this trial, now independently verified by a blinded review at the first assessment, deepening and continuing for months, gives us confidence in the potential of this treatment combination for patients who are non-responsive to anti-PD-1 therapy."

Eligible patients in KEYNOTE-695 had refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab). As previously reported, TAVO was well-tolerated, with primarily Grade 1 adverse advents associated with injection site or procedural pain. One TAVO related Grade 3 SAE of cellulitis was reported and resolved. KEYNOTE-695 is expected to be completed in 2019. Based on the outcome of the study, the Company plans to file for accelerated approval by end of 2019 or early 2020.

TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration.

1 Long GV, Weber JS, Larkin J et al. Nivolumab for patients with advanced melanoma treated beyond progression: analysis of 2 Phase 3 clinical trials. JAMA Oncol. 3(11), 1511–1519 (2017).

On December 12, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs, reported that it plans to release an update on clinical data from the ongoing Phase 2 trial of the combination of intratumoral tilsotolimod and ipilimumab for unresectable or metastatic melanoma following failure of anti-PD-1 inhibitor treatment prior to the opening of the U.S. financial markets on Friday, December 14, 2018 (Press release, Idera Pharmaceuticals, DEC 12, 2018, View Source [SID1234532053]).

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The company will host a conference call and live webcast, Friday, December 14 at 10:00 A.M. EST to review the data being presented along with a questions and answers session.

Investor Webcast Details
To participate in the conference call, please dial (844) 882-7837 (domestic) and (574) 990-9824 (international). The webcast can be accessed live or in archived form in the "Investors" section of the company’s website at www.iderapharma.com. The company will be posting a slide presentation to the Idera corporate website in the "Investors" section which will be referenced during the conference call.

Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

On December 12, 2018 BerGenBio ASA (OSE:BGBIO) presented DNB Healthcare Conference 2018 (Presentation, BerGenBio, DEC 12, 2018, View Source [SID1234532110]).

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On December 12, 2018 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the first commercial production of Axumin (fluciclovine (18F)) in France occurred recently, with the first French patients being dosed (Press release, Blue Earth Diagnostics, DEC 12, 2018, View Source [SID1234532031]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Axumin is commercially available in France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

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Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "Detection and localization of recurrent prostate cancer is a significant unmet medical need. Today’s announcement signifies Blue Earth Diagnostics’ commitment in maximizing access to Axumin for clinicians and their patients across Europe and a key milestone towards our goal."