On November 8, 2017 OncoSec Medical Incorporated ("OncoSec" or "Company") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported positive updated long-term follow-up data from its Phase 2 OMS I-102 combination study of ImmunoPulse IL-12 and pembrolizumab in patients unlikely to respond to anti-PD-1 therapy (Press release, OncoSec Medical, NOV 8, 2017, View Source [SID1234521755]). The updated data will be presented in an oral poster presentation (P524) by Dr. Alain Alagzi at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD on November 10th, 2017 at 12:45 p.m. EST.

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The updated clinical and correlative immune-focused biomarker data demonstrated a 57% progression free survival (PFS) rate at 15 months with 100% (11/11) duration of response and median PFS not yet reached. Building upon previously reported data of a best overall response rate (BORR) of 50% (41% complete response [CR] rate), the updated data further demonstrate that the combination of these therapies can prime a coordinated innate and adaptive immune response, and strongly suggests a synergistic relationship with anti-PD-1. The latest findings further demonstrate that this combination approach can reshape the tumor microenvironment, yielding a robust intratumoral and systemic anti-tumor response converting "cold" tumors to "hot," potentially improving clinical outcomes in patients predicted to not respond to anti-PD-1 therapy.

"Overall, the Phase 2 trial results, including progression free survival beyond two years in multiple patients, duration of response, best overall response rate, and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of ImmunoPulse IL-12 plus pembrolizumab as a viable treatment option for patients diagnosed with metastatic melanoma," said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

Dan O’Connor, CEO of OncoSec noted: "The robust PFS benefit and tolerability observed with ImmunoPulse IL-12 plus pembrolizumab is the first demonstrating efficacy in a predicted PD-1 non-responder population and shows that the combination represents a potentially important addition to the treatment landscape for metastatic melanoma patients who have progressed or are progressing on anti-PD-1 therapy."

The full abstract is available and can be viewed on the STIC website at www.sitcancer.org. The poster is available in the Publications section of OncoSec’s website.

Analyst Event in National Harbor, MD

OncoSec will host an analyst and investor event with clinical investigators on Friday, November 10, 2017 at 7:00 a.m. EST in National Harbor, MD during the 2017 Society of Immunotherapy for Cancer Annual Meeting. The event will include a presentation and discussion of updated clinical data for the company’s ImmunoPulse IL-12 program, highlighting the global, registration-directed PISCES/KEYNOTE-695 trial. The event will be held in-person and via live webcast.

Investors and analysts are invited to listen to a live audio webcast of the presentation. To access the audio broadcast, please dial (877) 731-1960 and enter the conference ID number 4938639. To join via webcast, please use the following link: View Source An archived version of the presentation will be available for 90 days on the "Investors" section of OncoSec’s website: View Source

For those interested in attending this event in person, please contact [email protected]. Please RSVP in advance as seating is limited.

Peer-Reviewed Publication

The findings published in Immunotherapy provide an overview of OncoSec’s preclinical and Phase 1 clinical data demonstrating that ImmunoPulse IL-12 plus electroporation is safe and well-tolerated by patients. Many patients do not respond to anti-PD-1 therapies alone, representing a significant unmet medical need. ImmunoPulse IL-12 has shown to increase intratumoral lymphocyte infiltration, pro-inflammatory cytokines and TH1 immune responses, potentially boosting the activity of PD-1 antibodies without significant systemic toxicity.

For the full-article please visit, View Source

About the SITC (Free SITC Whitepaper) Annual Meeting

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is a non-profit medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Currently, SITC (Free SITC Whitepaper) has nearly 1,600 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer. The 32nd SITC (Free SITC Whitepaper) Annual Meeting & Associated Programs will take place November 8-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, MD. For more information, please go to View Source

About PISCES/KEYNOTE-695

PISCES/KEYNOTE-695 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).

MEI Pharma has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, MEI Pharma, 2017, NOV 8, 2017, View Source [SID1234521731]).

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FibroGen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, FibroGen, 2017, NOV 8, 2017, View Source [SID1234521775]).

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Lexicon Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Lexicon Pharmaceuticals, 2017, NOV 8, 2017, View Source [SID1234521811]).

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On November 8, 2017 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial results for the three and nine months ended September 30, 2017 (Press release, Lipocine, NOV 8, 2017, View Source [SID1234521742]).

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Third Quarter and Recent Corporate Highlights

· Resubmitted a New Drug Application ("NDA") for TLANDO, Lipocine’s oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
o The U.S. Food & Drug Administration ("FDA") acknowledged receipt of the Company’s NDA resubmission for TLANDO, and assigned a new Prescription Drug User Fee Act ("PDUFA") action goal date of February 8, 2018.
o The FDA scheduled a Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") meeting on January 10, 2018 to discuss the NDA for TLANDO.
o The NDA includes the efficacy results of a dosing validation ("DV") study, which confirmed the validity of a fixed dose approach to orally administer TLANDO without the need for dose titration, as well as an integrated safety set ("ISS") from all previously conducted clinical trials, including 52-week safety results from the Phase 3 Study of Androgen Replacement ("SOAR") clinical study.

"We accomplished all of our goals for the third quarter, culminating in the resubmission and acceptance of the NDA for TLANDO by the FDA," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "TLANDO has the potential to be the first oral TRT option for patients and, if approved, will address a large and growing unmet medical need. We are preparing our presentation package for BRUDAC and look forward to discussing our NDA with the Advisory Committee in January 2018."

Third Quarter Ended September 30, 2017 Financial Results

Lipocine reported a net loss of $4.7 million, or ($0.22) per diluted share, for the third quarter ended September 30, 2017, compared with a net loss of $3.2 million, or ($0.18) per diluted share, in the third quarter ended September 30, 2016.

Research and development expenses were $2.0 million in the third quarter ended September 30, 2017, compared with $1.5 million in the third quarter ended September 30, 2016. The increase in research and development expenses was primarily due to an increase in contract research organization costs associated with the DV and Dosing Flexibility ("DF") clinical studies and an increase in contract manufacturing costs for LPCN 1107, offset by a decrease in travel and other allocated overhead costs.

General and administrative expenses were $2.7 million in the third quarter ended September 30, 2017, compared with $1.4 million in the third quarter ended September 30, 2016. The increase in was primarily due to an increase in market research and pre-commercialization activities related to TLANDO and an increase in personnel costs including accelerated vesting of stock options and restricted stock units related to a terminated employee.

As of September 30, 2017, the Company had $25.7 million of cash, cash equivalents and marketable investment securities compared to $26.8 million at December 31, 2016.

Nine Months Ended September 30, 2017 Financial Results

Lipocine reported a net loss of $15.7 million, or ($0.80) per diluted share, for the nine months ended September 30, 2017, compared with a net loss of $16.0 million, or ($0.88) per diluted share, in the nine-month period ended September 30, 2016.

Research and development expenses were $9.2 million in the nine months ended September 30, 2017, compared with $6.7 million in the nine months ended September 30, 2016. The increase in the nine months ended September 30, 2017 was primarily due to an increase in contract research organization costs related to the DV and DV clinical studies offset by a decrease in technical batch manufacturing costs for TLANDO, decreased personnel costs, decreased outside services costs and reduced travel and other allocated overhead costs.

General and administrative expenses were $6.6 million in the nine months ended September 30, 2017, compared with $9.0 million in the nine months ended September 30, 2016. The decrease in general and administrative expenses during the nine months ended September 30, 2017 was primarily due to a decrease in business development, market research and pre-commercialization activities related to TLANDO, a decrease in legal fees related to patent litigation, and a decrease in personnel costs.