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OncoSec Announces Dosing of First Patient in Registration-Directed Phase 2b Clinical Trial, PISCES/KEYNOTE-695, of ImmunoPulse® IL-12 in Combination with Pembrolizumab

On December 14, 2017 OncoSec Medical Incorporated ("OncoSec" or the "Company") (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported the initiation of patient dosing in PISCES/KEYNOTE-695, the company’s global, multi-center, registration-directed open-label Phase 2b clinical trial (Press release, OncoSec Medical, DEC 14, 2017, View Source [SID1234522642]). The trial will evaluate the combination of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), and pembrolizumab in patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy.

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"There remains a significant unmet medical need in oncology for patients in whom the existing PD-1 therapies do not work. Based on the encouraging data we presented at SITC (Free SITC Whitepaper), we believe the combination of ImmunoPulse IL-12 and pembrolizumab may offer a differentiated approach to reshaping the tumor microenvironment by converting immunologically cold tumors to hot," said Sharron Gargosky, Chief Clinical and Regulatory Officer of OncoSec. "We look forward to the continued advancement of this trial and to sharing data in 2018."

The Phase 2b, multicenter study of intratumoral tavo with electroporation in combination with intravenous pembrolizumab will enroll approximately 48 patients with a 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).

The Company’s prior Phase 2 OMS I-102 combination study of ImmunoPulse IL-12 and pembrolizumab in 22 patients unlikely to respond to anti-PD-1 therapy demonstrated a 50% best overall response rate and a 41% complete response rate. In addition, the trial showed a 57% progression free survival (PFS) rate at 15 months (median PFS not yet reached) and 100% (11/11) duration of response. In clinical studies to date, intratumoral tavo has demonstrated a favorable safety profile and has been well tolerated.

PISCES/KEYNOTE-695 is the second combination study conducted with pembrolizumab and, if successful, could form the basis for a BLA under the accelerated approval pathway.

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

About Metastatic Melanoma

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 in 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.

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

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

Kyn Therapeutics Announces $49 Million Series A Capital Available to Develop Cancer Therapy Candidates with Novel Approaches to Major Immunometabolism Pathways

On December 14, 2017 Kyn Therapeutics, a biotechnology company advancing new immunometabolism therapies for treating cancer, reported $49 million in Series A capital available to advance a pipeline of clinical- and pre-clinical stage therapies, including a program scheduled to enter clinical studies in 2018 (Press release, KYN Therapeutics, DEC 14, 2017, View Source [SID1234522661]). Atlas Venture and OrbiMed provided the investment.

Kyn Therapeutics is focused on immunometabolism, a rapidly growing area of immuno-oncology that leverages the powerful impact that various metabolic pathways and metabolites have on the immune system. Each Kyn Therapeutics candidate is designed to reverse the effects of an immunosuppressive metabolite promoted by cancer cells, and therefore complement or enhance the outcomes achieved by checkpoint inhibitor therapies. A majority of patients do not benefit from checkpoint inhibitors as many cancers are adept at evading or dampening an immune response through multiple mechanisms, including activation of immunosuppressive metabolic pathways. Kyn Therapeutics is focused on making the power of immunotherapy work for every patient with cancer, through strategic selection of candidates known to play key roles in major immunometabolism pathways.

"The promise of immunometabolism lies in overcoming the barriers cancer creates against treatment, and we are very excited about the opportunities we’ve created by harnessing compelling research in this area," said Mark Manfredi, chief executive officer of Kyn Therapeutics. "Our preclinical research has delivered exciting results both in single agent studies and in combination with leading checkpoint inhibitors and other mechanisms. We are moving rapidly to launch a clinical oncology study in 2018."

Kyn Therapeutics’ preclinical programs attack components of the IDO and TDO pathways by targeting their resultant immunosuppressive metabolite kynurenine as well as a downstream receptor.

The first program focuses on "Kynase", an enzyme that degrades kynurenine directly and thereby addresses both IDO- and/or TDO-driven immunosuppression. The second program blocks immunosuppression mediated by activation of the aryl hydrocarbon receptor (AHR), which is activated by various immunometabolites including kynurenine. Kyn Therapeutics believes these approaches will yield efficacy in tumors overexpressing IDO and/or TDO, granting broader clinical applicability to a therapeutic candidate. The Series A capital includes a $28 million allocation to these IDO/TDO programs.

"We believe Kyn Therapeutics has differentiated its approach in a field that is rapidly substantiating its early promise," said George Georgiou, a Kyn Therapeutics founder and professor in Engineering at the University of Texas, Austin. "We are excited at the possibility of delivering our therapeutics to the many patients who stand to benefit from the cancer immunotherapy revolution underway."

The most clinically advanced program in development by Kyn Therapeutics is named ARY-007 and blocks the EP4 receptor, which is involved in the highly characterized prostaglandin E2 pathway. The EP4 receptor is strongly associated with an immunosuppressive and tumor promotive effect via immune cell modulation. ARY-007 has demonstrated favorable therapeutic characteristics in human clinical studies for non-oncology indications, and Kyn Therapeutics will build on this earlier work as it prepares for a Phase 1b clinical oncology study, guided by well-established biomarkers. ARY-007 is held by Arrys Therapeutics, an affiliate of Kyn Therapeutics which has exclusively subcontracted the development of ARY-007 to Kyn Therapeutics. The Series A capital includes a $21 million allocation to Arrys Therapeutics for the ARY-007 program.

AmpliPhi Biosciences Provides Corporate and Strategic Update

On December 14, 2017 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, reported its progress in 2017 and near-term strategic goals and initiatives (Press release, AmpliPhi Biosciences, DEC 14, 2017, View Source [SID1234522649]).

2017 Corporate Highlights

In April, AmpliPhi received positive feedback from a U.S. Food and Drug Administration (FDA) Type B meeting in which the FDA "acknowledged that phage therapy is an exciting approach to treatment of multi-drug resistant organisms and expressed a commitment to addressing the unique regulatory challenges that might arise during product development." The FDA also stated that "the clinical safety and effectiveness data collected during development, including from emergency case studies, could inform future discussions for clinical development and ultimately, the regulatory pathway to approval."
In August, AmpliPhi announced the first-in-human administration of its therapeutic candidate AB-PA01 targeting Pseudomonas aeruginosa (P. aeruginosa) under an Emergency IND allowed by the FDA. AmpliPhi provided AB-PA01 for a patient suffering from a life-threatening multidrug-resistant P. aeruginosa lung infection. Multiple doses of AB-PA01 were administered intravenously and by inhalation through a nebulizer and were well tolerated.
In September, AmpliPhi announced the first-in-human intravenous administration of its therapeutic candidate AB-SA01 targeting Staphylococcus aureus (S. aureus) under the Special Access Scheme of the Australian Therapeutic Goods Administration. AmpliPhi provided AB-SA01 for a patient suffering from a life-threatening S. aureus endocarditis. AB-SA01 was administered intravenously over a two week duration and was well tolerated.
A total of seven patients, suffering from serious and life-threatening infections who were not responding to antibiotic therapy, have been treated with AB-SA01 or AB-PA01 in 2017.
Raised $9.4 million in net proceeds from an equity securities offering in May, and received a $2.0 million Research and Development Tax Incentive cash rebate in September from the Australian Tax Office based on the Company’s R&D spending in Australia during 2016.
Continued to raise awareness of the Company’s bacteriophage development programs through presentations and participation in various scientific and medical meetings, including: 2017 Australian Society of Otolaryngology Head and Neck Surgery Meeting in March, Solutions for Drug-Resistant Infections Meeting in Brisbane in April, and "Bacteriophage Therapy: Scientific and Regulatory Issues" workshop sponsored by the FDA and the National Institutes of Health in July.
In December, the Company engaged Ladenburg Thalmann & Co. Inc. to assist the Company in exploring strategic alternatives in an effort to maximize shareholder value. The Company has not set a timetable for completion of this exploratory process and cannot provide any assurances that the process will result in the consummation of a strategic transaction of any kind, or that the Company will not abandon the process. The Company does not intend to discuss or disclose further developments during this process unless and until its board of directors has approved a specific action or the Company otherwise determines that further disclosure is appropriate.
Potential Milestones and Initiatives for the First Half of 2018

In early 2018, the Company plans to present topline results from the treatment of seven patients with serious and life-threatening infections, not responding to antibiotics, completed under the Company’s single-patient expanded access program in 2017.

The Company intends to continue its expanded access clinical strategy in the first half of 2018, present data from approximately 25 expanded access clinical cases to the FDA in mid-2018 and initiate a Phase 2 or registrational clinical trial as early as the second half of 2018.

The Company will present an overview and update of its current business activities at the 9th Annual Biotech Showcase Conference on January 8, 2018 at 9:30 a.m. PT being held in San Francisco.

"AmpliPhi has made tremendous progress throughout 2017," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "To date, under the expanded access program, we have dosed seven patients in dire need, who were suffering from serious and life-threatening infections and were not responding to antibiotic therapies. We look forward to presenting topline results in early 2018. We have set a goal of dosing approximately 20 additional patients during the first half of 2018. We continue the dialogue with the FDA and key thought leaders in the infectious disease community regarding design of Phase 2 and registrational clinical studies of our bacteriophage therapies."

Advaxis to Host Business Update and Fiscal Year End 2017 Financial Results Conference Call on December 21, 2017

On December 14, 2017 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the Company will release financial results for the fiscal year ended October 31, 2017 on Wednesday, December 20, 2017 (Press release, Advaxis, DEC 14, 2017, View Source [SID1234522644]).

Advaxis’ senior management will host a conference call to review its financial results and provide a business update, which will include a discussion of the advantages of its Lm-based antigen delivery platform and clinical pipeline. The conference call and live audio webcast will begin at 10:00 a.m. Eastern time on Thursday, December 21, 2017.

Conference Call & Webcast Information

WHEN: Thursday, December 21, 2017 at 10:00 a.m. Eastern time.
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 4682169
WEBCAST: www.ir.advaxis.com/news-events

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning December 21, 2017 two hours after the close of the conference call. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide the operator with the conference ID: 4682169. In addition, the audio webcast will be archived on the Company’s website for a period of time at www.ir.advaxis.com/news-events.

Incyte to Present at Upcoming Investor Conference

On December 14, 2017 Incyte Corporation (Nasdaq:INCY) reported that it will present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2018 at 1:30 pm (PST) in San Francisco (Press release, Incyte, DEC 14, 2017, View Source;p=RssLanding&cat=news&id=2322704 [SID1234522646]).

The presentation and Q&A session will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations." Investors interested in listening to the live webcast should log on before the start time in order to download any software required.