On June 12, 2017 OncoSec Medical Incorporated ("OncoSec") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that they have engaged in a preclinical agreement through the OncoSec Technology Access Program (TAP) with Jounce Therapeutics, Inc., (NASDAQ:JNCE) Cambridge, MA, a company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment (Press release, OncoSec Medical, JUN 12, 2017, View Source [SID1234519503]).

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Under the agreement, Jounce can utilize OncoSec’s gene delivery technology to evaluate in vivo efficacy in murine models of intratumorally-delivered therapeutic candidates. The agreement includes the GENESIS research generator and proprietary applicators developed for research use.

"We are excited to provide a preclinical delivery solution to Jounce for early-stage research purposes and expand the data set from our delivery technologies through our Technology Access Program," said Punit Dhillon, CEO and President of OncoSec. "Through the establishment of these programs, OncoSec benefits from extensive, multi-party characterization and validation of our proprietary, state-of-the art electroporation technologies. We are pleased to be working with Jounce to help advance their preclinical programs with these technologies."

"OncoSec has developed a unique delivery technology that will enable us to rapidly assess potential candidates in preclinical models," said Debbie Law, Jounce’s Chief Scientific Officer. "We are delighted to be working with OncoSec and leveraging their technology to help us evaluate our preclinical immunotherapy programs."

About OncoSec Research Technologies and Technology Access Program:

The OncoSec GENESIS research generator was developed specifically for gene electro-transfer. It features customizable electroporation parameters for construct-specific optimization of expression, and it is the only in vivo electroporation device enabled with TRACE Technology (Tissue-Based, Real-Time Adaptive Control Electroporation.)

TRACE technology incorporates an electrochemical tissue-sensing control system to automatically adjust pulse width and treatment duration in real time during the electroporation procedure. This feature enables tissue- and therapeutic-specific delivery optimization, maximizing uptake of the therapeutic while reducing unnecessary cell ablation or damage. In research models, GENESIS with TRACE has yielded higher and more consistent in vivo protein expression versus fixed-parameter electroporation, even in heterogeneous tissues.

Potential advantages of GENESIS with TRACE for use in murine models include robust and conformationally-native in vivo expression of difficult proteins, including GPCRs and receptors that function in multimeric form. Moreover, the consistent results obtained with these technologies in heterogeneous tissues support reliable intratumoral delivery of a wide variety of DNA-encodable therapeutics across multiple syngeneic, xenograft, and PDX models. Using these technologies, OncoSec has expressed more than fifty proteins in vivo, including multimers and structurally-complex fusion proteins, and no protein tested to date has failed to successfully express.

The OncoSec Technology Access Program makes OncoSec’s electroporation technologies available to collaborators for preclinical research. Devices are available for intratumoral, intradermal, and intramuscular delivery. For more information, please contact [email protected].

For SEC reporting purposes, the agreement between OncoSec and Jounce is non-material.

On June 12, 2017 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for its biologics license application ("BLA") for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, under the 351(k) pathway (Press release, Coherus Biosciences, JUN 12, 2017, View Source/news-releases/news-release-details/coherus-biosciences-receives-complete-response-letter-fda-its" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-receives-complete-response-letter-fda-its" rel="nofollow">View Source [SID1234531703]).

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The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients. Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors.

Coherus will work with the FDA to address the information requests.

"While we are disappointed in the delay that this additional request has caused, we remain confident in our ability to address the FDA’s requests for the purpose of obtaining approval for CHS-1701," said Denny Lanfear, President and CEO of Coherus BioSciences. "We are encouraged that a patient study has not been requested and we expect that we will be able to respond to the FDA and meet with them to define a path forward in the coming months. Neulasta is the largest selling oncology biologic in the U.S., and we anticipate CHS-1701’s approval will generate significant U.S. healthcare savings while increasing patient access."

Coherus’ management team will host a conference call on Monday, June 12 at 8:00 a.m. EDT.

Conference Call Information
Dial-in: (844) 452-6826 (domestic) or (765) 507-2587 (international)
Conference ID: 35568643
Please join the conference call at least 10 minutes early to register.
A replay of this conference call will be posted to the company’s website View Source and will be available until July 12, 2017.

On June 12, 2017 Dragonfly Therapeutics, Inc. ("Dragonfly"), reported a global strategic collaboration with Celgene Corporation and its affiliates ("Celgene") to discover, develop and commercialize innovative immuno-oncology treatment options for patients with hematological malignancies based on Dragonfly’s Natural Killer ("NK") cell based TriNKET technology platform (Press release, Dragonfly Therapeutics, JUN 12, 2017, View Source [SID1234533242]).

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The collaboration allows Celgene the exclusive option to in-license worldwide rights for up to four therapeutic candidates with potential utility in the treatment of acute myeloid leukemia, multiple myeloma, and additional hematological malignancies. The collaboration includes a $33 million upfront payment, and potential future milestone and royalty payments.

"NK-cell biology and immunotherapy are increasingly critical areas of hematologic research and we are looking forward to working with Dragonfly’s team of world-leading experts," said Rupert Vessey, FRCP DPhil, President of Research and Early Development for Celgene Corporation. "This collaboration will leverage the strengths of each company as we work together to bring innovative therapies to patients."

"Through execution of this strategic alliance with Celgene, Dragonfly is well positioned to accelerate our efforts to bring potential new immuno-oncology treatment options to patients with hematological malignancies," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. "Celgene is a preeminent biopharmaceutical company with a demonstrated history of recognizing disruptive science that may lead to new treatment options for patients with cancer. We look forward to a successful collaboration."

On June 8, 2017 2X Oncology, Inc. ("2X" or the "Company"), a precision medicine company developing targeted therapeutics to address significant unmet needs in women’s cancer, reported that it has obtained the Investigational New Drug (IND) application for 2X-111 (doxorubicin hydrochloride and glutathione) from 2-BBB Medicines B.V., assuming all future development and ownership of the drug (Press release, 2X Oncology, JUN 8, 2017, View Source [SID1234526104]).

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2X-111 is being developed as a new treatment option for women with brain metastases from breast cancer and for patients with recurrent glioblastoma multiforme (GBM), an orphan-designated condition.

George O. Elston, CEO of 2X Oncology, said, "Having this IND in place is an important step as we focus on initiating Phase 2 clinical trials of 2X-111 in GBM and brain metastases from breast cancer later this year.

"These studies will employ our proprietary DRP companion diagnostic to identify patients based on their unique tumor mRNA expression and treat those most likely to respond to and benefit from therapy," Mr. Elston added.

"Patient selection based on the unique genetic properties of a tumor is an important new direction in the treatment of cancer, and we are pleased to have this capability for our programs and patients."

The Drug Response Predictor (DRP) technology utilizes messenger RNA (mRNA) from patient biopsies and uses proprietary analytics to create a unique fingerprint of relevant genes based on a tumor’s sensitivity, or resistance, to a compound. DRPs are specific for each product and have been validated in over 40 clinical studies.

"We expect data from these studies in 2018 which, if positive, can position this program for possible accelerated approval filings shortly thereafter," Mr. Elston concluded.

Formerly known as 2B3-101, 2X-111 improves on commercially available PEGylated liposomal doxorubicin products with an additional glutathione coating that safely enhances drug delivery across the blood-brain barrier. Doxorubicin is an anthracycline that inhibits the growth of many cancerous cell lines, including glioblastoma and breast cancer cell lines. It is among the most widely used anti-cancer agents.

An abstract on the predictive ability of the DRP in treating advanced breast cancer with a similar anthracycline, epirubicin, was presented in a poster session at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

The abstract describes a retrospective-prospective blinded study which evaluated the ability of the DRP to predict the efficacy of epirubicin in a cohort of 135 metastatic breast cancer patients. The DRP was significantly associated with progression free survival in this study. The estimated median time to progression for a patient with a DRP value of 25% was 7 months, versus 13 months for a patient with a DRP value of 75%.

Mr. Elston will discuss 2X-111 and other 2X pipeline drugs at the Jefferies 2017 Global Healthcare Conference on June 9, 2017, at 10:00am EDT. The presentation will be available as a live webcast and archived for post-listening on the Company’s website.

About Breast Cancer Brain Metastases

Breast cancer is the second most common common cause of brain metastases, with metastases occurring in 10–16 % of patients[1]. Patients who develop brain metastases tend to have poor prognosis with short overall survival. Furthermore, brain metastases are a major cause of morbidity, associated with progressive neurologic deficits that result in a reduced quality of life.

About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) is the most common class of malignant primary brain tumors and one of the most aggressive forms of cancer. This highly invasive and proliferative cancer resists standard chemotherapy and radiotherapy. Current therapeutic strategies for the treatment of GBM fail to demonstrate adequate efficacy and/or are generally palliative. Median overall survival is 12 to 14 months

On June 8, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported that it has commenced its phase 3 clinical program to evaluate the efficacy of Inovio’s DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus (HPV) (Press release, Inovio, JUN 8, 2017, View Source [SID1234519479]). Inovio’s study will assess the efficacy of VGX-3100 in regressing cervical HSIL (high-grade squamous intraepithelial lesions), a direct precursor to cervical cancer, and eliminating the HPV infection that causes these lesions. The pivotal data from this program will support the potential licensure of VGX-3100 as the first immunotherapy for this disease.

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Inovio satisfied the FDA’s request for information relating to its CELLECTRA 5PSP delivery device, resulting in the FDA removing the clinical hold on this program. Inovio plans to immediately begin recruiting patients for the phase 3 trial.

Inovio’s phase 3 program, named REVEAL (Randomized Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL), will consist of a primary study (REVEAL 1) and confirmatory study (REVEAL 2), as per FDA general guidance for phase 3 programs, to be conducted in parallel. The studies will each enroll 198 patients in more than 100 study centers globally. Mark Einstein, MD, MS, FACS, FACOG, Professor and Chair Department of Obstetrics, Gynecology and Women’s Health Assistant Dean, Clinical Research Unit, Rutgers New Jersey Medical School, is Principal Investigator for the studies.

The REVEAL studies are prospective, randomized (2:1), double-blind, placebo-controlled trials evaluating adult women with HPV 16/18 positive biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3. The primary endpoint is regression of cervical HSIL AND virologic clearance of HPV-16 and/or HPV-18 in the cervix. The studies will evaluate cervical tissue changes at approximately 9 months after beginning a three dose regimen of VGX-3100 administered at months 0, 1, and 3. Secondary endpoints include safety; tolerability; regression of CIN 2/3 to CIN 1 or normal; virologic clearance of HPV; efficacy measured by non-progression to cancer; and clearance of HPV from non-cervical anatomic locations.

VGX-3100 has the potential to be the first treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 stimulates a specific immune response to HPV-16 and HPV-18, targeting the infection and destroying pre-cancerous cells. There are no treatments available for HPV infection and surgery is the only approved treatment for cervical HSIL. While surgery is effective at removing dysplastic lesions, it does not treat the underlying HPV infection and carries increased risk of cervical incompetence and pre-term birth, which can result in fetal morbidity and mortality. VGX-3100 demonstrated in a phase 2b study (published in The Lancet) its ability to clear HPV-16 and HPV-18 infection and pre-cancerous lesions.

Dr. Mark Bagarazzi, Inovio’s Chief Medical Officer, said, "Despite the availability of preventive HPV vaccines for over a decade, HPV-related cervical HSIL and cancers remain a widely prevalent problem. Unfortunately, current treatments are invasive and do not address the underlying HPV infection. VGX-3100 has the potential to be a first-in-class HPV-specific immunotherapy offering women the prospect of preventing cervical cancer without undergoing an invasive surgical procedure that may compromise their reproductive health. We are pleased to be able to immediately begin recruiting patients at the first 15 sites by the end of this month."

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "Initiating our REVEAL phase 3 program marks a milestone for Inovio, for the next generation of DNA-based immunotherapies, and for women’s health. Combining this first phase 3 program with our previously announced phase 2 clinical trial of VGX-3100 for HPV-related vulvar neoplasia and our checkpoint inhibitor-based combination study with MedImmune/AstraZeneca targeting HPV associated cancers, Inovio is well positioned to comprehensively treat HPV-associated diseases across the continuum of HPV infection through to cancer in both men and women. Adding our recently announced collaborative immuno-oncology combination studies with Regeneron and Genentech, 2017 is a transformative year that is laying the foundation for multiple opportunities for important efficacy data."

About HPV and Cervical HSIL

HPV is the most common sexually transmitted infection, with over 14 million new infections annually. While many of these are transient infections, persistent high-risk infections can cause the formation of pre-cancerous lesions. Left untreated, women diagnosed with cervical HSIL are at increased risk of developing cervical cancer. HPV types 16 and 18 are responsible for 70% of cervical cancers, with more than 400,000 new cases of HPV 16/18 cervical HSIL annually in the US and Europe. Cervical cancer is a major global health problem, causing 260,000 deaths annually. While cervical HSIL and cervical cancer are the most well-known HPV related diseases, HPV is also a major cause of HSIL and cancer in the entire anogenital region and oropharynx. Currently there are no treatments available for HPV infection and surgery is the only approved treatment for cervical HSIL. While surgery is effective at removing lesions, it does not treat the underlying HPV infection and it carries increased risk of cervical incompetence and pre-term birth, which can result in fetal morbidity and mortality.

About VGX-3100

VGX-3100 is a DNA-based immunotherapy under investigation for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix (phase 3) and vulva (phase 2). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes destruction of pre-cancerous cells. In a randomized, double-blind, placebo-controlled phase 2b study in 167 adult women with histologically documented HPV 16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. The most common side effect was injection site pain, and no serious adverse events were reported. VGX-3100 utilizes the patient’s own immune system to clear HPV-16 and HPV-18 infection and pre-cancerous lesions without the increased risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts.