On October 2, 2018 Cotinga Pharmaceuticals Inc. (TSX Venture: COT; OTCQB: COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported its financial and operating results today for the three-month period ended July 31, 2018 (Press release, Cotinga, OCT 2, 2018, View Source [SID1234533150]):

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. Recent highlights include: Advanced the clinical development of COTI-2:

In May 2018, Cotinga announced FDA clearance of a protocol amendment for its ongoing Phase 1b/2a trial of COTI-2. The multi-part protocol amendment expands the trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.
Presented novel scientific findings from its COTI-2 clinical program:

In June 2018, Cotinga and its collaborators from MD Anderson Cancer Center presented data on COTI-2 at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois;
Subsequent to the reporting quarter, in September 2018, Cotinga presented data on COTI-2 at the 11th International Symposium on Translational Research in Oncology in Dublin, Ireland.
Secured financing and appointed management and board members to support corporate strategy:

In May 2018, Cotinga closed a brokered private placement and a non-brokered private placement for total proceeds of approximately CAD $2,010,000;
In July 2018, Cotinga announced the appointment of Victor Hugo as Chief Financial and the appointment of J. Matthew Bond as a member of the Board of Directors and Chairman of the Audit Committee.
"We began the fiscal year with renewed progress across the entire business, including implementation of an expanded protocol for our ongoing Phase 1b/2a clinical trial of COTI-2," said Alison Silva, President & Chief Executive Officer. "We were also pleased to reduce our operating expenses during the quarter, while simultaneously securing the capital and personnel necessary to support our corporate strategy. We look forward to continuing to provide updates at critical milestones as we efficiently advance COTI-2 through clinical development."

Upcoming Milestones

COTI-2:

Dose first patient with combination therapy in Phase 1b/2a clinical trial in solid tumor;
Complete additional exploratory endpoint data analysis for dose escalation portion of Phase 1 trial in gynecological malignancies;
Complete Phase 1 dose escalation trial in HNSCC;
Initiate p53 basket trial with COTI-2;
Initiate breast cancer trial with COTI-2.
COTI-219:

Complete IND-enabling studies;
Finalize GMP manufacturing;
File an IND.
Corporate:

Strengthen the balance sheet;
Opportunistically pursue regional or co-development partnerships for COTI-2, pipeline programs and other technologies.
Financial Results

The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1b/2a clinical trial of COTI-2.

For the three-months ended July 31, 2018, the Company incurred a net loss of $0.982 million, or $0.04 per share, compared to a net loss of $0.242 million, or $0.02 per share, for the three-months ended July 31, 2017. The increase in net loss during the three-month period is primarily due to changes in fair value warrant liability, partially offset by decreases in Research and Development (R&D) expense, Sales and Marketing (S&M) expense and General and Administrative (G&A) expense.

There was no revenue for the three-month period ended July 31, 2018 or in the comparative period in the year prior.

R&D expense in the three-month period ended July 31, 2018 decreased by $0.283 million over the same period in the year prior. The decrease in R&D expense in the three-month period is primarily due to a decrease in salaries and benefits due to lower headcount and preclinical testing.

S&M expense in the three-month period ended July 31, 2018 decreased by $0.048 million over the same period in the year prior. The decrease in R&D expense in the three-month period is primarily due to cost reduction implemented last financial year.

G&A expense in the three-month period ended July 31, 2018 decreased by $0.287 million over the same period in the year prior. The decrease in R&D expense in the three-month period is primarily due to a decrease in salaries due to lower head count and lower share-based compensation.

Detailed operating and financial results can be found in the Company’s Unaudited Condensed Interim Financial Statements and Management Discussion and Analysis for the three-month period ended July 31, 2018, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.

On October 2, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported publication of important research in the peer-reviewed journal Cancer Immunology Research (Press release, Oncolytics Biotech, OCT 2, 2018, View Source [SID1234530640]). The research showed that pelareorep, a systemically delivered oncolytic reovirus, can destroy tumor cells via a monocyte-mediated process even after the virions have been exposed to antibodies designed to neutralize the reovirus.

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"For some time there have been two schools of thought regarding oncolytic viruses: those that believe intratumoral delivery is necessary for treatment due to potential neutralization of the virus in the bloodstream and those that believe intravenous delivery is also an efficacious means of treatment with a virus," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "This key publication validates the systemic delivery of oncolytic viruses by proving that oncolytic viruses delivered intravenously can be effective even in the presence of neutralizing antibodies. It sends a message to everyone in the oncology community that systemic delivery of this drug class is not only viable, but may increase its effectiveness in the presence of neutralizing antibodies."

The study was conducted by Dr. Elizabeth Ilett and Dr. Rob Berkeley from the University of Leeds and Professor Alan Melcher from The Institute of Cancer Research, London. Oncolytics Biotech donated pelareorep for research.

In the study, researchers treated pelareorep with neutralizing antibodies derived from patients undergoing virus therapy and added the antibody-coated virions to melanoma cells, which resulted in no killing of melanoma cells. However, addition of monocytes to the culture led to reactivation of the neutralized virus particles, allowing them to effectively target and destroy the melanoma cells. Three different viruses that are currently being evaluated in clinical trials were tested in the study, with neutralized forms of two of the three viruses being reactivated by monocytes, a finding with immediate clinical significance.

"This discovery suggests that cancer treatments using systemic virus therapy could be significantly expanded in the future, as we previously, but erroneously, believed that follow-up doses were useless once the body had produced antibodies against the virus," said Dr. Ilett.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On October 2, 2018, Immunomedics, Inc. (the "Company") entered into privately negotiated exchange agreements (the "Exchange Agreements") with a limited number of holders ("Noteholders") of its outstanding 4.75% Convertible Senior Notes due 2020 (the "Convertible Notes"), pursuant to which the Company agreed to exchange, in a private placement in reliance on Section 4(a)(2) of the Securities Act of 1933, as amended (the "Exchanges"), approximately $12.9 million in aggregate principal amount of the Convertible Notes held by the Noteholders for approximately 2.57 million newly issued shares of the Company’s common stock, par value $0.01 per share (Filing, 8-K, Immunomedics, OCT 2, 2018, View Source [SID1234530614]).

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The Company anticipates that the Exchanges will be completed on or about October 5, 2018. Upon completion of the Exchanges, the aggregate principal amount of the Convertible Notes is expected to be reduced to approximately $7.1 million.

The Company expects to file the form of Exchange Agreement as an exhibit to its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2018. The foregoing description is qualified in its entirety by reference to the complete text of the form of Exchange Agreement when filed.

This Current Report does not constitute an offer to sell, or a solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering would be unlawful.

On October 2, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported the appointment of Aoife Brennan, M.B., B.Ch., as president and chief executive officer of Synlogic, effective immediately (Press release, Synlogic, OCT 2, 2018, View Source [SID1234530532]). Dr. Brennan joined Synlogic as chief medical officer in 2016 and has served as interim president and chief executive officer since May 2018.

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"After conducting a thorough search process, it was clear to the board of directors that Aoife is the right person to lead Synlogic at this time in the company’s evolution," said Peter Barrett, chairman of Synlogic’s board of directors. "Aoife stepped into the interim role and rapidly demonstrated her effectiveness. Her broad experience across multiple stages of drug development and therapeutic areas, her demonstrated leadership abilities, and her ambitious vision for Synlogic, make her uniquely qualified for the job. We are confident that under her leadership, Synlogic will be well-positioned to deliver Synthetic Biotic medicines to patients."

"I appreciate the confidence and support of the board of directors and am thrilled to be selected to lead Synlogic as we pioneer the development of a completely new class of living medicines," said Dr. Brennan. "We have made great progress to date, advancing two Synthetic BioticTM programs into the clinic. I look forward to continuing to execute on our plans for the clinical development of our lead candidates while capitalizing on the broad applicability and potential of our novel platform to build a pipeline of therapies for patients with serious and life-threatening diseases."

Prior to joining Synlogic, Dr. Brennan spent six years at Biogen in roles of increasing responsibility, most recently as vice president and head of the Rare Disease Innovation Unit, which included programs ranging from pre-clinical to commercial. She has also led programs across multiple therapeutic areas including the late-phase development of nusinersen for spinal muscular atrophy and treatments for Hemophilia B and Hemophilia A, ALPROLIX and ELOCTATE. Earlier, Dr. Brennan was director of clinical development at Tolerx, a start-up biotech company focused on immunotherapy for Type 1 diabetes. Dr. Brennan holds a medical degree from Trinity College Dublin, Ireland and completed her post-graduate training in internal medicine, endocrinology and metabolism at the Royal College of Physicians in Ireland. Additionally, she completed post-doctoral training in clinical research and metabolism at the Beth Israel Deaconess Medical Center in Boston and is a graduate of the Harvard Medical School Scholars in Clinical Science Program.

On October 2, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a paper published in a major cancer journal detailed results of a patient with head and neck cancer treated with MEDI0457 achieved a sustained complete response (full remission) on treatment with a subsequent PD-1 checkpoint inhibitor (Press release, Inovio, OCT 2, 2018, View Source [SID1234530271]). In the Inovio-sponsored study of 22 patients with head and neck squamous cell carcinoma the company reported 91% (20/22) showed T cell activity in the blood or tissue. MEDI0457­ – formerly called INO-3112 – was in 2015 licensed to MedImmune, the global biologics research and development arm of AstraZeneca. These immune data as well as the financial terms of the license agreement have been previously reported by Inovio.

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Dr. J. Joseph Kim, Inovio’s President and CEO, said, "We are buoyed by the study as it lends support to all of our HPV and oncology programs. These data demonstrated that Inovio’s technology based in MEDI0457 can generate durable HPV16/18 antigen-specific peripheral and tumor immune responses. The study supports our belief that this approach may be used as a complementary strategy to PD-1/PD-L1 inhibition in HPV-associated head and neck and other types of cancer to improve therapeutic outcomes. Inovio is collaborating with MedImmune (w/ MEDI0457) as well as Genentech and Regeneron (w/ INO-5401) in efficacy trials coupling Inovio’s DNA-based cancer immunotherapies with checkpoint inhibitors designed to increase response rates with data expected in 2019."

An article in the most recent edition of Clinical Cancer Research highlights data from an Inovio-sponsored trial that demonstrated that after a cancer progressed a patient was subsequently given a PD-1 checkpoint inhibitor. The patient achieved a complete response, which has sustained for over two years and counting. Increasing evidence suggests that response rates from checkpoint inhibitors can be enhanced when used in combination with cancer vaccines like MEDI0457 that generate tumor-specific T cells. Interim data from a MEDI0457 monotherapy study of head and neck cancer patients demonstrated that MEDI0457 generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue samples.

Charu Aggarwal, MD, MPH, the study’s principal investigator and an assistant professor of Hematology-Oncology at the University of Pennsylvania’s Perelman School of Medicine, said, "We wanted to know if this vaccine (MEDI0457) can boost the immune systems of patients with HPV-related head and neck cancer, potentially opening the door for better response rates to other existing therapies, and our findings show that we can."

The article notes that researchers administered four doses of MEDI0457 to 21 patients separated into two different groups. One group received a dose before surgery, followed by three doses after surgery. The second group received four doses following chemotherapy and radiation. Eighteen out of the 21 patients showed elevated T cell activity that lasted at least three months after the final vaccine dose, meaning the immune effect persisted for at least six months from the start of immunotherapy. Five tumors were biopsied both before and after one dose of the vaccine, and there was evidence of T cells infiltrating into tumors and expressing proteins associated with cell killing potential.

"We have not seen that kind of T cell infiltration with just one dose of a vaccine before," Dr. Aggarwal added. "These findings open the door for utilizing targeted immunotherapy approaches against specific cancer-causing targets like HPV."

Overall the characteristics of these immune response data mirrored those previously observed in a Phase 2b clinical study of VGX-3100 for HPV-associated cervical dysplasia. In that study, strong CD8+ T cell immune responses were positively correlated with achievement of primary and secondary efficacy endpoints. VGX-3100, which is currently in global REVEAL 1 Phase 3 trial, is the first therapy to demonstrate that activated killer T cells induced in the body have the power to clear neoplastic lesions as well as the virus which caused the disease.

About MEDI0457 and VGX-3100

MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which MedImmune in-licensed from Inovio) is under evaluation by MedImmune to treat HPV-associated cancers. Inovio is investigating VGX-3100, a DNA-based immunotherapy 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.

About HPV-Caused Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, currently infecting about 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. In 2018 an estimated 48,330 persons will get oral cavity or oropharyngeal cancer in the U.S. New cases of head and neck cancer occur nearly three times more often in men as in women. Incidence rates of head and neck cancers have been on the rise, especially HPV-associated oropharyngeal cancer in men, and are expected to continue growing.