On July 16, 2020 Oncorus, Inc., a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that it has initiated a Phase 1 study of its lead product candidate, ONCR-177, an intratumorally administered oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy being developed for multiple solid tumor indications (Press release, Oncorus, JUL 16, 2020, View Source [SID1234561981]). The Phase 1 open-label, multi-center, dose escalation and expansion study is designed to evaluate the safety and tolerability and to determine the recommended Phase 2 dose as well as preliminary anti-tumor activity of ONCR-177 alone and in combination with Merck’s anti-PD1-1, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors.

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"Initiating our first-in-human study of ONCR-177 is a significant milestone, bringing us a major step closer to delivering on our mission to realize the full promise of viral immunotherapy for cancer patients across multiple indications, including some of the most notoriously difficult-to-treat types of cancer," said Theodore (Ted) A. Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "Our oHSV Platform represents a potential breakthrough for the viral immunotherapy class due to the multiple proprietary innovations our team has developed to activate multiple arms of the immune system to enhance potency while balancing safety."

Dr. Ashburn continued, "A huge thank you to our team and collaborators for their tremendous effort preparing for this study amidst the unprecedented challenges presented by the COVID-19 pandemic. I’m proud and honored to work with such a bright, dedicated and patient-driven group of people."

"While we have seen great success with immuno-oncology as an approach in some patients, these therapies have not benefited all patients with cancer, and new strategies are needed," said Shiraj Sen, M.D., Ph.D., Associate Director, Drug Development Unit, Sarah Cannon Research Institute at HealthONE in Denver, Colorado. "Given its differentiated profile, ONCR-177 has the potential to enable more patients to respond to, and realize the benefits of, immuno-oncology treatment. We are pleased to be part of this important first-in-human study of this next-generation viral immunotherapy." Dr. Sen is a site investigator for the ONCR-177 Phase 1 study, and his site enrolled and dosed the first patient in this trial.

John Goldberg, M.D., Senior Vice President of Clinical Development at Oncorus, commented, "We are privileged to be working with preeminent cancer research institutions and leading researchers on the execution of this study. We are also thrilled to enter a clinical collaboration with Merck to study ONCR-177 in combination with KEYTRUDA, which is a key component of the trial. Above all, we are humbled to now be in a study in patients with ONCR-177 and believe in its potential to become a foundational component of oncologists’ anti-tumor arsenal. Our team is motivated by the courage of cancer patients and driven to enable every patient to win their war against this disease."

Oncorus has designed its proprietary oHSV Platform to develop improved intratumorally administered viral immunotherapies that have the potential to enhance potency without sacrificing safety, a challenge that has been encountered by earlier generation programs in this class. ONCR-177 is designed to mount a powerful, multidimensional attack on cancer; it induces immunogenic cancer cell death and ignites innate and adaptive immunity to drive a lasting and systemic anti-tumor response. In addition to its oncolytic activity, ONCR-177 is armed with five immunomodulatory transgenes: IL-12, CCL4, FLT3LG, and antagonists of clinically proven immune checkpoints PD-1 and CTLA-4. This represents a greater payload capacity than viral immunotherapies that are either currently approved or in clinical development.

In preclinical studies, ONCR-177 was shown to stimulate multiples arms of the immune system, drive abscopal activity and prolong survival while limiting systemic exposure to transgene products, such as IL-12, that generally cannot be safely dosed systemically due to toxicities.

ONCR-177 retains full replication competency to enable potent tumor cell killing. It also incorporates two highly innovative approaches — the use of microRNA target sequences and a proprietary mutation engineered in an HSV-1 protein, known as UL37 — to allow for tumor-specific replication, which restricts viral activity to tumor cells while sparing normal tissues.

About the Phase 1 ONCR-177 Study

The first part of the study involves a monotherapy dose escalation of ONCR-177 and will enroll approximately 21 cancer patients with advanced or metastatic solid tumors for whom surgical resection or locoregional therapy is not indicated, and who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or have a disease for which no standard of care exists.The Phase 1 trial will escalate the dose of ONCR-177 until the recommended phase 2 dose is determined.

Upon determination of the recommended Phase 2 dose, the study will then enroll patients to histology- specific expansion cohorts to demonstrate safety and initial efficacy of ONCR-177 as a monotherapy and in combination with KEYTRUDA, in addition to enabling biomarker exploration. The expansion cohorts will enroll patients with solid tumors who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or have a disease for which no standard of care exists, including patients with breast cancer, squamous cell carcinoma of the head and neck (SCCHN), and melanoma.

On July 16, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific (mAb2) antibodies, reported that further progress in its long-standing immuno-oncology collaboration with Merck KGaA, Darmstadt, Germany (Press release, F-star, JUL 16, 2020, View Source [SID1234561978]).

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Merck KGaA, Darmstadt, Germany has chosen to exercise early its option to license a preclinical program in the ongoing collaboration with F-star. Merck KGaA, Darmstadt, Germany will take over responsibility for future development and commercialization. This is the second license option exercised by Merck KGaA, Darmstadt, Germany who, in May 2019, brought the first program from the collaboration into its pipeline. An undisclosed option exercise payment has been made to F-star and Merck KGaA, Darmstadt, Germany will pay future success-based milestones and royalties on net sales resulting from the transaction.

The companies have also agreed to the licensing terms for the inclusion of two additional preclinical programs under the existing partnership. No financial terms related to the revised agreement are being disclosed.

Eliot Forster, CEO of F-star, said: "The continued success of our long-term collaboration with Merck KGaA, Darmstadt, Germany demonstrates the ability of our proprietary mAb2 antibody platform technology to produce multiple programs to overcome the current limitations of existing immuno-oncology therapies. We are thrilled that Merck KGaA, Darmstadt, Germany will take these new programs into its portfolio, while we continue to develop our pipeline of three clinical stage molecules that we believe have the potential to be best-in-class."

On July 16, 2020 MaaT Pharma reported the appointment of Claude Bertrand, PharmD, PhD, as an independent member to the company’s Board of Directors and welcomes John Weinberg, MD, as new Chief Medical Officer (Press release, MaaT Pharma, JUL 16, 2020, View Source [SID1234561975]). As an experienced executive in leading research and development efforts in senior positions at major international pharmaceutical companies such as Servier, Ipsen and AstraZeneca, Dr. Bertrand will provide his broad expertise in advancing novel therapeutics from discovery towards commercialization. Dr. Weinberg has over 25 years of experience in the pharmaceutical industry and will use his expertise in microbiome-based therapeutic development and immune-modulation to oversee MaaT Pharma’s clinical activities and direct clinical development strategies.

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"We are honored to add Dr. Bertrand to our Board, who brings with him decades of high-level leadership in pharmaceutical R&D, as we move towards late-stage development for our microbiome restoration therapeutics," said Hervé Affagard, co-founder and CEO of MaaT Pharma. "We also welcome John Weinberg to our leadership team. John has a proven track record of guiding and managing clinical development programs for microbiome therapeutics which will be critical as we accelerate the development of MaaT013 and expand our portfolio with our capsule formulation, MaaT033."

Dr. Bertrand commented on his appointment: "MaaT Pharma is pioneering an important approach to improving clinical outcomes in oncology through safe and effective microbiome-based biotherapeutics and has taken a leadership position in the rapidly evolving regulation and manufacturing of microbiome products. I look forward to working alongside my fellow board members to guide and support the development of the company and its exciting pipeline."

Dr. Weinberg stated: "I am convinced of the therapeutic potential of MaaT Pharma’s approach to restore the balance between the patient and their microbiome, especially in diseases in which immune modulation plays a key role; therefore, I am very excited to join as the company is poised to expand its therapeutic focus beyond hematological cancer indications. My goal is to define an innovative clinical development program and contribute to the continued growth of the pipeline."

Since 2017, Dr. Claude Betrand holds the position of Executive Vice President of R&D and Chief Scientific Officer at Servier, France’s largest independent pharmaceutical company, with a product portfolio addressing cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancer and diabetes. Prior to this, he served as Executive Vice-President of R&D at Ipsen Pharma for over seven years and as Global Senior Vice President for Respiratory & Inflammation Research Area at AstraZeneca for more than five years. His career also includes senior positions at Novartis, Roche, and Pfizer. Dr. Bertrand studied pharmacy and obtained his PharmD and PhD from Strasbourg University in immuno-pharmacology and neurogenic inflammation.

Prior to joining MaaT Pharma, Dr. John Weinberg held the position of Chief Medical Officer at the microbiome-focused company 4D Pharma PLC, where he was responsible for building and managing the clinical development program and initiating multiple Phase I/II studies. With more than 25 years in the pharmaceutical industry, he has held various senior positions at Veloxis Pharmaceuticals, Novartis Pharmaceuticals and Enzon Pharmaceuticals, gaining a breadth of international experience in clinical development of various oncology, hematology and transplantation therapeutics. Dr. Weinberg holds an MD from University of the Witwatersrand School of Medicine in Johannesburg, South Africa and an MBA from INSEAD in Fontainebleau, France.

On July 21, 2020 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second-quarter 2020 financial results on Thursday, July 30, 2020 after the financial markets close (Press release, Vertex Pharmaceuticals, JUL 16, 2020, View Source [SID1234561970]). The company will host a conference call and webcast at 5:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On July 16, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported the filing of the pivotal ENVASARC protocol with the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application (Press release, Tracon Pharmaceuticals, JUL 16, 2020, http://ir.traconpharma.com/news-releases/news-release-details/tracon-pharmaceuticals-announces-filing-protocol-envasarc [SID1234561969]). The application cross references the open envafolimab IND maintained by TRACON’s corporate partners 3D Medicines and Alphamab Oncology.

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TRACON previously reported results of a May 8 teleconference with the FDA whereby the agency agreed with TRACON’s proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS). TRACON expects to initiate enrollment in the ENVASARC trial at 25 sites in the U.S. in the second half of 2020.

ENVASARC Study Design

Key elements for the ENVASARC pivotal trial include:

Multi-center, open-label, randomized, non-comparative, parallel cohort study.
Eligible patients will have received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint.
Open-label format with blinded independent central review of efficacy endpoint data.
About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registrational trials. Envafolimab is currently dosing in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China. 3D Medicines and Alphamab Oncology, TRACON’s corporate partner for this program, plan to submit a BLA to NMPA in China for envafolimab in 2020 based on the ORR in MSI-H/dMMR advanced solid tumor patients. The confirmed ORR in MSI-H/dMMR colorectal cancer patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan reported at ASCO (Free ASCO Whitepaper) 2020 was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR colorectal cancer patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.