Pascal Biosciences and S?RSE Technology Announce Partnership for Cannabinoid Drug Development and Cancer Clinical Trials

On September 14, 2020 Pascal Biosciences Inc. (TSX.V:PAS) ("Pascal") and SōRSE Technology Corporation ("SōRSE") reported that they have entered into a Collaborative Research Agreement (the "Agreement") to advance Pascal’s PAS-393 into clinical testing (Press release, Pascal Biosciences, SEP 14, 2020, View Source [SID1234565089]). Pascal and SōRSE will share their respective technologies to test the cannabinoid PAS-393 in human volunteers, enabling testing of cancer patients treated with checkpoint inhibitors.

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As initially announced last March, this partnership leverages SōRSE’s industry-leading formulation technology with Pascal’s proprietary cannabinoid programs for clinical trials. This will be the first pharmaceutical use of the novel formulation technology developed by SōRSE. The Agreement will include Pascal’s intellectual property, which covers the use of cannabinoids in cancer patients treated with checkpoint inhibitors.

SōRSE currently sells and licenses a proprietary water-soluble cannabinoid emulsion technology (patent-pending) that enables increased bioavailability, accurate dosing, and more than 12 months’ shelf stability. Pascal and SōRSE scientists will optimize a cannabinoid formulation for human subjects and will then test the formulated PAS-393 in volunteers. SōRSE will provide US$750,000 in research funding to Pascal throughout the 15-month collaboration and will pay for related research expenditures.

Following characterization of safety and pharmacology in a Phase 1a clinical trial, Pascal and SōRSE may elect to continue clinical development as equal partners in a Phase 1b cancer trial in combination with a checkpoint inhibitor. Dr. Gray will present scientific data this September 16th at the 3rd Annual International Cannabinoid-Derived Pharmaceutical Conference occurring in Boston, MA; the topic of his presentation is "Identifying and Validating Mechanism of Action In vivo/vitro."

"This is an impressive step forward for both Pascal and SōRSE, and hopefully our product will be a significant help to patients," commented Dr. Patrick Gray, CEO of Pascal. "This will be the first clinical trial for each company, and we look forward to a long, fruitful relationship."

"At SōRSE, we’re driven by our mission to help people better their lives through superior cannabinoid ingredients and delivery methods," said SōRSE CEO Howard Lee. "We were thrilled when Pascal reached out to us in the summer of 2019 asking to use our emulsion in their research study on immune recognition markers on cancer cells. Today, we are excited to continue to support pharmaceutical studies of cannabinoids with Pascal and other world-class researchers."

SōRSE intends to collaborate with other researchers and product developers to study cannabinoids in other medical applications. Pascal will continue to pursue other non-cancer indications for PAS-393.

ORPHELIA Pharma will attend and support the annual SIOP Congress 2020

On September 14, 2020 ORPHELIA Pharma reported that it will support and attend the upcoming SIOP Congress from October 14th to 17th (52nd Congress of the International Society of Paediatric Oncology), which will be virtual this year (Press release, ORPHELIA Pharma, SEP 14, 2020, View Source [SID1234565088]).

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This event aims to bring together the oncology community and share the latest advances in pediatric oncology.

Join the ORPHELIA Pharma virtual symposium to share on innovation in the use of temozolomide in children, which will take place on Friday October 16th between 9:15 AM and 9:35 AM (Ottawa time) by logging on to the SIOP website (SIOP-Congress.org).

Navrogen Awarded National Cancer Institute Grant to Develop Next-Generation Rituximab With Enhanced Therapeutic Effects

On September 14, 2020 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, reported that it has been awarded a National Cancer Institute (NCI) R03 Grant to support its NAV-006 program involving the development of a next-generation rituximab that is refractory to the immuno-suppressive effects of the tumor microenvironment (Press release, Navrogen, SEP 14, 2020, View Source [SID1234565087]).

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Follicular lymphoma (FL) is characterized by proliferation of neoplastic B cells, with 15,000 new cases a year in the USA. CD20 is a protein expressed on malignant FL cells and is the target of the commercially approved monoclonal antibody, rituximab. Rituximab markedly improves progression-free survival and overall survival of FL patients. However, studies have shown that some patients have an immune-suppressed tumor microenvironment that reduces the efficacy of rituximab treatment.

Navrogen has employed its proprietary Humoral Immuno Oncology (HIO) technology to identify the factors reducing rituximab’s therapeutic effects against immuno-suppressed tumors. Navrogen will utilize the NCI grant support (1R03CA241784) to apply its block-removed immunoglobulin technology (BRITE) to create a next-generation rituximab that is refractory to the immuno-suppressive effects of the tumor microenvironment.

"I am delighted by the NCI’s endorsement of the NAV-006 program" said Dr. Luigi Grasso, Ph.D., co-founder and Chief Scientific Officer of Navrogen. "Humoral Immuno Oncology (HIO) is an understudied field and it is encouraging that the scientists in the peer-review panel who reviewed our proposal understood the significance of our discovery and the solutions that we have planned to deploy."

Navrogen will complete the tasks outlined in the awarded grant, and upon successful optimization will seek strategic partners to support later stages of development of the HIO-refractory rituximab.

Monopar Therapeutics to Present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 16, 2020

On September 14, 2020 Monopar Therapeutics Inc. (Nasdaq: MNPR) reported that Chandler D. Robinson, MD, Chief Executive Officer, will present a corporate update at the H.C. Wainwright 22nd Annual Global Investment Conference, Healthcare & Biotech Track (Press release, Monopar Therapeutics, SEP 14, 2020, https://ir.monopartx.com/news/detail/18/monopar-therapeutics-to-present-at-the-h-c-wainwright-22nd-annual-global-investment-conference-on-september-16-2020 [SID1234565086]). The conference will be held virtually.

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Presentation Details:

Date: Wednesday, September 16, 2020

Time: 1:30 PM EDT

Location: Virtual

View Source

For more information, please contact investor relations at [email protected].

ITI to Participate at World Vaccine Congress Washington 2020

On September 14, 2020 Immunomic Therapeutics, Inc. (ITI) reported that it will participate at the World Vaccine Congress Washington being held virtually September 28-October 1, 2020 (Press release, Immunomic Therapeutics, SEP 14, 2020, View Source [SID1234565085]). Andrew Eisen, MD, Ph.D., Immunomic’s Vice President of Clinical Development, will present a talk titled, "Pharmacodynamic Imaging in a CMV Vaccine Trial for Glioblastoma."

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In addition, Immunomic Therapeutics, lead founder and supporter of Why We Vax, a non-profit whose mission is to help educate communities with research backed facts on vaccines, will be leading a Q&A panel titled, "What If They Gave a COVID-19 Vaccine and Nobody Came," at 3:50pm EST on October 1, 2020.

"Vaccines are one of the safest, most widely-adopted health care practices in the world. Why We Vax will spread the message that vaccines are rigorously tested and provide the best defense against diseases. One example is Measles, which can have a lasting impact on a child’s immune system," said Dr. William Hearl, Why We Vax Chairman, Immunomic Therapeutics CEO, and experienced vaccinologist.

The World Vaccine Congress Washington is a multi-faceted conference experience with over 300 industry leading speakers, exclusive interviews, world leading presentations, live panel debates, and virtual face to face meetings.
Presentation details are as follows:

Dr. Andrew Eisen Presentation
Title: Pharmacodynamic Imaging In A CMV Vaccine Trial For GBM
Panel Category: Cancer and Immunotherapy Track
Panel Date and Time: Wednesday, September 30, 2020 2:30PM

Why We Vax Q&A Panel
Title: What If They Gave a COVID-19 Vaccine and Nobody Came
Category: Vaccine Safety track: Risk Assessment & Communication of Safety
Date and Time: Thursday, October 1, 2020 3:50PM

About UNITE
ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

About ITI-1000 and the Phase 2 (ATTAC-II) Study
ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improves survival. This study is enrolling up to 120 subjects at 3 clinical sites in the United States. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.