ITI’s CEO to Present at the 2nd Annual Glioblastoma Drug Development Summit

On December 1, 2020 Immunomic Therapeutics, Inc. (ITI) reported that it will be presenting at the 2nd Annual Glioblastoma Drug Development Virtual Summit (Press release, Immunomic Therapeutics, DEC 1, 2020, View Source [SID1234572023]). On Wednesday, December 9th, Chief Executive Officer at ITI, Dr. Bill Hearl, will be presenting a talk titled, "Adaptive T-cell Immunotherapy for Newly Diagnosed Glioblastoma: Using Targeted Antigen Presentation to Enhance Immune Responses." Dr. Hearl will discuss ITI’s investigational platform technology, the company’s lead program and its preliminary data in GBM, as well as the company’s future focus.

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Presentation details are as follows:

Title: Adaptive T-cell Immunotherapy for Newly Diagnosed Glioblastoma: Using Targeted Antigen Presentation to Enhance Immune Responses

Presentation Category: Vaccines

Date and Time: Wednesday, December 9, 2020 12:40 PM EST / 9:40 AM PDT

Location: Virtual Summit

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1, an endogenous protein in humans, for immune processing. 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 puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial 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 LAMP1 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.

Anixa Biosciences Announces Licensing Agreement with Cleveland Clinic for Ovarian Cancer Vaccine Technology

On December 1, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that it has entered into a license agreement with Cleveland Clinic for exclusive, world-wide rights to an innovative ovarian cancer vaccine technology (Press release, Anixa Biosciences, DEC 1, 2020, View Source [SID1234572022]).

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Cleveland Clinic immunologist Dr. Vincent Tuohy has been working on a method to vaccinate women against ovarian cancer and other gynecological malignancies. This development-stage vaccine targets the extracellular domain of anti-mullerian hormone receptor 2 (AMHR2-ED), that appears in many types of ovarian cancer. AMHR2-ED is one of several proteins identified by Dr. Tuohy as "retired" proteins. While these proteins are necessary during the early stages of life, they are "retired" as a person ages, and are no longer expressed, or made at appreciable levels, in healthy adults. AMHR2-ED re-appears in cancerous cells and accordingly, it is an attractive target for vaccination.

Anixa and Cleveland Clinic are already collaborating on a preventative breast cancer vaccine also developed by Dr. Tuohy based on his research into "retired" proteins. The organizations plan to begin human trials with the breast cancer vaccine in early 2021.

"Through this collaboration we are expanding into additional preventive and therapeutic areas and we look forward to seeing the development of this ovarian cancer vaccine," said Dr. Tuohy. "Research into cancer therapies has typically focused on attacking the disease after a patient has been diagnosed, but if we could immunize people to prevent the cancer from ever forming, it could represent a paradigm shift for patients, their caregivers and the healthcare system."

"We are pleased to broaden our relationship and to expand our work with Dr. Tuohy," stated Amit Kumar, Ph.D., President and Chief Executive Officer of Anixa. "Though it is still early days for the experimental ovarian cancer vaccine, pre-clinical research suggests the potential of this technology as both a prophylactic that prevents the occurrence of cancer, and a therapeutic that treats women with ovarian cancer."

Dr. Kumar added, "Anixa’s goal is to present patients that have limited treatment options with meaningful new therapeutic and prophylactic alternatives. We see this vaccine as a complementary component to our growing immuno-oncology portfolio, which includes a CAR-T therapy targeting ovarian cancer, for which we anticipate filing an IND shortly."

Conference Call Information:
Anixa will host a conference call and live audio webcast Thursday, December 3, 2020, at 1:15 p.m. PST. Interested parties may access the conference call by dialing:

An audio webcast will be accessible via the Investors section of the Anixa website: View Source An archive of the webcast will remain available for 30 days after the call.

Case-Coulter Translational Research Partnership awards $1.1 million in funding and support for promising biomedical engineering university technologies

On December 1, 2020 The Case-Coulter Translational Research Partnership (CCTRP) reported that it has announced more than $1.1 million in funding and other support for six biomedical technologies (Press release, Case Western Reserve University, DEC 1, 2020, View Source [SID1234572021]).

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The six Case Western Reserve projects were selected for full program funding, which ranges from $50,000 to $200,000 each. Several additional pilot projects have or will be awarded funding by the end of the year. All projects are partnerships between a clinician and a biomedical engineer, and are focused on solving areas of unmet healthcare needs.

The 14-year-old program—a collaboration between Case Western Reserve University and the Wallace H. Coulter Foundation—provides direct funding and support services to help campus research teams advance products from their laboratories to the marketplace, where they can improve patient care.

Funding supports steps involved in preparing projects for potential commercialization, such as demonstrating technical feasibility, analyzing the business opportunity and assessing market feasibility. Projects must have the potential to advance to a commercial entity within 12 to 30 months.

More than two-dozen companies have emerged from the partnership’s support, and licensing arrangements have enabled three-dozen technologies to reach patients. For each dollar the partnership has invested, the projects have garnered an additional $25 of investment.

"The Case-Coulter Translational Research Partnership continues to be a cornerstone, filling an essential gap to transition university biomedical technologies from research to products, where they can significantly improve the health of our society," said Robert Kirsch, the Allen H. and Constance T. Ford Professor and chair of the university’s Department of Biomedical Engineering.

"As a group, the quality of the evaluated technologies continues to improve each year, demonstrating the robustness of the biomedical research-based technology pipeline," said Stephen Fening, CCTRP director. "We had many more proposals that were deserving of inclusion into the program than we were able to accommodate, making the selection process more challenging than ever."

The six projects selected and their inventors are:

10-liter Scale Production of BG34-200 Immunotherapeutic Under cGMP Guidelines
Mei Zhang, assistant professor of biomedical engineering, and Alex Huang, professor of pediatrics and pathology.

A significant portion of patients with solid tumor cancers do not respond to immunotherapies due to a lack of T-cell-inflamed tumor microenvironment. This novel plant-derived non-toxic BG34-200 molecule can be intravenously injected to modulate macrophages and create a tumor microenvironment that is vital for the generation of antitumor T-cell responses. The team is launching a clinical trial targeting canine metastatic osteosarcoma to collect key and gap data in preparation for a first human clinical trial targeting pediatric osteosarcoma.

Drug-Free Targeted Prostate Cancer Treatment with TNT – Targeted Nanobubble Therapy
Agata Exner, professor of radiology and biomedical engineering, Jim Basilion, professor of radiology and biomedical engineering, and Lee Ponsky, professor of urology

Drug-free, low-toxicity prostate cancer treatment using nanobubbles (NBs) are targeted to the prostate specific membrane antigen (PSMA) biomarker overexpressed on prostate tumor cells. The nanobubbles are injected into the bloodstream and specifically seek out only the cancer cells. Once inside the target cell, the NBs remain trapped and can be excited with an ultrasound pulse. Exposure to ultrasound results in collapse of the bubbles, leading to a highly focused mechanical disruption of the cancer cells and cell death. The approach, which we call TNT (targeted nanobubble therapy) can fit into the existing clinical work-flow and can be carried out with standard clinical ultrasound equipment. TNT can treat tumors without severe side effects, as it will be effective only when NBs are sonicated and will destroy only the cancer cells and not the surrounding healthy cells.

TraumaChek: A Field-deployable Dielectric Coagulometer for Comprehensive Assessment of Trauma-induced Coagulopathy
Anirban Sen Gupta, professor of biomedical engineering, Pedram Mohseni, professor of electrical engineering and biomedical engineering, and Sanjay Ahuja, professor of pediatrics

TraumaChek is a multichannel, handheld blood-coagulation analyzer for early, rapid and comprehensive assessment of trauma-induced coagulopathy. It is designed to guide hemorrhage control, transfusion and resuscitative management of trauma at the point-of-injury by first responders and at the point-of-care by hospital clinicians.

Minimally Invasive Interfascicular Nerve Stimulation (MiiNS) System for Chronic Pain Management
Dustin Tyler, the Kent H. Smith Professor of Biomedical Engineering, Emily Graczyk, research assistant professor of biomedical engineering, and Jennifer Sweet, professor of neurological surgery

This is a drug-free technology to provide targeted, comfortable, worry-free relief to people suffering from long-term pain. The discomfort and emotional stress from pain affects a person’s activity, sleep and ability to live a healthy life, leading to other serious health problems. Their Minimally Invasive Interfascicular Nerve Stimulation (MiiNS) technology provides a targeted, personally customized and comfortable treatment without side effects, addiction or surgical procedures. MiiNS can be implanted by a doctor during a simple office visit to provide long-lasting pain relief.

BAFF CAR-NK Cells for Therapy of B Cell Malignancies
Reshmi Parameswaran, assistant professor of medicine, and Pallavi Tiwari, assistant professor of biomedical engineering

BAFF CAR-­NK cells can specifically kill B cell cancers in a very effective manner with minimum side effects. This is a potential curative therapeutic strategy for patients who are not responding to current treatment methods.

PhotoSorb: Safe and Long-lasting Sunscreen
Vijay Krishna, assistant staff in Cleveland Clinic’s Department of Biomedical Engineering, and Edward Maytin, staff in Cleveland Clinic’s Department of Dermatology

Every year, more than a million new cases of skin cancer, including melanoma, are diagnosed in the United States. The primary cause is exposure to ultraviolet radiation (UV) from sunlight. Sunscreens can block UV, but increasing concerns about the health and environmental risks of chemical sunscreens now on the market underscores an urgent need for safer, more effective alternatives. A team from biomedical engineering and dermatology at Cleveland Clinic is developing a novel sunscreen (PhotoSorb) that appears to be safer and more stable than current sunscreens, and also has the potential to actually prevent skin cancers.

Regulus Therapeutics Announces Private Placement of Equity

On December 1, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that it has entered into a definitive securities purchase agreement in connection with a private placement to existing institutional and other accredited investors as well as new institutional investors (Press release, Regulus, DEC 1, 2020, View Source [SID1234572020]). Upon the closing of the financing, which is anticipated to occur on December 3, 2020, the Company expects to receive gross proceeds of approximately $19.4 million, not including any proceeds that may be received upon exercise of warrants. The closing of the financing is subject to customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the financing.

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Under the securities purchase agreement, the investors have agreed to purchase approximately 24.3 million shares of the Company’s Common Stock ("Common Stock") and accompanying warrants to purchase up to an aggregate of approximately 18.2 million shares of Common Stock, at a combined purchase price of $0.7158 per share and accompanying warrant to purchase 0.75 of a share of Common Stock, except that the price per share for executive officers and directors participating as investors in the financing is $0.7239 per share and accompanying warrant to purchase 0.75 of a share of Common Stock. Certain investors have also agreed to purchase, in lieu of shares of Common Stock, an aggregate of approximately 272,970 shares of non-voting Class A-3 convertible preferred stock at a price of $6.22 per share, and accompanying warrants to purchase an aggregate of up to approximately 2.0 million shares of Common Stock at a price of $0.125 for each share of Common Stock underlying the warrants. Each share of non-voting Class A-3 convertible preferred stock will be convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The warrants will be exercisable for a period of five years following the date of issuance and will have an exercise price of $0.7464 per share, subject to proportional adjustments in the event of stock splits or combinations or similar events. The closing is expected to occur on December 3, 2020, subject to customary closing conditions.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

Sierra Oncology to Host KOL Panel Event to Discuss Updated Phase 3 Myelofibrosis Data Presented at ASH

On December 1, 2020 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported it will host an analyst and investor event on Wednesday, December 16, 2020 at 10:00 am ET (Press release, Sierra Oncology, DEC 1, 2020, View Source [SID1234572014]). The event will feature three leading myelofibrosis experts:

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Jean-Jacques Kiladjian, MD, PhD, Saint-Louis Hospital; Paris Diderot University
Ruben Mesa, MD, Director of the Mays Cancer Center, home to UT Health San Antonio, MD Anderson Cancer Center
Srdan Verstovsek, MD, PhD, University of Texas; MD Anderson Cancer Center
The call will include an overview of momelotinib data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, a panel discussion moderated by Barbara Klencke, MD, Chief Development Officer of Sierra Oncology, and an open question & answer session with attendees.

Analyst & Investor Event and Webcast Information

Date and Time: Wednesday, December 16, 2020, 10:00 am ET

To register, please click here.

The presentation will be webcast live, and an archive of the presentation will be accessible after the event through the Sierra Oncology website: www.SierraOncology.com.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 inhibitor currently under investigation for the treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is driven by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. Top-line data are anticipated in H1 2022. The U.S. Food & Drug Administration has granted Fast Track designation for momelotinib.