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Curocell announces Korean FDA clearance of the IND for CRC01, a first in kind immune checkpoint receptors downregulated CD19 CAR-T therapy

On February 22, 2021 Curocell, Inc., a clinical-stage biotech developing next-generation CAR-T (OVIS) therapies, reported that the Ministry of Food and Drug Safety (MFDS) of Korea has approved its Phase 1/2 clinical study application for CRC01, CD19 CAR-T cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma(DLBCL) (Press release, Curocell, FEB 22, 2021, View Source [SID1234575408]). This study is expected to be initiated in the first half of 2021.

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"We are excited to receive Korea’s first IND clearance for a CAR-T therapy," said Gunsoo Kim, CEO of Curocell. "OVIS is a unique CAR-T platform that combines CAR-T with immune checkpoint receptor inhibition. This unique technology can be a breakthrough for patients who are difficult to treat with conventional CD19 CAR-T."

About CRC01

CRC01, recognized CD19 and is based on OVIS, a first in class CAR-T platform co-developed with KAIST. OVIS downregulates PD1 and TIGIT in the same viral vector, designed to express a CAR protein, allowing cost-effective and simple manufacturing. Curocell holds the global development and commercial rights for CRC01 and OVIS.

Leap Therapeutics to Present at Upcoming Virtual Investor Conferences

On February 22, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that Douglas E. Onsi, President and Chief Executive Officer, will present a corporate overview at the following virtual investor conferences (Press release, Leap Therapeutics, FEB 22, 2021, View Source [SID1234575407]):

Raymond James 42nd Annual Institutional Investors Conference
Date: Monday, March 1
Presentation Time: 10 a.m. Eastern Time

H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, March 9 – Wednesday, March 10

The H.C. Wainwright presentation will be available on Tuesday, March 9, 2021 at 7:00 a.m. Eastern Time and may be accessed on the Investors page of the company’s website at View Source, and a live webcast of the Raymond James presentation can be accessed in the same section of the Company’s website. A replay of the events will also be available for a limited time.

Miravo Healthcare™ Announces Fourth Quarter 2020 Results Release Date and Conference Call Details

On February 22, 2021 Nuvo Pharmaceuticals Inc. (TSX: MRV) (OTCQX: MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported it expects to release its fourth quarter 2020 financial results before markets open on Monday, March 8, 2021 (Press release, Nuvo Pharmaceuticals, FEB 22, 2021, View Source [SID1234575406]).

The Company will subsequently hold a conference call the same day, Monday, March 8, 2021 at 11:00 a.m. ET, hosted by Jesse Ledger, Miravo’s President & Chief Executive Officer and other senior management. A question-and-answer session will follow the corporate update.

Therapeutic Solutions International Uses StemVacs™ Platform to Generate Personalized Adoptive T Cell Therapy Targeting Cancer Stem Cells

On February 22, 2021 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported today novel data and filing of a patent application demonstrating that StemVacs cells carrying proprietary sequences from the cancer-specific antigen Brother of the Regulator of Imprinted Sites (BORIS), were able to elicit the generation of T cells capable of selectively killing cancer stem cells (Press release, Therapeutics Solutions International, FEB 22, 2021, View Source [SID1234575405]).

In contrast to other markers associated with cancer, BORIS is not simply a "flag" that is recognized by the immune system, but it is essential for cancer to be cancer. Dr. Thomas Ichim, Board Member of the Company, published that gene silencing of BORIS resulted in the death of cancer cells.1 National Institutes of Health Scientist Dr. Dmitri Loukinov, as well as other collaborators, published with Dr. Ichim that DNA immunization with BORIS resulted in suppression of aggressive breast cancer,2 as well as induction of T cells capable of killing glioma, leukemia, and mastocytoma.3

"Despite living in what is called the Golden Age of Immunotherapy, the majority of cancers still do not undergo substantial responses to current treatments," said Dr. James Veltmeyer, Chief Medical Officer of the Company and co-inventor of the patent application. "What is impressive about the StemVacs approach is that it can generate personalized T cells that selectively seek and destroy cancer stem cells. It is the cancer stem cells that are the ‘roots’ of the cancer. They are resistant to chemotherapy and radiotherapy and to my knowledge the only possible way of eliminating cancer stem cells is through immunotherapy."

"Having worked in the area of cellular therapy and vaccine development, the possibility of using an allogeneic dendritic cell-based approach to ex vivo generate cancer stem cell killing T effector cells is tantalizing," said Feng Lin, MD, Ph.D., Chief Scientific Officer of the Company. "I look forward to continuation of these studies and eventual clinical utilization."

Researchers believe current cancer treatments sometimes fail because they don’t destroy the cancer stem cells. Think of cancer as a weed: the stem cells are the root while the remaining majority of the cells are the part of the weed above ground. If you remove only the leaves but not the root, the weed will grow back. The same is true for cancer: if you do not kill the cancer stem cells, the cancer is likely to return.4

"Cellular therapy is the future of medicine," said Famela Ramos, Vice President of Business Development of the Company and co-inventor of the patent. "This demonstration that StemVacs can generate "patient specific" killer cells that can be reinfused in patients offers a new area of product development for us, as well as an ability to implement a two-punch attack on the tumor."

"At Therapeutic Solutions International we are focused on researching, patenting, and implementing the most innovative and potentially effective immunotherapies we can develop," said Timothy Dixon, President and CEO of the Company and co-inventor of the patent. "The ability to generate tailor-made killer T cells that appear to selectively target cancer stem cells provides yet another complementary cellular immunotherapy in our growing armamentarium against this terrible disease."

ESSA Pharma Announces Closing of $130 Million Public Offering of Common Stock

On February 22, 2021 ESSA Pharma Inc. ("ESSA", or the "Company") (Nasdaq: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the closing of an underwritten public offering of 4,830,918 of its common shares at a public offering price of $27.00 per share before underwriting discounts (the "Offering") (Press release, ESSA, FEB 22, 2021, View Source [SID1234575404]). ESSA granted the underwriters a 30-day option to purchase up to an additional 724,637 common shares. The gross proceeds from the Offering were approximately $130 million.

ESSA intends to use the net proceeds from the Offering to fund clinical activities, chemistry, manufacturing and controls, and research and development, as well as working capital and general corporate purposes. Clinical activities include supporting multiple combination studies with EPI-7386 and anti-androgens, a Phase 2 clinical study, and preparatory work on a Phase 3 confirmatory study.

Jefferies and Piper Sandler acted as joint book-running managers for the Offering. Oppenheimer & Co. acted as lead manager for the Offering and Bloom Burton Securities Inc. acted as co-manager for the Offering.

The securities described above were offered by ESSA in the United States pursuant to a shelf registration statement on Form S-3 (File No. 333-250971) that was previously filed by ESSA with the Securities and Exchange Commission (the "SEC") and became effective on December 29, 2020 and in Canada pursuant to ESSA’s Canadian short form base shelf prospectus (the "Canadian Base Shelf Prospectus") dated August 24, 2020 that was previously filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario.

A preliminary prospectus supplement related to the Offering was filed with the SEC on February 16, 2021, and a final prospectus supplement related to the Offering was filed with the SEC on February 18, 2021, and each are available on the SEC’s website at View Source A preliminary prospectus supplement to ESSA’s Canadian Base Shelf Prospectus was also filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario on February 16, 2021 and is available at View Source and a final prospectus related to the Offering was filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario on February 18, 2021 and is available at View Source.

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