On 9 September 2021 ONK Therapeutics Ltd, an innovative NK cell therapy company, reported that the US Patent and Trademark Office (USPTO) has granted its licensed patent that covers CISH knockout (KO) in NK cells, irrespective of the source of the NK cells, including, for example, human cord blood-derived and human induced pluripotent stem cell (iPSC)-derived cells (Patent No. 11104735) (Press release, ONK Therapeutics, SEP 9, 2021, View Source [SID1234587484]).

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Earlier this year ONK entered into an exclusive global patent license agreement with Australia’s Walter and Eliza Hall Institute of Medical Research (WEHI) providing it rights to CISH KO in the field of human NK cells for the treatment of cancer, with the right to sublicence.

"We are excited to have this unparalleled opportunity to explore the potential of CISH KO in human NK cells. We believe this is the foundational patent, based on the earliest scientific discoveries which cover CISH KO NK cells from any source, and we intend to evaluate this edit in both umbilical cord blood and iPSC-derived NK cells," said ONK Therapeutics’ CEO Chris Nowers.

CISH KO has been shown to improve the persistence, metabolic profile, and cytotoxic potential of NK cells. While several other companies and academic centers are exploring the potential of a CISH KO on NK cells, the research team at WEHI, in 2015, was the first to show the critical role CIS, the protein encoded by CISH, plays in negatively regulating the function of NK cells.

Prof. Michael O’Dwyer, founder and CSO of ONK Therapeutics said, "Editing of NK cells to knock out CISH has the potential to improve the potency of the NK cell-based therapies and provide greater benefit to patients."

We are building an unrivaled and broad IP estate against multiple NK cell checkpoint receptors, including extracellular proteins CD96, TIGIT, Siglec-7 and PD-1 as part of our innovative strategy to engineer a highly differentiated NK cell therapy platform that has broad potential across both hematological malignancies and solid tumors."

WEHI’s Head of Biotechnology and Commercialisation Dr Anne-Laure Puaux said, "Cell-based therapies have demonstrated their enormous potential as disease-modifying therapies in oncology. By licensing our intellectual property to ONK Therapeutics we are supporting the opportunity to develop more potent cell-based therapies for the future benefit of cancer patients."

In addition to this granted CISH KO US patent, ONK Therapeutics has filed a US continuation patent application. Parallel filings are also under review in the EU by the European Patent Office (EPO) as well as in China, Japan, Australia and New Zealand, thus providing excellent coverage for the company’s commercial interests.

-Ends-

About CISH and the WEHI patent

CIS (encoded by the gene CISH) is a member of the suppressor of cytokine signaling (SOCS) family of proteins. When NK cells are stimulated with growth factors, such as interleukin 15 (IL-15), which encourage their growth, survival, and killing capability, there is an increase in the activity of CIS protein, which acts as a brake or checkpoint, on further NK cell growth and function.

The WEHI team found that when CIS was removed from NK cells by deleting the CISH gene, the NK cells were more responsive to growth factors and had improved survival and killing capacity(1). Improving the metabolic fitness of NK cells to enhance glycolysis and oxidative phosphorylation is important for optimizing the anti-tumor activity of NK cells, especially against solid tumors(2-3).

1. Delconte, R., Kolesnik, T., Dagley, L. et al. CIS is a potent checkpoint in NK cell–mediated tumor immunity. Nat Immunol 17, 816–824 (2016) View Source

2. Daher et al., Targeting a cytokine checkpoint enhances the fitness of armored cord blood CAR-NK cells Blood Sept 9, 2020

3. Zhu et al., Metabolic Reprograming via Deletion of CISH in Human iPSC-Derived NK Cells Promotes In Vivo Persistence and Enhances Anti-tumor Activity Cell Stem Cell Sept 3, 2020

On September 9, 2021 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in three virtual investor conferences in September 2021 (Press release, Fortress Biotech, SEP 9, 2021, View Source [SID1234587542]).

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Details of the events are as follows:

H.C. Wainwright 23rd Annual Global Investment Conference: The company’s presentation will be available for on-demand viewing on Fortress’ website beginning on Monday, September 13, 2021, at 7:00 a.m. ET and will remain available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the presentation. The company will participate in one-on-one meetings during the conference as well.
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: The company will present on Monday, September 20, 2021, at 2:55 p.m. ET and will participate in one-on-one meetings during the conference. A webcast of the presentation will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the meeting.
Cantor Global Healthcare Conference: The company will present on Tuesday, September 28, 2021, at 3:20 p.m. ET and will participate in one-on-one meetings during the conference. A webcast of the presentation will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the meeting.

On September 9, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will take part in two fireside chats, Baird’s 2021 Global Healthcare Conference, September 14-15 and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, September 20-23, 2021 (Press release, Cue Biopharma, SEP 9, 2021, View Source [SID1234608272]). Both conferences will be held virtually.

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During the fireside chats, Cue Biopharma will provide a data update highlighting its lead clinical program, CUE-101, representative of the IL-2 based CUE-100 series for the treatment of second line and beyond patients with HPV+ recurrent/metastatic head and neck cancer. The discussion will also focus on the Company’s latest developments and pipeline progress.

Presentation Details:
Baird’s 2021 Global Healthcare Conference
Date and Time: Tuesday, September 14, 3:45 – 4:15 p.m. EDT
The webcasted fireside chat will be hosted on the conference website and available only to conference participants. Please visit View Source for more information.

Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Date and Time: Wednesday, September 22, 1:15 – 1:55 p.m. EDT
A live and archived webcast of the fireside chat will be available on the Events page in the Investors and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

About Baird’s 2021 Global Healthcare Conference
Baird’s 2021 Global Healthcare Conference brings institutional and private equity investors together with senior management from over 100 public and privately held companies. The conference will feature companies across the following sectors: Biotechnology, Healthcare Supply Chain & Pharma Services, Healthcare Information Technology, Life Sciences & Diagnostics, Medical Technology and Facilities & Services.

About Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Oppenheimer & Co. Inc. hosts multiple conferences a year covering many different industries. These conferences bring together corporate leaders, financial sponsors and institutional investors to explore market and sector trends. September 20-22 will feature presentations and one-on-one meetings in a virtual format with a select group of public companies in the Healthcare Life Sciences and MedTech arena. Thursday, September 23 will be the Private Company Day within the Summit and will feature a select group of emerging biotechnology and life science private companies. Investors will have the opportunity to meet virtually with management teams to discuss in detail key therapeutic programs in development and recent corporate updates.

On September 9, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported it submitted a Patent Cooperation Treaty (PCT) application for the combination therapy of olinvacimab, the Company’s anti-VEGFR2 antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 antibody, for the treatment of cancer (Press release, PharmAbcine, SEP 9, 2021, View Source [SID1234649188]).

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The PCT application is an international application that preserves the priority date. The PCT is an international treaty that has over 150 Contracting States worldwide. It assists applicants in seeking patent protection internationally for their inventions, helps patent offices with their patent granting decisions, and facilitates public access to a wealth of technical information relating to those inventions.

The application, which was submitted jointly with MSD, is based on the Phase Ib olinvacimab and pembrolizumab combo trial in metastatic Triple-Negative Breast Cancer (mTNBC). According to the interim result presented at San Antonio Breast Cancer Symposium (SABCS) 2020, the combo therapy showed encouraging efficacy data, including 50% Overall Response Rate (ORR) and 67% Disease Control Rate (DCR) in the high-dose olinvacimab (16mg/kg) cohort (n=6pts).

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

Olinvacimab, an anti-VEGFR2 (Vascular Endothelial Growth Factor Receptor 2) fully human antibody, is the Company’s leading pipeline and is undergoing multiple global clinical trials. In early September 2021, PharmAbcine initiated a Phase II olinvacimab and pembrolizumab combo study for the treatment of mTNBC (metastatic Triple-Negative Breast Cancer) in Australia. Also, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients at multiple sites in both US and Australia and two Phase Ib olinvacimab and pembrolizumab combo trials in mTNBC and rGBM in Australia are still ongoing.

"Submission of this patent application will be our first step in securing the novelty of the combo therapy." said Dr. Jin-San Yoo, CEO of PharmAbcine. "We will move onto getting our patent secured in multiple countries with great needs for a cancer treatment."

On September 9, 2021 Anticancer Bioscience (ACB), pioneers in synthetic lethal approaches to precision oncology, reported its first granted US patent (11104633), entitled "cancer treatment using compounds that selectively target polyploid cancer cells for disruption", which was issued by the US Patent and Trademark Office (USPTO) on August 31 (Press release, Anticancer Bioscience, SEP 9, 2021, View Source [SID1234587452]).

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The method covered in this patent has been used to identify compounds that selectively kill polyploid cells, key to the discovery of inhibitors of MYC, overexpression of which occurs in over half of tumors, and is correlated with poorly differentiated and aggressive cancer.

Dun Yang PhD, Founder, President, and CEO of ACB, said: "The grant of our first patent in the USA is a key milestone and underlines our innovative approach to identifying first-in-class and best-in-class approaches for the treatment of cancer, using synthetic lethal approaches. It forms part of our growing patent estate with nine additional patents pending, covering both methods and composition of matter."

ACB is applying synthetic lethal approaches to develop targeted cancer therapies. These have the potential to be much safer and more effective than current therapies. ACB has access to world-leading cancer biology expertise and drug discovery platforms that enable the company to identify novel compounds that can target both genetic and epigenetic vulnerabilities of cancer cells. ACB has bespoke chemical compound libraries and has invested in developing one of the world’s largest natural product libraries, providing a rich screening resource for potential cancer therapeutics.

With five drug discovery programs, ACB is progressing rapidly through optimization to candidate selection toward IND enabling studies, with the aim of initiating two clinical trials in the USA in 2022.