On April 12, 2022 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and development in immuno-oncology, reported that the company has been granted a patent (Patent No. US 11,299,550 B2) on its anti-CD73 antibodies by the United States Patent and Trademark Office (USPTO) (Press release, Phanes Therapeutics, APR 12, 2022, View Source [SID1234612106]). The patent includes the invention of PT199, for which the company just received clearance from the US Food and Drug Administration to commence Phase I studies.

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PT199 is an anti-CD73 mAb with a differentiated mechanism of action and is designed to counter the adenosine-mediated immunosuppressive tumor microenvironment. PT199 fully inhibits both soluble and membrane-bound CD73, unlike some other CD73 inhibitors which exhibit incomplete inhibition. Moreover, at higher concentrations, no loss of inhibition or "hook effect" is observed with PT199. Hence, PT199 addresses the limitations of current CD73 inhibitors and is expected to increase antitumor immune activation, and potentially offer a new treatment option for cancer patients.

The multi-center Phase I clinical trial of PT199 is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT199 alone and in combination with a PD-1 inhibitor, in patients with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.

"This couldn’t have come at a better time," said Dr. Ming Wang, PhD, MBA, Founder and CEO of Phanes Therapeutics. "This will be a transformational year for Phanes as we expand from a research to a clinical stage organization. We expect to file two additional INDs in 2022, both first-in-class bispecific antibody programs, and anticipate receiving more issued patents."

On April 12, 2022 ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative ZielFind drug discovery platform, reported that it will present new, preclinical data on the efficacy of its ZB131 drug in cholangiocarcinoma (CCA) models at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, ZielBio, APR 12, 2022, View Source [SID1234612105]). The conference will take place April 8-13, 2022 in New Orleans and virtually. Dr. Lindsey Brinton, Head of Discovery at ZielBio, will present the data in a talk on Tuesday, April 12 at 3:05 in La Nouvelle Orleans C.

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The new preclinical research suggests that ZB131 is effective as a monotherapy in the treatment of CCA, a form of cancer which develops in the bile ducts. When used as a combination therapy with the standard-of-care chemotherapy drug, gemcitabine, ZB131 enhanced the chemotherapy’s anti-tumor effects.

CCA is a cancer with a high unmet need and a survival rate of <20% five years post-diagnosis. Most non-palliative patients relapse within two years and treatments in the advanced setting are limited. CCA tumors are characterized by high expression (>85%) of cancer specific plectin (CSP).

CSP is a pro-tumorigenic protein exclusively expressed on the surface of cancer cells. The common presence of CSP on the surface of CCA cells suggests that anti-CSP therapy may be effective in treating this form of cancer. ZB131 is a first-in-class humanized monoclonal antibody with a high affinity to and specificity for CSP.

In this study, ZB131 was administered as a monotherapy to mice inoculated with human CCA cells (CCA-xenografted mice). ZB131 significantly suppressed tumor growth in the majority of mice, and caused complete regression in 17% of mice. In another group of CCA-xenografted mice, ZB131 was administered in combination with the chemotherapy drug gemcitabine (100 mg/kg). In this group, ZB131 showed an increased tumor response (91% suppression) when compared to gemcitabine alone (74% suppression).

"These findings further confirm that ZB131, currently in Phase 1 clinical trials, presents an exciting possibility for the treatment of CCA and other CSP-positive cancers," said Dr. Kimberly Kelly, CEO of ZielBio. "ZB131 has shown strong antitumor activity in vitro and in mouse models. Additionally, it has demonstrated an excellent safety profile with no toxicities identified in GLP-enabling toxicology studies in non-human primates. We are eager to present these data with the AACR (Free AACR Whitepaper) community and to see what new data arises from our current Phase 1 clinical trial of ZB131."

On April 12, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported it will participate in the Virtual Investor Glioblastoma Multiforme (GBM) Spotlight event on Thursday, April 14th at 11:30 AM ET (Press release, CNS Pharmaceuticals, APR 12, 2022, View Source [SID1234612104]).

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For the spotlight event, John Climaco, CEO of CNS Pharmaceuticals will be joined by Key Opinion Leader Samuel A. Goldlust, MD, to discuss GBM, the unmet need and the work CNS Pharmaceuticals is doing to advance Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer.

Dr. Goldlust is a leading Neuro-Oncologist who currently serves as the Pitkin Chair in Neuro-Oncology and Medical Director of the Brain and Spine Institute, John Theurer Cancer Center and an investigator in the Company’s global potentially pivotal study of Berubicin.

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Anthracyclines, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents, are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center. The Company is currently conducting a potentially pivotal global study evaluating the efficacy and safety of Berubicin in the treatment of GBM.

A live video webcast of the presentation will be available on the Events page of the Investors section of the Company’s website (cnspharma.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On April 12, 2022 MediLink Therapeutics reported that YL201, the first compound based on MediLink’s proprietary antibody-drug conjugate (ADC) technology platform, has been cleared on its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its Phase I first-in-human study (Press release, Medilink, APR 12, 2022, View Source [SID1234612103]).

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YL201 uses a novel "TMALIN" (Tumor Microenviroment Activable Linker) ADC technology developed at MediLink Therapeutics to resolve potential ADC resistance and stability issues. Preclinical data demonstrated great efficacy of YL201 in various in vivo tumor models, such as non-small cell lung cancer, prostate cancer and esophageal squamous cell carcinoma, and furthermore YL201 shows good tolerability in non-human primates. The clearance of our first IND marks an important milestone for MediLink and brings novel treatment opportunity of this conjugate drug to global cancer patients.

On April 12, 2022 Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms, reported the presentation of data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in New Orleans, LA, taking place from April 8-13, 2022 (Press release, Shoreline Biosciences, APR 12, 2022, View Source [SID1234612102]). Shoreline presented two posters demonstrating its novel methodologies to produce clinical scale iPSC-derived iNK cells.

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Shoreline has developed a proprietary methodology to create differentiated iNK cells for large-scale, "off-the-shelf" production. Shoreline’s methodology supports the production of phenotypically and functionally mature iNK cells from both wildtype and genetically engineered iPSCs. In particular, the generation of iPSC-derived NK cells bearing a knock-out of the gene encoding cytokine-inducible SH2-containing protein (CISH) was described at the AACR (Free AACR Whitepaper) meeting. Shoreline’s CISH-KO iNK cells have demonstrated improved in vivo anti-tumor activity, persistence, metabolic fitness, and resistance to cell exhaustion.

To improve the targeting and potency of its iNK cells, Shoreline has also developed a proprietary Chimeric Antigen Receptor (CAR) screening platform to identify CARs that function optimally in NK cells. Compared to CARs developed for T cells and transferred into NK cells, Shoreline’s NK-optimized CARs yield significantly increased tumor killing activity.

"The presentations at AACR (Free AACR Whitepaper) 2022 on our CISH-KO iNK cells and natural killer-optimized CARs demonstrate our sophisticated expertise in iPSC differentiation, gene editing, and CAR-NK development. This technology is being applied to multiple therapeutic programs, and along with our partnerships with Kite and BeiGene, serves as the basis for our strong pipeline of novel cancer therapies," said Robert Hollingsworth, Ph.D., CSO of Shoreline. "Our differentiated approaches improve upon existing CAR-NK and CAR-T technologies, and we are continuing to optimize our cell therapies for potency, durability, and safety. We are excited to advance these therapies into clinical testing and eventually provide important new options for cancer patients."

Details of the Shoreline posters are below:

Title: "Development of an iPSC-derived NK cell screening platform for discovery of NK cell optimized Chimeric Antigen Receptors (CARs) for next-generation CAR-NK cell immunotherapies"
Session Title: Adoptive Cell Therapy 1
Session Date and Time: Sunday April 10, 2022 1:30 PM – 5:00 PM
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 36

Title: "A novel method to produce clinical scale induced pluripotent stem cell-derived natural killer (iPSC-NK) cells with improved anti-tumor activity for next-generation allogenic cell therapies"
Abstract Number: 4319
Session Title: Stem Cells and Regulatory Pathways in Cancer
Session Date and Time: Tuesday April 12, 2022 1:30 PM – 5:00 PM
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 12

Abstracts and full session details can be accessed through the AACR (Free AACR Whitepaper) meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2022 | April 8-13, 2022 | New Orleans