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

On April 12, 2022 Trishula Therapeutics, Inc., a clinical stage, privately held company developing TTX-030, a first-in-class investigational anti-CD39 antibody in advanced cancers, reported preliminary results from an ongoing Phase 1 trial evaluating TTX-030 in combination with budigalimab (investigational anti-PD-1) and FOLFOX for the first-line treatment of patients with locally advanced/metastatic HER2 negative gastric or gastroesophageal junction cancer (Press release, Trishula Therapeutics, APR 12, 2022, View Source [SID1234612101]). Study results were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans. The data presented demonstrates that TTX-030 combination treatment was generally well-tolerated and showed encouraging signs of anti-tumor activity.

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"The response rates including in patients with PD-L1 low tumors seen in this preliminary analysis are very encouraging and support the potential of TTX-030 to impact the standard of care for patients with gastric and gastroesophageal cancer," said Zev Wainberg, M.D., Professor of Medicine at UCLA and co-director of the UCLA GI Oncology Program. "We look forward to the complete findings from this trial and the further advancement of this promising treatment approach."

Preliminary efficacy and safety results were presented as of an interim data cut of March 1, 2022. A total of 44 patients were enrolled. Twenty-six (26) patients were still on study treatment, and the median duration on study was 214 days (range 8-464+ days). Among 40 efficacy-evaluable patients, 21 patients (25 patients including unconfirmed) achieved best overall response of partial response or better including 4 CRs: ORR=52.5% (62,5% including unconfirmed), and disease-control rate = 92.5%. Thirty-seven (37) of the efficacy-evaluable patients had known PD-L1 Combined Positive Score (CPS); response rates in patients with CPS ≥1 were 65% (77% including unconfirmed).

Twenty-seven of 44 patients (61%) experienced at least one adverse event (AE) of any grade considered related to TTX-030 (investigator assessment), including 9 patients (20.5%) with Grade 3/4 AEs. Adverse events were overall consistent with those seen with standard-of-care (chemotherapy plus anti-PD-1).

"Our data highlighted at AACR (Free AACR Whitepaper) represents the first promising clinical findings of an anti–CD39 antibody in patients with gastric cancers and supports the role of TTX-030 in reversing adenosine-mediated immunosuppression," said Anil Singhal, Chief Executive Officer. "We look forward to the continued advancement of this clinical study of TTX-030, which we believe has the potential to significantly improve the treatment paradigm for cancer patients."

AACR Oral Presentation Details:

Title: Safety and efficacy of TTX-030, an anti-CD39 antibody, in combination with chemoimmunotherapy for the 1st line treatment of locally advanced or metastatic gastric/GEJ cancer.

Abstract Number: 8213

About TTX-030 Phase 1 Trial

The ongoing Phase 1 trial is evaluating TTX-030 in different treatment combinations in patients with advanced unresectable or metastatic cancer of the stomach or gastroesophageal junction with HER2-negative disease and no prior treatment for metastatic disease or adjuvant therapy within six months of enrollment. The primary endpoint is safety and tolerability with secondary endpoints of overall response (ORR) assessed using Response Evaluation criteria in Solid Tumors (RECIST/iRECIST) and progression free survival. Patients receive treatment with mFOLOFOX, Budigaglimab and TTX-330 030 on a 28-day cycle until disease progression.