On June 7, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in therapeutic monoclonal antibody space reported their Phase I Clinical Data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in Chicago in a poster presentation (Press release, Nascent Biotech, JUN 7, 2023, View Source [SID1234632563]). The abstract may be viewed on the Company web site here. The data is also available at View Source

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"The presentation displayed our Phase I data, which included our safety data at various dose cohorts and early outcomes data, was well received and viewed by interested parties at the conference. In summary, it showed the drug to be very safe at 5 ascending dose cohorts and definitive bioactivity in several patients," stated Dr. Mini Gill who presented for the Company.

Nascent Biotech therapeutic antibody Pritumumab (PTB) is a natural human antibody. This monoclonal antibody targets cell surface Vimentin (ectodomain vimentin), shown to be expressed on the surface of epithelial cancers. PTB is a targeted immunotherapy that binds to the tumor via cell surface vimentin and recruits the host immune system to eliminate cancer cells.

On June 7, 2023 NanOlogy LLC, a clinical-stage oncology company, reported a presentation of clinical research involving its large surface area microparticle (LSAM) investigational drugs at DDW 2023 in May and publication at ASCO (Free ASCO Whitepaper) Annual Meeting in June (Press release, NanOlogy, JUN 7, 2023, View Source;utm_medium=rss&utm_campaign=nanology-presents-clinical-research-at-2023-ddw-and-asco-involving-its-large-surface-area-microparticle-investigational-drugs [SID1234632562]).

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The DDW poster entitled "Intracystic Injection of Large Surface Area Microparticle Paclitaxel (LSAM-PTX) for Chemoablation of Intraductal Papillary Mucinous Neoplasms: Insights from an Expanded Access Protocol," was presented by the research team of Somashekar Krishna, MD of The Ohio State University Wexner Medical Center. Dr. Krishna, a global expert in the treatment of mucinous pancreatic neoplasms, was a clinical investigator and author of published results (Endosc Int Open 2022) of an earlier clinical trial of intracystic LSAM-PTX in pancreatic cysts. The expanded access protocol prospectively evaluated safety and response of six subjects from the trial who received additional doses of LSAM-PTX. "In this protocol, intracystic LSAM-PTX was safe and resulted in cyst volume and surface area reduction, morphological changes, and loss of pathogenic mutations," said Dr. Krishna. "Further clinical research is warranted particularly in nonsurgical high-risk cyst patients because of the lack of approved treatments to decrease risk for progression to pancreatic cancer."

The ASCO (Free ASCO Whitepaper) abstract (e15187) entitled "Safety of locally administered large surface area microparticle paclitaxel (LSAM-PTX) and docetaxel (LSAM-DTX) in combination with standard of care therapies," was accepted for publication in the ASCO (Free ASCO Whitepaper) annual meeting library. The abstract, authored by Shelagh Verco, PhD, Holly Maulhardt, and other NanOlogy researchers, reviews the safety of both investigational drugs in combination with SOC therapies including various chemotherapies, immune checkpoint inhibitors, and/or radiation across 7 clinical trials totaling 156 patients. The review concluded that local treatment of solid tumors with LSAM-PTX or LSAM-DTX has the potential to overcome some limitations of SOC therapies by increasing tumor dwell time and reducing systemic toxicities which are often exacerbated in combinatorial treatment regimens.

On June 7, 2023 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors, reported that members of its senior management team will participate in the Goldman Sachs 44th Annual Global Healthcare Conference on Wednesday, June 14 at 2:00pm PT (Press release, Lyell Immunopharma, JUN 7, 2023, View Source [SID1234632561]).

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A live webcast of the fireside chat can be accessed through the investor relations section of the Company’s website at www.lyell.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 90 days following the presentation date.

On June 7, 2023 Fate Therapeutics, Inc. (the "Company") reported that it will present at the 2023 Jefferies Healthcare Conference. The presentation will provide a business update, including a regulatory and clinical update on its FT522 program (Press release, Fate Therapeutics, JUN 7, 2023, View Source [SID1234632559]).

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The Company previously disclosed on May 3, 2023 that it had submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to investigate the safety and activity of FT522 in combination with CD20-targeted monoclonal antibody therapy in patients with relapsed / refractory B-cell lymphoma. The Company’s IND application has been allowed by the FDA, and the Company is currently conducting study start-up activities at multiple clinical sites.

The dose-escalating Phase 1 clinical trial is designed to assess a three-dose schedule of FT522 in each of two regimens:

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Regimen A – up to two treatment cycles, with each treatment cycle consisting of conditioning chemotherapy, a single dose of rituximab, and three doses of FT522.
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Regimen B – up to two treatment cycles, with each treatment cycle consisting of a single dose of rituximab and three doses of FT522 (without conditioning chemotherapy).
Patient enrollment into Regimen A will commence utilizing a three-dose schedule of FT522 at 300 million cells per dose. Subject to clearance of dose-limiting toxicities at this initial dose level of Regimen A, patient enrollment into Regimen B will then commence utilizing a three-dose schedule of FT522 at 300 million cells per dose. Dose escalation of each regimen may proceed independently.

On June 7, 2023 EpicentRx, Inc. ("EpicentRx"), a leading-edge, clinical-stage biopharmaceutical company, reported clinical progress updates for two lead oncology treatment candidates, RRx-001 and AdAPT-001, at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 2-6, 2023, in Chicago, IL and virtually (Press release, EpicentRx, JUN 7, 2023, View Source [SID1234632558]).

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The company presented study design details for the Phase 2b KEVLARx study of RRx-001, which received FDA Fast Track designation for the treatment of severe oral mucositis based on data from the previous Phase 2a PREVLAR study. The company also presented promising first-in-human data for its transforming growth factor beta (TGFβ) trap vector, AdAPT-001.

"What patients need is not the ‘same old, same old’ but potentially well-tolerated, novel therapies like RRx-001 and AdAPT-001 that work differently to harm diseases, not the patients with these diseases," said Tony Reid, Chief Executive Officer of EpicentRx. "With a growing body of data and our recent FDA Fast Track Designation of RRx-001 and positive Phase 1 data for AdAPT-001, EpicentRx is well positioned to move our pipeline forward and demonstrate success in additional disease indications."

RRx-001 UPDATES

Following the positive announcement of the Phase 2a PREVLAR study, EpicentRx received U.S. Food and Drug Administration (FDA) Fast Track designation, which expedites the development and review process for RRx-001. The FDA also gave regulatory approval for the company to initiate a follow-on, multicenter, randomized Phase 2b study of RRx-001. Details about this study, called KEVLARx, were provided today at ASCO (Free ASCO Whitepaper) (Abstract 416822). Data from the previous PREVLAR trial showed that pretreatment with only 4 doses of RRx-001, prior to the start of chemotherapy and radiation, which is easy and convenient for both physicians and patients, delayed the onset, lessened the severity, and shortened the duration of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer.

RRx-001 is a small molecule inflammasome NLRP3/KEAP1 inhibitor with tumor-targeted cytotoxicity and healthy tissue cytoprotective properties being developed as a companion therapy to current oncology treatments. The protective properties of RRx-001 have been demonstrated with irinotecan, cisplatin, carboplatin, and etoposide treatment in solid tumors in Phase 2 studies.

AdAPT-001 IMMUNOTHERAPY UPDATES

EpicentRx also presented data from the first-in-human (FIH) trial of AdAPT-001, which carries a TGF-β trap that binds to and eliminates the pathologic cytokine, TGF-β, in tumors. Data from this FIH trial showed that AdAPT-001 (Abstract 2550) is well tolerated with promising single agent activity that includes 3 partial responses, and 5 patients with prolonged stable disease of 6 months or more.