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.

On June 7, 2023 Eagle Pharmaceuticals presented its corporate presentation (Presentation, Eagle Pharmaceuticals, JUN 7, 2023, View Source [SID1234632554]).

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On June 7, 2023 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a global clinical-stage biopharmaceutical company focused on using a groundbreaking technology platform for drug discovery and developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs, reported new data from a Phase 1 investigator initiated study highlighting a reduction in chemotherapy-induced infectious neutropenic fever with lead asset Plinabulin in combination with pegfilgrastim in multiple myeloma (MM) patients who underwent autologous hematopoietic stem cell transplantation (AHCT) and received a high dose of melphalan, a type of chemotherapy and one of the most active treatments for MM (NCT05130827) (Press release, BeyondSpring Pharmaceuticals, JUN 7, 2023, View Source;utm_medium=rss&utm_campaign=beyondspring-and-leading-cancer-center-present-poster-highlighting-plinabulins-ability-to-reduce-infectious-neutropenic-fever-for-multiple-myeloma-patients-undergoing-ahct [SID1234632552]). BeyondSpring and Memorial Sloan Kettering Cancer Center (MSK) presented the data at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Between January 2022 and February 2023, 15 patients with a median age of 64 received Plinabulin after a high dose of melphalan. One dose of 40mg of Plinabulin was given to patients via IV infusion one to three hours after stem cell infusion on Day 0, and 6mg of pegfilgrastim was given on Day 1.

The Plinabulin and pegfilgrastim combination appears well tolerated without additional major toxicities post AHCT. Although the combination did not decrease days of severe neutropenia compared with historical data of pegfilgrastim alone, the addition of Plinabulin potentially decreased other clinical consequences:

Reduced rate of infection-related neutropenic fever: Out of 15 patients, 7 had no fevers and 1 had a true neutropenic fever;
Reduced red blood cell (RBC) transfusion: Median of zero RBC transfusion per patient with the use of Plinabulin and pegfilgrastim;
Reduced platelet transfusion: Median of two platelet transfusions per patient with the combination.
"The Plinabulin-pegfilgrastim combination represents a new potential supportive care for MM patients undergoing AHCT. From this pilot study, we saw a trend in the combination in reducing infectious neutropenic fevers and RBC and platelet transfusion requirements compared to historical expectations, which are clinically important benefits." said Dr. Gunjan Shah, MD, MS, Assistant Attending Physician at MSK and Principal Investigator of the trial.

On June 7, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Pascal Touchon, President and Chief Executive Officer, will participate in a fireside chat at the Goldman Sachs 44th Annual Global Healthcare Conference on Wednesday, June 14, 2023 at 4:00 p.m. PDT / 7:00 p.m. EDT (Press release, Atara Biotherapeutics, JUN 7, 2023, View Source [SID1234632551]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be available by visiting the Investors and Media section of atarabio.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation.