On April 30, 2021 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel, cross-modality medicines for unmet needs in cancer, reported the initiation of patient dosing in TWT-202, its Phase 1b/2 study to evaluate its CFI-400945, an oral, first-in-class inhibitor of Polo-like kinase 4 (PLK4) in patients with Leukemia as a monotherapy or in combination with hypomethylating agents (Press release, Tio Bioventures, APR 30, 2021, View Source [SID1234578817]). Dosing of the first patient in the trial commenced April 16th at the University of Texas MD Anderson Cancer Center, Houston, TX.

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"Oral PLK4 inhibition opens a completely new approach to target therapeutic vulnerability in high risk MDS and AML and is very amenable to combination with other effective therapeutic agents," said Principal Investigator, Dr. Gautam Borthukar, MD, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center.

"We are excited about the initiation of TWT-202 with our highly potent PLK4 inhibitor," said Dr. Michael Tusche, Treadwell co-CEO. "Previous clinical studies have shown that CFI-400945 can lead to single agent complete remissions in high-risk refractory AML patients. We look forward to continuing the development of this agent with the goal of delivering first in class medicines to patients in need."

The Phase 1b/2 clinical trial of CFI-400945, is an open-label, multi-center, dose optimization study designed to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CFI-400945 as a single agent or in combination with azacytidine or decitabine in patients with acute myeloid leukemia, myelodysplastic syndrome or chronic myelomonocytic leukemia. The trial will enrol approximately 72 patients at up to 20 sites in North America and Asia. It will involve 3 arms including monotherapy and combination dose optimization and expansion, as well as a food effect study.

About CFI-400945

CFI-400945 is a highly potent and selective inhibitor of the serine/threonine kinase PLK4, a cell cycle kinase known to be the master upstream regulatory of centriole duplication and is critical for the maintenance of genomic integrity. PLK4 is overexpressed in a variety of solid tumors and elevated expression is associated with poor clinical outcomes. Depletion of PLK4 expression in cancer cells by RNA interference leads to mitotic defects and cell death. PLK4 was identified as a drug target based on functional screening to identify vulnerabilities of genomically unstable cancers. Anti-tumor activity of CFI-400945 has been shown in mice bearing human cancer xenografts, including robust tumor growth inhibition and durable tumor regression in primary tumor xenografts from breast cancer. CFI-400945 is a potent, selective, orally administered, first-in-class inhibitor of the serine/threonine kinase, polo-like kinase 4 (PLK4). CFI-400945 is currently in multiple investigator-initiated studies in solid and liquid malignancies,

On April 29, 2021 Zelluna Immunotherapy AS reported an exclusive research collaboration with Etcembly Ltd to discover T cell receptors immune pattern recognition system EMLy (Press release, Etcembly, APR 29, 2021, View Source [SID1234612570]).

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Zelluna Immunotherapy, the company pioneering allogeneic "off the shelf" TCR based natural killer (TCR-NK) cells for the treatment of cancer, and Etcembly, a start-up developing innovative machine learning techniques in immune pattern recognition for in silico discovery of novel TCR specificities, today announce an exclusive collaboration to discover TCRs with an initial focus on a widely expressed and well-validated solid cancer antigen.

TCR-NK products are a novel class of allogeneic cellular therapies that combine the inherent killing mechanism, efficiency, and the allogeneic nature of NK cells with the targeting capabilities of TCRs. TCR engineered NK cells may unlock the potential to treat a wide range of currently untreatable cancers.

Luise Weigand, Head of Research at Zelluna said…

"I am delighted that we have the opportunity to combine our proprietary TCR-NK platform with the high potential of Etcembly’s innovative approach to TCR discovery through the application of artificial intelligence. We are looking forward to working with the Etcembly team on breaking new ground in the discovery of highly potent TCRs for cancer immunotherapy. This collaboration forms part of our wider strategy for discovering TCRs which includes in-licensing and our own recently initiated discovery efforts."
Dr Michelle Teng, Founder CEO of Etcembly continues…

"We relish this unprecedented opportunity to work with Zelluna at such an early stage of our company – a testament to the confidence in our immune prediction platform EMLy. This is the start of an exciting collaboration in pursuit of defining a new paradigm of learn drug discovery for immunotherapy."

On April 29, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2021 first quarter financial results on Monday, May 10, 2021, before the market opens (Press release, Eagle Pharmaceuticals, APR 29, 2021, View Source [SID1234584738]).

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Scott Tarriff, Chief Executive Officer, Brian Cahill, Chief Financial Officer, will host a conference call to discuss the results as follows:

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-6980 (US) or 402-220-6062 (International) and entering conference call ID EGRXQ121. The webcast will be archived for 30 days at the aforementioned URL.

On April 29, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it has initiated a registration-intent Phase II clinical trial of HMPL-689, its highly selective and potent PI3Kδ inhibitor, in China in patients with relapsed or refractory follicular lymphoma ("FL") and marginal zone lymphoma ("MZL"), two subtypes non-Hodgkin’s lymphoma ("NHL") (Press release, Hutchison China MediTech, APR 29, 2021, View Source [SID1234583630]). The first patient was dosed today .

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The clinical trial is a multi-center, single-arm, open-label clinical study to evaluate the efficacy and safety of HMPL-689 once a day oral monotherapy in approximately 100 patients with relapsed/refractory FL and approximately 80 patients with relapsed/refractory MZL. Relapsed/refractory is defined when a patient has not achieved response (complete response or partial response) after the latest line of systemic treatment, or has progressive disease or relapse after achieving response. The primary endpoint is objective response rate ("ORR"), with secondary endpoints including complete response rate (CRR), progression-free survival (PFS), time to response (TTR) and duration of response (DoR). The trial is being conducted in over 35 sites in China. More information will be available at clinicaltrials.gov, using identifier NCT04849351.

The initiation of the Phase II trial is based on the highly promising preliminary results from the Phase Ib expansion study ongoing in China, which show that HMPL-689 was well tolerated, exhibiting dose-proportional pharmacokinetics ("PK"), a manageable toxicity profile, and single-agent clinical activity in relapsed/refractory B-cell lymphoma patients. Additional details may be found at clinicaltrials.gov, using identifier NCT03128164.

About PI3Kδ and NHL

PI3Kδ (phosphoinositide 3-kinase delta) is a lipid kinase that controls the activation of several important signaling proteins. Upon an antigen binding to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, PI3Kδ is considered to be a promising target for drugs that aim to prevent or treat hematologic cancer.

FL accounts for approximately 17% of NHL and MZL accounts for approximately 8% of NHL. In the U.S., there were estimated 13,000 and 6,000 new cases of FL and MZL in 2020, respectively. In China, there were estimated 16,000 and 7,000 new cases of FL and MZL in 2020, respectively 1,2,3.

About HMPL-689

HMPL-689 is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. HMPL-689’s PK properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, HMPL-689 has the potential to demonstrate an optimal benefit-risk profile in this class.

HUTCHMED has initiated an extensive, globally-focused clinical development pathway for HMPL-689. In addition to the currently Phase II trial and the supportive Phase I trial in China, HMPL-689 is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory NHL.

HUTCHMED currently retains all rights to HMPL-689 worldwide.

Evelo Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Evelo Biosciences, 2021, NOV 5, 2019, View Source [SID1234578723]).

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