On June 1, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that it has received a milestone payment under its collaboration and license agreement with the healthcare division of Merck KGaA, Darmstadt, Germany, related to a patient enrollment achievement in the Phase 1 dose escalation and expansion study of M1231 in adult patients with metastatic solid tumors, including non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma (Press release, Sutro Biopharma, JUN 1, 2021, View Source [SID1234583355]). M1231 is an investigational bispecific antibody-drug conjugate (ADC) targeting MUC1-EGFR.

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"The robustness and flexibility of our cell-free platform and our wholly-owned manufacturing facility have enabled the discovery and early clinical supply of M1231," said Bill Newell, Chief Executive Officer of Sutro. "The continuing progress of the program is indicative of the commitment both parties have made to drive development of M1231 and represents an important achievement in the work of the collaboration to address unmet medical needs of cancer patients."

Trevor Hallam, Ph.D., Sutro’s President of Research and Chief Scientific Officer added, "This partnership demonstrates the combined strength of Sutro and Merck KGaA, Darmstadt, Germany to expand the boundaries of antibody-drug conjugate. M1231 is a first-in-class investigational bispecific ADC; by targeting both MUC1 and EGFR, M1231 could potentially increase tumor selectivity, payload delivery, and reduce on-target toxicity on normal tissues."

M1231 was generated using Sutro’s XpressCF and Sutro’s XpressCF+ cell-free protein synthesis and conjugation technologies and includes a Sutro proprietary linker-warhead. The ADC is based on Merck KGaA, Darmstadt, Germany’s strand-exchange engineered domain (SEED) antibody platform. As part of the agreement, Sutro is manufacturing the antibody and linker-warhead for the early clinical supply and is eligible for further payments and tiered royalties ranging from low to mid-single digit percentages, along with certain additional one-time royalties, on worldwide sales of any commercial products that may result from the collaboration. Merck KGaA, Darmstadt, Germany will be responsible for drug product, clinical development and, upon regulatory approval, the commercialization of this product candidate.

On June 1, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that members of its senior management team will participate in a virtual event to discuss data from its ongoing Phase 1 clinical trial evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, as a monotherapy and in combination with nivolumab (Press release, Compugen, JUN 1, 2021, View Source [SID1234583354]). The data will be presented in an oral presenation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting, on June 7, 2021.

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The vitual fireside chat, hosted by Asthika Goonewardene, Truist Securities Biotech Analyst, will take place on June 8, 2021 at 12:00 PM ET.

Participating on behalf of Compugen are Anat Cohen-Dayag, PhD, President and CEO; Ari Krashin, Chief Financial and Operating Officer; Henry Adewoye, PhD, Senior Vice President and Chief Medical Officer and Eran Ophir, PhD, Vice President, Research and Drug Discovery.

The event will also be available via live webcast through Compugen’s website, located at the following link.

On June 1, 2021 Ryvu Therapeutics (WSE: RVU) reported that the latest results from the DIAMOND-01 clinical trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) will be disclosed through poster presentations at both the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congresses, to be held on June 4-8, and June 9-17, respectively (Press release, Ryvu Therapeutics, JUN 1, 2021, View Source [SID1234583353]).

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DIAMOND-01 is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24 (MEN1703), a first in class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini Group from Ryvu Therapeutics, which is currently investigated as single agent for the treatment of patients with Acute Myeloid Leukemia (AML).

In the dose escalation part of DIAMOND-01 trial, SEL24(MEN1703) demonstrated a manageable safety profile up to the recommended dose (RD) of 125 mg/day, along with initial evidence of anti-leukemic activity in a single agent setting.

Data reported in the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) posters refers to the patients enrolled in the Phase II, cohort expansion part of the study, which confirmed the manageable safety profile of the drug at the RD and showed preliminary single agent efficacy in relapsed/refractory AML, particularly in patients with IDH mutant disease either naïve or previously exposed to IDH inhibitors. These results warrant further investigation of SEL24 (MEN1703) in AML, with a potential to focus on the IDH mutated subset.

"We are thrilled to share encouraging results for SEL24 (MEN1703) in treating patients with Acute Myeloid Leukemia," said Dirk Laurent, M.D., Global Therapeutic Area Head – Oncology at Menarini Ricerche, the R&D division of the Menarini Group. "The data, which will be presented in our posters at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual meetings, provides a strong rationale for further clinical development, including the potential to focus on a molecularly defined subset of patients. This accomplishment reflects our sustained commitment to improving the lives of patients with difficult-to-treat cancer and underscores the value of our precision oncology approach."

"We are very happy to see that SEL24 (MEN1703), developed in collaboration with Menarini, continues to build momentum in the clinic demonstrating promising single agent efficacy in a genetically well-defined patient population after earlier encouraging safety and efficacy data in all-comer AML setting" – said Setareh Shamsili, MD, PhD, Chief Medical Officer of Ryvu Therapeutics.

ASCO Poster details

Updated results from DIAMOND-01 (CLI24-001) trial: a Phase I/II study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in acute myeloid leukemia.
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Abstract Code. 7023, Poster presentation

EHA Poster details

Results from DIAMOND-01 (CLI24-001) trial: First in Human Study of SEL24/MEN1703, a dual PIM/FLT3 Kinase Inhibitor, in patients with Acute Myeloid Leukemia
Session: Acute myeloid leukemia – Clinical

Abstract Code: EP455, Poster presentation

About SEL24 (MEN1703)

SEL24 (MEN1703) is a first-in-class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini from Ryvu Therapeutics. It is an investigational compound, not approved for use by regulatory authorities, currently being evaluated in the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) for the treatment of Acute Myeloid Leukemia.

On June 1, 2021 The Menarini Group reported that additional data have been generated on SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, as part of the DIAMOND-01 trial (Press release, Menarini, JUN 1, 2021, View Source [SID1234583352]). The results will be presented at both the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congresses, held on June 4-8, and June 9-17, respectively.
DIAMOND-01 (CLI24-001; clinicaltrials.gov identifier NCT03008187) is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor licensed by Menarini from Ryvu Therapeutics and currently investigated as a single agent for the treatment of patients with Acute Myeloid Leukemia (AML).

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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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In the dose escalation part of the DIAMOND-01 trial, SEL24/MEN1703 demonstrated a manageable safety profile up to the recommended dose (RD) of 125 mg/day, along with initial evidence of anti-leukemic activity in a single agent setting.

Data reported in the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) posters refer to patients enrolled in the Phase II, cohort expansion part of the study, which confirmed the manageable safety profile of the drug at the RD and showed preliminary single agent efficacy in relapsed/refractory AML, particularly in patients with IDH mutant disease either naïve or previously exposed to IDH inhibitors. These results warrant further investigation of SEL24/MEN1703 in AML, with a potential to focus in the IDH mutated subset.

"We are thrilled to share encouraging results for SEL24/MEN1703 in treating patients with Acute Myeloid Leukemia," said Dirk Laurent, M.D., Global Therapeutic Area Head – Oncology at Menarini Ricerche, the R&D division of the Menarini Group. "The data, which will be presented in our posters at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual meetings, provides a strong rationale for further clinical development, including the potential to focus on a molecularly defined subset of patients. This accomplishment reflects our sustained commitment to improving the lives of patients with difficult-to-treat cancer and underscores the value of our precision oncology approach."

ASCO Poster details

Updated results from DIAMOND-01 (CLI24-001) trial: a Phase I/II study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in acute myeloid leukemia.
Topic: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract Code: 7023, Poster presentation
EHA Poster details

Results from DIAMOND-01 (CLI24-001) trial: First in Human Study of SEL24/MEN1703, a dual PIM/FLT3 Kinase Inhibitor, in patients with Acute Myeloid Leukemia
Topic: Acute myeloid leukemia – Clinical
Abstract Code: EP455, Poster presentation
About SEL24/MEN1703

SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini from Ryvu Therapeutics. It is an investigational compound, not approved for use by regulatory authorities, currently being evaluated in the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) for the treatment of Acute Myeloid Leukemia.

About Menarini in Oncology

At Menarini, we understand that patients’ hope for a better life is inextricably linked to the progress of scientific and medical research – that is what drives us forward.

Menarini Ricerche is the Menarini Group’s division dedicated to R&D, with a strong commitment to oncology research and development, focused both on therapeutics and diagnostics. We invest in the development of precision medicine through our pipeline of investigational drugs, which includes both small molecules and biologics investigated for the treatment of hematologic and solid tumors. We are also committed to developing innovative technologies for the detection and analysis of circulating tumor cells through the work of Menarini Silicon Biosystems.

The acquisition of Stemline Therapeutics, a New York-based biopharmaceutical company, marked the entry of the Menarini Group into the U.S. biopharmaceutical oncology market and, together with the license agreement reached with Radius Health, strengthened Menarini’s oncology portfolio with the addition of both commercial and clinical-stage assets.

For further information about Menarini’s pipeline, please visit the dedicated page on our website at View Source

On June 1, 2021 Eucure Biopharma reported that it will present findings from two Phase I clinical trials at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held from June 4th to 8th (Press release, Eucure, JUN 1, 2021, View Source [SID1234583351]).

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The first trial (poster #2580; NCT04481009) is designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of YH003 (an anti-CD40 monoclonal antibody (mAb)) combined with Toripalimab (Tuoyi; an anti-PD-1 mAb) in subjects with advanced solid tumors. As of December 31, 2020, there were no dose-limiting toxicity (DLT) events or severe adverse events (AE) observed in 9 subjects/3 dose levels (ranging from 0.03 to 0.3 mg/kg). Of the 5 subjects that completed at least one tumor assessment, one subject with ocular melanoma who failed prior Opdivo and Opdivo/Yervoy combination therapy achieved partial remission (PR), and two patients maintained stable disease (SD).

The second trial (poster #2577; NCT04357756) is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of an anti-CTLA-4 antibody, YH001, combined with Toripalimab in subjects with advanced solid tumors. As of December 31, 2020, no DLT or severe AE were observed at 4 dose levels (ranging from 0.05 to 1 mg/kg). Seven of 10 subjects completed at least one tumor assessment, of which 4 subjects maintained SD. As of March 1, 2021, one subject with GEJ cancer that maintained SD in the first tumor assessment achieved PR in the second assessment, with a 60.9% reduction in the target lesion compared to baseline.

About YH003
YH003 is a humanized IgG2 agonistic monoclonal antibody that targets CD40 signaling. Preclinical studies demonstrated that YH003 promotes antigen-presenting cell activation and infiltration of effector T cells into tumors. YH003 demonstrated potent anti-tumor effects in Biocytogen’s humanized CD40 mice, both alone and in combination with anti-PD-1 monoclonal antibodies. YH003 has been approved to enter Phase II trials in Australia for pancreatic cancer and PD1-resistant melanoma.

About YH001
YH001 is a humanized IgG1 monoclonal antibody that blocks the association of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) with CD80/CD86. YH001 can trigger antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to remove CTLA-4 expressing cells, especially regulatory T cells, to enhance T-cell-mediated antitumor immune responses. Preclinical data indicates that YH001 outperforms Ipilimumab (a currently approved CTLA-4 drug) in CTLA-4 binding affinity and inducing ADCC activity.