On June 1, 2021 Rubedo Life Sciences, a drug discovery company developing targeted therapeutics for age-related diseases, reported a collaboration with Cedars-Sinai Medical Center in Los Angeles, to advance its idiopathic pulmonary fibrosis (IPF) program and establish collaborative studies (Press release, Cedars-Sinai Medical Center, JUN 1, 2021, View Source [SID1234583336]).

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As part of the collaboration, Cory Hogaboam, Ph.D., Professor of Medicine and Research Scientist in the Women’s Guild Lung Institute at Cedars Sinai Medical Center will be joining Rubedo’s Scientific Advisory Board (SAB). Dr. Hogaboam’s distinguished career encompasses more than 20 years of scientific experience and he is also an Adjunct Professor of Pathology at the University of Michigan Medical School. He joins current SAB members, Dr. Mark Pegram and Dr. Lidia Shapira at Stanford University School of Medicine, and Distinguished Professor Paul Insel at University of California San Diego School of Medicine.

Rubedo’s most advanced program targets a type of rare but pathogenic cell types that emerges with and in diseases, called senescent cells. Senescent cells are pro-inflammatory, pro-fibrotic and pro-cancerogenic cells caused by different types of cellular stress and damage. As we age, they accumulate in the body in multiple tissues. Cellular senescence is a master regulator of aging and drive many age-related diseases.

"We are excited to announce this collaboration with Cedars Sinai Medical Center, and work with Dr. Hogaboam’s lab," said Marco Quarta, CEO at Rubedo Life Sciences." Rubedo’s strategy for entry into the longevity space is a senolytic program, targeting the pro inflammatory and pro fibrotic senescent cells. Our first clinical program will be IPF, which is an unmet medical need and we look forward to working with Cedars Sinai Medical Center."

"I joined forces advising and collaborating with Rubedo because throughout my career working on IPF, I came to the conclusion that targeting cellular senescence is the only way to unlock a possible cure for this devastating age-related disease," said Dr. Cory Hogaboam, Professor of Medicine, Chronic Lung Diseases, at Cedars-Sinai Medical Centers. "Among all the proposed senolytic therapies, Rubedo has a unique platform that promises to successfully deliver an effective pharmacological treatment for IPF."

Rubedo’s proprietary Alembic drug discovery platform combines computational and chemistry proprietary technologies to generate novel prodrugs that selectively target multiple pathologic cell types (including rare cell types) driving age-related diseases.

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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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 Cellestia Biotech, specialized in targeting Transcription Factors (TFs) involved in human diseases reported that it will present updated clinical data of its ongoing Phase 1 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 underscoring the ambition to become a leader in the field of TFs (Press release, Cellestia Biotech, JUN 1, 2021, View Source [SID1234583304]).

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Dr. Florian Vogl, CMO of Cellestia Biotech said: "Our clinical data at ASCO (Free ASCO Whitepaper) this year validate our transformative scientific approach and open the path for CB-103 to become a new treatment option for patients with NOTCH-driven cancers and non-oncology conditions such as autoimmune and inflammatory diseases."

Dr. Michael Bauer, CEO of Cellestia stated: "Cellestia is shifting the boundaries of biomedical research: the outstanding clinical data on CB-103 confirm Cellestia´s ability to develop novel therapies targeting Transcription Factors that historically have been considered difficult or impossible to target. We have shown we can do it and we will further expand our pipeline to address currently unmet medical needs."

Presentation details:

Title: Phase 1 study of CB-103, a novel first-in-class inhibitor of the CSL-NICD gene transcription factor complex in human cancers

Abstract Number: 3020

Session: Poster Discussion Session, Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology ]]Presenting Author: Elena López-Miranda, MD, Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain

Date / Time: (Virtual) Friday, June 4th, poster and recording available on demand at ASCO (Free ASCO Whitepaper).org from 9:00 AM EST A copy of the poster can be accessed on www.cellestia.com after the presentation concludes, and the recorded oral presentation will be hosted on the online ASCO (Free ASCO Whitepaper) Meeting Library. Cellestia Biotech AG Hochbergerstr. 60C www.cellestia.com CH-4057 Basel

About Cellestia’s clinical Phase 1 trial
CB103-C-101 is a Phase 1/2a multicenter, open-label, dose-escalation study with expansion arms of CB-103 in adult patients with locally advanced or metastatic solid tumors and hematological malignancies characterized by alterations of the Notch signaling pathway. The study is open for enrollment at sites in Europe and Switzerland, the US, and Asia (China, Korea).

About Transcription Factors (TF)
Transcription refers to the first step of gene expression where an RNA is created from a DNA template. Transcription factors (TF) are DNA-binding proteins that play a key role in gene transcription. Through their ability to initiate or repress site-specific transcription, each cell in our bodies can differentiate into a different cell type despite containing the same exact genetic code. Transcription factors also make genetic fine-tuning possible. Modulating the activity and the amount of transcription factor can increase or decrease the rates of the chosen gene’s transcription. Ultimately, transcription factors can be thought of as the "gatekeepers" that determine if a gene is expressed or not.

On June 1, 2021 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial will proceed as planned following the review of safety data from more than 20 patients enrolled into the trial to date (Press release, Tracon Pharmaceuticals, JUN 1, 2021, View Source [SID1234583321]). The safety data reviewed included data from more than 10 patients enrolled into cohort A of treatment with single agent envafolimab and more than 10 patients enrolled into cohort B of treatment with envafolimab and Yervoy (ipilimumab).

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"We are pleased with the recommendation of the Data Monitoring Committee to continue the ENVASARC pivotal trial as planned," said James Freddo, M.D., TRACON’s Chief Medical Officer, "Envafolimab has been well tolerated as a single agent and when combined with Yervoy in these patients with refractory sarcoma who are enrolled in the ENVASARC trial. Based on the current accrual rate, we expect the Data Monitoring Committee to review additional safety data in the third quarter and to review interim efficacy data in the fourth quarter of this year."

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

On June 1, 2021 Lengo Therapeutics, a biopharmaceutical company developing novel precision medicines targeting driver mutations in oncology, reported the appointment of Diana Hausman, M.D., as Chief Medical Officer (Press release, Lengo Therapeutics, JUN 1, 2021, View Source [SID1234583337]). In this role, Dr. Hausman will be responsible for leading clinical development and strategy for the Company.

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"Diana brings invaluable experience and expertise to our team, as we advance our pipeline of best-in-class precision therapeutics for treatment-resistant cancers," said Helen Jenkins, Chief Executive Officer, Lengo Therapeutics. "Her experience leading several clinical programs in oncology from first in human through to registrational studies is incredibly relevant, as we prepare for our next stage of growth."

"I am excited to join the incredible team at Lengo, and work alongside a world-class team of scientists and leaders in kinase inhibition developing transformative therapeutics in oncology," said Dr. Hausman. "I look forward to leveraging my extensive clinical experience in the biotechnology industry to lead the continued development of Lengo’s pipeline for cancer patients with unmet medical needs."

Dr. Diana Hausman is a board-certified medical oncologist with over 20 years of clinical drug development experience. Prior to joining Lengo, she served as Chief Medical Officer for Zymeworks Inc. for 5 years. While at Zymeworks, Dr. Hausman oversaw all aspects of clinical development, including advancement of the HER2-targeted biparatopic antibody zanidatamab from initial IND to ongoing global Phase 2 and pivotal studies, including breakthrough therapy designation for biliary tract cancer.

Dr. Hausman was previously CMO at Oncothyreon Inc where she oversaw the Phase 1b and early Phase 2 clinical program for the HER2-targeted small molecule, tucatinib. She has also held positions of increasing responsibility at ZymoGenetics, Berlex, and Immunex, working across multiple indications, including oncology, hematology, hepatitis C and autoimmune disease. Dr. Hausman received her internal medicine and specialty training in hematology and medical oncology at the University of Washington. She received her M.D. degree from the University of Pennsylvania, Philadelphia, PA, and an A.B. in biology from Princeton University.