CellCentric to present haem clinical data at ASH

On November 4, 2022 CellCentric, a privately owned, clinical stage biotechnology company pioneering small molecule inhibition of p300/CBP to treat cancer, reported that the Chief Investigator of its haematological malignancies programme, Professor Tim Somervaille, will be presenting compelling pre-clinical and early phase clinical activity data for inobrodib (CCS1477) at the American Society of Haematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition 2022, in New Orleans on the 9-13th December (Press release, CellCentric, NOV 4, 2022, View Source [SID1234623019]).

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Presentation Details:

CellCentric has developed a first-in-class small molecule inhibitor drug, inobrodib, that targets twin cancer gene regulators, p300 and CBP. An extensive Phase I clinical programme has been undertaken, and a recommended Phase II dose and schedule (RP2D) as monotherapy has been established. At the RP2D, this novel drug has been shown to be well tolerated long term, delivering objective responses in multiple specific settings as monotherapy, including in relapsed refractory multiple myeloma (MM), acute myeloid leukaemia (AML) and lymphomas.

Inhibiting p300/CBP impacts the expression of key cancer drivers including MYC, IRF4 and the androgen receptor (AR). MYC and IRF4 are particularly important in the progression of certain blood cancers. CellCentric has demonstrated that its pioneering drug, inobrodib, has a direct impact on these key oncogenes.

Inobrodib is formulated as a capsule, taken orally. Patients appreciate being able to take medicines themselves, at home, with less impact on routines and quality of life.

Andrew Hughes, CellCentric Board member and previous head of global clinical Phase I/II oncology at AstraZeneca, said: "It is fabulous to see the pre-clinical promise of targeting p300/CBP translate into the clinic and deliver meaningful results for people with cancer. Many first in class compounds fail to achieve long term tolerability, as well as delivering efficacy. Targeting the bromodomain of p300/CBP is proving to have been the right drug discovery strategy."

Tim Somervaille, Professor of Haematological Oncology at Cancer Research UK Manchester Institute and The University of Manchester, Honorary Consultant Haematologist at The Christie NHS Foundation Trust and Chief Investigator of the multi-centre international inobrodib Haematological Malignancy study commented: "These initial data provide great promise for the potential clinical utility of inobrodib as monotherapy, to treat late stage multiple myeloma patients, who have few alternate choices. We are expanding our existing encouraging cohorts, and also testing inobrodib now in combination with existing standard of care agents."

As well as testing in heavily pre-treated, relapsed refractory haematological malignancy patients, CellCentric also has a study evaluating inobrodib for solid tumours, including late-stage prostate cancer, known to be driven by MYC and AR. The Company continues to explore the drug both as monotherapy and in combination with existing agents, in these additional settings. These data will be reported separately.

OSE Immunotherapeutics Announces Award for OSE-127’s Upcoming Oral Presentation in Acute Lymphoblastic Leukemia at the 2022 American Society of Hematology (ASH) Annual Meeting

On November 3, 2022 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported that its leukemia research program on OSE-127 has been selected for an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting (New Orleans, Louisiana; December 10 – 13, 2022) (Press release, OSE Immunotherapeutics, NOV 3, 2022, View Source [SID1234646952]). This upcoming presentation has received the merit-based "Abstract Achievement Award" from the peerreview committee.

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are honored by the recognition and the interest in the quality of our research in Leukemia from the prestigious American Society of Hematology (ASH) (Free ASH Whitepaper). This award is the result of our fruitful collaboration with the University of Kiel evaluating, in patient-derived xenograft models, the therapeutic potential of OSE-127 in targeting and blocking the high and dysregulated IL-7 receptor-expression observed in more than 80% of B- or T-Acute Lymphoblastic Leukemia (ALL) patients".

Pr. Denis Schewe (Head of the Pediatrics Department, Otto-von-Guericke-University, Magdeburg and formerly from the University Medical Center Schleswig-Holstein of Kiel) and Dr. Lennart Lenk (Department of Pediatrics I, Christian-Albrechts University Kiel and University Medical Center Schleswig-Holstein, Kiel), leading the research program in collaboration with OSE Immunotherapeutics, say: "Acute lymphoblastic leukemia is a very aggressive tumor arising from B or T cells precursors (B- and T-ALL, respectively). Relapse remains a clinical challenge in B-ALL in highrisk patients and treatment options for T-ALL remain very limited. Novel targeted immunotherapy approaches are urgently needed to prevent relapse and to treat refractory diseases in ALL patients".

The global intellectual property for OSE-127 has been further strengthened, based on a unique and innovative dual anti-leukemic mechanism of action. This antibody both blocks oncogenic interleukin-7 fuel pathway and simultaneously triggers macrophage-driven phagocytosis of leukemic cells. Additional patent applications were filed in 2021 and 2022 covering the use of anti-IL-7 receptor antagonist antibodies with macrophage-redirected phagocytic activity for the targeted treatment of IL-7 receptor-positive cancers.

Furthermore, OSE-127 is currently being developed in clinical stage in partnership with Servier. Two clinical studies are ongoing in inflammatory diseases: a phase 2a study conducted in primary Sjögren’s syndrome by Servier and a phase 2 study conducted in ulcerative colitis by OSE Immunotherapeutics.

About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is a heterogeneous group of lymphoid disorders resulting from clonal proliferation of immature lymphocytes of B-cell (85%) or T-cell (15%) lineages(1) in the blood, bone marrow, and other lymphoid organs.

Although it is one of the most common cancers in children, accounting for approximately 25% of all
childhood cancer diagnoses among children under 15 years of age (2), adults can also develop ALL.
About 40% cases of ALL diagnosed are in adults and among them about 50% present refractory disease
or undergo relapse under current conventional therapies(2)

FDA Acceptance of Auransa’s IND Application for AU409 for Treatment of Patients with Hepatocellular Carcinoma

On November 3, 2022 Auransa Inc., a clinical stage drug development company using propriety AI drug discovery platform to identify novel drug candidates for oncology, CNS and inflammatory diseases, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AU409, a novel, orally active agent showing anticancer activity in preclinical studies of hepatocellular carcinoma (HCC) (Press release, Auransa, NOV 3, 2022, View Source [SID1234635671]). Initial clinical studies will focus on patients with advanced primary liver cancers and patients with advanced solid tumor with liver predominant metastatic disease.

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"The FDA’s acceptance of the IND for AU409 is an important milestone for Auransa’s AI drug discovery platform. We look forward to initiating the Phase 1 study, our first-in-human trial of a compound derived from Auransa’s proprietary SMarTR Engine." said Pek Lum, Ph.D., founder and chief executive officer of Auransa.

"AU409’s anti-cancer activity in preclinical models is through a mechanism of action distinct from currently available, FDA approved tyrosine kinase inhibitors used for hepatocellular carcinoma making this an important new opportunity for clinical testing." said Andrew Protter, Ph.D. Auransa’s Chief Scientific Officer.

About AU409
AU409 is a novel small molecule with oral active in models of hepatocellular carcinoma. In preclinical studies, AU409 has been shown to modulate transcription of certain genes thereby altering the gene expression profile of liver cancer cells. The mechanism of action of AU409 is distinct from that of current drugs approved for HCC including the tyrosine kinase inhibitors (TKIs) such as sorafenib or regorafenib. Non-clinical safety, toxicology and genetic toxicology studies support the first in human clinical studies being proposed.

About Hepatocellular Carcinoma
Despite major improvements in the treatment of primary liver cancers including hepatocellular carcinoma, patients with advanced disease continue to have limited median overall survival due to primary or secondary resistance to existing therapies. While chronic hepatitis B and C infections continue to be important risk factors for liver cancer, the rising prevalence of obesity, non-alcoholic steatohepatitis (NASH) and alcohol consumption are becoming the dominant risk factors for liver cancer in the United States as well as the rest of the world. Liver cancer has recently been estimated to be the third most common cancer related death worldwide.

Third Quarter 2022 report

On November 3, 2022 Targovax reported its financial report of third quarter 2022 (Presentation, Targovax, NOV 3, 2022, View Source [SID1234624679]).

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Cellectis Provides Business Update and Reports Financial Results for Third Quarter and First Nine Months 2022

On November 3, 2022 Cellectis reported Business Update and Reports Financial Results for Third Quarter and First Nine Months 2022 (Press release, Cellectis, NOV 3, 2022, View Source [SID1234624610]).

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