Study shows protein inhibitor as potential treatment approach for common mutations found in non-Hodgkin lymphomas

On January 8, 2020 A study at The University of Texas MD Anderson Cancer Center reported a potential new approach to treating two of the most common subtypes of lymphoma through manipulation of molecular programs controlled by the cAMP-response element binding protein (CREBBP) (Press release, MD Anderson, JAN 8, 2020, View Source [SID1234553265]). Mutations of CREBBP are frequently found in follicular lymphoma and diffuse large B-cell lymphomas (DLBCL), and allow malignant cells to hide from the immune system.

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Study results were published in the Jan. 8 online issue of Cancer Discovery. Co-lead investigators, Michael Green, Ph.D., assistant professor of Lymphoma & Myeloma at MD Anderson and Ari Melnick, M.D., of Weill Cornell Medical School, reported on how inhibition of a protein called histone deacetylase 3 (HDAC3) restores immune programs lost as a result of CREBBP mutations, paving the way for potential immunotherapy approaches for common forms of non-Hodgkin lymphoma.

CREBBP is the second most frequently mutated chromatin-modifying gene in both follicular lymphoma and DLBCL. It encodes a protein that alters the activity of genes by modifying the histone proteins around which DNA is wrapped.

"CREBBP mutations are highly recurrent in B-cell lymphomas and either inactivate its histone acetyltransferase (HAT) domain or truncate the protein," said Green." We showed that these two classes of mutations yield different degrees of disruption of the epigenome, with HAT mutations being more severe and associated with inferior clinical outcome."

Through CRISPR/Cas9 gene editing of cell lines and using mouse models, the research team also showed that HDAC3 selective inhibitors reverse aberrant epigenetic programming caused by CREBBP resulting in growth inhibition of lymphoma cells and restoration of immune surveillance.

"Our study characterized the molecular consequences of CREBBP mutations and identified key cellular pathways silenced as a result of unopposed HDAC3 activity," said Green. "We demonstrated how inhibition of HDAC3 restores these pathways, suppressing growth and most critically enabling T cells to recognize and kill lymphoma cells."

HDAC3 inhibitors appear to affect expression of major histocompatibility molecular class II (MHC class II), molecules, which are antigen presentation proteins crucial for initiating adaptive immune responses.

"The frequency of MHC class II loss in DLBCL exceeds the frequency of CREBBP mutations in this disease through unknown mechanisms," said Green. "The ability of HDAC3 inhibition to induce MHC class II expression may have potentially broad implications for immunotherapy. We believe that inhibition of HDAC3 represents a novel mechanism-based immune-epigenetic therapy for CREBBP- mutant lymphomas."

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The study was funded by the National Institutes of Health (R01 CA201380, R01 CA055349, U54 OD020335 01, P50 CA192937, P30 CA016672, and P30 CA008748); the Chemotherapy Foundation; the Star Cancer Consortium; the Jaime Erin Follicular Lymphoma Research Consortium; the Schweitzer Family Fund; and the Futcher Foundation. The study was also supported with funding from the B-Cell Lymphoma Moon Shot, part of MD Anderson’s Moon Shots Program, a collaborative effort to accelerate the development of scientific discoveries into clinical advances that save patients’ lives. Green previously served on the Scientific Advisory Board of KDAc Therapeutics, and he owns stock equity in the company.

MD Anderson study participants included Saber Tadros, Ph.D.; Neeraj Jain, Ph.D.; Haopeng Yang, Ph.D.; Man Chun John Ma, Ph.D.; Sreejoyee Ghosh, Ph.D.; Loretta Nastoupil, M.D.; and Sattva Neelapu, M.D., all of the Department of Lymphoma & Myeloma; and Cassian Yee, M.D., of the Department of Melanoma Medical Oncology.

Adagene Completes $69 Million Series D Financing Led by Growth Investor General Atlantic

On January 8, 2020 Adagene, Inc., a clinical-stage, leading-edge oncology immunotherapy company driven by a powerful antibody discovery and engineering platform, reported the completion of a $69 million Series D financing, including $50 million from lead investor General Atlantic (Press release, Adagene, JAN 8, 2020, View Source [SID1234553209]). Adagene has raised more than $150 million from private financings since 2014.

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"Strong support from our new and existing investors endorses Adagene’s technology platform and strategy to develop differentiated immunotherapies in areas where others have failed," said Peter Luo, Ph.D., Co-founder and Chief Executive Officer of Adagene. "This financial commitment enables us to continue developing our lead clinical programs, ADG106 and ADG116, while extending the frontiers of our novel technology. We look forward to advancing our clinical pipeline and exploring strategic and synergistic opportunities to facilitate long-term sustainable growth."

"We believe China is a rising, vibrant hub for global life sciences innovation. Adagene represents a new-generation biotechnology company that is driving global innovation. Its cutting-edge Dynamic Precision Library platform, combined with its dedicated founders and management team, allows Adagene to advance assets of true novelty to the value inflection point," said Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic. "We are proud to partner with Adagene as we increase our commitment to the life sciences industry in China."

"Adagene demonstrates that some of the world’s most exciting life sciences developments are now happening in China. We look forward to working closely with Dr. Luo and the entire Adagene team to support the company’s vision to bring innovative therapeutics to patients around the world," said David Hodgson, Vice Chairman of General Atlantic.

About Adagene’s Lead Clinical Programs

ADG106
Adagene’s lead agonist program, ADG106, is a fully human agonistic anti-CD137 monoclonal IgG4 antibody that targets a unique conserved epitope of CD137 and is cross-reactive across human, monkey and mouse. ADG106 has a novel mechanism of action for CD137 agonism (which activates CD137 in a native ligand-like fashion), CD137 ligand antagonism (which blocks reverse signaling of CD137 ligand), and potent cross-linking via Fc receptor. ADG106 is being evaluated in an ongoing Phase 1 clinical trial in the U.S. and China in patients with advanced or metastatic solid and liquid tumors. ADG106 has demonstrated a superior safety profile and no dose-dependent liver toxicity has been observed to date. Early efficacy signals and significant biomarker response demonstrating T-cell proliferation have also been observed.

ADG116
Adagene’s lead antagonist program, ADG116, is a fully human and cross-reactive antagonistic anti-CTLA-4 monoclonal IgG1 antibody that binds to a unique conserved epitope on CTLA-4. ADG116 has a novel mechanism of action including dynamic modulation of CTLA-4 by soft ligand blocking and highly effective depletion of regulatory T cells. ADG116 has demonstrated a superior safety profile and efficacy in pre-clinical studies. The U.S. Food and Drug Administration has approved Adagene’s IND application for ADG116

Helix BioPharma Corp. To Present At The Biotech Showcase In San Francisco

On January 8, 2020 Helix BioPharma Corp. (TSX: "HBP") ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has been selected to present at the Biotech Showcase Conference on Tuesday, January 14, 2020 at 11:00am (PT) at Hilton San Francisco Union Square (Press release, Helix BioPharma, JAN 8, 2020, View Source [SID1234553138]).

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Biotech Showcase Conference, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

During the conference, Helix will discuss its current development programs and opportunities for partnership. Helix will also update clinical progress on L-DOS47, its lead candidate for the treatment of non-squamous non-small cell lung cancer and pancreatic cancer.

"We are making excellent progress with our various DOS47 clinical initiatives," said Dr. Heman Chao, Helix’s Chief Executive Officer. "I look forward to updating everyone with our progress, especially our new pancreatic cancer study where we recently commenced patient dosing."

ANAPTYSBIO TO PRESENT AT J.P. MORGAN ANNUAL HEALTHCARE CONFERENCE

On January 8, 2020 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, reported that Hamza Suria, chief executive officer of AnaptysBio, will present at the J.P. Morgan 38th Annual Healthcare Conference on Wednesday, Jan. 15, 2020 at 2:30 p.m. PT at the Westin St. Francis in San Francisco (Press release, AnaptysBio, JAN 8, 2020, View Source [SID1234553067]).

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A webcast of the presentation will be available through the investor section of the AnaptysBio website. A replay of the webcast will be available for 90 days following the event.

Stemline Therapeutics to Present at the 38th Annual J.P. Morgan Healthcare Conference

On January 8, 2020 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that management will present at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 9:30 AM PT at the Westin St. Francis Hotel in San Francisco, CA (Press release, Stemline Therapeutics, JAN 8, 2020, View Source [SID1234552935]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

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About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.