On November 4, 2021 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its unique ability to decode the gut microbiome’s interaction with the immune system, reported the launch of its new corporate brand and visual identity supported by a new website (Press release, Enterome, NOV 4, 2021, View Source [SID1234594562]).

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These changes reflect the significant progress that Enterome has made with its two advanced, fully owned, OncoMimics and EndoMimics pipelines of transformational medicines for cancer and immune diseases, respectively.

Enterome’s most advanced OncoMimics drug candidates are:

EO2401, a therapeutic cancer vaccine candidate currently in clinical development for recurrent glioblastoma and adrenal tumors. EO2401 has already shown strong immunogenicity data in brain and adrenal cancer patients with clinical proof of concept data expected in H1 2022, and
EO2463, a second OncoMimic cancer vaccine, in clinical development for the treatment of indolent non-Hodgkin lymphoma with clinical proof of concept data planned for H1 2023
In addition, the Company’s most advanced EndoMimics candidate is:

EB1010, a new orally delivered bioactive and a potent local inducer of IL-10, which has been selected to provide improved therapeutic outcomes for patients with inflammatory bowel disease (IBD). EB1010 is expected to enter clinical trial in 2023
The Enterome name was created using a combination of the Greek prefix "ENTER", which means ’from the gut’ and the suffix of gen’OME’. This name highlights Enterome’s world-leading ability to interrogate the collective gut microbiome genome to identify and characterize bioactive proteins and peptides as a foundation to generate novel therapeutic vaccines and biological drugs.

Enterome’s drug discovery platform leverages a unique combination of biocomputational tools and bioassays, to explore new therapeutic solutions from the world’s largest database of 20 million functionally annotated full-length gut microbiome proteins. This use of cutting-edge tools means that Enterome’s platform is more efficient than well established, labor-intensive drug discovery approaches. Enterome’s platform has already demonstrated it is highly productive and has generated multiple pipelines of transformative drug candidates, targeting a broad range of therapeutic areas.

BeiGene has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On November 4, 2021 Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, reported that an abstract has been accepted for presentation at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 11-14, 2021 in Atlanta, GA (Press release, Advaxis, NOV 4, 2021, View Source [SID1234595577]).

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Title: Aspacytarabine (BST-236) As Monotherapy Is Safe, Well-Tolerated and Effective for the Treatment of Adults with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Therapy. Results of a Phase 2 Study

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I

Date: Saturday, December 11, 2021

Time: 5:30 PM – 7:30 PM

Location: Hall B5
The above abstract was published today and is now available on the ASH (Free ASH Whitepaper) website at www.hematology.org.

About Aspacytarabine (BST-236)

Aspacytarabine is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine serves as the backbone of AML therapy for over 45 years due to its superior efficacy, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities, which significantly limit its use, especially in older and medically compromised patients. Due to its unique pharmacokinetics and metabolism, aspacytarabine enables high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, aspacytarabine may serve as a new therapy for AML and other hematological malignancies and disorders, including for older adults who are unfit for intensive therapy.

Aspacytarabine was granted FDA Fast Track Designation for treatment of AML patients unfit for standard chemotherapy, and FDA and EMA Orphan Drug Designations, which entitle Biosight to seven and ten years of market exclusivity in the U.S. and Europe, respectively, upon aspacytarabine marketing approval for the treatment of AML in each territory.

Interim results from an ongoing Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and single-agent activity, and additional studies are ongoing to evaluate aspacytarabine as a second line treatment for patients with relapsed or refractory MDS or AML. For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov.

On November 4, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported five poster presentations from the Company’s pacritinib program at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, being held virtually and in Atlanta, Georgia, December 11-14, 2021 (Press release, CTI BioPharma, NOV 4, 2021, View Source [SID1234594370]).

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(PRNewsfoto/CTI BioPharma Corp.)

The details of the poster presentations are as follows:

Abstract Title: A Retrospective Head-to-Head Comparison between Pacritinib and Ruxolitinib in Patients with Myelofibrosis and Moderate to Severe Thrombocytopenia
Publication Number: 3639
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Session Date: Monday, December 13, 2021
Presentation Time: 6:00–8:00 p.m. ET
Location: Georgia World Congress Center, Hall B5
Presenter: Dr. John Mascarenhas

Abstract title: Safety Analysis of Pacritinib in Patients with Myelofibrosis and Severe Thrombocytopenia
Publication Number: 3640
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Session Date: Monday, December 13, 2021
Presentation Time: 6:00 p.m.–8:00 p.m. ET
Location: Georgia World Congress Center, Hall B5
Presenter: Dr. John Mascarenhas

Abstract Title: Long-Term Treatment with Pacritinib on a Compassionate Use Basis in Patients with Advanced Myelofibrosis
Publication Number: 3649
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Session Date: Monday, December 13, 2021
Presentation Time: 6:00 p.m.–8:00 p.m. ET
Location: Georgia World Congress Center, Hall B5
Presenter: Dr. (Professor) Claire Harrison

Abstract title: The Impact of Pacritinib on Myelofibrosis Symptoms in Patients with Moderate and Severe Thrombocytopenia: A Retrospective Analysis of Patients in the Persist-2 Study
Publication Number: 3628
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Session Date: Monday, December 13, 2021
Presentation Time: 6:00 p.m.–8:00 p.m. ET
Location: Georgia World Congress Center, Hall B5
Presenter: Dr. Jeanne Palmer

Abstract title: Evidence of NF-ΚB Pathway Activation in Patients with Advanced, High Molecular Risk Myelofibrosis
Publication Number: 3584
Session Name: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster III
Session Date: Monday, December 13, 2021
Presentation Time: 6:00–8:00 p.m. ET
Location: Georgia World Congress Center, Hall B5
Presenter: Dr. Jennifer O’Sullivan

The full abstracts can be viewed here.

About Pacritinib

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1 and CSF1R, but not JAK1. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT.

On November 4, 2021 Seagen Inc. (Nasdaq:SGEN) reported that new data for ADCETRIS (brentuximab vedotin), including five oral presentations, will be featured at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 11-14, 2021 (Press release, Seagen, NOV 4, 2021, View Source [SID1234594398]). Data presentations will include updated safety and efficacy results from clinical trials examining the potential of ADCETRIS with novel combinations in patients with advanced stage classical Hodgkin lymphoma (HL), in patients with newly diagnosed CD30-expressing peripheral T-cell lymphoma (PTCL) and in patients with other histologies.

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"We look forward to sharing new data for the continued development of ADCETRIS in combination with other therapies across patient populations," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Additionally, initial results will be presented from our SEA-BCMA program in patients with relapsed/refractory multiple myeloma."

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and expressed on the surface of several types of PTCL. ADCETRIS is approved in more than 75 countries for relapsed or refractory HL and systemic anaplastic large cell lymphoma (sALCL).

Presentations of Company-Sponsored ADCETRIS Trials:

Abstract Title

Abstract #

Presentation

Lead Author

The ECHELON-2 Trial: 5-Year Exploratory Subgroup Analyses of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) vs CHOP in Frontline Treatment of Pts with CD30-Positive Peripheral T-Cell Lymphoma

#135

Oral presentation /
Saturday, Dec. 11,
12:00 – 1:30 p.m. EST

S. Horwitz

Classical Hodgkin Lymphoma: Real-World Observations from Physicians, Patients, and Caregivers on the Disease and Its Treatment (CONNECT): Observations of Physicians on Treatment and Interim PET-Adapted Regimens

#1390

Poster presentation /
Saturday, Dec. 11,
5:30 – 7:30 p.m. EST

S. Parsons

Classical Hodgkin Lymphoma: Real-World Observations from Physicians, Patients, and Caregivers on the Disease and Its Treatment (CONNECT)—a Cross-Sectional Survey of Patients with Stage III or IV Classical Hodgkin Lymphoma Compared By Age

#1966

Poster presentation /
Saturday, Dec. 11,
5:30 – 7:30 p.m. EST

D. Flora

Pharmacodynamics of SEA-BCMA, a Nonfucosylated Antibody Targeting BCMA, in Patients with Relapsed/Refractory Multiple Myeloma

#1197

Poster presentation /
Saturday, Dec. 11,
5:30 – 7:30 p.m. EST

D. Taft

Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine (AN+AD) for advanced stage classic Hodgkin lymphoma: preliminary results from the single-arm phase 2 study (SGN35-027 Part B)

#2454

Poster presentation /
Sunday, Dec. 12,
6:00 – 8:00 p.m. EST

H. Lee

An Oncology Simulation Model to Estimate 10-Year Progression-Free Survival and Overall Survival Based on the 5-Year Update from the Echelon-2 Trial in Frontline Patients with Peripheral T-Cell Lymphoma: A United States Perspective

#2440

Poster presentation /
Sunday, Dec. 12,
6:00 – 8:00 p.m. EST

T. Phillips

Classical Hodgkin Lymphoma: Real-World Observations from Physicians, Patients, and Caregivers on the Disease and Its Treatment (CONNECT): Physician First-Line Treatment Preferences for Stage III or IV Classical Hodgkin Lymphoma

#2467

Poster presentation /
Sunday, Dec. 12,
6:00 – 8:00 p.m. EST

A. Evens

An Oncology Simulation Model to Estimate 10-Year Progression-Free Survival and Overall Survival Based on the 5-Year Update from the Echelon-2 Trial in Frontline Patients with Peripheral T-Cell Lymphoma: A United States Perspective

#2466

Poster presentation /
Sunday, Dec. 12,
6:00 – 8:00 p.m. EST

J. Burke

SEA-BCMA, an investigational nonfucosylated monoclonal antibody: interim results of a phase 1 study in relapsed/refractory multiple myeloma patients (SGNBCMA-001)

#2740

Poster presentation /
Sunday, Dec. 12,
6:00 – 8:00 p.m. EST

J. Hoffman

Trials-In-Progress

Brentuximab Vedotin in Combination with Nivolumab, Doxorubicin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma (SGN35-027, Trial in Progress)

#1369

Poster presentation /
Saturday, Dec. 11,
5:30 – 7:30 p.m. EST

I. Flinn

Brentuximab Vedotin in Combination with Lenalidomide and Rituximab in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (ECHELON-3, Trial in Progress)

#3564

Poster presentation /
Monday, Dec. 13,
6:00 – 8:00 p.m. EST

N. Bartlett

Frontline Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin and Prednisone in Patients With Peripheral T Cell Lymphoma With Less Than 10% CD30 Expression (SGN35 032, Trial in Progress)

#1401

Poster presentation /
Saturday, Dec. 11,
5:30 – 7:30 p.m. EST

D. Jagadeesh

Presentations of Investigator-Sponsored and Cooperative Group ADCETRIS Trials:

Abstract Title

Abstract #

Presentation

Lead Author

Brentuximab vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients with CD30-Expressing Peripheral T-cell Lymphomas

#133

Oral presentation /
Saturday, Dec. 11,
12:00 – 1:30 p.m. EST

A. Herrera

The Eatl-001 Trial: Results of a Phase 2 Study of Brentuximab vedotin and CHP Followed By Consolidation with High-Dose Therapy – Autologous Stem-Cell Transplantation (HDTASCT) in the Frontline Treatment of Patients with Enteropathy-Associated T-Cell Lymphoma

#136

Oral presentation /
Saturday, Dec. 11,
12:00 – 1:30 p.m. EST

D. Sibon

Interim results of a multicenter pilot study evaluating brentuximab vedotin with cyclophosphamide, doxorubicin, etoposide, and prednisone (BV-CHEP) for the treatment of aggressive adult T-cell leukemia/lymphoma

#1395

Poster presentation /

Saturday, Dec. 11,
5:30 – 7:30 p.m. EST

C. Dittus

Pacific: A Phase II Study of Brentuximab vedotin and Nivolumab Alone and then Combined with Rituximab, Cyclophosphamide, Doxorubicin and Prednisone for Patients with Untreated Primary Mediastinal Large B-Cell Lymphoma

#1408

Poster presentation /
Saturday, Dec. 11,
5:30 – 7:30 p.m. EST

R. Steiner

Brentuximab vedotin plus ESHAP (BRESHAP) versus ESHAP as salvage strategy for patients with primary refractory or relapsed classical Hodgkin’s Lymphoma. Preliminary results from the BRESELIBET prospective clinical

#2459

Poster presentation /
Sunday, Dec. 12,
6:00 – 8:00 p.m. EST

A. Sureda

Effect of Brentuximab Vedotin Addition to Chemotherapy and Prognostic Factors in 718 Patients with Relapsed/Refractory Hodgkin Lymphoma

#879

Oral presentation /
Monday, Dec. 13,
6:15 – 7:45 p.m. EST

J. Driessen

The Evolution of Children’s Oncology Group Hodgkin Lymphoma Trials: Predicted Impact on Late Cardiac Toxicity

#81

Oral presentation /
Monday, Dec. 13,
6:15 – 7:45 p.m. EST

A. Lo