On May 14, 2020 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that mitapivat and ivosidenib clinical data will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress being held virtually June 11-14, 2020 (Press release, Agios Pharmaceuticals, MAY 14, 2020, View Source [SID1234557999]).

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The accepted abstracts are listed below and are available online on the EHA (Free EHA Whitepaper) meeting library website: View Source All presentations can be accessed on demand by registered meeting attendees on the EHA (Free EHA Whitepaper) Virtual Congress platform as of Friday, June 12 at 08:30 a.m. CEST / 2:30 a.m. ET and will be accessible until October 15, 2020.

Oral Presentation:

Title: Proof of concept for the oral pyruvate kinase activator mitapivat in adults with non-transfusion-dependent thalassemia: Interim results from an ongoing, phase 2, open-label, multicenter study
Date & Time: Friday, June 12, 2020 at 8:30 a.m. CEST / 2:30 a.m. ET
Oral Abstract Session: New therapeutic approaches for thalassemia
Abstract: S297
Presenter: Kevin H. M. Kuo, M.D., Toronto General Hospital

Poster Presentations:

Title: Mitapivat (AG-348) long-term safety and efficacy in pyruvate kinase deficiency: 3-year results of the Drive PK study
Poster Session: Enzymopathies, membranopathies and other anemias
Abstract: EP1561
Author: Rachael F. Grace, M.D., Boston Children’s Hospital

Title: Ivosidenib improves overall survival relative to standard therapies in relapsed or refractory mutant IDH1 AML: Results from matched comparisons to historical controls
Poster Session: Acute myeloid leukemia – Clinical
Abstract: EP540
Author: Peter Paschka, M.D., Universitätsklinikum Ulm

Title: Ivosidenib (IVO) in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS): Updated enrollment of a phase 1 dose escalation and expansion study
Poster Session: Myelodysplastic syndromes – Clinical
Abstract: EP826
Author: Courtney D. DiNardo, M.D., University of Texas MD Anderson Cancer Center

Title: Pharmacokinetic/pharmacodynamic evaluation of ivosidenib or enasidenib combined with intensive induction and consolidation chemotherapy in patients with newly diagnosed IDH1/2-mutant AML
Poster Session: Acute myeloid leukemia – Clinical
Abstract: EP620
Author: Yue Chen, Agios Pharmaceuticals

Title: Ivosidenib (IVO) prior to hematopoietic cell transplant for patients with IDH1-mutant relapsed or refractory acute myeloid leukemia (R/R AML)
Poster Session: Acute myeloid leukemia – Clinical
Abstract: EP577
Author: Courtney D. DiNardo, M.D., University of Texas MD Anderson Cancer Center

Publication Only:

Title: Agile: Phase 3, double-blind, randomized, placebo-controlled study of ivosidenib in combination with azacitidine in adults with newly diagnosed acute myeloid leukemia and an IDH1 mutation
Publication Only (in abstract book): 04. Acute myeloid leukemia – Clinical
Abstract: PB1862
Author: Pau Montesinos, M.D., Ph.D., Hospital Universitari i Politècnic La Fe

Conference Call Information
Agios will host a virtual investor event on June 12, 2020 at 7:30 a.m. ET to review the mitapivat clinical data. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On May 14, 2020 Genmab A/S (Nasdaq: GMAB) reported that eight industry sponsored abstracts regarding Genmab and partner programs were accepted for presentation at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) EHA (Free EHA Whitepaper)25 Virtual Congress 2020, taking place virtually on June 11-14, 2020 (Press release, Genmab, MAY 14, 2020, View Source [SID1234557998]). A list of accepted Industry-sponsored abstracts featured at the congress includes two abstracts on epcoritamab (DuoBody-CD3xCD20), one on HexaBody-CD38, one on DuoHexaBody-CD37 and four daratumumab abstracts. The abstracts have been published on the EHA (Free EHA Whitepaper) website and may be accessed via www.ehaweb.org. All e-Poster presentations will be made available on the on-demand Virtual Congress platform Friday, June 12 at 08:30 CEST.

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"We are very pleased to see that once again a broad spectrum of data from Genmab’s innovative clinical and pre-clinical proprietary pipeline has been accepted for presentation at the prestigious EHA (Free EHA Whitepaper) Congress," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Industry-Sponsored Abstracts are as follows:

Epcoritamab (DuoBody-CD3xCD20):
Subcutaneous epcoritamab (DuoBody-CD3×CD20) induces complete response in heavily pre-treated patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma: Phase 1/2 dose escalation

Evaluation of pharmacodynamic biomarkers of epcoritamab (GEN3013; CD3CD20): Results from a Phase 1/2 dose-escalation study in relapsed/refractory B-cell Non-Hodgkin Lymphoma

HexaBody-CD38:
Superior anti-tumor activity of HexaBody-CD38 in preclinical models of Multiple Myeloma, B Cell Lymphoma and AML

DuoHexaBody-CD37:
DuoHexaBody-CD37 shows potent anti-tumor activity in pre-clinical B-cell lymphoma models in vitro and in vivo

Daratumumab (Submitted by Janssen Biotech, Inc.):
Phase 3 Study of Daratumumab/Bortezomib/Dexamethasone Versus Bortezomib/Dexamethasone in Chinese Patients with Relapsed/Refractory Multiple Myeloma: MMY3009 (LEPUS)

Corticosteriod Tapering in Patients with Relapsed or Refractory Multiple Myeloma Receiving Subcutaneous Daratumumab: Part 3 of the Open-label, Multicenter, Phase 1b PAVO Study

Impact of Depth of Response and Minimal Residual Disease on Health-Related Quality of Life of Transplant-Ineligible Patients with Newly-Diagnosed Multiple Myeloma

Daratumumab + Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma: Baseline slimCRAB-based Subgroup Analysis of CASSIOPEIA

On May 14, 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 that topline data of the recently completed L-DOS47 dose escalation study in combination with pemetrexed and carboplatin in recurrent or metastatic non-squamous non-small cell lung cancer ("LDOS001") will be published at the ASCO (Free ASCO Whitepaper) 2020 Annual Conference (Press release, Helix BioPharma, MAY 14, 2020, View Source [SID1234557997]).

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The ASCO (Free ASCO Whitepaper) publication details are:

Abstract: e21680

Title: Phase I dose escalation study of immunoconjugate L-DOS47 in combination with pemetrexed/carboplatin in non-squamous non-small cell lung cancer ("NSCLC") patients.

Authors: Afshin Dowlati, Chandra Prakash Belani, George R. Simon, Heman Chao, Sarina Anne Piha-Paul; University Hospitals Case Medical Center, Cleveland, OH; Penn State Cancer Institute, Hershey, PA; Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; Helix BioPharma Corp, Aurora, ON; Department of Investigational Cancer Therapeutics (Phase I Program), The University of Texas MD Anderson Cancer Center, Houston, TX.

NCT Registration number: NCT02309892

Results: Fourteen (14) patients were enrolled across 6 dosing cohorts in the study. No dose limiting toxicities were observed. Of the twelve (12) patients evaluated for efficacy, 5 patients (41.7%) had a partial response ("PR"), 4 patients (33.3%) experienced stable disease ("SD") and 3 patients (25.0%) had progressive disease ("PD"). The objective response rate is 41.7%. The clinical benefit rate is 75.0%. L-DOS47, in combination with pemetrexed/carboplatin, appears to be well tolerated with promising anti-tumor activity against non-squamous NSCLC.

"I would like to thank the patients and their families who participated in our clinical study, as well as the principle investigators and associates who helped conduct the study," said Dr. Heman Chao, Helix’s Chief Executive Officer. "We are very optimistic with L-DOS47’s demonstrated excellent safety profile and encouraging efficacy data."

On May 14, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of upcoming data presentations at the 56thAmerican Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held virtually May 29 – June 1, 2020 and the 25thEuropean Hematology Association (EHA) (Free EHA Whitepaper) annual congress, to be held virtually June 11 – 14, 2020 (Press release, TG Therapeutics, MAY 14, 2020, View Source [SID1234557996]). Details of the data presentations are included below.

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are extremely pleased to present data from three combination trials at the upcoming June conferences, which we believe underscores the progress we have made in our combinatorial approach, as well as the potential utility of our lead drug candidates in oncology. We are particularly excited to share the final results from the GENUINE Phase 3 trial, evaluating ublituximab in high-risk CLL patients, which is the first randomized trial to demonstrate a PFS benefit with the addition of an anti-CD20 antibody to ibrutinib, compared to ibrutinib monotherapy. Additionally, it is encouraging to see long-term results from the combination of umbralisib and ibrutinib continue to show the potential versatility of umbralisib in combination regimens." Mr. Weiss continued, "Lastly, we look forward to presenting updated results from our proprietary triple combination of ublituximab, umbralisib, and our highly selective, BTK inhibitor, TG-1701, which to date has shown encouraging clinical activity at all dose levels evaluated."

Data to be presented at the ASCO (Free ASCO Whitepaper) meeting:

Presentation Title: Effect of adding ublituximab to ibrutinib on PFS, ORR, and MRD negativity in previously treated high-risk chronic lymphocytic leukemia: Final results of the GENUINE phase III study

Abstract Number: 7506
Available on Demand: Friday, May 29, 2020 at 8:00 AM ET
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Lead Author: Jeff P. Sharman, MD, Willamette Valley Cancer Institute, US Oncology Research, Eugene, OR
The above abstract is now available via the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org.

Data to be presented at the EHA (Free EHA Whitepaper) meeting:

Presentation Title: Long term results of a Phase I/Ib study of ibrutinib in combination with umbralisib in patients with relapsed/refractory CLL or MCL

Abstract Number: EP689
Available on Demand: Friday, June 12, 2020 at 8:30 CEST
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Lead Author: Matthew Davids, MD, MMSc, Medical Oncology, Dana Farber Cancer Institute, Boston, MA
Presentation Title: Safety and activity of the once daily selective bruton tyrosine kinase (BTK) inhibitor TG-1701 in patients with chronic lymphocytic leukemia (CLL) and lymphoma

Abstract Number: EP705
Available on Demand: Friday, June 12, 2020 at 8:30 CEST
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Lead Author: Chan Cheah, MD, Haematology, Linear Clinical Research, and Sir Charles Gardiner Hospital, Nedlands, Australia
The above abstracts are now available via the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org.

Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

On May 14, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) reported updated results from the ongoing Phase 2 L-MIND study investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) (Press release, MorphoSys, MAY 14, 2020, View Source [SID1234557995]). The results, based on a November 30, 2019 data cut-off, corroborate previously reported primary analysis data.

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In this long-term analysis of the L-MIND data, 80 study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis. After a minimum of two years’ follow-up, outcomes from the L-MIND study are consistent with the primary analysis and confirm the durability of the response (DoR) and overall survival (OS) of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in autologous stem cell transplantation (ASCT)-ineligible patients with r/r DLBCL. Assessment by an independent review committee (IRC) at data cut-off showed an objective response rate (ORR) of 58.8% (47 out of 80 patients) and a complete response (CR) rate of 41.3% (33 out of 80 patients). Median duration of response (mDOR) was 34.6 months, with median overall survival (mOS) of 31.6 months and median progression-free survival (mPFS) of 16.2 months. The safety profile was consistent with that observed in previously reported studies of tafasitamab in combination with lenalidomide. The full analysis will be presented virtually at the 25th EHA (Free EHA Whitepaper) Annual Congress to be held June 11-14, 2020.

"We are extremely encouraged by the long-term data from our L-MIND study which confirms the previously reported results from the primary analysis," commented Dr. Malte Peters, Chief Research and Development Officer, MorphoSys. "Tafasitamab in combination with lenalidomide has the potential to address the significant medical need in patients suffering from r/r DLBCL, and we are working diligently towards our key priority of making tafasitamab available to eligible patients."

"The updated data for L-MIND reinforce the potential of tafasitamab in combination with lenalidomide as treatment for patients with r/r DLBCL. We look forward to working with our partners at MorphoSys as we seek to bring this new therapeutic option to eligible patients globally," Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte.

A Biologics License Application (BLA) for tafasitamab in combination with lenalidomide for r/r DLBCL is currently under Priority Review by the U.S. Food and Drug Administration (FDA) (PDUFA action date August 30, 2020). The BLA is based on data including the primary analysis of L-MIND with a previous cut-off date as of November 30, 2018, and the primary analysis data from the retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received lenalidomide monotherapy.

In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved, MorphoSys and Incyte will co-commercialize tafasitamab in the United States while Incyte has exclusive commercialization rights outside the United States.

About L-MIND
L-MIND is a single arm, open-label Phase 2 study, investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy and subsequent autologous stem cell transplantation. The study’s primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion. Primary analysis data with a cut-off date of November 30, 2018 included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update were based on response rates assessed by an independent review committee for all 80 patients.

About Re-MIND
Re-MIND, an observational retrospective study, was designed to isolate the contribution of tafasitamab in the combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory DLBCL who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys’ L-MIND trial. Re-MIND collected the efficacy data from 490 r/r DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively. The primary endpoint of Re-MIND has been met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy.

About tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved in the U.S., MorphoSys and Incyte will co-commercialize tafasitamab; Incyte will have exclusive commercialization rights outside the U.S. Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials, including L-MIND and Re-MIND. Additionally, tafasitamab is being evaluated as part of the ongoing Phase 3 study B-MIND study assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. Tafasitamab is also currently being investigated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.