1stOncology™: Cancer Intelligence Service – Page 10779 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

InnoCare to Present Clinical Data of Orelabrutinib at the Upcoming 62nd Annual Meeting of ASH

On November 5, 2020 InnoCare Pharma (HKEX: 09969), a clinical-stage biopharmaceutical company, reported that the company will present latest clinical data of its BTK inhibitor Orelabrutinib at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 5-8, 2020, which will be held online (Press release, InnoCare Pharma, NOV 5, 2020, View Source [SID1234570180]). The study in Patients with Relapsed or Refractory Mantle Cell Lymphoma, led by Dr. Jun Zhu, and the study in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Cell Leukemia, led by Dr. Jianyong Li, will be presented in three posters. This is the second consecutive year for InnoCare to present Orelabrutinib data at ASH (Free ASH Whitepaper).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Poster Presentation 1：

Title：Pooled Analysis of Safety Data from Clinical Trials of Orelabrutinib Monotherapy in Hematologic Malignancies

Abstract Number：1140

Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I

Session Date: Saturday, December 5, 2020

Presentation Time: 7:00 AM-3:30 PM

Location: Poster Hall (Virtual Meeting)

Presenter: Yuqin Song, M.D., Ph.D.

Abstract website: View Source

Poster Presentation 2：

Title：Long-Term Safety and Efficacy of Orelabrutinib Monotherapy in Chinese Patients with Relapsed or Refractory Mantle Cell Lymphoma: A Multicenter, Open-Label, Phase II Study

Abstract Number：2048

Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II

Session Date: Sunday, December 6, 2020

Presentation Time: 7:00 AM-3:30 PM

Location: Poster Hall (Virtual Meeting)

Presenter: Yuqin Song, M.D., Ph.D.

Abstract website: View Source

Poster Presentation 3：

Title：Updated Results from the Phase II Study of Orelabrutinib Monotherapy in Chinese Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Cell Leukemia

Abstract Number：1320

Session Name: 642. CLL: Therapy, excluding Transplantation: Poster I

Session Date: Saturday, December 5, 2020

Presentation Time: 7:00 AM-3:30 PM

Location: Poster Hall (Virtual Meeting)

Presenter: Wei Xu, M.D.

Abstract website: View Source

InnoCare will release detailed Orelabrutinib clinical data during ASH (Free ASH Whitepaper) meetings.

About Orelabrutinib

Orelabrutinib is a selective BTK inhibitor for the treatment of cancers and autoimmune diseases, which has been supported by the national special project for the development of major new drugs. Currently, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies. Current clinical data have demonstrated orelabrutinib’s robust efficacy and safety profile. Orelabrutinib’s two indications have been included in priority review by the NMPA.

Interim Data From Imago BioSciences’ Phase 2b Study of Bomedemstat (IMG-7289) for Treatment of Myelofibrosis to Be Presented at 62nd American Society of Hematology Annual Meeting

On November 5, 2020 Imago BioSciences, Inc., ("Imago") a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported that interim data from its ongoing Phase 2b study evaluating bomedemstat (IMG-7289) for the treatment of myelofibrosis will be presented in an oral session during the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually Dec. 5-8, 2020 (Press release, Imago BioSciences, NOV 5, 2020, View Source [SID1234570179]). An abstract containing preliminary findings will be published in the meeting program on Nov. 5, with updated findings presented during the oral session.

Oral Presentation Information:

Session: 634 – Myeloproliferative Syndromes: Clinical: New Therapies and JAKi-based Combinations for Myelofibrosis
Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (bomedemstat) for the Treatment of Advanced Myelofibrosis
Presenter: Kristen M. Pettit, M.D., Assistant Professor of Medicine at the University of Michigan, Rogel Cancer Center, Ann Arbor, Michigan
Presentation Date: 7:30 am ET on Saturday, Dec. 5, 2020
About Bomedemstat (IMG-7289)

Bomedemstat is being evaluated in an open-label Phase 2 clinical trial for the treatment of advanced myelofibrosis (MF), a bone marrow cancer that interferes with the production of blood cells. MF patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor are eligible for the study of bomedemstat as monotherapy. The endpoints include spleen volume reduction and symptom improvement at 12 and 24 weeks of treatment. Preliminary results were most recently presented at the 2020 European Hematology Association (EHA) (Free EHA Whitepaper). In addition to the MF study, bomedemstat is also being evaluated for the treatment of essential thrombocythemia and polycythemia vera.

Bomedemstat is an orally available small molecule discovered and developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, bomedemstat demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat is an investigational agent currently being evaluated in multiple ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185, NCT04262141, NCT04254978 and NCT04081220). Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, Orphan Drug Designation for treatment of acute myeloid leukemia and PRIME designation by the European Medicines Agency for the treatment of MF.

ADC Therapeutics to Host Third Quarter 2020 Financial Results Conference Call on November 12, 2020

On November 5, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that it will host a conference call and live webcast on Thursday, November 12, 2020 at 8:30 am ET to report financial results for the third quarter ended September 30, 2020 and provide business updates (Press release, ADC Therapeutics, NOV 5, 2020, View Source [SID1234570178]).

To access the live call, please dial 833-249-8403 (domestic) or + 41 225675632 (international). A live webcast of the presentation will be available under "Events and Presentations" on the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available after the completion of the event and for 30 days following the call.

Legend Biotech Announces ASH 2020 Data Presentations for Ciltacabtagene Autoleucel (cilta-cel), an Investigational BCMA CAR-T Cell Therapy in Development for Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)

On November 5, 2020 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that new and updated data from CARTITUDE-1 and LEGEND-2 studies, respectively, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place virtually December 5-8, 2020 (Press release, Legend Biotech, NOV 5, 2020, View Source [SID1234570177]).

CARTITUDE-1 data for oral presentation will highlight Phase 1b/2 efficacy and safety results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel). Additional poster presentations for cilta-cel data will include detailed analyses of cytokine release syndrome and health-related quality of life outcomes from CARTITUDE-1. LEGEND-2 data in patients with relapsed or refractory multiple myeloma and extramedullary disease will also be presented as a poster.

"We look forward to sharing new data from the CARTITUDE-1 study in the US and the LEGEND-2 study in China," said Ying Huang, PhD, interim-CEO and CFO of Legend Biotech. "With our successful clinical efforts and the Company’s collaboration with Janssen, we are uniquely positioned to deliver a novel therapy to patients with multiple myeloma."

On Saturday, December 5th, during the Myeloma session entitled: Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel Therapies Targeting B Cell Maturation Antigen in Relapsed/Refractory Multiple Myeloma, the Phase 1b/2 clinical efficacy and safety data for cilta-cel from the CARTITUDE-1 study will be presented.

Following are details of the five abstracts that have been accepted for presentation at the 62nd ASH (Free ASH Whitepaper) Annual Meeting & Exposition. For additional information visit: View Source

Abstract No.

Title

Date/Time

Oral Presentation

Abstract #177

CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma

Saturday, Dec. 5
12:00 p.m. PT

Poster Presentations

Abstract #1412

Patient Expectations and Perceptions of Treatment in CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma

Saturday, Dec. 5
7:00 a.m. – 3:30 p.m. PT

Abstract #2291

Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma

Sunday, Dec. 6
7:00 a.m. – 3:30 p.m. PT

Abstract #2304

Chimeric Antigen Receptor T Cell Therapy in the Relapsed or Refractory Multiple Myeloma with Extramedullary Disease–a Single Institution Observation in China (LEGEND-2)

Sunday, Dec. 6

7:00 a.m. – 3:30 p.m. PT

Abstract #3240

Cytokine Release Syndrome in Patients With Relapsed/Refractory Multiple Myeloma Treated With Ciltacabtagene Autoleucel in the Phase 1b/2 CARTITUDE-1 Study

Monday, Dec. 7
7:00 a.m. – 3:30 p.m. PT

About CARTITUDE-1
Cilta-cel is currently being investigated in the Phase 1b/2 CARTITUDE-1 (MMY2001, NCT03548207) registration study conducted in the US and Japan for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.1

About LEGEND-2
LEGEND-2 (NCT03090659) is an ongoing single-arm, open-label Phase 1 study of 74 patients being conducted at four participating hospitals in China evaluating the efficacy and safety of LCAR-B38M CAR-T cells for the treatment of relapsed or refractory multiple myeloma.2

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.3 Although treatment may result in remission, unfortunately, patients will most likely relapse.4 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.5 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.6,7 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.8 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.9

About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel.

In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.

Lantheus Holdings, Inc. Reports Third Quarter 2020 Financial Results

On November 5, 2020 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, reported financial results for its third quarter ended September 30, 2020 (Press release, Lantheus Medical Imaging, NOV 5, 2020, View Source [SID1234570176]).

The Company’s worldwide revenue for the third quarter of 2020 totaled $88.5 million, compared with $85.8 million for the third quarter of 2019, representing an increase of 3.2% from the prior year period.

The Company’s third quarter 2020 net loss was $6.4 million, or $(0.10) per fully diluted share, as compared to net income of $4.9 million, or $0.12 per fully diluted share for the third quarter of 2019.

The Company’s third quarter 2020 adjusted fully diluted earnings per share were $0.04, as compared to $0.28 for the third quarter of 2019, representing a decrease of 87.1% from the prior year period.

Lastly, net cash provided by operating activities was $8.6 million for the third quarter 2020. Free Cash Flow was $4.8 million in the third quarter of 2020, representing a decrease of approximately $18.3 million from the prior year period.

"We continued to see steady recovery throughout the quarter primarily driven by DEFINITY and complemented by accelerated synergy capture, delivering a strong adjusted EPS performance," said Mary Anne Heino, President and CEO. "Importantly, despite increased investment during the quarter related to our newly-combined business and our on-going integration efforts, we generated positive free cash flow. We remain committed to executing on our corporate initiatives even during these unprecedented times. In our first quarter as an integrated company, we received approval for VIALMIXRFID and submitted the NDA for our PSMA-targeted PET imaging agent, PyL. We believe these accomplishments and our continued financial discipline position us to drive sustainable future growth and enhanced shareholder value."

Outlook

On April 9, 2020, the Company withdrew full year 2020 revenue, revenue growth, and adjusted fully diluted earnings per share guidance as a result of the continued uncertainties surrounding the scope, duration and impacts of the COVID-19 pandemic. Due to these uncertainties, and uncertain timing of global recovery and economic normalization, the Company continues to be unable to provide guidance as to the overall impacts on its operations and financial results during the ongoing pandemic.

Internet Posting of Information

The Company routinely posts information that may be important to investors in the "Investors" section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.

Conference Call and Webcast

As previously announced, the Company will host a conference call and webcast on Thursday, November 5, 2020 at 8:00 a.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 8872902. A live webcast will be available in the Investors section of the Company’s website at www.lantheus.com.

A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.