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]).

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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.

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]).

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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.

On November 5, 2020 AVEO Oncology (NASDAQ: AVEO) and EUSA Pharma reported that previously reported results from the Phase 1b/2 TiNivo study of oral (PO) tivozanib, AVEO’s next-generation vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI) drug candidate, in combination with intravenous (IV) nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced or metastatic renal cell carcinoma (mRCC), were published in Annals of Oncology (Press release, AVEO, NOV 5, 2020, View Source [SID1234570175]). The article, titled "TiNivo: Safety and Efficacy of Tivozanib-Nivolumab Combination Therapy in Patients with Metastatic Renal Cell Carcinoma", is available online first via this link.

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"With a favorable tolerability profile, I believe that tivozanib holds potential to serve as a highly relevant VEGF TKI to use in combination with immunotherapy," said Laurence Albiges, MD, PhD, chair of the genitourinary group and vice chair of the department of cancer medicine at the Gustave Roussy Institute in Paris. "Additionally, the combination demonstrated anti-tumor activity and extended progression free survival (PFS), suggestive of the potential for favorable durability of response. These results serve as impetus for the continued evaluation of this promising combination."

"Evidenced by its activity, favorable tolerability profile, and its ability to significantly reduce regulatory T cells1, we believe tivozanib could serve as a VEGF TKI of choice in the immunotherapy combination setting," said Michael Bailey, president and chief executive officer of AVEO. "As we continue to execute on the DEDUCTIVE trial of tivozanib in combination with IMFINZI (durvalumab) in hepatocellular carcinoma, we look forward to establishing next steps in the clinic for the tivozanib-nivolumab combination in mRCC."

"We are pleased to see the publication of data from the TiNivo study, highlighting the favorable tolerability profile of the molecule in the setting of immuno-oncology agent combination," said Lee Morley, chief executive officer of EUSA Pharma. "We continue the commercial launch of FOTIVDA (tivozanib) in Europe for the first line treatment of RCC and are excited by the potential of tivozanib in other oncology settings."

The Phase 1b/2 study enrolled a total of 28 patients. The Phase 2 portion of the study (n=22) was designed to assess the safety, tolerability, and anti-tumor activity of the full dose and schedule of PO tivozanib (1.5 mg/QD for 21 days followed by a 7-day rest period), as established in the Phase 1b portion of the study (n=6), in combination with IV nivolumab (240 mg every 2 weeks). The combination was generally well tolerated and showed additive or synergistic activity for objective response rate and PFS in both treatment naïve and previously treated patients with mRCC. Overall median PFS for the 25 patients treated at the study’s full dose and schedule was 18.9 months (95% CI: 16.4; NR), with a median follow-up of 19.0 months. Median PFS for previously untreated patients (n=12) was 18.9 months, while median PFS for previously treated patients (n=13) has not yet been reached as of the data cutoff date. An objective response rate (complete response + partial response) of 56% was observed, including one treatment naïve patient (1/12) achieving a complete response, and a disease control rate of 96% (complete response + partial response + stable disease) was observed. Treatment-related Grade 3/4 adverse events (AEs) were reported in 20 patients (80%). Seven patients (28%) discontinued due to treatment-related AEs. The most common treatment-related Grade 3/4 AE was hypertension, reported in 13 patients (52%). Overall, four patients (17%) experienced a dose reduction of tivozanib due to AEs.

About Tivozanib

Tivozanib is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved as FOTIVDA for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union and other countries in the EUSA territory. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.2,3 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models1 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.4 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin in non-oncology indications.

On November 5, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that Derek Maetzold, president and chief executive officer, is scheduled to present a company overview at the Canaccord Genuity 2020 Virtual MedTech & Diagnostics Forum on Nov. 19, 2020, at 9:30 a.m. Eastern time (Press release, Castle Biosciences, NOV 5, 2020, View Source [SID1234570174]).

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A live audio webcast of the company’s presentation will be available by visiting Castle Biosciences’ website at View Source A replay of the webcast will be available for two weeks following the conclusion of the live broadcast.

On November 5, 2020 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported it will present data from its preclinical MALT1 inhibitor program at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held virtually December 5-8, 2020 (Press release, Schrodinger, NOV 5, 2020, View Source [SID1234570173]).

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MALT1 is a potential therapeutic target for non-Hodgkin’s B-cell lymphomas (NHL), chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), which are areas of high unmet medical need, especially in relapsed/refractory settings. Schrödinger has identified novel MALT1 inhibitors, which have shown antiproliferative effects in non-Hodgkin’s B-cell lymphoma models in preclinical studies.

Dose-dependent single agent anti-tumor activity was observed in a mouse xenograft model of B-cell lymphoma with the novel MALT1 inhibitors. When combined with ibrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, the activity observed supports the potential for MALT1 inhibitors to be used in combination to overcome drug-induced resistance in patients with relapsed/refractory B-cell lymphoma.

"We look forward to sharing our updated MALT1 results and advancing the program to IND-enabling studies in the coming year," said Karen Akinsanya, Ph.D., Executive Vice President, Chief Biomedical Scientist and Head of Discovery R&D at Schrödinger. "We are proud of the rapid progress we have made on our MALT1 program. Our physics-based software platform helped to accelerate compound optimization, enabling candidate selection in under two years."

The abstract is available online on the ASH (Free ASH Whitepaper) website and will be presented at the poster session in December.