Nanobiotix to Present at the UBS Global Healthcare Virtual Conference

On May 12, 2021 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that Laurent Levy, chief executive officer, will present at the UBS Global Healthcare Virtual Conference on Monday, May 24, 2021 at 7:00 am Eastern Time (Press release, Nanobiotix, MAY 12, 2021, View Source [SID1234579826]).

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A live webcast of the presentation may be accessed by visiting the events section of the company’s website at www.nanobiotix.com. A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on the company’s website.

Epizyme Announces Preclinical and Clinical Data to be Presented in Oral and Poster Sessions at Upcoming Medical Conferences in June

On May 12,, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that new preclinical and clinical data will be presented at upcoming medical meetings in June (Press release, Epizyme, MAY 12, 2021, View Source [SID1234579825]).

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"We look forward to sharing our preclinical data at EHA (Free EHA Whitepaper) that provide the therapeutic rationale for targeting SETD2 in multiple myeloma and are so pleased that it has been chosen for an oral presentation. These data are the basis for moving our SETD2 inhibitor program forward and, as we have previously reported, we remain on track for our planned IND submission in mid-2021 and plan to initiate a first-in-human clinical trial by year end," said Dr. Jeffery Kutok, Epizyme’s Chief Scientific Officer. "As our SETD2 inhibitor program began to take shape, we were struck by the many parallels we saw with our EZH2 inhibitor, TAZVERIK (tazemetostat). SETD2 is a histone methyltransferase, like EHZ2, and plays multiple key roles in cellular processes and cancer. We’re excited about the potential of SETD2 inhibition in several settings, including high-risk t(4;14) myeloma, and more broadly in myeloma without the t(4;14) mutation, as well as other B-cell malignancies. We see potential as a monotherapy, as well as in combination with existing and emerging therapies in myeloma, with preclinical data also showing synergy with tazemetostat."

"We are excited to share safety and preliminary activity data related to the EZH-301 confirmatory study of tazemetostat in Epithelioid Sarcoma (ES) at ASCO (Free ASCO Whitepaper), a key milestone toward our goal of demonstrating the benefits of tazemetostat to patients in earlier lines of treatment for ES and Follicular Lymphoma by exploring combinations with standard of care therapies," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "As we outlined during our recent Vision Call, we plan to further explore tazemetostat as both monotherapy and in combinations across multiple hematologic and solid tumor cancers in clinical studies, which are on track to initiate later this year."

Details of the presentations are listed below:

EHA Oral Presentation

Title: Discovery of a selective inhibitor of the SETD2 histone methyltransferase with potent in vitro and in vivo activity in preclinical models of multiple myeloma
Session: Basic and translational myeloma research
Presenter: Dr. Jennifer Totman
Abstract Code: S176
Live Q&A: Monday, June 14; 2021 8:45-9:30 p.m. CEST/2:45-3:30 p.m. EDT.

The EHA (Free EHA Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the EHA (Free EHA Whitepaper) website on Friday, June 11, 2021 at 9:00 a.m. CEST/3:00 a.m. EDT.

ASCO Poster Presentation

Title: Results of the phase 1b soft-tissue sarcoma (STS) portion of the global randomized, double-blind, placebo-controlled study of tazemetostat (TAZ) plus doxorubicin (DOX) as frontline therapy for advanced epithelioid sarcoma (ES)
Session: Sarcoma
Presenter: Sant P. Chawla, M.D.
Abstract No.: 11563

The ASCO (Free ASCO Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the ASCO (Free ASCO Whitepaper) website on Friday, June 4, 2021 at 9:00 a.m. EDT.

About TAZVERIK (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

Bluestar Genomics Closes $70M Series C Funding, Expands Scientific Advisory Board

On May 12, 2021 Bluestar Genomics, an innovative company leading the development of next-generation epigenomic approaches to early cancer detection, reported the company had raised $70 million in new equity funding (Press release, Bluestar Genomics, MAY 12, 2021, View Source [SID1234579824]). Led with the increased funding by the current investor, Mattias Westman, founding partner of Prosperity Capital Management, the oversubscribed Series C round includes several existing investors and multiple new investors: Pathology Asia Holdings Pte Ltd (Pathology Asia), the largest independent medical diagnostics group in Southeast Asia, as well as a venture fund based in San Francisco, CA, and a large, diversified asset manager on the west coast, among others. VAHOCA Pte Ltd acted as a financial advisor to Bluestar Genomics.

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Separately, the company announces the expansion of its Scientific Advisory Board, with the appointment of Drs. Felix Feng, professor of radiation oncology, urology, and medicine, University of California San Francisco, and Craig Venter, Ph.D., chairman and CEO of the J. Craig Venter Institute. With the new appointment, Feng and Venter are joining Alan Ashworth, Ph.D., FRS, president, Helen Diller Comprehensive Cancer Center, University of California, San Francisco.

"As we continue to champion the development of next-generation non-invasive cancer detection, we welcome Drs. Feng and Venter to our team. Their leading scientific and clinical expertise will help accelerate our development and commercialization efforts," said Samuel Levy, Ph.D., chief executive, and chief scientific officer at Bluestar Genomics. "Collectively, these milestones will extend our ability to deliver on our promise to improve on existing cancer screening and provide a new solution where none exists."

Series C investments and scientific advisory board membership expansion are largely inspired by Bluestar Genomics’ groundbreaking technology platform that employs state-of-the-art machine learning coupled with the 5-hydroxymethylcytosine (5hmC) as a screening method to detect cancer in multiple organs in men and women. The company’s novel approach has recently demonstrated positive results in two studies published in Nature Communications and earned the FDA’s breakthrough device designation for the company’s proprietary non-invasive pancreatic cancer detection test.

"The convergence of innovative technologies has pushed the cost of multi-cancer screening down by 20-fold, allowing for continued optimization of cancer detection via routine blood draw to improve patient early treatment options," said Venter. "With the multi-cancer screening market projected to scale to more than $100 billion in the U.S. alone, Bluestar Genomics’ technology is uniquely positioned to address the needs of over 60 million patients. I am excited to become part of such a pivotal contribution to improving patient lives through completely unlocking the full potential of genomics."

Xencor to Present at the 2021 RBC Capital Markets Global Healthcare Virtual Conference

On May 12, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that Bassil Dahiyat, Ph.D., president and chief executive officer, will participate in a virtual fireside chat at the 2021 RBC Capital Markets Global Healthcare Virtual Conference on Wednesday, May 19, 2021 at 1:20 p.m. ET / 10:20 a.m. PT (Press release, Xencor, MAY 12, 2021, View Source [SID1234579823]).

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A live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Following the webcast, a replay will be archived on the website for at least 30 days.

Legend Biotech Reports New and Updated Data from BCMA CAR-T Program at 2021 ASCO and EHA Meetings

On May 12, 2021 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 15 abstracts have been accepted at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper)’s (EHA) (Free EHA Whitepaper) 2021 Virtual Congress, including new and updated data from the CARTITUDE clinical development program being led by Janssen Research & Development, LLC (Janssen) for the investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, ciltacabtagene autoleucel (cilta-cel) (Press release, Legend Biotech, MAY 12, 2021, View Source [SID1234579822]).

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"The Legend Biotech team, together with our collaborator Janssen, look forward to sharing the updated efficacy and longer-term safety data for cilta-cel," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "These exciting data and a wide range of other abstracts highlight our continued commitment and efforts to developing innovative treatments that will make a difference in the lives of those living with multiple myeloma."

Longer-term follow-up efficacy and safety results from the Phase 1b/2 CARTITUDE-1 study of cilta-cel in patients with relapsed/refractory multiple myeloma (Abstract #8005) will be featured in an oral presentation at the 2021 ASCO (Free ASCO Whitepaper) Meeting and as a poster presentation at EHA (Free EHA Whitepaper) (Abstract #EP964). Results from this study supported recent U.S. and European regulatory filings submitted by Legend Biotech’s collaborator, Janssen.

For the first time, data from Cohort A of the CARTITUDE-2 study evaluating the safety and efficacy of cilta-cel in patients with progressive multiple myeloma who have received 1-3 prior lines of therapy, will be presented, being featured as a poster presentation at ASCO (Free ASCO Whitepaper) (Abstract #8013) and in an oral presentation at EHA (Free EHA Whitepaper) (Abstract # S190). Poster presentations at both meetings will provide additional efficacy and safety information with cilta-cel in comparison to standard of care therapies and neurological adverse event mitigation measures.

Select abstracts from both Congresses are below.

ASCO Presentations (June 4-8, 2021)

Abstract No.

Title

Date/ Time

Abstract #8005

Oral Presentation

Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)–directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1​

Tuesday, June 8th 8:00-11:00 AM EDT

Abstract #8013

Poster Discussion

CARTITUDE-2: Efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma (MM) after 1–3 prior lines of therapy​

Friday, June 4th @ 9:00AM EDT

Abstract #8028

Poster Presentation

Incidence, mitigation, and management of neurologic adverse events in patients with multiple myeloma (MM) treated with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-2​

Friday, June 4th @ 9:00 AM EDT

Abstract #8045

Poster Presentation

Comparison of outcomes with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 vs real-world standard of care (RW SOC) for patients (pts) with triple-class exposed relapsed/refractory multiple myeloma (RRMM)

Friday, June 4th @ 9:00 AM EDT

Abstract #8030

Poster Presentation

Cilta-cel vs. conventional treatment in patients with relapse/refractory multiple myeloma​

Friday, June 4th @ 9:00 AM EDT

Abstract #8041

Poster Presentation

LocoMMotion: A prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed/refractory multiple myeloma (RRMM) receiving ≥3 prior lines of therapy.

Friday, June 4th @ 9:00 AM EDT

The abstracts will be released on ASCO (Free ASCO Whitepaper) Meeting Library on May 19th, 2021 at 5:00 PM EDT.

EHA Presentations (June 9-17, 2021)

Abstract No.

Title

Date/ Time

Abstract #S190

Oral​

Efficacy and safety of the BCMA-directed CAR-T cell therapy, ciltacabtagene autoleucel, in patients with progressive multiple myeloma (MM) after 1–3 prior lines of therapy: Initial results from CARTITUDE-2

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP964

EPoster​

Updated CARTITUDE-1 results of ciltacabtagene autoleucel, a B-cell maturation antigen–directed chimeric antigen receptor T cell therapy, in relapsed/refractory multiple myeloma

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP1003

EPoster​

Incidence, mitigation, and management of neurologic adverse events in the phase 2 CARTITUDE-2 study of ciltacabtagene autoleucel in patients with multiple myeloma

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP987

EPoster​

A prospective, non-interventional, multinational study of real-life standard of care in patients with relapsed/refractory multiple myeloma receiving ≥3 prior lines of therapy: Interim data from LocoMMotion

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP990

EPoster​

Comparison of ciltacabtagene autoleucel versus conventional treatment in patients with relapsed/refractory multiple myeloma

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP1049

EPoster​

Ciltacabtagene autoleucel versus selinexor + dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) treated with ≥3 lines of prior therapy: A matching adjusted indirect comparison

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP978

EPoster​

Matching adjusted indirect comparison of ciltacabtagene autoleucel versus belantamab mafodotin in patients with relapsed/refractory multiple myeloma (RRMM) treated with ≥3 lines of prior therapy

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP977

EPoster​

Comparison of outcomes with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 versus standard of care in triple-class exposed multiple myeloma patients in clinical trials of daratumumab

Available starting Friday, June 11th @ 9:00AM CEST

Abstract # EP972

EPoster​

Ciltacabtagene autoleucel for triple-class exposed multiple myeloma: Adjusted comparison of CARTITUDE-1 outcomes versus real world clinical practice observed in German registry

Available starting Friday, June 11th @ 9:00AM CEST

The abstracts are available on the EHA (Free EHA Whitepaper) website at: View Source

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.1 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.

About CARTITUDE-2

CARTITUDE-2 (NCT04133636) is an ongoing Phase 2 multicohort study evaluating the safety and efficacy of cilta-cel in various clinical settings. Cohort A included patients who had progressive multiple myeloma after 1–3 prior lines of therapy, including PI and IMiD, were lenalidomide refractory, and had no prior exposure to BCMA-targeting agents. The primary objective was percentage of patients with negative minimal residual disease (MRD).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 outside of China 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 and/or refractory multiple myeloma and in earlier lines of treatment. Cilta-cel is a differentiated CAR-T therapy 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. 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 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. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.