On October 27, 2021, Acceleron Pharma reported that Bristol Myers Squibb ("BMS") announced the net sales of REBLOZYL (luspatercept-aamt) were approximately $160 million for the quarter ended September 30, 2021, which include approximately $20 million to $25 million of sales from an inventory build due to the transition to wholesaler distribution and approximately $13.5 million of net sales outside of the United States (Press release, Acceleron Pharma, OCT 27, 2021, View Source [SID1234592008]).

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As previously disclosed, under the collaboration agreement between Acceleron Pharma Inc. (the "Company") and BMS for REBLOZYL, the Company is eligible to receive tiered royalty payments from BMS on net sales of REBLOZYL in the low-to-mid 20% range. The Company expects to report royalty revenue of approximately $32.0 million from net sales of REBLOZYL in the quarter ended September 30, 2021.

This preliminary unaudited revenue estimate is the responsibility of management and is subject to the completion of the Company’s customary quarter-end financial closing procedures, including management’s review and finalization, as well as review procedures by the Company’s independent registered public accounting firm, which have not yet been completed. During the course of the Company’s review process, items may be identified that would require it to make adjustments, which could result in material changes to the Company’s preliminary unaudited estimated financial results. Consequently, this revenue estimate should not be viewed as a substitute for the Company’s earnings release and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2021.

The information contained in this Item is being furnished and shall not be deemed "filed" for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing.

On October 27, 2021 Race Oncology Limited ("Race") reported it has entered into a research collaboration with Dr Dan Dominissini of the Chaim Sheba Medical Center, Israel to analyse clinical patient samples from the ongoing Zantrene Phase 1b/2 trial in relapsed/refractory Acute Myeloid Leukaemia (R/R AML) for FTO and FTO-related biomarkers (ASX Announcement: 9 August 2021) (Press release, Race Oncology, OCT 27, 2021, View Source [SID1234592003]).

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The biomarker testing will include FTO gene sequencing, FTO protein levels (intracellular staining and flow cytometry), FTO mRNA levels, and analysis of the m6A/A ratio in mRNA from patient tumour samples before, during and after treatment with Zantrene.

Dr Dominissini is a world-renowned expert in RNA methylation and m6A RNA methylation and has authored more than 32 publications in high impact peer-reviewed journals including Nature, Science and Cell.

This research collaboration has strategic importance for Race as the data will advance Race’s ‘Three Pillar’ strategy announced at the 2020 AGM (ASX Announcement: 30 November 2020).

"We are delighted to be extending our successful collaboration with the team at Chaim Sheba to generate important data on the effects of Zantrene on FTO and related molecules. These data will give us the first insights into the effect of Zantrene in patients on FTO and m6A RNA methylation and continues to advance our Three Pillar Strategy."

Race CSO Dr Daniel Tillett
"Conceptual and technological breakthroughs since 2011, by our group and others, have introduced the novel notion that internal chemical modifications of mRNA and long non-coding RNA are abundant, dynamic and sometimes reversible events, which constitute essential regulatory elements in RNA metabolism. Dedicated cellular machineries that install (‘writers’), remove (‘erasers’) and recognize (‘readers’) the various RNA modifications have been discovered, revealing essential roles for mRNA and lncRNA modification in various cellular, developmental and disease processes, and providing avenues for therapeutic intervention. N6-methyladenosine (m6A) is the most prevalent internal mRNA modification, removed by the enzyme FTO, with established key roles in carcinogenesis. We are excited to see these basic discoveries translated into the clinic by the Zantrene study of Race Oncology for relapsed or refractory AML. We hope that our scientific collaboration will advance the understanding of the correlation between FTO and m6A status in AML and response to treatment."

Dr Dominissini from Chaim Sheba
Relapsed or Refractory Acute Myeloid Leukemia
Primary refractory or relapsed acute myeloid leukemia is associated with poor prognosis and remains a major therapeutic challenge. Primary refractory AML is defined by the absence of complete remission (CR), manifested by blast count of ≥5% in bone marrow after one or two cycles of intense induction chemotherapy.

Up to 30% of adults with newly diagnosed AML fail to achieve CR after two courses of intensive chemotherapy.

Even when CR is achieved through intense chemotherapy, approximately half of the younger and 80% of the older patient’s relapse. In both clinical situations, refractory and/or relapsed AML, active disease remains a major therapeutic challenge despite recent advances.

Study Design
Samples will be taken from patients participating in the existing study, "An open-label, Phase 1b/2 study of intravenous FluCloZan (fludarabine, clofarabine, Zantrene (bisantrene dihydrochloride)" in cohorts of adult patients with R/R AML using a Simon’s 2-stage design: a Phase 1b lead-in dose escalation stage to establish the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of FluCloZan and a Phase 2 expansion stage to determine efficacy and confirm safety of the FluCloXan regimen at the RP2D in up to 17 subjects.

On October 27, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it will report its third quarter 2021 financial and operating results after the close of U.S. financial markets on Wednesday, November 3, 2021 (Press release, Tracon Pharmaceuticals, OCT 27, 2021, View Source [SID1234592002]). In addition, management will host a conference call to provide an update on corporate activities and discuss the financial results.

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On October 27, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that it will host a conference call and live webcast on Tuesday, November 2, 2021 at 8:30 a.m. EDT to report financial results for the third quarter 2021 and provide business updates (Press release, ADC Therapeutics, OCT 27, 2021, View Source [SID1234592001]).

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To access the live call, please dial 833-303-1198 (domestic) or +1 914-987-7415 (international) and provide conference ID 4035885. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

On October 27, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will announce its financial results for the third quarter on Tuesday, November 9th, 2021 (Press release, BioNTech, OCT 27, 2021, View Source [SID1234592000]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. ET (2.00 p.m. CET) to report its financial results and provide a corporate update for the third quarter 2021.

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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

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The slide presentation and audio of the webcast will be available via this link.

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.