On September 23, 2021Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, reported updated clinical data, including median overall survival (mOS), from the ASCERTAIN phase 3 trial of INQOVI, the company’s orally administered fixed-dose combination of decitabine and cedazuridine (ASTX727 or DEC-C) in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML). mOS was 31.7 months (Press release, Astex Pharmaceuticals, SEP 23, 2021, View Source [SID1234590216]).

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The data were featured in a presentation given today at the 16th International Congress on Myelodysplastic Syndromes in Toronto, Canada, by Michael Savona, MD, Professor of Medicine and Cancer Biology, Department of Internal Medicine at Vanderbilt University School of Medicine, Tenn., on behalf of the study investigators.

The ASCERTAIN clinical trial was designed as a randomized crossover study comparing oral decitabine (35mg) and cedazuridine (100mg) fixed-dose combination tablet given once daily for 5 days on a 28-day cycle to IV decitabine (20mg/m2) administered as a daily 1-hour IV infusion for 5 days on a 28-day cycle, in the first 2 cycles. Patients continued to receive oral decitabine and cedazuridine from Cycle 3 onwards. The primary endpoint data for the study of total 5-day decitabine area-under-the-curve (AUC) equivalence of oral decitabine and cedazuridine and IV decitabine was previously presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.1 The oral/IV decitabine 5-day AUC was 98.9% with a 90% Confidence Interval between 92.7% and 105.6%.

Safety findings from the study were similar to those anticipated with IV decitabine, with incidence of cytopenias slightly higher with INQOVI during Cycle 1 compared to IV decitabine. The most common adverse events (AEs) of thrombocytopenia, neutropenia, and anemia were consistent with expected AEs with parenteral hypomethylating agent treatment.

In the more mature data set used to evaluate overall survival, the complete response (CR) rate for evaluable patients was 22%, with an overall response rate (CR + Partial Response + Marrow CR + Hematological Improvement) of 62%.

"Taken together, the ASCERTAIN phase 3 study data support considerable therapeutic utility of oral decitabine and cedazuridine in the treatment of patients with MDS and CMML," said Co-Principal Investigator of the ASCERTAIN phase 3 study, Michael Savona, MD. "The fixed-dose combination of decitabine and cedazuridine is the only available oral DNA methyltransferase inhibitor / hypomethylating agent that has demonstrated equivalent exposure to an IV form. The median overall survival data from this study makes oral decitabine and cedazuridine an alternative option to parenteral administration of decitabine for patients with these diseases."

Added Timothy Whitten, president and CEO of Taiho Oncology, Inc., Astex’s commercialization partner for INQOVI in the United States: "We are encouraged by data from the ASCERTAIN trial that continue to show oral decitabine and cedazuridine is a promising treatment option for patients living with MDS and CMML. Importantly, patients can benefit from the convenience of an at-home hypomethylating agent treatment and potentially reduce the number of office visits and associated travel."

Based on the data from the ASCERTAIN clinical program, INQOVI is being investigated in combination with other agents in hematological malignancies, according to Harold Keer, MD, PhD, chief medical officer of Astex Pharmaceuticals, Inc. "The first of these studies is investigating the all-oral combination of decitabine and cedazuridine with venetoclax for the treatment of AML. We are extremely grateful to all the patients, caregivers, partner research and manufacturing organizations, as well as the healthcare professionals who have contributed to the clinical development program of oral decitabine and cedazuridine."

INQOVI is an orally administered, fixed-dose combination of the approved anti-cancer DNA hypomethylating agent, decitabine, together with cedazuridine,2 an inhibitor of cytidine deaminase.3 By inhibiting cytidine deaminase in the gut and the liver, INQOVI is designed to allow for oral delivery of decitabine over five days in a given cycle to achieve comparable systemic exposure to IV decitabine. The phase 1 and phase 2 clinical study results have been published in Lancet Haematology4 and Blood,5 respectively.

INQOVI was approved in July 2020 by the U.S. Food and Drug Administration (FDA) and by Health Canada. INQOVI is the first and only oral hypomethylating agent approved by the FDA and by Health Canada for the treatment of adults with intermediate and high-risk MDS including CMML.6

Commercialization of INQOVI in the U.S. and Canada is conducted by Taiho Oncology, Inc. and Taiho Pharma Canada, Inc., respectively. Astex, Otsuka and Taiho are all members of the Otsuka group of companies.

The presentation can be downloaded from the Astex website at: View Source – International MDS Symposium September 2021

Learn more about INQOVI at View Source

INDICATIONS

INQOVI (decitabine and cedazuridine) is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.6

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Myelosuppression: Fatal and serious myelosuppression can occur with INQOVI. Based on laboratory values, new or worsening thrombocytopenia occurred in 82% of patients, with Grade 3 or 4 occurring in 76%. Neutropenia occurred in 73% of patients, with Grade 3 or 4 occurring in 71%. Anemia occurred in 71% of patients, with Grade 3 or 4 occurring in 55%. Febrile neutropenia occurred in 33% of patients, with Grade 3 or 4 occurring in 32%. Myelosuppression (thrombocytopenia, neutropenia, anemia, and febrile neutropenia) is the most frequent cause of INQOVI dose reduction or interruption, occurring in 36% of patients. Permanent discontinuation due to myelosuppression (febrile neutropenia) occurred in 1% of patients. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying MDS.

Fatal and serious infectious complications can occur with INQOVI. Pneumonia occurred in 21% of patients, with Grade 3 or 4 occurring in 15%. Sepsis occurred in 14% of patients, with Grade 3 or 4 occurring in 11%. Fatal pneumonia occurred in 1% of patients, fatal sepsis in 1%, and fatal septic shock in 1%.

Obtain complete blood cell counts prior to initiation of INQOVI, prior to each cycle, and as clinically indicated to monitor response and toxicity. Administer growth factors, and anti‑infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose as recommended.

Embryo-Fetal Toxicity: INQOVI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise patients to use effective contraception during treatment with INQOVI and for 6 months (females) or 3 months (males) after last dose.

ADVERSE REACTIONS

Serious adverse reactions in > 5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Fatal adverse reactions included sepsis (1%), septic shock (1%), pneumonia (1%), respiratory failure (1%), and one case each of cerebral hemorrhage and sudden death.

The most common adverse reactions (≥ 20%) were fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased. The most common Grade 3 or 4 laboratory abnormalities (>50%) were leukocytes decreased, platelet count decreased, neutrophil count decreased, and hemoglobin decreased.

USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with INQOVI and for at least 2 weeks after the last dose.

Renal Impairment: No dosage modification of INQOVI is recommended for patients with mild or moderate renal impairment (creatinine clearance [CLcr] of 30 to 89 mL/min based on Cockcroft-Gault). Due to the potential for increased adverse reactions, monitor patients with moderate renal impairment (CLcr 30 to 59 mL/min) frequently for adverse reactions. INQOVI has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min) or end-stage renal disease (ESRD: CLcr <15 mL/min).

Please see the accompanying Full Prescribing Information.

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias affecting one or more of the three lineages. U.S. incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.7,8 The prevalence has been estimated to be from 60,000 to 170,000 in the U.S.9 MDS may evolve into acute myeloid leukemia (AML) in one-third of patients.10 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML.

CMML is a clonal hematopoietic malignancy characterized by accumulation of abnormal monocytes in the bone marrow and in blood. The incidence of CMML in the U.S. is approximately 1,100 new cases per year,11 and CMML may transform into AML in 15% to 30% of patients.12

On September 23, 2021 GlycoMimetics reported that Efficacy and safety data from a Phase 1/2 clinical study of uproleselan, GlycoMimetics’ lead investigational drug, were published online September 16, 2021 in the journal BLOOD (Press release, GlycoMimetics, SEP 23, 2021, View Source [SID1234590215]). In the manuscript, scientists highlight an analysis of minimal residual disease (MRD) and report an MRD negative rate of 69 percent in trial participants with relapsed/refractory acute myeloid leukemia (AML), indicating an enhanced depth of response following addition of uproleselan to salvage therapy. The paper also confirms that uproleselan can be safely combined with an intensive salvage chemotherapy regimen without adding toxicity in both relapsed/refractory and in newly diagnosed older AML patients and builds upon results first reported at the 2018 ASH (Free ASH Whitepaper) Meeting. The paper’s lead author, Daniel J. DeAngelo, M.D., Ph.D., of the Dana Farber Cancer Institute in Boston, noted that "the combination of uproleselan with a standard salvage regimen of mitoxantrone, etoposide and cytarabine (MEC) demonstrated a substantial improvement in both response rate and survival in relapsed/refractory AML patients compared to previously reported results with chemotherapy alone."

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"The results of this Phase 1/2 study demonstrate the safety and tolerability of uproleselan in combination with an intensive salvage chemotherapeutic regimen. The reported response rates and survival outcomes are superior to what has been seen with chemotherapy alone in similar relapsed/refractory AML patient populations," noted Eric J. Feldman, M.D., GlycoMimetics’ Chief Medical Officer. "In particular, the MRD negative rate of 69 percent in the relapsed/refractory cohort is unprecedented in producing a high proportion of patients who underwent a successful transplant. We are confident that our ongoing Phase 3 randomized trial will confirm the efficacy seen in the Phase 1/2 study and will help to establish uproleselan in combination with intensive chemotherapy as the new standard of care in relapsed/refractory AML."

According to Dr. DeAngelo, principal investigator of the company’s ongoing Phase 3 registrational trial, "We believe that uproleselan is clearly a novel and potent inhibitor of E-selectin that has been shown in the clinic to overcome chemotherapy resistance. Should the ongoing registrational trial prove positive, we will have created a foundational paradigm shift that has the potential to significantly impact outcomes for AML patients worldwide."

Key Data

MRD was assessed by multi-parametric flow cytometry in the relapsed/refractory cohort. Of the 16 evaluable patients, 11 patients (69%) were MRD negative at the end of induction. Following treatment with MEC plus the recommended Phase 2 dose (RP2D) of uproleselan, 31% of patients (17/54) underwent allogeneic hematopoietic stem cell transplant. Of the 22 patients achieving CR/CRi, 11 (50%) underwent transplant.
Median overall survival at the RP2D of 10 mg/kg in relapsed/refractory and newly diagnosed AML patients was 8.8 and 12.6 months, respectively.
The addition of uproleselan was associated with low rates of oral mucositis.
E-selectin-mediated drug resistance contributes to poor outcomes in patients with AML.
E‑selectin ligand expression on leukemic blasts was higher in patients with relapsed versus primary refractory AML, and with high-risk cytogenetics and secondary AML in newly diagnosed older patients. In the Relapsed/Refractory cohort, E‑selectin expression above 10% was associated with a higher response rate and improved survival.
About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

On September 23, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported multiple senior leadership appointments including Arun Swaminathan, Ph.D., as Chief Business and Commercial Officer, Paul Diamond, Ph.D., as Vice President, Patent and Legal Counsel and Avinash Desai, M.D., who previously served as Executive Vice President, Clinical Development, Operations and Medical Affairs, to the position of Chief Medical Officer, effective immediately (Press release, Actinium Pharmaceuticals, SEP 23, 2021, View Source [SID1234590214]). These senior leadership additions add over 50 years of experience in key areas aligned with Actinium’s growth strategy.

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Sandesh Seth, Actinium’s Chairman and CEO, said, "I am thrilled to welcome Arun and Paul to the Actinium team. Arun brings a unique blend of experiences across commercial-focused roles at global biopharmaceutical companies, as well as an entrepreneurial mindset and track record of value creation in smaller organizations. His scientific training, experience and business acumen make him ideal to lead our commercial planning for Iomab-B, following the recent completion of the Phase 3 SIERRA trial and to lead our business development activities focused on our clinical assets and AWE technology platform to further expand our leadership in target radiotherapies."

Sandesh Seth, continued, "Equally exciting is Paul’s appointment, which coincides with our expansion in R&D, leveraging our AWE technology platform, which is expected to yield new programs in the coming months. Paul is a highly experienced and proven patent attorney who brings a strong scientific pedigree. He will be imbedded in the R&D activity at Actinium to ensure our patent portfolio is architected in line with our development objectives through value-added patent development and prosecution. With our clinical progress led by Iomab-B, novel clinical pipeline of actinium-225 targeted radiotherapies and enhanced R&D capabilities overlaid with our strong balance sheet, we are excited with the caliber of talent being attracted to and joining Actinium."

"I am excited to announce Dr. Desai’s promotion to Chief Medical Officer, in place of Dr. Berger, who will be leaving the Company effective September 24th. I have been impressed with Dr. Desai’s execution since he joined Actinium last November. In this short time, he has taken the lead on clinical operations for Iomab-B and implemented strategies that led to the completion of our Phase 3 SIERRA trial, with the last 25 percent of patients being enrolled faster than any previous cohort, despite the challenging environment from the ongoing COVID pandemic. Additionally, he has assumed leadership of our CMC operations and further strengthened its integration with our clinical team. With SIERRA enrollment complete, Dr. Desai will leverage his extensive drug development experience to execute the BLA filing strategy he has led. Finally, with his extensive medical affairs experience in oncology, he will be invaluable in our Iomab-B commercial planning. With Dr. Desai and Dr. Swaminathan onboard, I am confident in our team’s capabilities and look forward to working with them in executing our strategic vision to create value for patients and shareholders."

Dr. Swaminathan stated, "I am excited to join the Actinium team just as enrollment is completed for the pivotal Phase 3 SIERRA trial of Iomab-B. This is an exciting time in the Company’s evolution, as it sets the stage for us to further leverage the SIERRA study to expand our pipeline of target radiotherapies across hematologic and solid tumor indications, leveraging our AWE technology platform. With the growing interest in targeted radiotherapy, Actinium’s capabilities, clinical development experience, intellectual property and supply chain set us apart. Through the development of Iomab-B and Actimab-A, Actinium has gained tremendous insights into the development of targeted radiotherapies across multiple isotopes, targeting agents and indications, which I look forward to leveraging in my business development efforts. Additionally, through the Phase 3 SIERRA and Phase 1/2 Actimab-A trials, Actinium has developed a supply chain that can bring targeted radiotherapies to the point of care in many of the leading comprehensive cancer centers across the United States and Canada, where a significant number of patients with advanced cancers are treated. As we begin our commercial planning, first for Iomab-B, I am struck by the concentrated nature of the bone marrow transplant market and the opportunity to leverage a conditioning-focused commercial organization across transplant, cell, and gene therapies for potential future indications beyond acute myeloid leukemia. We believe there is a significant opportunity across several of these indications, which are expected to build upon the growing awareness of Iomab-B among transplant centers and physicians."

Dr. Avinash Desai, added, "I am honored and excited to be promoted to the role of Chief Medical Officer at Actinium. I have a deep passion and energy for oncology drug development that I will continue to apply to the advancement of Actinium’s pipeline of novel and differentiated targeted radiotherapies together with my amazing clinical development, clinical operations, and CMC colleagues at Actinium. Across our pipeline, I believe we have the opportunity to transform patient outcomes, particularly in indications not adequately addressed by traditional therapeutics. Iomab-B is a prime example, as the older, relapsed/refractory AML patients with active disease are not considered eligible for transplant with traditional cytotoxic conditioning regimens, yet in the SIERRA trial, 100% of patients receiving Iomab-B have accessed transplant and engrafted without delay. After completing SIERRA enrollment with strong momentum, we look forward to preparing for a BLA filing and with Arun’s joining, beginning commercial planning for Iomab-B. Beyond Iomab-B, our Iomab-ACT initiative for cell and gene therapy conditioning and actinium-225 alpha therapy and combination trials in relapsed/refractory hematology indications have the same paradigm-shifting potential as Iomab-B. Finally, I am excited to leverage our clinical experience and capabilities with our AWE technology platform to unveil new targeted radiotherapies to further bolster Actinium’s pipeline."

Arun Swaminathan, Ph.D., Chief Business and Commercial Officer

Dr. Swaminathan is a highly accomplished executive with over 20 years of experience in the global biopharmaceutical industry, which has included increasing positions of responsibility across commercial, business development, and clinical roles. He has a proven track record of converting great science into successful business opportunities. Prior to joining Actinium, Dr. Swaminathan was the Chief Business Officer and Senior Vice President at Alteogen Inc. a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics. In this role, his negotiations with partners led to deals totaling over $6 billion in potential value, including agreements with two of the top ten global pharmaceutical companies. During his tenure at Alteogen, the Company’s market value increased from approximately $400 million to over $4 billion. Dr. Swaminathan joined Alteogen after they entered into an agreement with Lynkogen Inc. and gained full rights to develop the assets. As CEO and co-founder of Lynkogen, he raised capital, in-licensed potentially transformative drug candidates to address complex metabolic diseases and advanced Lynkogen from concept to a pre-clinical stage company with a lead drug candidate ready for IND enabling studies that he successfully negotiated for out-licensing. Previously, Dr. Swaminathan held commercial and business development roles at Bristol Myers Squibb over 12 years during two tenures, most recently as Worldwide Brand Director, where he managed products with over $2 billion in annual sales across the top 10 global markets. Earlier at BMS, Dr. Swaminathan advanced from principal scientist to associate director, working on approved products including Nulojix, Orencia and Eliquis. Between his tenures at BMS, he spent nearly four years at Covance (now Labcorp Drug Development), where he rose to Marketing Head, in charge of a $1 billion clinical business. Dr. Swaminathan received his Ph.D., Pharmaceutical Sciences at the University of Pittsburgh, and is a graduate of the Marketing Management Program at Wharton, University of Pennsylvania.

Avinash Desai, M.D., Chief Medical Officer

Dr. Desai is a hematologist/oncologist with nearly 25 years of drug development industry experience. Over the course of his career, Dr. Desai has successfully designed and implemented clinical development, U.S. and global medical affairs, and life cycle management plans for a variety of pharmaceutical products. This has included participation in multiple INDs, NDAs, and sNDA submissions and efficiently managing the product Scientific Advisory Boards (SAB) and Data and Safety Monitoring Boards (DSMB) for hematology, oncology, and therapeutic candidates. Most recently, Dr. Desai, served as Vice President, Head of U.S. Medical Affairs – Oncology at Glaxo Smith Kline (GSK). At GSK, he established the U.S. medical affairs oncology team that oversaw the launch readiness plans for three novel oncology products—Blenrep in multiple myeloma, Zejula in ovarian cancer, and dostarlimab in endometrial cancer. Prior to GSK, Dr. Desai has overseen the clinical development, implementation, and delivery of oncology life cycle management plans for various oncology therapies at several leading global pharmaceutical companies, including Eli Lilly & Company (Lilly), Janssen Pharmaceuticals, Inc. and Takeda, Inc. Prior to GSK, he was the VP of Global Medical Affairs at Lilly, during which time he oversaw the global medical affairs team for Lilly’s GI Oncology portfolio. Earlier in his career, Dr. Desai contributed to the approval of Janssen’s myeloma drug Darzalex (daratumumab) and leading and strategically executing medical affairs activities globally for Velcade (bortezomib). Prior to Janssen, Dr. Desai was responsible for the international development of oncology products in solid tumors and hematological malignancies at Sanofi, where he successfully executed pivotal trials that led to NDA submission for Jevtana (cabazitaxel).

Paul Diamond, Ph.D., Esq., Vice President, Patent and Legal Counsel

Dr. Diamond joins Actinium with over 20 years of experience in patent law, developing and executing IP strategy within the biotechnology industry. He joins Actinium from Enzo Biochem, Inc., where he was Senior Counsel, Patents and Business Development. As Enzo’s sole patent attorney and senior-most counsel, he reported to the CEO and led all IP related and essential in-house legal functions. During his time at Enzo, Dr. Diamond obtained critical, high-value patent coverage for key products and technologies and managed high-profile litigations and settlement negotiations that resulted in a number of sizeable settlements. Prior to Enzo, Dr. Diamond first practiced IP law at global law firm White & Case LLP before opening his own practice, Diamond Law Office, LLC, where he was of counsel to the firms Lucas & Mercanti, LLP and Zuber, Lawler & Del Duca, LLP. Paul received his law degree from Fordham University School of Law. He also has a strong scientific background, receiving a B.A. in Biology from The Johns Hopkins University and a Ph.D. in Molecular and Cellular Biology from Harvard University.

On September 23, 2021 Abbott (NYSE: ABT) reported that will announce its third-quarter 2021 financial results on Wednesday, Oct. 20, 2021, before the market opens (Press release, Abbott, SEP 23, 2021, View Source [SID1234590213]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On September 23, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, reported it will be presenting at the Benzinga Healthcare Small Cap Conference on Wednesday, September 29, 2021 (Press release, Scopus BioPharma, SEP 23, 2021, View Source [SID1234590205]).

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The company will present on the launch of Duet Therapeutics, its wholly-owned subsidiary focused on immuno-oncology. Scopus announced the launch of Duet on September 2, 2021.

Alan Horsager, Ph.D., President — Immuno-Oncology of Scopus and President and Chief Executive Officer of Duet, will be presenting on behalf of the company. Dr. Horsager’s presentation will be part of the Green Track on Wednesday, September 29, 2021. The presentation will be streamed live beginning at 4:20 PM EST and will be accessible by clicking here.

If you are an institutional investor interested in scheduling a one-on-one meeting with the company, please click here to register for the conference and request a one-on-one meeting.

About the Duet Platform

Duet Therapeutics integrates the immunotherapy assets of Scopus and Olimmune, creating the Duet Platform. Olimmune was acquired by Scopus in June 2021. Duet is a wholly-owned subsidiary of Scopus.

The Duet Platform is comprised of three distinctive, complementary CpG-STAT3 inhibitors:

• RNA silencing CpG-STAT3siRNA ("DUET-01")

• Antisense CpG-STAT3ASO ("DUET-02")

• DNA-binding inhibitor CpG-STAT3decoy ("DUET-03")

DUET-01 is in a Phase 1 clinical trial, as a monotherapy, for B-cell non-Hodgkin lymphoma. Duet expects to file two INDs for DUET-02 in Q4 2022 in genitourinary and head & neck cancers, with clinical Phase 1 trials beginning in Q1 2023 in the United States. Duet is also evaluating combination therapies with checkpoint inhibitors.