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Vincerx Pharma Hosting Key Opinion Leader Webinar on VIP152 Data Presented at the American Society of Hematology Annual Meeting

On December 6, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it will host a key opinion leader (KOL) webinar to discuss the data presented on the Company’s lead asset, VIP152, in chronic lymphocytic leukemia (CLL) and diffuse large B-Cell lymphoma (DLBCL) at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Saturday, December 11, 2021 at 7:30pm Eastern Standard Time (Press release, Vincerx Pharma, DEC 6, 2021, View Source [SID1234596473]).

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The webinar will feature presentations from KOLs John C. Byrd, M.D. (University of Cincinnati) and Rosa Lapalombella, Ph.D. (The Ohio State University) who will discuss the current treatment landscape and unmet medical need in treating patients suffering from chronic lymphocytic leukemia (CLL) and the VIP152 data presented earlier that day at the ASH (Free ASH Whitepaper) Annual Meeting.

Vincerx Pharma’s Vice President of Translational Medicine, Melanie Frigault, Ph.D., will also discuss the VIP152 mechanism of action in lymphoma poster presented at ASH (Free ASH Whitepaper). VIP152 is a potent and highly selective CDK9 inhibitor optimized for intermittent intravenous treatment. VIP152’s differentiated profile for selectivity, potency, and durability has translated to early signals of clinical activity in Phase 1, notably in patient populations with high unmet medical needs including double-hit DLBCL. In addition, VIP152 has demonstrated on-target disruption of PTEFb function with durable reductions in kinase activity, mRNA and protein levels of key oncogenes including MYC and MCL-1.

A live Q&A session will follow the formal presentations. To register for the webinar, please click here.

John C Byrd, M.D. is the Chairman of the Scientific Advisory Board of Vincerx and an internationally known researcher and clinical specialist in leukemia and other hematologic malignancies. Dr. Byrd is currently the Department Chair, The Gordon and Helen Hughes Taylor Professor, University of Cincinnati. Previously, he was the D Warren Brown Chair of Leukemia Research at the Ohio State University College of Medicine.

Dr. Byrd’s research has shown that therapeutic agents such as rituximab, idelalisib, ibrutinib and acalabrutinib are effective against chronic lymphocytic leukemia (CLL) and has led efforts to understand how resistance develops to these agents. Dr. Byrd continues to study novel immune-based therapies for CLL. However, five years ago, he transitioned much of his experimental therapeutics effort toward acute myelogenous leukemia (AML); where he has been attempting to identify genomic-specific targeted therapies in the laboratory and translate them to clinical trials. He serves as the chief medical officer for Beat AML, a precision medicine effort.

Dr. Byrd received his medical degree in 1991 from the University of Arkansas for Medical Sciences. He completed his internship and residency in internal medicine at the Walter Reed Army Medical Center in Washington, D.C., and then completed a fellowship at Walter Reed in hematology, oncology and bone marrow transplantation. Dr. Byrd also received a year of translational laboratory training at Johns Hopkins University.

Rosa Lapalombella, Ph.D. is Professor with Tenure at The Ohio State University (OSU) where she also serves as the Associate Director for Basic Research in the Division of Hematology.

Dr. Lapalombella has a strong history of translational medical research. Her research focus is on epigenetic alterations of cancer cells and the development of experimental therapeutics for hematologic disease. Her work has contributed to the translation of five therapeutic agents into clinical trials for CLL and has been reported in more than 60 articles in Cancer Discovery, Cancer Cell, Journal of Clinical Oncology, Leukemia and Blood. Dr. Lapalombella earned her Ph.D. from the University of Bologna, Italy and completed four years of postdoctoral training at the Ohio State University before joining the Faculty at OSU.

Melanie Frigault, Ph.D. is the Vice President of Translational Medicine of Vincerx. In the year before joining Vincerx, Dr. Frigault was the U.S. head of Translational Medicine at AstraZeneca with a strategic focus on precision medicine and accelerating clinical development using novel biomarker-based endpoints in hematologic malignancies and solid tumors. From 2016 to 2020, Dr. Frigault established a translational science department at Acerta Pharma in South San Francisco, CA to support development of CALQUENCE in mantle cell lymphoma (2017) and chronic lymphocytic leukemia (2019) with clinical biomarker data. Dr. Frigault held positions of increasing responsibility at AstraZeneca from 2011 to 2016 where she inserted science into the development of the portfolio ranging from target selection to phase 3 pivotal trials including biomarker discovery and companion diagnostic development. Dr. Frigault began her clinical research career at Novartis Institute of Biomedical Research in Cambridge, MA where she developed biomarkers and drove preclinical collaborations to inform clinical development.

Dr. Frigault obtained her Ph.D. in Biochemistry from McGill University, Québec, Canada.

Karyopharm Announces Dosing of First Patient in a New Phase 2 Study Evaluating Single-Agent Selinexor Versus Physician’s Choice in Previously Treated Myelofibrosis

On December 6, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported dosing of the first patient in a new Phase 2 study evaluating oral selinexor, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, as a monotherapy versus physician’s choice in patients with myelofibrosis (MF) previously treated with a JAK 1/2 inhibitor (XPORT-MF-035; NCT04562870) (Press release, Karyopharm, DEC 6, 2021, View Source [SID1234596468]).

This randomized, multi-center, open-label Phase 2 study is designed to evaluate the safety and efficacy of selinexor monotherapy and is expected to enroll up to 112 patients, who will be randomized 1:1 to receive either low dose, once-weekly oral selinexor or physician’s standard treatment choice (per clinical practice). The primary endpoint of the study is the percentage of patients with spleen volume reduction (SVR) of ≥35% from baseline as assessed by an Independent Review Committee. The first patient has been dosed at the Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola, Italy, by the Lead Principal Investigator, Dr. Alessandro Lucchesi, Sr. Consultant and Research Hematologist under the guide of Professor Giovanni Martinelli, the Chief Scientific Director.

Initiation of this Phase 2 study follows encouraging preliminary data from the Phase 2 ESSENTIAL trial, which will be highlighted in an oral presentation given by Srinivas Tantravahi, MBBS, MRCP, University of Utah Hospital, at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2021 Annual and Exposition on Saturday, December 11, 2021 at 1:00 p.m. ET. In the investigator-sponsored ESSENTIAL study (NCT03627403), which is evaluating selinexor in patients with MF previously treated with a JAK inhibitor, preliminary data showed that 33% of patients that received at least 24 weeks of selinexor treatment achieved ≥35% SVR. The responses were durable, and the first patient remained on study for more than two years. Patients had a median duration of 22 months of prior JAK inhibitor therapy with 11 out of 12 patients having disease refractory to ruxolitinib.

"As part of our strategic imperatives and pipeline priorities, we remain focused on diseases with the highest unmet needs and greatest potential to make an impact in patient outcomes," said Sharon Shacham, PhD, MBA, Co-Founder and Chief Scientific Officer of Karyopharm. "Myelofibrosis is a serious and life–threatening blood cancer defined by stem cell–derived clonal myeloproliferation, bone marrow fibrosis, anemia, enlarged spleen, low blood counts and short survival. With JAK inhibitors being the only class of drugs approved for this disease, there remains limited therapeutic options for patients who either progress following treatment with a JAK inhibitor or are intolerant. We believe selinexor has the potential to hold an important place in the myelofibrosis treatment paradigm and with dosing of the first patient underway, we plan to provide updates as the study progresses."

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B–cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.

Enveric Biosciences Appoints Dr. Bob Dagher as Chief Medical Officer

On December 6, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-centric biotechnology company developing next-generation mental health and oncology treatments by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, reported the appointment of Bob Dagher, MD, as Chief Medical Officer, effective immediately (Press release, Enveric Biosciences, DEC 6, 2021, View Source [SID1234596465]).

Dr. Dagher brings over 20 years of experience working in clinical development in the pharmaceutical industry for both small and large pharmaceutical companies and as a board-certified physician from the American Board of neurology and psychiatry. He has an extensive therapeutic background concentrated in the neuroscience space which includes a focus on psychotic, affective and anxiety disorders, as well as neuroimmunology, neurodegeneration and movement disorders. Furthermore, Dr. Dagher has supported and driven successful drug development programs from preclinical stages through Phase 4 clinical trials.

"Dr. Dagher joins our team at a crucial time where we are continuing to build momentum and drive development of our key psychedelic molecules for the mind and cannabinoids for the body," said Dr. Joseph Tucker, Chief Executive Officer, Enveric Biosciences. "Dr. Dagher brings extensive experience working in the pharmaceutical industry with a focus and passion for drug development for neurological and mental health indications. His experience is expected to be very valuable as he will lead Enveric alongside our clinical team in continuing to advance our pipeline. Dr. Dagher’s addition to Enveric is key addition as we continue our focus on building a world-class management team."

"As a trailblazing Company working to discover and develop the next-generation treatments through the use of both psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, Enveric has major potential to make a real difference for mental health and cancer patients in need," said Dr. Dagher. "As Chief Medical Officer, I look forward to working with the leadership and clinical teams to harness the power of these groundbreaking technologies to truly help bring solutions to various indications ranging from cancer-related distress to a whole host of other mental health disorders."

Prior to joining Enveric, Dr. Dagher served as the Chief Medical Officer at WCG MedAvante-ProPhase where he led the clinical science organization to help forge and develop compelling scientific solutions to match industry challenges. Before joining WCG, Dr. Dagher served as the Chief Medical Officer at Cadent Therapeutics, where he led and advanced the company’s pipeline of small molecules, coupled with the implementation of precision biomarkers, for the development of innovative programs in rare diseases and common indications targeting movement and cognitive disorders. Following his early experience treating patients in academic and private practice settings, Dr. Dagher started his career in the pharmaceutical industry at GlaxoSmithKline, followed by Sanofi/Genzyme working on neurology, psychiatry, and urology indications.

Robert Wilkins, MD, stepped down from his role of Chief Medical Officer on November 29th, 2021. David Johnson, Executive Chairman, stated, "I want to thank Robert for his commitment to Enveric over the past two years. His contributions to our team have been significant and meaningful. His leadership has helped guide our transformation into the biotechnology company we are today. We relied on Robert’s expertise having worked with several biomedical startups in the past and have valued his deep knowledge in the pharmaceutical space. His guidance and insights have helped shape Enveric’s leadership team. We are grateful for the significant contributions he has made to Enveric and wish him the best of luck on his future endeavors."

HUTCHMED Completes Planned Enrollment of FRESCO-2, a Global Phase III Trial of Fruquintinib in Metastatic Colorectal Cancer

On December 6, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has completed patient enrollment of FRESCO-2, a Phase III registration study of fruquintinib, an investigational treatment for the treatment of patients with metastatic colorectal cancer ("CRC") in the U.S., Europe, Japan and Australia. The enrollment goal was reached on December 2, 2021 (Press release, Hutchison China MediTech, DEC 6, 2021, View Source [SID1234596462]).

FRESCO-2 is a randomized, double-blind, placebo-controlled, multicenter trial being conducted in patients with metastatic CRC. The primary endpoint of the study is overall survival ("OS"). This large Phase III trial enrolled patients in over 150 sites in 14 countries. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539.

Dr. Marek Kania, EVP, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said, "HUTCHMED continues to execute on developing novel oncology medicines for patients worldwide despite the backdrop of the global pandemic. We would like to thank investigators, patients and their families for taking part in this study and we look forward to seeing the results of this study in patients with metastatic CRC, where there is a high unmet need for new treatment options."

Topline results from the FRESCO-2 trial are expected to be reported in the second half of 2022 when the event-driven primary endpoint, OS, is mature. If positive, HUTCHMED would initiate plans to apply for marketing authorization of fruquintinib by the U.S. Food and Drug Administration ("FDA"), the European Medicines Agency ("EMA") and the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA"). The U.S. FDA granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020. Clinical data from the completed Phase III FRESCO study in Chinese patients, additional supporting studies in CRC and this FRESCO-2 global study, if positive, could support a future U.S. FDA New Drug Application ("NDA") for the treatment of patients with advanced metastatic CRC (third-line and later). The FRESCO-2 study design was also reviewed and endorsed by the EMA and PMDA.

HUTCHMED retains all commercial rights to fruquintinib outside of China. In China, where fruquintinib is marketed under the brand name ELUNATE, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing. Fruquintinib is not approved for use outside of China.

About CRC
CRC is a cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, estimated to have caused more than 915,000 deaths in 2020.[2] In the U.S., an estimated 150,000 people will have been diagnosed with CRC and 53,000 people will have died from CRC in 2021.[3] In Europe, CRC is the second most common cancer, with an estimated 507,000 new cases and 240,000 deaths in 2020.2 In Japan, CRC is the most common cancer, with an estimated 147,000 new cases and 59,000 deaths in 2020.2

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

About Fruquintinib Approval in China
Metastatic colorectal cancer in China: Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in late November 2018 under the brand name ELUNATE. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. ELUNATE is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study1, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

About Fruquintinib Development Beyond CRC Monotherapy
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

Gastric Cancer ("GC") in China: In October 2017, HUTCHMED initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or esophagogastric junction ("GEJ") adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients are randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is OS. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored (clinicaltrials.gov identifier: NCT03223376). In June 2020, HUTCHMED completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent Biologics, Inc. and marketed as TYVYT in China).

Metastatic breast and endometrial cancers in the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced, refractory triple negative breast cancer ("TNBC") and endometrial cancer ("EMC"). This study is being conducted to investigate if the addition of fruquintinib can potentially induce activity to immune checkpoint inhibitor therapy in TNBC and EMC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04577963. Safety and preliminary efficacy of fruquintinib were demonstrated in advanced solid tumors, including TNBC, in a Phase I study conducted in China (NCT01645215) and a Phase I/Ib study is ongoing in the United States (NCT03251378).

Gastric, colorectal and non-small cell lung cancers in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic, unresectable GC, CRC or non-small cell lung cancer ("NSCLC"). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04716634.

Solid tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced cervical cancer, EMC, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT03903705. Preliminary results of certain cohorts were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO).

EISAI TO PRESENT ABSTRACTS ON ONCOLOGY PRODUCTS AND PIPELINE AT 44TH ANNUAL SAN ANTONIO BREAST CANCER SYMPOSIUM

On December 6, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that presentations on a series of abstracts highlighting updates on its in-house discovered eribulin mesylate (product name: Halaven, halichondrin class microtubule dynamics inhibitor, "eribulin"), MORAb-202, an antibody drug conjugate (ADC), and H3B-6545 (selective estrogen alpha receptor covalent antagonist), discovered by Eisai’s U.S. research subsidiary H3 Biomedicine Inc., will be given at the 44th San Antonio Breast Cancer Symposium (SABCS2021) to be held, partly virtual, from December 7 to 10, 2021, in San Antonio, Texas in the United States (Press release, Eisai, DEC 6, 2021, View Source [SID1234596453]).

At this symposium, regarding eribulin, the result of non-clinical studies on its effects to subsequent chemotherapy through the induction of epithelial-mesenchymal transition (Abstract No: P3-06-01) is scheduled to be presented.

MORAb-202 is Eisai’s first ADC and combines Eisai’s in-house developed anti-folate receptor alpha (FR) antibody, to Eisai’s anticancer agent eribulin, using an enzyme cleavable linker. At this symposium, regarding MORAb-202, the experimental results of antitumor efficacy in Patient-Derived Xenograft models of triple-negative breast cancer (Abstract No: P5-08-02) is scheduled to be presented. In June 2021, Eisai and Bristol-Myers Squibb Company (Headquarters: the United States) entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202.

In addition, regarding H3B-6545, the results of Phase II clinical study evaluating monotherapy (Abstract No: P1-17-10) and Phase 1b study evaluating the combination therapy with palbociclib (Abstract No: P1-17-03) in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer will be presented.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is aspiring to making further contribution to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers through creating innovative new drugs based on cutting-edge cancer research.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval. No.21-96 December 6, 2021 Eisai Co., Ltd.

Major poster presentations at SABCS2021:

Product / Compound Abstract No. Title / Scheduled Date and Time (local time: Central Standard Time) Eribulin P3-06-01 Eribulin alters the chromatin landscape to induce MET, attenuating metastatic progression and sensitizing breast tumors to subsequent chemotherapy December 9 (Thu), 7:00AM-8:30AM MORAb-202 P5-08-02 MORAb-202, an Antibody-drug-conjugate (ADC) targeting Folate Receptor Alpha (FRα), exhibits durable anti-tumor efficacy in PDx models of TNBC December 10 (Fri), 7:00AM-8:30AM H3B-6545 P1-17-10 H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer – A Phase II study December 8 (Wed), 7:00AM-8:30AM H3B-6545 P1-17-03 H3B-6545 in combination with palbociclib in women with metastatic estrogen receptor–positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer, Phase 1b study December 8 (Wed), 7:00AM-8:30AM Media Inquiries: Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 [Notes to editors]

1. Eisai’s Focus on Cancer Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.