On December 6, 2021 Bellicum Pharmaceuticals Presented the Corporate Presentation (Presentation, Bellicum Pharmaceuticals, DEC 6, 2021, View Source [SID1234596476]).

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On December 06, 2021 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer, reported it will host an analyst and investor event on Thursday, December 16, 2021, at 12:00 pm ET (Press release, Sierra Oncology, DEC 6, 2021, View Source [SID1234596507]). The event will feature a presentation by Prithviraj Bose, MD, Department of Leukemia, MD Anderson Cancer Center, on the importance of treating anemia in myelofibrosis patients. Dr. Bose will also review momelotinib data from the Phase 3 SIMPLIFY studies. Sierra management will discuss the MOMENTUM trial design as well as highlight registration and commercialization preparations currently underway. An open question & answer session with all presenters will conclude the event.

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Analyst & Investor Event Webcast Information

Date and Time: Thursday, December 16, 2021, 12:00 pm ET

To register, please click here.

The presentation will be webcast live, and an archive of the presentation will be accessible for approximately 30 days after the event through the Sierra Oncology website: www.SierraOncology.com.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1/ALK2 inhibitor currently under investigation for the treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Sierra Oncology is currently awaiting topline results of the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study evaluating momelotinib for the treatment of symptomatic and anemic myelofibrosis patients. Top-line data are anticipated by February 2022. Assuming positive data, the company plans to file a New Drug Application with the US Food & Drug Administration (FDA) in the second quarter of 2022. The FDA has granted Fast Track designation for momelotinib.

On December 6, 2021 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, reported that it has completed patient enrollment in its Pivotal Phase 3 trial of I/ONTAK, an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) (Press release, Citius Pharmaceuticals, DEC 6, 2021, View Source [SID1234596526]). The treatment phase for the study has been completed with topline results expected in the first half of 2022 and a biologics license application (BLA) expected to be filed with the U.S. Food and Drug Administration (FDA) in the second half of 2022.

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"Completing enrollment in the Pivotal Phase 3 study of I/ONTAK moves us another step closer to expanding treatment options for patients suffering from advanced CTCL. We expect I/ONTAK’s unique mechanism-of-action to offer oncologists an important therapeutic alternative to current targeted therapies which have limited duration of response and are often discontinued due to toxicity. We look forward to reviewing the complete safety and efficacy data and anticipate providing topline results in the first half of next year, followed by a BLA submission in the second half of 2022," stated Myron Holubiak, Chief Executive Officer of Citius.

A total of 70 patients were enrolled in the main part of the I/ONTAK Phase 3 study, a multicenter, open-label, single-arm Pivotal study of I/ONTAK in participants with recurrent or persistent CTCL (NCT01871727). Positive efficacy data from an initial 21-subject lead-in study supported proceeding with the main study with an optimal dose level of 9 micrograms per kilogram (mcg/kg) of I/ONTAK. Subjects were administered I/ONTAK by intravenous infusion over 60 minutes (+/-10 minutes) on 5 consecutive days per cycle every 21 days.

The primary outcome measure for the main study is the Objective Response Rate (ORR). The ORR is defined as the proportion of subjects with a significant reduction in tumor size that can be classified as achieving either a partial response (PR) or a complete response (CR). The primary endpoint and quality of life analyses of the study will be performed on the combined data set from subjects in the main study plus subjects in the lead-in part of the study who received 9 micrograms per kilogram through the data cutoff date. Multiple secondary endpoints including duration of response, time to response, and safety will be evaluated.

About I/ONTAK

I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. ONTAK was marketed in the U.S. from 2008 to 2014, when it was voluntarily withdrawn from the market to enable manufacturing improvements. These improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan for the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, respectively, making it eligible for seven years of market exclusivity post-approval.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sezary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and has usually spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple systemic agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no cure for advanced CTCL. Approximately 3,000 new cases are reported in the United States every year, with an estimated 30,000 – 40,000 individuals living with the disease.

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]).

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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.

On December 6, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), reported that it will host an investor event on updated data from the ongoing MARIO-3 clinical study during the San Antonio Breast Cancer Symposium (SABCS 2021) on Friday, December 10th at 9:30 am ET (Press release, Infinity Pharmaceuticals, DEC 6, 2021, View Source [SID1234596477]).

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The webinar will feature a presentation from Key Opinion Leader (KOL) Hatem Soliman, MD, MARIO-3 Investigator and Medical Director, Clinical Trials Office at the Moffitt Cancer Center.

Dr Soliman will discuss the evolving treatment landscape in TNBC and the significant unmet medical need that remains for patients with frontline, metastatic TNBC.
Importantly, Dr Soliman will review the MARIO-3 study design and summarize patient demographics and baseline characteristics as well as the updated safety and efficacy data from the MARIO-3 study.
Infinity’s Chief Medical Officer, Dr. Robert Ilaria, will review of eganelisib’s mechanism of action and translational data from the MARIO-3 study.

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

Hatem Soliman, MD is one of the leading breast cancer physicians in the country and an investigator on the MARIO-3 study. Dr. Soliman serves as the Medical Director of the Clinical Trials Office at the Moffitt Cancer Center, with extensive experience as a clinical investigator conducting both translational research in breast cancer immunotherapy and leading numerous clinical trials as principal investigator since joining the faculty at Moffitt in 2008. He also serves as the Course Director for the fellowship clinical research rotation, medical director of the phase 1 program, chair of Moffitt’s clinical research leadership council, chair of clinical research feasibility committee, and principal investigator for Moffitt’s CPDM CCSG application, which was recently rated as outstanding and awarded funding for an additional five years.

Dr. Soliman received his BS in Genetics from the University of Georgia Athens in 1996 and then went on to receive his medical degree from the Medical College of Georgia in 2002. His residency and fellowship training in oncology/hematology was completed through the University of South Florida/Moffitt Cancer Center program in 2008. During fellowship, he authored investigator initiated early phase trials with mentorship from Dr. Daniel Sullivan, former ACD and EVP of Moffitt, in collaboration with the NCI CTEP RAID program investigators Drs. Jaime Zwiebel and Howard Streicher. Upon graduation, Dr. Soliman was offered an assistant member position at Moffitt as a clinical investigator to continue early drug development and translational research activities.