On December 1, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported that it will host a virtual Investor and Analyst Event on Friday, December 11, 2020, at 1:00 p.m. CT / 2:00 p.m. ET (Press release, Odonate Therapeutics, DEC 1, 2020, View Source [SID1234572037]). The event will follow the presentation of the results of CONTESSA, a Phase 3 study of tesetaxel in patients with metastatic breast cancer, at the 2020 SABCS, which is scheduled to occur at 8:45 a.m. CT / 9:45 a.m. ET on December 11, 2020 (View Source). Featured speakers will include Lee Schwartzberg, M.D., FACP, Chief Medical Director, West Cancer Center & Research Institute, and Andrew Seidman, M.D., Medical Director, Bobst International Center, Memorial Sloan Kettering Cancer Center and Professor of Medicine, Weill Cornell Medical College.

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Event Information

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA. Odonate recently announced positive top-line results from CONTESSA, and full results are scheduled to be presented at the San Antonio Breast Cancer Symposium in December 2020.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in 685 patients randomized 1:1 with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

On December 1, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and Hikma Pharmaceuticals, a multi-national pharmaceutical company and leading licensing partner in the Middle East and North Africa ("MENA") region specializing in the development and commercialization of a broad range of high-quality medicines, reported that the companies have entered into an exclusive licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") and other types of cancer in MENA (Press release, Sesen Bio, DEC 1, 2020, View Source [SID1234572036]). Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review.

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"Sesen is committed to saving and improving the lives of patients, and Hikma is an ideal partner to deliver Vicineum to patients with NMIBC in the MENA region," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "As we continue to work toward regulatory approval in the US and Europe, we also continue to execute partnerships outside of the US as part of our mission to deliver this important medicine to patients around the world. Hikma has strong expertise in commercializing innovative products in the MENA region and a successful track record of serving patients worldwide. This partnership represents a further step in realizing the significant global opportunity for Vicineum."

"At Hikma, we believe that partnerships with innovative pharma companies are a key contributor to the success of our business. We are very pleased to enter into an exclusive partnership with Sesen given their expertise in NMIBC and the strong clinical profile of Vicineum," said Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA. "As a company whose mission is to put better health within reach every day, we regard being the partner of choice to Sesen in MENA as a key collaboration that augments Hikma’s biotechnology and oncology portfolio to deliver on our strategy of bringing innovative products to patients in the region. Vicineum – our first innovative fusion protein – is a highly differentiated product candidate and is positioned to make a meaningful impact on the lives of bladder cancer patients."

Under the terms of the agreement, Sesen Bio granted Hikma an exclusive license to register and commercialize Vicineum in all 19 MENA markets in an arrangement anticipated to deliver equal value share to both parties. Financial terms of the agreement are confidential and include an upfront payment to Sesen Bio, sales related milestone payments and royalties on net sales in the region for the term of the agreement. Sesen Bio retains full development and commercialization rights for Vicineum for the treatment of NMIBC in the US and the rest of the world excluding Greater China and MENA.

Al-Tamimi and Hogan Lovells acted as legal advisors to Sesen Bio for this transaction.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review. Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

About Non-Muscle Invasive Bladder Cancer
Bladder cancer is the sixth most commonly diagnosed cancer in the United States, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and more than 60 percent of all patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.

On December 1, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that it will host a key opinion leader (KOL) call on MB-106 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma on Wednesday, December 9, 2020, at 1:00 p.m. EST (Press release, Mustang Bio, DEC 1, 2020, View Source [SID1234572035]).

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The call will feature presentations by KOLs Mazyar Shadman, M.D., M.P.H., Fred Hutchinson Cancer Research Center ("Fred Hutch"), and Brian Till, M.D., Fred Hutch, who will discuss the interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphoma that the company is developing in collaboration with Fred Hutch. Data from this study have been selected for a poster presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

During the call, Drs. Shadman and Till will also discuss the modified cell manufacturing process that was co-developed by Fred Hutch and Mustang Bio, as well as the correlative science observed in the study to date. The Mustang team will then give a corporate update on its pipeline and future plans. Following the formal presentations, the Mustang team, along with Drs. Till and Shadman, will be available for questions.

To register for the call, please click here.

About Dr. Shadman
Mazyar Shadman, M.D., M.P.H., is an associate professor at the University of Washington (UW) and Fred Hutch. He is a hematologic malignancies expert who specializes in treating patients with lymphoma / chronic lymphocytic leukemia (CLL). He is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cell), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies. Dr. Shadman received his M.D. from Tehran University in Iran. He finished internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his training in hematology and medical oncology fellowships at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for National Cancer Institute’s cancer research training program at Fred Hutch, where he studies cancer epidemiology.

About Dr. Till
Brian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.

On December 1, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported the pricing of an underwritten public offering of 4,794,521 shares of its common stock at a public offering price of $36.50 per share (Press release, Intellia Therapeutics, DEC 1, 2020, View Source [SID1234572034]). Intellia also granted the underwriters a 30-day option to purchase up to an additional 719,178 shares of its common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $175 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares in the offering are to be sold by Intellia.

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Goldman Sachs & Co. LLC, Jefferies and SVB Leerink are acting as joint book-running managers for the offering. The offering is expected to close on or about December 4, 2020, subject to customary closing conditions.

The shares of common stock are being offered by Intellia pursuant to a shelf registration statement that was previously filed with, and subsequently declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on November 30, 2020. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; or Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at [email protected]; or SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 1, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that the Company has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, DEC 1, 2020, View Source [SID1234572033]). The U.S. FDA previously granted Fast Track Designation to the combination of ublituximab and umbralisib (U2) for the treatment of adult patients with CLL and Orphan Drug Designation (ODD) covering ublituximab in combination with umbralisib for the treatment of CLL. The Company expects to complete the BLA rolling submission in the first half of 2021.

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Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "The initiation of a BLA submission for ublituximab in combination with umbralisib is an important milestone for us, and one that brings us one step closer to our goal of developing combination therapies for patients in need. This application, as well as the recently granted Fast Track Designation, is supported by the UNITY-CLL Phase 3 trial which met its primary endpoint of improvement in progression-free survival compared to obinutuzumab plus chlorambucil and will be presented in an oral presentation at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting beginning this weekend." Mr. Weiss continued, "I want to thank the patients, caregivers and research teams who participated in our clinical trials and helped to advance the U2 combination to this stage. We believe, if approved, U2 has the potential to become an important treatment option to both front line and relapsed/refractory patients with CLL."

The Company has previously submitted a New Drug Application (NDA) to the FDA for umbralisib to treat relapsed/refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL) and the FDA has granted Prescription Drug User Fee Act (PDUFA) goal dates of February 15, 2021 for MZL and June 15, 2021 for FL.

ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the combination of ublituximab plus umbralisib, or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, umbralisib single agent, ublituximab plus umbralisib, and an active control arm of obinutuzumab plus chlorambucil. A prespecified analysis was conducted to assess the contribution of ublituximab and umbralisib in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Approximately 420 subjects enrolled to the two combination arms and approximately 60% of patients were treatment-naïve and 40% were relapsed or refractory. The primary endpoint for this study was superior progression-free survival (PFS) for the U2 combination compared to the control arm to support the submission for full approval of the U2 combination in CLL. Positive topline results from this trial were announced in May 2020. The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia, and in 2020 it is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States1. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.

ABOUT FAST TRACK
Fast Track is a program designed to expedite the development and review of drugs that treat serious conditions and that demonstrate the potential to address an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy.

A drug that receives Fast Track designation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologics License Application or New Drug Application.

ABOUT ORPHAN DRUG DESIGNATION
Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.