On December 9, 2019 Constellation Pharmaceuticals, Inc., (Nasdaq: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it has commenced an underwritten public offering of 4.75 million shares of its common stock (Press release, Constellation Pharmaceuticals, DEC 9, 2019, View Source [SID1234552111]). All of the shares are being offered by Constellation. In addition, Constellation expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock sold in the public offering.

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J.P. Morgan, Jefferies and Cowen are acting as joint book-running managers for the offering. RBC Capital Markets is acting as a bookrunner, and SunTrust Robinson Humphrey is acting as lead manager for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares are being offered by Constellation pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on December 9, 2019.

This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering is expected to be filed with the SEC and, if and when filed, copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell, or a 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 9, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that on December 6, 2019, the Company initiated the submission of its Biologics License Application (BLA) for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) under Rolling Review to the U.S. Food and Drug Administration (FDA) (Press release, Sesen Bio, DEC 9, 2019, View Source [SID1234552128]). Vicinium was granted Fast-Track Designation by the FDA in 2018.

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"There remains a significant unmet medical need in NMIBC that has also been further complicated by the ongoing BCG shortage," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "The initiation of the rolling BLA for Vicinium marks a tremendous achievement for Sesen Bio and an important step forward in our efforts to help save and renew the lives of patients with cancer."

The Company has submitted completed non-clinical and clinical modules, and a partially completed Chemistry, Manufacturing and Controls (CMC) module. The Company anticipates completing the BLA submission with the finalization of the CMC module in 2020. If the FDA accepts the BLA filing, the Company plans to request a Priority Review.

In addition, Dr. Cannell will host a conference call and webcast on Monday, December 16th at 8 AM ET to provide a regulatory update for Vicinium.

To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 5285284. The webcast can be accessed from the Investor Relations section of the Company’s website at www.sesenbio.com. The replay of the webcast will be available in the Investor Relations section of the Company’s website at www.sesenbio.com for 60 days following the call.

About Vicinium

Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium 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. Vicinium 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 Vicinium 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 Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On December 9, 2019 Kite, a Gilead Company (Nasdaq: GILD), reported primary results from ZUMA-2, a global, multicenter, single-arm, open-label Phase 2 study of KTE-X19, an investigational CD19 chimeric antigen receptor (CAR) T cell therapy, in adult patients with relapsed or refractory mantle cell lymphoma (MCL) (Press release, Kite Pharma, DEC 9, 2019, View Source [SID1234552146]). After a single infusion of KTE-X19, the best objective response via independent radiologic central review (n=60 evaluable for efficacy analysis) was 93 percent, with 67 percent of patients having achieved a complete response. These findings were presented today at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, in Orlando from December 7–10, 2019.

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"There is a significant need for novel treatment options for patients with MCL, especially those whose disease has progressed following several lines of previous therapy," said Michael Wang, MD, ZUMA-2 Lead Investigator and Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. "The impressive response rates observed with KTE-X19 support its potential as the first cell therapy for people living with MCL."

With a median follow-up of 12.3 months (range: 7.0 to 32.3 months) at the time of data cutoff, 57 percent of patients remained in an ongoing response. Of the first 28 patients treated (minimum follow-up of 24 months), 43 percent were alive and remained in continued remission without additional therapy. The 12-month estimates of progression-free survival (PFS) and overall survival (OS) were 61 percent and 83 percent, respectively. Median duration of response, PFS and OS were not yet reached.

Among the 68 patients evaluable for safety, cytokine release syndrome (CRS) and neurologic events were observed in 91 percent and 63 percent of patients, respectively. Grade 3 or higher CRS and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred.

"Today’s results represent a significant milestone for Kite and for the MCL community," said Christi Shaw, Chief Executive Officer of Kite. "With KTE-X19, we have the opportunity to deliver on the promise of our industry-leading cell therapy development program with a second CAR T therapy, and the first ever for patients with relapsed or refractory MCL. We look forward to progressing KTE-X19 with the FDA and other regulatory authorities to bring it to patients as quickly as possible."

Based on the results of the trial, Kite plans to submit a Biologics License Application (BLA) for KTE-X19 to the U.S. Food and Drug Administration (FDA) by the end of this year and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first quarter of 2020. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the EMA for relapsed or refractory MCL based on interim data from ZUMA-2.

KTE-X19 is investigational and not approved anywhere globally. Its efficacy and safety have not been established. More information about clinical trials with KTE-X19 is available at www.clinicaltrials.gov.

About MCL

MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the "mantle zone" of the lymph node and typically affects men over the age of 60.

About ZUMA-2

ZUMA-2 is a single-arm, multicenter, open-label Phase 2 study involving 74 enrolled/leukapheresed adult patients (≥18 years old) with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and the BTK inhibitors ibrutinib or acalabrutinib. The objectives of the study are to evaluate the efficacy (60 patients) and safety (68 patients) after a single infusion of KTE-X19 in this patient population. The primary endpoint for the study is objective response rate (ORR). ORR in this trial is defined as the combined rate of complete responses and partial responses as assessed by an Independent Radiology Review Committee.

Secondary endpoints include duration of response, best objective response, progression-free survival, overall survival, incidence of adverse events, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, levels of cytokines in serum, and changes over time in the EQ-5D scale score and visual analogue scale score. The study is ongoing.

About KTE-X19

KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell therapy. KTE-X19 uses the XLP manufacturing process that includes T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is a necessary step in certain B-cell malignancies with evidence of circulating lymphoblasts. KTE-X19 is currently in Phase 1/2 trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

On December 9, 2019 Samus Therapeutics, Inc. ("Samus" or the "Company"), a privately held, Boston-based, biopharmaceutical company developing epichaperome inhibitors to intervene in pathological processes and initiate the degradation of disease-associated proteins, reported a poster presentation addressing the Company’s Phase 1 study evaluating orally administered PU-H71 with ruxolitinib in patients with myelofibrosis no longer fully responsive to orally administered ruxolitinib (Press release, Samus Therapeutics, DEC 9, 2019, View Source [SID1234552162]). The poster is being presented today at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting in Orlando.

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"Preclinical data show us that the activity of mutated JAK2 is tightly regulated by epichaperomes, a complex network of proteins which forms under cellular stress, such as in cancer, and nucleates on heat shock protein 90," commented Barbara Wallner, Chief Scientific Officer of Samus Therapeutics. "PU-H71 offers a novel approach to address frontline treatment of myelofibrosis in combination to potentially improve outcomes."

The combination multicenter Phase 1b study is designed to assess the safety, tolerability, pharmacodynamics, and preliminary efficacy of orally administered PU-H71 in myelofibrosis, for which the U.S. Food and Drug Administration granted Orphan Drug designation in 2018. The study will enroll patients who have active disease and have been receiving ruxolitinib therapy for at least 3 months. The study employs a standard 3+3 dose escalation design beginning with 50 mg/day of PU-H71 to determine the maximum tolerated dose (MTD). Enrollment in the study is now ongoing in the United States.

"Early study of intravenously administered PU-H71 in myelofibrosis in combination with ruxolitinib identified a safe and tolerable dose and we redirected our efforts to oral administration," said Dick Bagley, President and Interim Chief Executive Officer of Samus Therapeutics. "We believe that the combination of PU-H71 and ruxolitinib could deliver added clinical benefit in this extraordinarily difficult to treat hematological malignancy."

Details for the ASH (Free ASH Whitepaper) 2019 presentation are as follows:

Title: Phase 1b Study of the Epichaperome Inhibitor PU-H71 Administered Orally with Ruxolitinib Continuation for the Treatment of Patients with Myelofibrosis
Lead author: Dr. Naveen Pemmaraju, Associate Professor, Department of Leukemia, MD Anderson Cancer Center
Paper #: 4178
Session: 634. Myeloproliferative Syndromes: Clinical: Poster III
Date and Time: Monday, December 9, 2019; 6:00 PM-8:00 PM ET
Location: Orange County Convention Center, Hall B

On December 9, 2019 Qilu Pharmaceutical reported that The National Medical Products Administration approved it’s Ankeda as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer (Press release, Qilu Pharmaceutical, DEC 9, 2019, View Source [SID1234595070]). Ankeda is the first Avastin biosimilar approved in China for the treatment of cancer.

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The NMPA’s approval of Ankeda is based on review of evidence that includes extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ankeda is biosimilar to Avastin.

Qilu made big investment on Ankeda development. It took less than 1.5 years for the NMPA to greenlight Qilu’s Ankeda. Qilu is committed to bringing more biosimilars to patients to help lower healthcare costs and increase access to important therapies.