On January 6, 2020 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that Jigar Raythatha, CEO, will present a company overview at the J.P. Morgan Healthcare Conference at 12 noon PST/3:00 PM EST on Monday, January 13, 2020, followed by a question-and-answer session at 1:30 PM PST/4:30 PM EST (Press release, Constellation Pharmaceuticals, JAN 6, 2020, View Source [SID1234552716]).

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A live audio webcast of the presentation and archive for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replay will be available for 30 days following the live presentation.

On January 6, 2020 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the publication of a review in Nature Reviews Drug Discovery by Prof. Stéphane Depil1*, Dr. Philippe Duchateau2, Prof. Stephan Grupp3, Prof. Ghulam Mufti4 and Dr. Laurent Poirot2 (Press release, Cellectis, JAN 6, 2020, View Source [SID1234552715]). The authors review the opportunities and challenges presented by universal allogeneic CAR T-cell therapies.

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One of the most promising approaches in cancer treatment is chimeric antigen receptor (CAR) T-cell therapy, in which part of the body’s own immunological defendors, T-cells, are redirected against cancerous cells after being engineered to express CARs. Since their initial development in the early 90s, CAR T-cells have evolved through several generations. The use of autologous (patient-derived) CAR T-cells has proven to be successful in treating people with certain blood cancers such as B-cell malignancies. However, autologous CAR T-cell therapy is not suitable for all patients, and it often requires a long and expensive manufacturing process since each treatment must be made individually for each patient.

Cellectis was the first company to develop and test an allogeneic CAR T-cell therapy in patients, where T-cells are derived from healthy donors. This gives rise to off-the-shelf product candidates which aim to be suitable for many patients as opposed to only a single person.

"We realized early on that refined gene-editing techniques were what was needed to take an allogeneic approach to CAR T-cell therapy," said Dr. Laurent Poirot, VP, Immunology Division, Cellectis. "Despite the complexity of this approach, we decided to follow this route because we are confident that it can provide the most impact for a maximum number of people living with severe cancers. This comprehensive review underlines just how much this technology has evolved in very little time. It also gives us exciting areas to explore as we continue to improve our product candidates."

One of the major challenges in the allogeneic approach involves mitigating the risk of graft-versus-host-disease (GvHD) — a medical complication that can present itself in people that have received tissues or cells from another person. The review examines aspects of this challenge and helps weigh the pros and cons associated with the different methods used to create allogeneic CAR T-cells. It also outlines some of the gene-editing work that Cellectis has done in this area along with complementary approaches being taken by others in the field, such as using cells other than conventional T-cells, also known as alpha beta T-cells.

"Our immune system, including our T-cells, is incredibly sophisticated. We know that T-cells can now be retasked to successfully fight cancer. There are amazing approaches to gene editing that are driving progress towards the most safe and efficacious versions of allogeneic products. It is exciting to see these approaches applied to ‘off the shelf’ CAR T-cell products," said Prof. Stephan Grupp, Chief of Cell Therapy and Transplant Section at the Children’s Hospital of Philadelphia, Professor of Pediatrics at the Perelman School of Medicine, and a member of Cellectis’ Clinical Advisory Board. "I’m looking forward to seeing emerging clinical data as well as even newer approaches, as Cellectis’ expertise in gene-editing technology continues to transform CAR-T".

On January 6, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131 in Lymphoplasmacytic Lymphoma (LPL) (Press release, Cellectar Biosciences, JAN 6, 2020, View Source [SID1234552714]). CLR 131 is the company’s lead Phospholipid Drug ConjugateTM (PDC) product candidate currently in a Phase 2 clinical study in relapsed or refractory select B-cell lymphomas, including Lymphoplasmacytic Lymphoma (LPL).

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"The orphan designation from the FDA for LPL represents the sixth for CLR 131 and underscores Cellectar’s commitment to develop therapies for rare cancers with limited treatment options and high unmet need," stated James Caruso, president and CEO of Cellectar Biosciences. "CLR 131 has demonstrated encouraging results in our ongoing Phase 2 CLOVER-1 trial in select B-cell lymphomas, which includes LPL patients. We look forward to sharing Phase 2 LPL clinical data in the near term."

The FDA grants ODD to therapies targeting conditions that affect fewer than 200,000 people in the U.S. The designation provides seven years of market exclusivity, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the New Drug Application user fee. CLR 131 has previously been granted Orphan Drug designation for the treatment of multiple myeloma by both the U.S. and the European Commission and Rare Pediatric Disease and Orphan Drug designations for the treatments of neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing’s sarcoma.

About Lymphoplasmacytic Lymphoma (LPL)

LPL is a rare type of non-Hodgkin’s lymphoma that develops slowly and affects mostly older adults. The average age at diagnosis is 60. Lymphomas are cancers of the lymph system, a part of the immune system that helps to fight off infections. In lymphoma, white blood cells, either B lymphocytes or T lymphocytes, grow out of control because of a mutation. In LPL, abnormal B lymphocytes reproduce in the bone marrow and displace healthy blood cells, compromising the body’s immune system and potentially resulting in anemia, neutropenia, or thrombocytopenia.

About the Phase 2 CLOVER-1 Trial

CLOVER-1 is a Phase 2 study of CLR 131 being conducted in approximately 10 leading cancer centers in the United States in patients with relapsed or refractory B-cell hematologic cancers. The hematologic cancers being studied in the trial include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

The study will enroll up to 80 patients. Its primary endpoint is clinical benefit response (CBR), with additional endpoints of overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a fractionated dose of 37.5mCi/m2 of CLR 131 administered in two 30-minute infusions of 18.75mCi/m2 of CLR 131 administered on day 1 and day 7 (± 1), with the option for a second dose cycle approximately 75-180 days later.

Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the trial. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

About CLR 131

CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma by both the U.S. and the European Commission, and was granted U.S. Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

On January 6, 2020 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will present at the J.P. Morgan 38th Annual Healthcare Conference on Monday, January 13, 2020 in San Francisco (Press release, Bristol-Myers Squibb, JAN 6, 2020, View Source [SID1234552713]). Giovanni Caforio, chairman and chief executive officer, will make a formal presentation about the company at 7:30 a.m. PT (10:30 a.m. ET).

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Investors and the general public are invited to listen to a live webcast of the presentation at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the presentation will be available later that day.

On January 6, 2020 GlycoMimetics, Inc. (NASDAQ: GLYC), a leader in the field of applied glycotechnology for cancer, and Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies, reported an exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China (Press release, Apollomics, JAN 6, 2020, View Source [SID1234552712]).

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Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization in Greater China. The companies will also collaborate to advance the preclinical and clinical development of GMI-1687, a highly potent, subcutaneous E-selectin antagonist with broad clinical potential. Subject to the terms of the agreement, GlycoMimetics will receive an upfront cash payment of $9 million and will be eligible to receive potential milestone payments totaling approximately $180 million, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for uproleselan and GMI-1687 in Greater China. GlycoMimetics will supply uproleselan and GMI-1687 to Apollomics via a clinical and commercial supply agreement. GlycoMimetics retains all rights for both compounds in the rest of the world.

"We believe Apollomics is the ideal long-term strategic partner for uproleselan and GMI-1687 in Greater China. The company has a highly experienced leadership team and drug development capabilities that complement our desire to bring these novel therapies to patients with AML and other hematologic malignancies," said Rachel King, GlycoMimetics Chief Executive Officer. "We are excited about the opportunity to expand the reach of uproleselan and GMI-1687 with this agreement."

Guo-Liang Yu, Ph.D., Chief Executive Officer of Apollomics, added, "Our portfolio of assets is composed of highly specific, targeted agents, and we believe that the mechanism of action for uproleselan and GMI-1687 to selectively bind to E-selectin is the perfect complement to our pipeline. The work done by GlycoMimetics will allow Apollomics to leverage emerging data in AML and other hematologic malignancies in which uproleselan and GMI-1687 might be effective and beneficial for patients in Greater China."

About Uproleselan (GMI-1271) and GMI-1687

Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors 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. Food and Drug Administration (FDA) 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 or 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.

GMI-1687 is a rationally designed, innovative antagonist of E-selectin that is potentially suitable for subcutaneous (SC) administration. When given by SC injection in preclinical models, GMI-1687 has been observed to have equivalent activity to uproleselan, but at an approximately 250-fold lower dose. GlycoMimetics believes that GMI-1687 could be developed as a potential life-cycle expansion to broaden the clinical usefulness of an E-selectin antagonist to conditions where outpatient treatment is preferred or required. GMI-1687 is currently undergoing investigational new drug (IND)-enabling studies.