On January 6, 2020 Genmab A/S (Nasdaq: GMAB) reported that its CEO, Jan van de Winkel, Ph.D., will present a company update at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco at 3:30 PM PST on January 15, 2020 (12:30 AM CET, January 16) (Press release, Genmab, JAN 6, 2020, View Source [SID1234552719]). The live and archived webcast of the presentation will be available on Genmab’s website at View Source

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On January 6, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported that its Board of Directors unanimously appointed Enrique Conterno as the company’s Chief Executive Officer and a member of the Board of Directors, effective (Press release, FibroGen, JAN 6, 2020, View Source [SID1234552718]). Conterno previously worked as a senior vice president for Eli Lilly and Company, serving as President, Lilly USA, President, Lilly Diabetes, and a member of Lilly’s corporate executive committee.

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"Following a comprehensive search, we are confident Enrique is the right individual to assume leadership of FibroGen at this pivotal time," said Tom Kearns, previously Chairman of the Board, and lead independent director. "Enrique’s nearly three decades of experience in the global healthcare industry include multiple strategic leadership roles and the oversight of several significant product launches, including the diabetes field’s first-ever cardiovascular approval. Enrique re-established Lilly’s leadership position in diabetes, growing the business from approximately $3 billion to over $10 billion in annual revenue. Enrique is extremely qualified to lead FibroGen as we prepare for the global commercialization of roxadustat and continue the advancement of our clinical programs."

"I am energized to join a company with such an innovative pipeline, as well as the first-in-class asset roxadustat, which has the potential to change the treatment paradigm in anemia that has seen little progress in the last 30 years," said Conterno. "This is a tremendously exciting time for FibroGen and I am grateful to have the opportunity to work with this team as we continue to apply groundbreaking science with the goal of helping patients around the world."

Jim Schoeneck has served as the company’s Interim CEO since August 2019, following the unexpected passing of founder and long-term CEO, Tom Neff. With the hiring of Enrique, Jim is appointed Chairman of the Board of Directors and will continue to serve the company during a transition period as Interim President.

"On behalf of the Board of Directors, I would like to thank Jim Schoeneck for his dedicated leadership during this transition," said Kearns. "Jim’s knowledge of the industry, as well as our science and strategy, has been instrumental in keeping the company focused on top priorities during a difficult and critical period in its development, including the filing of the roxadustat U.S. NDA. Jim will be instrumental in working with Enrique and the rest of the Board to continue to fulfill the founding vision for the company, bringing novel, first-in-class medicines to patients."

A native of Peru, Conterno holds a bachelor’s degree in mechanical engineering from Case Western Reserve University and a master’s degree in business administration from Duke University. Conterno joined Eli Lilly and Company in 1992 and spent the next two decades working in the U.S. and internationally across sales, marketing, finance, business development, and general management roles. Conterno became the President of Lilly Diabetes in 2009. In addition to those responsibilities, Conterno took on the role of President of Lilly USA in January 2017. Conterno retired from Eli Lilly and Company at the end of 2019 after 27 years of service with the company.

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.