Cellectar Biosciences, Inc.

Celularity Inc. is a clinical-stage biotechnology enterprise dedicated to pioneering "off-the-shelf" allogeneic cell therapies, which are developed from placental sources. These innovative treatments are designed to combat a range of serious conditions, including various cancers, immune system dysfunctions, and infectious diseases. The company’s operations are segmented into three distinct areas: Cell Therapy, Degenerative Disease, and BioBanking. Their therapeutic pipeline features several key candidates: CYCART-19, a placental-derived CAR-T therapy, currently in Phase I trials for B-cell malignancies; CYNK-001, an unmodified natural killer (NK) cell also from placental sources, advancing through Phase I trials for acute myeloid leukemia and Phase I/IIa trials for glioblastoma multiforme and COVID-19; and CYNK-101, an allogeneic genetically modified NK cell, which is in Phase I for HER2+ gastric and gastroesophageal cancers. Furthermore, two mesenchymal-like adherent stromal cell candidates, APPL-001 and PDA-002 (both derived from placentas), are in pre-clinical development for Crohn's disease and facioscapulohumeral muscular dystrophy, respectively. In addition to its therapeutic development, Celularity is involved in commercial activities, offering surgical and wound care products like Biovance and Interfyl through sales and licensing agreements. The company also specializes in collecting stem cells from umbilical cords and placentas, providing storage services under its LifebankUSA brand. Founded in 2016, Celularity Inc. maintains its headquarters in Florham Park, New Jersey.

PDS Biotechnology Corporation is a clinical-stage biopharmaceutical firm dedicated to advancing innovative, multi-functional immunotherapies to combat cancer. Its primary drug candidate, PDS0101 (HPV16), is currently undergoing Phase II clinical trials, positioned as an initial treatment option for recurrent or metastatic head and neck cancer, human papillomavirus (HPV)-associated malignancies, and cervical cancer. The company's developmental pipeline further includes several preclinical product candidates. These comprise PDS0102, utilizing T-cell receptor gamma alternate reading frame protein (TARP) for prostate and breast cancers; PDS0103 (MUC-1) targeting ovarian, colorectal, lung, and breast cancers; and PDS0104, which incorporates Tyrosinase-related protein 2 for the treatment of melanoma. Beyond oncology, PDS Biotechnology is also engaged in developing treatments for infectious diseases, with candidates such as PDS0201 for tuberculosis, PDS0202 as an investigational influenza vaccine, and PDS0203, a vaccine aimed at preventing COVID-19. The company has established strategic partnerships and licensing agreements with notable entities including the National Institutes of Health, Merck Eprova AG, The U.S. Department of Health and Human Services, and MSD International GmbH. PDS Biotechnology Corporation was founded in 2005 and is headquartered in Florham Park, New Jersey.

Celldex Therapeutics, Inc. is a biopharmaceutical company dedicated to developing antibody-based treatments, specifically monoclonal and bispecific antibodies, for a range of diseases. Their pipeline features therapeutic candidates aimed at both inflammatory conditions and various forms of cancer. Among their key clinical programs: CDX-0159 is a Phase I monoclonal antibody designed to bind to and inhibit the activity of the KIT receptor tyrosine kinase. CDX-1140 is a human agonist monoclonal antibody that targets CD40, a critical immune response activator found on immune cells such as dendritic cells, macrophages, and B cells, as well as on several cancer cell types. CDX-527 is a bispecific antibody that integrates Celldex's proprietary anti-PD-L1 and CD27 human antibodies. Its mechanism involves combining CD27 costimulation with blockade of the PD-L1/PD-1 pathway to prime and activate anti-tumor T-cell responses. The company has established several research collaborations and licensing agreements, including partnerships with the University of Southampton for developing human antibodies targeting CD27, Amgen Inc. for exclusive rights to CDX-301 and CD40 ligand, and Yale University. Incorporated in 1983, Celldex Therapeutics, Inc. is headquartered in Hampton, New Jersey.

Legend Biotech Corporation, through its subsidiaries, operates as a biopharmaceutical company that discovers, develops, manufactures, and commercializes novel cell therapies for oncology and other indications in the United States, China, and Europe. Its lead product candidate is ciltacabtagene autoleucel, or cilta-cel, which is a chimeric antigen receptor (CAR-T) therapy for the treatment of multiple myeloma (MM). The company also has a portfolio of earlier-stage autologous CAR-T product candidates targeting various cancers, including acute lymphoblastic leukemia, gastric cancer, esophageal cancer, pancreatic cancer, colorectal cancer, small cell lung cancer, and non-small cell lung cancer. In addition, it develops allogeneic gamma delta CAR-T and allogeneic CAR-NK product candidates targeting B-cell maturation antigen (BCMA) for MM, which are in investigator-initiated Phase 1 clinical trials in China. The company has a collaboration and license agreement with Janssen Biotech, Inc. for the development and commercialization of cilta-cel, as well as a license agreement with Novartis Pharma AG for the development, manufacture, and commercialization of CAR-T cell therapies targeting delta-like ligand protein 3. Legend Biotech Corporation was founded in 2014 and is headquartered in Somerset, New Jersey.

Cellectis S.A. is a biotechnology firm in the clinical development stage, concentrating on the creation of immuno-oncology therapies. These therapies harness gene-edited T-cells engineered to express chimeric antigen receptors, designed to specifically identify and eliminate malignant cells. Its operations are divided into two distinct divisions: Therapeutics and Plants. The therapeutic pipeline includes several product candidates currently undergoing development. Among these is UCART19, an allogeneic T-cell therapy targeting CD19-expressing blood cancers such as acute lymphoblastic leukemia. Other key developments encompass ALLO-501 and ALLO-501A, designed for diffuse large B-cell lymphoma and follicular lymphoma in relapsed or refractory patients; ALLO-316, intended for Renal Cell Carcinoma; UCART123 for acute myeloid leukemia; and UCART22 for B-cell acute lymphoblastic leukemia. Furthermore, UCARTCS1 and ALLO-715 are being developed to combat multiple myeloma. Strategic partnerships form a crucial part of its operations, encompassing alliances with entities such as Allogene Therapeutics, Inc., Les Laboratoires Servier, The University of Texas M.D. Anderson Cancer Center, and Iovance Biotherapeutics. The firm also maintains a dedicated research and development collaboration with Cytovia Therapeutics, Inc. Established in 1999, Cellectis S.A. maintains its principal offices in Paris, France.

HEIDELBERG PHARMA AGHPHA · BiotechnologyLadenburg, Germany

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Heidelberg Pharma AG is a biopharmaceutical firm dedicated to oncology, with a specific emphasis on its innovative antibody-targeted amanitin conjugates (ATAC) technology. The company conducts its activities across Germany, various other European countries, the United States, and globally. Its primary drug candidate, HDP-101, is presently in Phase I/IIa clinical trials for individuals suffering from relapsed or refractory multiple myeloma. The pipeline also features several other ATAC compounds: HDP-102 is being developed for non-Hodgkin lymphoma; HDP-103 targets metastatic castration-resistant prostate cancer; HDP-104 is aimed at various tumor types; and HDP-XX addresses both solid and hematological tumors. Further development programs include MGTA-ATACs, designed for hematopoietic stem cells (HSCs) and conditioning treatments for blood cancers and genetic conditions, alongside TAK-ATACs for broader oncology use. Heidelberg Pharma's offerings extend to diagnostic and therapeutic antibodies. TLX250-CDx, a diagnostic antibody for imaging purposes, is in Phase III for renal cancer, Phase I for urothelial carcinoma (bladder cancer), and Phase II for triple-negative breast cancer. Additionally, TLX250 (girentuximab), a therapeutic antibody, is undergoing Phase II evaluation for patients with advanced clear cell renal cell carcinoma. The company's diverse portfolio is complemented by RHB-107, an oral serine protease inhibitor in Phase II/III studies for both COVID-19 and advanced cholangiocarcinoma, as well as LH011 for pancreatic cancer. A significant licensing agreement and strategic partnership with Huadong Medicine Co., Ltd. grants the latter development and commercialization rights for HDP-101 and HDP-103 throughout Asia. Established in Ladenburg, Germany, in 1997, the company was formerly known as Wilex AG before rebranding to Heidelberg Pharma AG in October 2017.