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Details:
Dr. Reddy’s Capecitabine Tablets, USP are available in 150 mg and 500 mg strengths in bottle count sizes of 60 and 120, respectively.
Lead Product(s): Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 17, 2021
Details:
The net proceeds will be used to advance the development of PCS6422 (eniluracil) administered in combination with capecitabine, for the treatment of advanced, refractory gastrointestinal tract tumors.
Lead Product(s): Eniluracil,Capecitabine
Therapeutic Area: Oncology Product Name: PCS6422
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $7.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 01, 2024
Details:
NGC-Cap is PCS6422 (eniluracil) administered in combination with capecitabine, a precursor of the cancer drug 5-FU. It is being evaluated in phase 1 clinical trials for the treatment of gastrointestinal cancer.
Lead Product(s): Eniluracil,Capecitabine
Therapeutic Area: Oncology Product Name: PCS6422
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2024
Details:
IMAB362 (zolbetuximab) is a chimeric IgG1 monoclonal antibody that binds to claudin 18.2 (CLDN18.2). It is being evaluated in phase 3 studies for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
Lead Product(s): Zolbetuximab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: IMAB362
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2024
Details:
Under the agreement, Compugen provided an exclusive license to AstraZeneca to use its monospecific antibodies that bind to TIGIT, including AZD2936 (rilvegostomig), a PD-1/TIGIT bispecific antibody.
Lead Product(s): Rilvegostomig,Capecitabine
Therapeutic Area: Oncology Product Name: AZD2936
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: $210.0 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement January 08, 2024
Details:
Under the agreement, AstraZeneca has the rights for the development of bi-specific and multi-specific antibody products, including rilvegostomig, a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902.
Lead Product(s): Rilvegostomig,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: $210.0 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement December 19, 2023
Details:
NGC-Cap combines the administration of PCS6422, the Company’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with the administration of low doses of the commonly used chemotherapy capecitabine.
Lead Product(s): Capecitabine,Eniluracil
Therapeutic Area: Oncology Product Name: NGC-Cap
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2023
Details:
AK104 (cadonilimab) is a bispecific antibody that targets both PD-1 & CTLA-4. It is under phase 3 clinical development in combination with chemotherapy for the treatment of unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Lead Product(s): Cadonilimab,Capecitabine,Oxaliplatin
Therapeutic Area: Oncology Product Name: AK104
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2023
Details:
Ivaltinostat is a novel anticancer therapeutic candidate that inhibits enzymatic activity of histone deacetylase. It is being developed for the treatment of metastatic pancreatic ductal adenocarcinoma.
Lead Product(s): CG200745,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2023
Details:
Xeloda (capecitabine) is an oral small molecule, thymidylate synthase inhibitor, which is approved for the treatment of metastatic colorectal cancer and breast cancer.
Lead Product(s): Capecitabine
Therapeutic Area: Oncology Product Name: Xeloda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2023
Details:
IMAB362 (zolbetuximab) is an investigational, first-in-class chimeric IgG1 mAb that targets and binds to CLDN18.2 present on the cancer cell surface of gastric epithelial cells. It induces cancer cell death by activating ADCC and CDC immune system.
Lead Product(s): Zolbetuximab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: IMAB362
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2023
Details:
IMAB362 (zolbetuximab) is an investigational, first-in-class chimeric IgG1 mAb that targets and binds to CLDN18.2 present on the cancer cell surface of gastric epithelial cells. It induces cancer cell death by activating ADCC and CDC immune system.
Lead Product(s): Zolbetuximab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: IMAB362
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2023
Details:
CYT-0851, its investigational monocarboxylate transporter inhibitor, which is investigated combination study with capecitabine or gemcitabine in advanced ovarian cancer and other solid tumors.
Lead Product(s): Rad51-IN-2,Capecitabine
Therapeutic Area: Oncology Product Name: CYT-0851
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2023
Details:
The Company intends to use the net proceeds to fund the research and development of its product candidates, including ARX788, a next-generation, site-specific anti-HER2 ADC, being developed for the treatment of HER2-positive metastatic breast cancer.
Lead Product(s): ARX788,Capecitabine,Lapatinib Ditosylate
Therapeutic Area: Oncology Product Name: ARX788
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $75.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 28, 2023
Details:
IMAB362 (zolbetuximab) is an investigational, first-in-class chimeric IgG1 mAb that targets and binds to CLDN18.2 present on the cancer cell surface of gastric epithelial cells. It induces cancer cell death by activating ADCC and CDC immune system.
Lead Product(s): Zolbetuximab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: IMAB362
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2023
Details:
AB011 is a humanized CLDN18.2 monoclonal antibody (mAb) product that has received an investigational new drug (IND) approval from the National Medical Products Administration (NMPA) for the treatment of CLDN18.2 positive solid tumors.
Lead Product(s): AB011,Atezolizumab,Capecitabine
Therapeutic Area: Oncology Product Name: AB011
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2023
Details:
TST001 (osemitamab) is a high affinity humanized anti-Claudin18.2 mAb with enhanced ADCC and CDC activities and potent anti-tumor activities in tumor xenograft models. It is being investigated in combination with CAPOX for gastric/gastro-esophageal junction cancer.
Lead Product(s): Osemitamab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: TST001
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2023
Details:
BGB-A317 (tislelizumab) is a humanized IgG4 anti-PD-1 mAb, designed to minimize binding to Fcγ receptors on macrophages, helping immune cells to detect and fight tumors. It is being investigated for Advanced gastric or gastroesophageal junction adenocarcinoma.
Lead Product(s): Tislelizumab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2023
Details:
IMAB362 (zolbetuximab) is an investigational, first-in-class chimeric IgG1 mAb that targets and binds to CLDN18.2 present on the cancer cell surface of gastric epithelial cells. It induces cancer cell death by activating ADCC and CDC immune system.
Lead Product(s): Zolbetuximab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: IMAB362
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2023
Details:
ARX788, an anti-HER2 antibody drug conjugate currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials.
Lead Product(s): ARX788,Capecitabine,Lapatinib Ditosylate
Therapeutic Area: Oncology Product Name: ARX788
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2023
Details:
CYT-0851, an oral investigational drug that inhibits monocarboxylate transporters. Product is being investigation in combination with capecitabine and gemcitabine in a Phase 1/2 clinical study, including patients with advanced ovarian cancer.
Lead Product(s): Rad51-IN-2,Capecitabine
Therapeutic Area: Oncology Product Name: CYT-0851
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
ZW25 (zanidatamab) is an investigational bispecific antibody, based on Zymeworks' Azymetric™ platform, that simultaneously bind two non-overlapping epitopes of HER2, which encourages antitumor activity in patients. It is being investigated for solid tumors that express HER2.
Lead Product(s): Zanidatamab,Capecitabine,Oxaliplatin
Therapeutic Area: Oncology Product Name: ZW25
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Zymeworks
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
IMAB362 (Zolbetuximab), is an investigational first-in-class Claudin-18.2 targeted monoclonal antibody, for the first-line treatment of patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma.
Lead Product(s): Zolbetuximab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: IMAB362
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2022
Details:
XELODA (capecitabine) is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5- fluorouracil.
Lead Product(s): Capecitabine
Therapeutic Area: Oncology Product Name: Xeloda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2022
Details:
As a small molecule that can cross the blood brain barrier, Nerlynx (neratinib) potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option.
Lead Product(s): Neratinib,Capecitabine,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
TST001 (Osemitamab) is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC") and complement-dependent cytotoxicity ("CDC") activities and potent anti-tumor activities in tumor xenograft models.
Lead Product(s): TST001,Capecitabine,Oxaliplatin
Therapeutic Area: Oncology Product Name: TST001
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2022
Details:
DZD1516 was well tolerated at doses ≤ 250 mg, and in consistent with its high selectivity, no wild-type EGFR-related AEs have been reported. Thus, 250 mg was defined as MTD.
Lead Product(s): DZD1516,Trastuzumab,Capecitabine
Therapeutic Area: Oncology Product Name: DZD1516
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2022
Details:
TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models.
Lead Product(s): TST001,Capecitabine,Oxaliplatin
Therapeutic Area: Oncology Product Name: TST001
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2022
Details:
Sintilimab, marketed as TYVYT in China, is a PD-1 immunoglobulin G4 monoclonal antibody, is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on surface of T-cells, blocks PD-L1 pathway, and reactivates T-cells to kill cancer cells.
Lead Product(s): Sintilimab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: Tyvyt
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2022
Details:
TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models.
Lead Product(s): TST001,Capecitabine,Oxaliplatin
Therapeutic Area: Oncology Product Name: TST001
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Epizyme
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
Study of ZW25 (zanidatamab) in combination with docetaxel results in 90.5% confirmed objective response rate (cORR) in first-line treatment of advanced HER2-positive breast cancer.
Lead Product(s): Zanidatamab,Tislelizumab,Capecitabine
Therapeutic Area: Oncology Product Name: ZW25
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
Zymeworks' global Phase 3 study, HERIZON-GEA-01, which is investigating ZW25 (zanidatamab) in combination with chemotherapy plus or minus tislelizumab for first-line treatment of locally advanced, unresectable, or metastatic HER2-positive gastroesophageal adenocarcinoma.
Lead Product(s): Zanidatamab,Capecitabine,Oxaliplatin
Therapeutic Area: Oncology Product Name: ZW25
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2022
Details:
Zanidatamab, a HER2-targeted bispecific antibody, in combination with chemotherapy and tislelizumab as first-line therapy for patients with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GJEC): Preliminary results from a Phase 1b/2 study.
Lead Product(s): Zanidatamab,Capecitabine,Oxaliplatin
Therapeutic Area: Oncology Product Name: ZW25
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
Under the agreement, R-PHARM US has appointed Vector Pharma as exclusive distributor to import, use, market, sell and distribute Ixempra (ixabepilone) in the Middle East & North African territories.
Lead Product(s): Ixabepilone,Capecitabine
Therapeutic Area: Oncology Product Name: Ixempra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: R-Pharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 22, 2021
Details:
Pivotal HER2CLIMB trial showed that TUKYSA resulted in a robust and durable prolongation of overall survival that was consistent with results from the primary analysis for HER2-positive metastatic breast cancer patients with brain metastases.
Lead Product(s): Tucatinib,Capecitabine,Trastuzumab
Therapeutic Area: Oncology Product Name: Tukysa
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2021
Details:
Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric™ platform. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.
Lead Product(s): Zanidatamab,Tucatinib,Capecitabine
Therapeutic Area: Oncology Product Name: ZW25
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2021
Details:
Zanidatamab binds to HER2 across a range of expression levels and has demonstrated multiple mechanisms of action including the formation of receptor clusters, resulting in receptor internalization and downregulation that affect signal transduction .
Lead Product(s): Zanidatamab,Tucatinib,Capecitabine
Therapeutic Area: Oncology Product Name: ZW25
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
LipoMedix's lead compound, Promitil® (PL-MLP), will be manufactured in the United States by ForDoz Pharma (ForDoz), specialty pharmaceutical company focused on the development, manufacturing, and commercialization of value-added sterile and complex injectable products.
Lead Product(s): Pegylated liposomal Mitomycin-c prodrug,Capecitabine
Therapeutic Area: Oncology Product Name: Promitil
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: LipoMedix
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 10, 2021
Details:
Fordoz will support LipoMedix to develop and manufacture Promitil in the United States. Promitil's unique liposomal formulation is designed for selective delivery of the therapeutic agent to cancer-affected tissues and is ideally suited for cancer chemoradiotherapy.
Lead Product(s): Pegylated liposomal Mitomycin-c prodrug,Capecitabine
Therapeutic Area: Oncology Product Name: Promitil
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: LipoMedix
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 10, 2021
Details:
MARGENZA (margetuximab-cmkb) is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin® (trastuzumab), both combined with chemotherapy, in a head-to-head Phase 3 clinical trial.
Lead Product(s): Margetuximab,Capecitabine,Eribulin
Therapeutic Area: Oncology Product Name: Margenza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2020
Details:
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with MBC. CONTESSA met the primary endpoint of improved PFS as assessed by the IRC.
Lead Product(s): Tesetaxel,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2020
Details:
The presentation entitled, “Impact of neratinib plus capecitabine on outcomes in HER2-positive metastatic breast cancer patients with central nervous system disease at baseline: Findings from the phase 3 NALA trial,” is being presented at a Spotlight Poster Discussion Session.
Lead Product(s): Neratinib,Capecitabine
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2020
Details:
MAHOGANY is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GC/GEJ.
Lead Product(s): Margetuximab,Retifanlimab,Capecitabine
Therapeutic Area: Oncology Product Name: MGAH22
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 got each each 21-day cycle plus a reduced dose of capecitabine to the approved dose of capecitabine alone in patients with HER2 (-), HR (+) MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.
Lead Product(s): Tesetaxel,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2020
Details:
CS1001-201 study demonstrated an objective response rate of 44.7% , a complete response rate of 31.6%, mOS of 19.7 months and an one-year overall survival rate of 55.5% in patients with relapsed or refractory extranodal natural killer /T cell lymphoma treated with sugemalimab.
Lead Product(s): Sugemalimab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
Seattle Genetics has granted Merck an exclusive license to commercialize TUKYSA® (tucatinib), a small molecule tyrosine kinase inhibitor, for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S.
Lead Product(s): Trastuzumab,Capecitabine
Therapeutic Area: Oncology Product Name: Tukysa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: $275.0 million Upfront Cash: $125.0 million
Deal Type: Licensing Agreement September 14, 2020
Details:
The SNDS is supported by the results of the Phase IIINALA trial, a randomized controlled trial of neratinib plus capecitabine versus Tykerb® (lapatinib) plus capecitabine in HER2-positive metastatic breast cancer patients previously treated with = 2 HER2-directed regimens.
Lead Product(s): Neratinib,Capecitabine
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development, regulatory and commercial preparation activities relating to tesetaxel, as well as for working capital and general corporate purposes.
Lead Product(s): Tesetaxel,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $80.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 27, 2020
Details:
PCS6422 is an oral drug to be administered with fluoropyrimidine cancer drugs to decrease the breakdown of the cancer drug to inactive metabolites or metabolites that are known to cause unwanted side effects and to interfere with the anticancer activity.
Lead Product(s): Eniluracil,Capecitabine
Therapeutic Area: Oncology Product Name: PCS6422
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Processa Pharmaceuticals
Deal Size: $103.1 million Upfront Cash: $88.0 million
Deal Type: Licensing Agreement August 27, 2020
Details:
CONTESSA met the primary endpoint of improved PFS as assessed by the IRC. Median PFS was 9.8 months for tesetaxel plus a reduced dose of capecitabine versus 6.9 months for the approved dose of capecitabine alone, an improvement of 2.9 months.
Lead Product(s): Tesetaxel,Capecitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
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