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Details:
The FDA approved COSELA™ (trilaciclib) as the first and only myeloprotection therapy to decrease the incidence of chemotherapy-induced myelosuppression.
Lead Product(s): Trilaciclib,Irinotecan Hydrochloride,Oxaliplatin
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: G1 Therapeutics, Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2021
Details:
Leap intends to use the net proceeds from the financing to fund the continued development of its lead monoclonal antibody program, DKN-01 for the treatment of Colorectal Cancer.
Lead Product(s): Sirexatamab,Fluorouracil,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: DKN-01
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: $40.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement April 11, 2024
Details:
Orotecan (irinotecan HCl) is a topoisomerase-I inhibitor approved by the FDA. It is now being evaluated for the treatment of recurrent pediatric solid tumors.
Lead Product(s): Irinotecan Hydrochloride,Temozolomide
Therapeutic Area: Oncology Product Name: Orotecan
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 April 08, 2024
Details:
Ipsen acquired exclusive commercialization rights for the current and potential future Onivyde, a unique encapsulation formulation of irinotecan in a long-circulating liposomal, as a first-line treatment of metastatic adenocarcinoma on the pancreas in the US.
Lead Product(s): Irinotecan Hydrochloride,Fluorouracil,Calcium Folinate
Therapeutic Area: Oncology Product Name: Onivyde
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ipsen
Deal Size: $1,025.0 million Upfront Cash: $575.0 million
Deal Type: Acquisition March 27, 2024
Details:
SNB-101 (SN-38) is an anticancer agent that is the world's first nanoparticle formulation of the anticancer drug SN-38. It uses a delivery system sophisticatedly designed via dual nano-micelle technology. It is being evaluated for the treatment of pancreatic cancer.
Lead Product(s): Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: SNB-101
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 February 29, 2024
Details:
Onivyde (irinotecan), liposomal injection is a small molecule drug that blocks an enzyme called topoisomerase I. It is being developed for the treatment of metastatic pancreatic adenocarcinoma.
Lead Product(s): Irinotecan Hydrochloride,Fluorouracil,Calcium Folinate
Therapeutic Area: Oncology Product Name: Onivyde
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 13, 2024
Details:
Under the agreement, Merck will receive an exclusive license to RGX-202 (ompenaclid), currently in Phase II development for RAS-mutated advanced or metastatic colorectal cancer, outside of the United States and an option to co-develop and co-promote ompenaclid in the US.
Lead Product(s): RGX-202,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: RGX-202
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck Group
Deal Size: Undisclosed Upfront Cash: $45.0 million
Deal Type: Licensing Agreement January 04, 2024
Details:
INBRX-109 is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation, which is investigated for Ewing sarcoma.
Lead Product(s): INBRX-109,Temozolomide,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: INBRX-109
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 02, 2023
Details:
Natrunix (vilamakitug) is a unique kind of drug, an immunoglobulin cloned from a naturally occurring immune response from a healthy human donor, and is investigated in combination with chemotherapy for treating pancreatic cancer.
Lead Product(s): Vilamakitug,Irinotecan Hydrochloride,Calcium Folinate
Therapeutic Area: Oncology Product Name: Natrunix
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 August 30, 2023
Details:
OT-101, is a first-in-class anti-TGF-β2 RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer (metastatic pancreatic cancer) patients. TGF-β2 has been implicated as a key contributor to the immunosuppressive landscape of the TME in HGG.
Lead Product(s): Trabedersen,Fluorouracil,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: OT-101
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Cromos Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 23, 2023
Details:
SNB-101 is the world's first product to use the active metabolite (SN-38) of Irinotecan as an API, and dual nano-micelle technology which is a core platform technology of SN Bioscience is applied.
Lead Product(s): Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: SNB-101
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 July 20, 2023
Details:
DKN-01, is an anti-Dickkopf-1 (DKK1) antibody and in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced CRC.
Lead Product(s): Sirexatamab,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: DKN-01
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 July 12, 2023
Details:
The license will allow Welton to use the Apisolex excipient worldwide to develop and commercialize a novel formulation of WP-038 (SN-38) to treat colorectal and associated gastro-intestinal cancers.
Lead Product(s): Irinotecan Hydrochloride,Apisolex
Therapeutic Area: Oncology Product Name: WP-038
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Welton Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 20, 2023
Details:
Onivyde (irinotecan) is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, which is investigated for treatment of pancreatic ductal adenocarcinoma.
Lead Product(s): Irinotecan Hydrochloride,Fluorouracil,Calcium Folinate
Therapeutic Area: Oncology Product Name: Onivyde
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 June 14, 2023
Details:
Braftovi (Encorafenib) Is An Oral Small Molecule Braf Kinase Inhibitor And Combination With Cetuximab Used for Patients With Patients With Braf V600E Alterations In Metastatic Colorectal Cancer.
Lead Product(s): Encorafenib,Cetuximab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Braftovi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2023
Details:
AUM001 is a mRNA translation inhibitor that targets MNK 1/2 and the chokepoint of multiple pro-oncogenic signalling pathways, being investigated for the treatment of metastatic colorectal cancer.
Lead Product(s): AUM001,Pembrolizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: AUM001
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 May 30, 2023
Details:
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 has an important role in mediating an immune suppressive tumor microenvironment and in promoting tumor proliferation, metastasis, and angiogenesis.
Lead Product(s): DKN-01,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: DKN-01
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 April 12, 2023
Details:
PCM-075 (onvansertib) is a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as KRAS/NRAS-mutated cancers.
Lead Product(s): Onvansertib,Irinotecan Hydrochloride,Calcium Folinate
Therapeutic Area: Oncology Product Name: PCM-075
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 March 28, 2023
Details:
RRx-001 is a highly selective NLRP3 inhibitor with vascular normalization and tumor associated macrophage polarization properties that resensitizes tumors. RRx-001 is under investigation for SCLC and for protection against oral mucositis in first line head and neck cancer.
Lead Product(s): RRx-001,Irinotecan Hydrochloride,Bevacizumab
Therapeutic Area: Oncology Product Name: RRx-001
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 January 20, 2023
Details:
Onivyde (irinotecan) is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die.
Lead Product(s): Irinotecan Hydrochloride,Oxaliplatin,Fluorouracil
Therapeutic Area: Oncology Product Name: Onivyde
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 January 20, 2023
Details:
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways and has an important role in promoting tumor proliferation, metastasis, angiogenesis.
Lead Product(s): DKN-01,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: DKN-01
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 October 17, 2022
Details:
Durable responses to treatment, with a median duration of response (mDoR) of 11.7 months, reported in Phase 1b/2 clinical trial of PCM-075 (onvansertib) plus FOLFIRI/bevacizumab in second-line KRAS-mutated mCRC.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: PCM-075
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 September 11, 2022
Details:
PCM-075 (onvansertib) effectively targets PLK1 an enzyme over-expressed in many cancer types. It’s been known for decades to to be hijacked by tumor cells allowing uncontrolled growth in the M phase of the cell cycle.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: PCM-075
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 September 06, 2022
Details:
The press release indicates that the “the primary endpoint OS was not met in patients treated with Onivyde (irinotecan) versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed.
Lead Product(s): Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Onivyde
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merrimack Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2022
Details:
The analysis concluded that the primary endpoint OS was not met in patients treated with Onivyde (irinotecan) versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed.
Lead Product(s): Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Onivyde
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 02, 2022
Details:
Proceeds will support the development of lead candidate RGX-202-01 (“RGX-202”), an oral small molecule inhibitor of SLC6a8 to treat RAS mutant advanced colorectal cancer and RGX-104, an oral small molecule activator of LXR/APOE to treat lung and endometrial cancer.
Lead Product(s): RGX-202-01,Irinotecan Hydrochloride,Calcium Folinate
Therapeutic Area: Oncology Product Name: RGX-202-01
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sands Capital
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Series D Financing July 11, 2022
Details:
RGX-202-01 is an oral, potential first-in-class small molecule inhibitor of SLC6a8, a creatine transporter that drives colorectal cancer and certain other cancers’ progression.
Lead Product(s): RGX-202-01,Irinotecan Hydrochloride,Calcium Folinate
Therapeutic Area: Oncology Product Name: RGX-202-01
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 June 28, 2022
Details:
Bevagen®(Bevacizumab) is biosimilar of the recombinant humanized anti-VEGF monoclonal antibody bevacizumab. Vascular endothelial growth factor (VEGF) is a critical factor in promoting angiogenesis, and is highly expressed by the endothelial cells in most tumors.
Lead Product(s): Bevacizumab,Fluoropyrimidine,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Bevagen
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Etana
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2022
Details:
Cosela (trilaciclib), an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes. It is approved by the U.S. FDA in another indication.
Lead Product(s): Trilaciclib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Cosela
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 June 13, 2022
Details:
Initial results suggest sequential combination of anti-PD-L1 checkpoint inhibitor atezolizumab with individualized cancer therapy BNT122 (autogene cevumeran), and chemotherapy showed a favorable safety profile, while the product candidate was feasibly manufactured.
Lead Product(s): Autogene Cevumeran,Atezolizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: BNT122
Highest Development Status: Phase IProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2022
Details:
RGX-202-01 is an oral, potential first-in-class small molecule inhibitor of SLC6a8, a creatine transporter that drives colorectal cancer and certain other cancers’ progression.
Lead Product(s): RGX-202-01,Irinotecan Hydrochloride,Calcium Folinate
Therapeutic Area: Oncology Product Name: RGX-202-01
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 May 26, 2022
Details:
RGX-202-01, oral small-molecule inhibitor of SLC6A8 that induces apoptosis of colorectal cancer cell, is being tested in combination with the FOLFIRI and bevacizumab in a Phase 1b clinical trial for 2nd line treatment of patients with cancer whose tumors express CKB.
Lead Product(s): RGX-202-01,Irinotecan Hydrochloride,Calcium Folinate
Therapeutic Area: Oncology Product Name: RGX-202-01
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 April 27, 2022
Details:
ART0380, an ataxia telangiectasia, and Rad3-related (“ATR”) Inhibitor, demonstrated a predictable safety profile and no unexpected safety findings supported by data from over 35 patients in Phase 1a dose escalation.
Lead Product(s): ART0380,Gemcitabine,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: ART0380
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 April 05, 2022
Details:
Results showed that the use of trilaciclib prior to chemotherapy was associated with a 50% reduction in the percent of patients with grade ≥ 3 myelosuppressive hematologic adverse events in at least one blood cell lineage and 74% reduction in the percent.
Lead Product(s): Trilaciclib,Irinotecan Hydrochloride,Oxaliplatin
Therapeutic Area: Oncology Product Name: G1T28
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
The Data Review Committee has declared the 900 µg/kg mitazalimab, an agonistic or stimulatory antibody that targets CD40 dose to be safe and recommended that the dosing level should be continued for the Phase II study.
Lead Product(s): Mitazalimab,Oxaliplatin,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: ADC-1013
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 March 23, 2022
Details:
The genesis for the PIRATE trial was based on several preceding clinical trials which have established potential evidence that RRx-001 increases chemotherapy delivery and uptake in tumors.
Lead Product(s): RRx-001,Temozolomide,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: RRx-001
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Texas Children’s Hospital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 23, 2022
Details:
Phase 1b/2 trial of onvansertib in combination with standard-of-care FOLFIRI and Avastin® (bevacizumab) to evaluate the safety and preliminary efficacy of the combination regimen in the second-line treatment of patients with KRAS-mutated mCRC.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: PCM-075
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 18, 2022
Details:
Zepzelca (lurbinectedin) is a DNA-negative allosteric modulator. It is being developed for the treatment of patients with relapsed small cell lung cancer.
Lead Product(s): Lurbinectedin,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Zepzelca
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jazz Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2021
Details:
XBiotech’s pancreatic cancer program, 1-BETTER, launched with a randomized, double-blind, placebo controlled Phase 1-2 study, allows the Company to evaluate dose levels, drug interaction and anti-cancer activity for Natrunix™.
Lead Product(s): XB2001,Irinotecan Hydrochloride,Fluorouracil
Therapeutic Area: Oncology Product Name: XB2001
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 08, 2021
Details:
This trial is an open-label, multi-center study designed to assess the safety and efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide®), leucovorin, and 5-FU as a second-line treatment in patients with metastatic PDAC.
Lead Product(s): Onvansertib,Irinotecan Hydrochloride,Fluorouracil
Therapeutic Area: Oncology Product Name: Undisclosed
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 June 08, 2021
Details:
As NOXXON advances its pipeline with upcoming start of clinical trials this additional liquidity will focus on manufacturing of NOX-A12 clinical trial supply in anticipation of upcoming clinical trials.
Lead Product(s): Olaptesed Pegol,Pembrolizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: NOX-A12
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ATLAS PHARMS LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing June 01, 2021
Details:
CPI-613® (devimistat) is a first-in-class clinical lead compound of Rafael, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells.
Lead Product(s): Devimistat,Oxaliplatin,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: CPI-613
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 May 26, 2021
Details:
XBiotech’s new drug XB2001 is a naturally occurring antibody that potently neutralizes IL-1⍺ and is thus a safe and promising approach to block inflammation that occurs with advanced malignancies and chemotherapy.
Lead Product(s): XB2001,Irinotecan Hydrochloride,Fluorouracil
Therapeutic Area: Oncology Product Name: XB2001
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 April 19, 2021
Details:
Trial will evaluate the safety and efficacy of onvansertib in combination with standard-of-care for second-line treatment of patients with metastatic PDAC who have failed first line treatment with a gemcitabine-based chemotherapy regimen.
Lead Product(s): Onvansertib,Irinotecan Hydrochloride,Calcium Folinate
Therapeutic Area: Oncology Product Name: Undisclosed
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 January 26, 2021
Details:
Neoadjuvant modified FOLFIRINOX (mFOLFIRINOX) improved overall survival relative to historical data in patients with borderline resectable adenocarcinoma of the pancreas; But, addition of hypofractionated radiation therapy did not improve OS compared to historical data.
Lead Product(s): Oxaliplatin,Irinotecan Hydrochloride,Fluorouracil
Therapeutic Area: Oncology Product Name: mFOLFIRINOX
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 January 21, 2021
Details:
The results of the study showed substantial improvement as compared to historical results across all study endpoints. BioLineRx plans to present the full data set at an upcoming medical conference.
Lead Product(s): Motixafortide,Pembrolizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: BL-8040
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2020
Details:
U.S FDA has granted the company Fast Track designation for irinotecan liposome injection (Onivyde) in study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen, reflecting the unmet medical need.
Lead Product(s): Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Onivyde
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 November 30, 2020
Details:
CPI-613® (devimistat) is a first-in-class clinical lead compound of Rafael, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells.
Lead Product(s): Devimistat,Oxaliplatin,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: CPI-613
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 November 10, 2020
Details:
CPI-613® (devimistat) is a first-in-class clinical lead compound of Rafael, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells.
Lead Product(s): Devimistat,Oxaliplatin,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: CPI-613
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 20, 2020
Details:
The addition of onvansertib to standard-of-care shows promise as a novel second-line option for patients with difficult-to-treat KRAS-mutated mCRC.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
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 September 17, 2020
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