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Details:
VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.
Lead Product(s): Venetoclax,Azacitidine
Therapeutic Area: Oncology Product Name: Venclexta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Mecce 2023
Not Confirmed
Contact SupplierDetails:
VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.
Lead Product(s): Venetoclax,Azacitidine
Therapeutic Area: Oncology Product Name: Venclyxta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2021
Mecce 2023
Not Confirmed
Contact SupplierDetails:
Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and pharmacokinetics of VENCLYXTO in combination with hypomethylating agents in adult patients with AML.
Lead Product(s): Venetoclax,Azacitidine
Therapeutic Area: Oncology Product Name: Venclyxto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Mecce 2023
Not Confirmed
Contact SupplierDetails:
In the VIALE-A trial, the median overall survival of patients who received VENCLEXTA plus azacitidine was 14.7 months (11.9, 18.7) vs 9.6 months (7.4, 12.7) in patients who received azacitidine in combination with placebo.
Lead Product(s): Venetoclax,Azacitidine
Therapeutic Area: Oncology Product Name: Venclexta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Genentech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2020
Mecce 2023
Not Confirmed
Contact SupplierDetails:
Phase 3 VIALE-A study showed a 34 percent reduction in the risk of death in AML patients who were ineligible for intensive chemotherapy treated with venetoclax plus azacitidine compared to azacitidine plus placebo.
Lead Product(s): Venetoclax,Azacitidine
Therapeutic Area: Oncology Product Name: Venclexta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Genentech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2020
Mecce 2023
Not Confirmed
Contact Supplier
Details:
The Company intends to use the net proceeds for further development of its product candidates, including SP 2577 (seclidemstat), a potent and orally bioavailable inhibitor of lysine-specific demethylase 1.
Lead Product(s): Seclidemstat,Azacitidine
Therapeutic Area: Oncology Product Name: SP 2577
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement May 16, 2023
Details:
The Company intends to use the net proceeds for further development of its product candidates, including SP 2577 (seclidemstat), a potent and orally bioavailable inhibitor of lysine-specific demethylase 1.
Lead Product(s): Seclidemstat,Azacitidine
Therapeutic Area: Oncology Product Name: SP 2577
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement May 12, 2023
Details:
ABBV-IMAB-TJC4 (lemzoparlimab) is a novel CD47 antibody, in combination with azacitidine (AZA), currently being investigated in China for patients with higher-risk myelodysplastic syndrome (MDS).
Lead Product(s): Lemzoparlimab,Azacitidine
Therapeutic Area: Oncology Product Name: ABBV-IMAB-TJC4
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 April 24, 2023
Details:
With the partial hold, FDA is requesting additional data from the study, including data related to the death of R/R AML patient who experienced, among several conditions, rhabdomyolysis, which has previously been identified as a dose-limiting toxicity of CA-4948 (emavusertib).
Lead Product(s): Emavusertib,Azacitidine
Therapeutic Area: Oncology Product Name: CA-4948
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aurigene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2023
Details:
Under the Licensing Agreement, OncoVerity will optimize JNJ-74494550 (cusatuzumab), a first-in-class anti-CD70 antibody, in acute myeloid leukemia (AML) and explore its application in other cancers.
Lead Product(s): Cusatuzumab,Azacitidine
Therapeutic Area: Oncology Product Name: JNJ-74494550
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: OncoVerity
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 27, 2023
Details:
The net proceeds will be used for the continued development JNJ-74494550 (cusatuzumab), a first-in-class anti-CD70 antibody for the treatment of acute myeloid leukemia (AML).
Lead Product(s): Cusatuzumab,Azacitidine
Therapeutic Area: Oncology Product Name: JNJ-74494550
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Argenx
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Series A Financing March 27, 2023
Details:
AB8939 is a new synthetic microtubule-destabilizing drug, having broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome Pgp and MPO mediated drug resistance.
Lead Product(s): AB8939,Azacitidine
Therapeutic Area: Oncology Product Name: AB8939
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 March 13, 2023
Details:
Rezlidhia (olutasidenib) is a small-molecule inhibitor of mutated isocitrate dehydrogenase-1 (IDH1). It is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptibleisocitrate dehydrogenase-1 (IDH1) mutation.
Lead Product(s): Olutasidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Rezlidhia
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 02, 2023
Details:
SY-1425 (tamibarotene), an oral first-inclass selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with azacitidine for the treatment of newly diagnosed HR-MDS patients with RARA gene overexpression.
Lead Product(s): Tamibarotene,Azacitidine
Therapeutic Area: Oncology Product Name: SY-1425
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 26, 2023
Details:
Rezlidhia (olutasidenib) is a small-molecule inhibitor of mutated isocitrate dehydrogenase-1 (IDH1). It is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptibleisocitrate dehydrogenase-1 (IDH1) mutation.
Lead Product(s): Olutasidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Rezlidhia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2023
Details:
Azacitidine is a pyrimidine nucleoside analog of cytidine. It is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow.
Lead Product(s): Azacitidine
Therapeutic Area: Oncology Product Name: Vidaza-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2023
Details:
The rates of myelosuppression were comparable to SY-1425 (azacitidine) monotherapy in this population suggesting no added hematologic toxicity from tamibarotene when used in combination with azacitidine. The majority of non-hematologic adverse events (AEs) were low grade.
Lead Product(s): Tamibarotene,Azacitidine
Therapeutic Area: Oncology Product Name: SY-1425
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 12, 2022
Details:
APVO436 is a bispecific CD3xCD123 ADAPTIR currently in Phase 1b development in a multi-center, multi-cohort trial designed to evaluate safety, tolerability and efficacy in combination therapy and monotherapy for patients with AML.
Lead Product(s): APVO436,Azacitidine,Venetoclax
Therapeutic Area: Oncology Product Name: APVO436
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 December 12, 2022
Details:
Evorpacept in combination with azacitidine and venetoclax was generally well tolerated (N=14) with no maximum tolerated dose identified and a maximum administered dose of 60 mg/kg Q4W.
Lead Product(s): Evorpacept,Venetoclax,Azacitidine
Therapeutic Area: Oncology Product Name: ALX148
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 December 12, 2022
Details:
SY-1425, having tamibarotene in combination with venetoclax and azacitidine administered at approved doses showed no evidence of increased toxicity relative to the doublet combination of venetoclax and azacitidine.
Lead Product(s): Tamibarotene,Azacitidine,Venetoclax
Therapeutic Area: Oncology Product Name: SY-1425
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 10, 2022
Details:
IBI188 is an IgG4 recombinant human anti-CD47 monoclonal antibody developed by Innovent Biologics. The Phase Ib study aims to evaluate the efficacy and safety of IBI188 in combination with AZA as first line therapy for newly diagnosed higher risk MDS.
Lead Product(s): IBI188,Azacitidine
Therapeutic Area: Oncology Product Name: IBI188
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 December 10, 2022
Details:
REZLIDHIA (olutasidenib) is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells.
Lead Product(s): Olutasidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Rezlidhia
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 02, 2022
Details:
REZLIDHIA (olutasidenib) is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells.
Lead Product(s): Olutasidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Rezlidhia
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 01, 2022
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