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Details:

PRIMCYV® is a targeted therapy containing the active constituent palbociclib, a first-in-class CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of adult patients with HR+, HER2- metastatic breast cancer.


Lead Product(s): Palbociclib,Fulvestrant

Therapeutic Area: Oncology Product Name: Primcyv

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 13, 2023

Details:

The pivotal study (AMEERA-3) of amcenestrant versus physician’s choice in locally advanced or metastatic estrogen receptor-positive (ER+) breast cancer is fully recruited; readout expected in H2 2021.


Lead Product(s): Amcenestrant,Palbociclib

Therapeutic Area: Oncology Product Name: SAR439859

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 19, 2021

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Iran Expo

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Company going to present clinical data on its oncology portfolio including data on its Phase 1/2 study of SAR439859, an oral selective estrogen receptor degrader (SERD), in estrogen receptor-positive (ER+)/HER2- metastatic breast cancer.


Lead Product(s): Amcenestrant,Palbociclib

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 May 13, 2020

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Iran Expo

Not Confirmed

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Details:

Relay Therapeutics expects to use net proceeds to advance RLY-2608, , a first-in-class mutant-selective allosteric PI3Ka inhibitor that decouples anti-tumor activity from hyperinsulinemia, towards registrational trial.


Lead Product(s): RLY-2608,Fulvestrant,Palbociclib

Therapeutic Area: Oncology Product Name: RLY-2608

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Nextech

Deal Size: $30.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement January 08, 2024

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Under the agreement, Avenzo will develop and commercialize AVZO-021 (formerly ARTS-021), a potentially best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor globally, excluding Greater China.


Lead Product(s): AVZO-021,Palbociclib,Fulvestrant

Therapeutic Area: Oncology Product Name: ARTS-021

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Avenzo Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 04, 2024

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GDC-0077 (inavolisib) is an investigational, highly selective inhibitor and degrader of mutant PI3K alpha. It is being evaluated in combination with palbociclib & fulvestrant for the treatment of HER2-negative breast cancer With a PIK3CA Mutation.


Lead Product(s): Inavolisib,Palbociclib,Fulvestrant

Therapeutic Area: Oncology Product Name: GDC-0077

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 08, 2023

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GDC-0077 (inavolisib) is an oral therapy with high in vitro potency and selectivity for PI3Kα inhibition. It is being evaluated in phase 3 trials for treatment of patients with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.


Lead Product(s): Inavolisib,Palbociclib,Fulvestrant

Therapeutic Area: Oncology Product Name: GDC-0077

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 05, 2023

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GDC-0077 (inavolisib palbociclib fulvestrant) is a PI3K alpha Inhibitor Small molecule drug candidate, which is currently being evaluated for the treatment of HR+/HER2-breast Cancer with a PIK3CA mutation via oral tablet.


Lead Product(s): Inavolisib,Palbociclib,Fulvestrant

Therapeutic Area: Oncology Product Name: GDC-0077

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 05, 2023

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Olema intends to use the net proceeds to fund research and development of palazestrant OP-1250 (palazestrant), a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist and a selective ER degrader.


Lead Product(s): Palazestrant,Palbociclib

Therapeutic Area: Oncology Product Name: OP-1250

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Paradigm BioCapital

Deal Size: $130.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement September 05, 2023

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OP-1250 is an estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD), which is being investigated in combination with palbociclib, a CDK4/6 inhibitor, for the treatment of ER+/HER2- metastatic breast cancer.


Lead Product(s): OP-1250,Palbociclib

Therapeutic Area: Oncology Product Name: OP-1250

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 11, 2023

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TTI-101 is an orally bioavailable, small-molecule inhibitor of signal transducer and activator of transcription 3, a transcription factor whose upregulation and activation governs many hallmarks of cancer, inflammation, and fibrosis.


Lead Product(s): TTI-101,Palbociclib

Therapeutic Area: Oncology Product Name: TTI-101

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 February 23, 2023

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Palborest (palbociclib) is a piperazine pyridopyrimidine3, second generation cyclin-dependent kinase inhibitor. Approved in combination with hormonal therapies for hormone receptor positive, human epidermal growth factor receptor negative breast cancer.


Lead Product(s): Palbociclib

Therapeutic Area: Oncology Product Name: Palborest

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 17, 2023

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Paleno™ (palbociclib) is a cyclin-dependent kinase inhibitor (key regulators of cell growth) selected from a group of pyridopyrimidine compounds due to its favorable physical and pharmaceutical properties.


Lead Product(s): Palbociclib

Therapeutic Area: Oncology Product Name: Paleno

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 11, 2023

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PKI-587 (Gedatolisib) is a potent, reversible dual inhibitor that selectively targets all Class I PI3K isoforms and mTOR. Its in Phase 1b clinical trial in combination with palbociclib and endocrine therapy for patients with HR+/HER2- advanced breast cancer.


Lead Product(s): Gedatolisib,Palbociclib,Fulvestrant

Therapeutic Area: Oncology Product Name: PKI-587

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 09, 2022

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Camizestrant (AZD9833) is a potent, next-generation oral SERD and pure ERα antagonist, that has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations.


Lead Product(s): Camizestrant,Palbociclib,Luteinizing Hormone

Therapeutic Area: Oncology Product Name: AZD9833

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 08, 2022

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Gedatolisib for the treatment of HR+/HER2- advanced breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor.


Lead Product(s): Gedatolisib,Palbociclib,Fulvestrant

Therapeutic Area: Oncology Product Name: PKI-587

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 07, 2022

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OP-1250 demonstrated favorable pharmacokinetics characterized by high oral bioavailability, dose proportional exposure and a long half-life of eight days, with steady-state plasma levels showing minimal peak-to-trough variability, enabling consistent inhibition of ER.


Lead Product(s): OP-1250,Palbociclib

Therapeutic Area: Oncology Product Name: OP-1250

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 07, 2022

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PKI-587 (gedatolisib) is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTOR. Its MOA and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR.


Lead Product(s): Gedatolisib,Palbociclib,Undisclosed

Therapeutic Area: Oncology Product Name: PKI-587

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 November 22, 2022

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ARV-471 is an investigational, orally-bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.


Lead Product(s): ARV-471,Palbociclib

Therapeutic Area: Oncology Product Name: ARV-471

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 22, 2022

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ZW49 (zanidatamab) is bispecific antibody, based on Zymeworks’ Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding.


Lead Product(s): Zanidatamab,Palbociclib,Fulvestrant

Therapeutic Area: Oncology Product Name: ZW49

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 November 21, 2022

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ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.


Lead Product(s): Onapristone,Letrozole,Palbociclib

Therapeutic Area: Oncology Product Name: ONA-XR

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: The Menarini Group

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 02, 2022

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OP-1250, is an orally-available small molecule with combined activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD).


Lead Product(s): OP-1250,Palbociclib

Therapeutic Area: Oncology Product Name: OP-1250

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 09, 2022

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With a median follow-up of 90 months, patients receiving IBRANCE (palbociclib) in combination with letrozole had numerically longer OS compared to placebo plus letrozole (median 53.9 months vs median 51.2 months) results were not statistically significant.


Lead Product(s): Palbociclib

Therapeutic Area: Oncology Product Name: Ibrance

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 04, 2022

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After balancing for baseline demographic and clinical characteristics, median OS (95% CI) was significantly longer in Ibrance (palbociclib) group versus AI group (49.1 [45.2–57.7] vs 43.2 [37.6–48.0] months; hazard ratio (HR) = 0.76 [95% CI, 0.65–0.87]; P=0.0001).


Lead Product(s): Palbociclib,Letrozole

Therapeutic Area: Oncology Product Name: Ibrance

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 04, 2022

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Studies demonstrated that combination of TTI-101 with palbociclib is synergistic in arresting tumor growth in murine models derived from metastatic breast cancer patients who had developed resistance to palbociclib.


Lead Product(s): TTI-101,Palbociclib

Therapeutic Area: Oncology Product Name: TTI-101

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 07, 2022

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The results showed ARV-471 has the potential to become a first-in-category treatment, and a new standard of care, for ER+/HER2- breast cancer patients and showed clinical benefits including tumor shrinkage and good tolerability.


Lead Product(s): ARV-471,Palbociclib

Therapeutic Area: Oncology Product Name: ARV-471

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 10, 2021

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Under the terms of collaboration with Pfizer will provide Ibrance® (palbociclib) for use in Celcuity's Phase 3 clinical trial to evaluate gedatolisib, in combination with palbociclib, and Faslodex® (fulvestrant), in patients with ER+/HER2- advanced breast cancer.


Lead Product(s): Gedatolisib,Palbociclib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration November 15, 2021

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Under terms of the agreement, Ascentage Pharma is responsible for conducting the trial and Pfizer is responsible for supplying study drug for Phase Ib/II dose-escalation and expansion study, to evaluate the anticancer activity of lisaftoclax in combination with palbociclib.


Lead Product(s): Lisaftoclax,Palbociclib

Therapeutic Area: Oncology Product Name: APG-2575

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Ascentage Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration November 08, 2021

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First phase II data will be presented from an interim analysis of giredestrant, a next-generation oral selective oestrogen receptor degrader (SERD), in neoadjuvant, ER-positive, HER2-negative early breast cancer.


Lead Product(s): Giredestrant,Palbociclib

Therapeutic Area: Oncology Product Name: GDC-9545

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 September 07, 2021

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First data to be presented from the Phase II coopERA Breast Cancer study evaluating neoadjuvant giredestrant treatment for estrogen receptor-positive, HER2-negative breast cancer.


Lead Product(s): Giredestrant,Palbociclib

Therapeutic Area: Oncology Product Name: GDC-9545

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 September 06, 2021

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Giredestrant is an oral selective estrogen receptor degrader (SERD) that was shown to be well tolerated with encouraging anti-tumour activity both alone and in combination with palbociclib in estrogen-receptor positive (ER+) metastatic breast cancer patients.


Lead Product(s): Giredestrant,Palbociclib

Therapeutic Area: Oncology Product Name: GDC-9545

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: F. Hoffmann-La Roche

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 31, 2021

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Collaboration combines Arvinas’ investigational estrogen receptor-targeting breast cancer therapy with Pfizer’s deep experience in breast oncology therapeutics. ARV-471 is currently in Phase 2 trial for patients with locally advanced/metastatic ER+/HER2- breast cancer.


Lead Product(s): ARV-471,Palbociclib

Therapeutic Area: Oncology Product Name: ARV-471

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: $2,050.0 million Upfront Cash: $650.0 million

Deal Type: Collaboration July 22, 2021

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Giredestrant is an oral selective estrogen receptor degrader (SERD) that was shown to be well tolerated with encouraging tumour activity both alone and in combination with palbociclib in estrogen-receptor positive (ER+) metastatic breast cancer patients.


Lead Product(s): Giredestrant,Palbociclib

Therapeutic Area: Oncology Product Name: GDC-9545

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: F. Hoffmann-La Roche

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 06, 2021

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IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are key regulators of the cell cycle that trigger cellular progression. The certificate extends the term of the U.S. Patent by more than four years until March 5, 2027.


Lead Product(s): Palbociclib

Therapeutic Area: Oncology Product Name: Ibrance

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 05, 2021

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ARV-471 demonstrates evidence of anti-tumor activity, and potential for best-in-class safety, and estrogen receptor (ER) degradation profile and robust efficacy signals in a heavily pretreated patient population.


Lead Product(s): ARV-471,Palbociclib

Therapeutic Area: Oncology Product Name: ARV-471

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 December 14, 2020

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New data from the SERENA-1 Phase I trial show strong efficacy and safety profile for next-generation oral SERD AZD9833 in HR-positive advanced breast cancer.


Lead Product(s): Camizestrant,Palbociclib

Therapeutic Area: Oncology Product Name: AZD9833

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 03, 2020

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Olema Oncology will evaluate OP-1250, in combination with Pfizer's IBRANCE® in patients with recurrent, locally advanced or metastatic estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative breast cancer. Pfizer will supply IBRANCE for the study.


Lead Product(s): OP-1250,Palbociclib

Therapeutic Area: Oncology Product Name: OP-1250

Highest Development Status: UndisclosedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Olema Oncology

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement November 13, 2020

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The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), lbrance Capsules, 75 mg, 100 mg, and 125 mg, of Pfizer Inc. (Pfizer).


Lead Product(s): Palbociclib

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 November 09, 2020

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The new cohort of the Phase 1/2 clinical trial will be evaluating the safety and anti-tumor activity of telaglenastat in combination with palbociclib in patients with advanced, metastatic PDAC whose tumors harbor mutations in both KRAS and CDKN2A.


Lead Product(s): Telaglenastat,Palbociclib

Therapeutic Area: Oncology Product Name: CB-839

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 04, 2020

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PENELOPE-B is a randomized, double-blind, placebo-controlled Phase 3 study comparing one year of palbociclib plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy.


Lead Product(s): Palbociclib,Trastuzumab,Letrozole

Therapeutic Area: Oncology Product Name: Ibrance

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 09, 2020

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The PALLAS trial compares palbociclib +Standard adjuvant endocrine therapy to standard adjuvant endocrine therapy alone in women and men with HR+, human epidermal growth factor receptor 2-negative early Breast cancer and is an academically-led global collaboration.


Lead Product(s): Palbociclib,Standard adjuvant endocrine therapy

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 May 29, 2020

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Jiangsu Alphamab, as the study sponsor, will oversee and run the trial, and Pfizer will supply palbociclib.


Lead Product(s): KN026,Palbociclib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Alphamab Oncology

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration March 27, 2020

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The company currently has three product candidates in Phase 1/2 trials.


Lead Product(s): ZN-c5,Palbociclib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Morgan Stanley

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 09, 2020

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Zymeworks’ HER2-targeted bispecific antibody ZW25 is being evaluated in combination with Pfizer’s Ibrance. Zymeworks will sponsor the study, and Pfizer will provide palbociclib.


Lead Product(s): ZW25,Palbociclib,Fulvestrant

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement January 12, 2020

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