lutetium-177 Octreotate (PNT2003)
/ Lantheus, Eli Lilly
- LARVOL DELTA
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November 14, 2022
Lantheus and POINT Biopharma Announce Strategic Collaboration and Exclusive License Agreements for the Commercialization of PNT2002 & PNT2003
(GlobeNewswire)
- "Lantheus Holdings, Inc...and POINT Biopharma Global Inc....announced a set of strategic collaboration agreements in which Lantheus will license exclusive worldwide rights1 to POINT’s PNT2002 and PNT2003 product candidates....Under the agreements, POINT will fund and complete its Phase 3 SPLASH trial for PNT2002, following which Lantheus will file the New Drug Application (NDA) in collaboration with POINT. For PNT2003, POINT will facilitate completion of the ongoing University Health Network (UHN)-sponsored ongoing OZM-067 study in Canada, while Lantheus will prepare and submit the regulatory filings in the U.S. Upon consummation of the agreements, the companies will form joint steering committees to oversee the clinical studies, regulatory filings, manufacturing and commercial readiness for both PNT2002 and PNT2003."
Licensing / partnership • NDA • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor
November 14, 2022
Lantheus and POINT Biopharma Announce Strategic Collaboration and Exclusive License Agreements for the Commercialization of PNT2002 & PNT2003
(GlobeNewswire)
- "'We are excited to continue developing and scaling our manufacturing capabilities to support the PNT2002 and PNT2003 launches and continue development of PNT2004, our pan-cancer FAP-α program, which is currently in Phase 1, and PNT2001, our actinium-225 next-generation PSMA program which is expected to begin Phase 1 in 2023'."
Launch • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor
November 14, 2022
"$LNTH Lantheus and POINT Biopharma Announce Strategic Collaboration and Exclusive License Agreements for the Commercialization of PNT2002 & PNT2003 https://t.co/5ClNLYgJK0"
(@stock_titan)
Licensing / partnership • M&A
April 11, 2022
Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors
(clinicaltrials.gov)
- P=N/A | N=195 | Active, not recruiting | Sponsor: University Health Network, Toronto | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2024 ➔ Jun 2026 | Trial primary completion date: Jan 2024 ➔ Jun 2026
Enrollment closed • Trial completion date • Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • CHGA
March 25, 2022
POINT Biopharma Reports Fiscal 2021 Financial Results and Provides Business Update
(GlobeNewswire)
- "The Company is assessing two distinct pathways for PNT2003 with regulatory authorities. These pathways include a 505(b)(2) with the FDA’s Division of Oncology Products and an ANDA with the FDA’s Office of Generic Drugs. The Company is currently waiting to complete discussions with the FDA prior to making a public announcement regarding the pathway which will be pursued. The sponsor of PNT2003 clinical trial has informed the Company that all patients will have completed the primary follow-up in the second quarter of 2022 and will have data to report to the Company in the second half of 2022."
Clinical data • FDA event • New trial • Oncology • Solid Tumor
February 01, 2022
POINT Biopharma Provides Update on Manufacturing, Supply Chain and Late-Stage Programs
(GlobeNewswire)
- "POINT Biopharma Global...announced business progress updates, including the completion of its Indianapolis, Indiana production facility, as well as the scheduled presentation of dosimetry data from the lead-in cohort of the Company’s Phase 3 trial in mCRPC at the 2022 SNMMI Mid-Winter & ACNM Annual Meeting, taking place February 25-27, 2022....The Company continues to expect to report top line data from SPLASH mid-2023....PNT2003: Results of regulatory discussions regarding pathway expected by end of 1Q2022."
Commercial • P3 data • Regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer
December 13, 2021
The association between lesion tracer uptake on 68Ga-DOTATATE PET with morphological response to 177Lu-DOTATATE therapy in patients with progressive metastatic neuroendocrine tumors.
(PubMed, Nucl Med Commun)
- "In patients with SSTR-RADS 5 PM-NETs treated with 177Lu-DOTATATE, there was similar response to therapy for all lesions with PET-generated Krenning score ≥2. No correlation was found between lesion's POD and level of tracer uptake."
Clinical • Journal • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR • SSTR2
August 13, 2021
POINT Biopharma Reports Second Quarter 2021 Financial Results and Provides Business Update
(GlobeNewswire)
- “PNT2002…The Company expects to report top-line data from the SPLASH study in mid-2023…PNT2003…The Company expects to report data from this study in the first half of 2022…PNT2001…The Company expects to advance a single compound from the family and initiate IND-enabling studies for this program in 2022.”
IND • P3 data • P3 data: top line • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor
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