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Newly printed poster on the single-arm 27-patient security and dosimetry lead-in gives key updates together with:
A median rPFS time of 11.5 months
A greatest radiographic goal response (CR, PR) was achieved in 60% of the ten members with evaluable illness at baseline
PNT2002 was effectively tolerated with no treatment-related deaths
INDIANAPOLIS, Sept. 10, 2022 (GLOBE NEWSWIRE) — POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), an organization accelerating the invention, growth and world entry to life-changing radiopharmaceuticals, at the moment printed a poster at ESMO Congress 2022 containing up to date efficacy and security information from the 27-patient security and dosimetry lead-in cohort for the Company’s part 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the therapy of metastatic castration-resistant prostate most cancers (mCRPC). Key findings embrace a median rPFS time of 11.5 months, together with a well-tolerated security profile with no treatment-related deaths and few treatment-related AEs of grade 3 or greater.
“rPFS is the primary endpoint of the SPLASH trial, making these positive signals from the lead-in cohort extremely promising,” stated Dr. Neil Fleshner, Chief Medical Officer of POINT Biopharma. “I believe the dosing schedule of four cycles of 177Lu-PNT2002 at 6.8 GBq per cycle every 8 weeks is a unique differentiator offering lower overall whole-body radiation and shorter overall treatment than currently approved PSMA RLT therapies.”
The full poster is on the market to obtain on the Company’s investor relations web site, positioned at https://www.pointbiopharma.com/investors#investor-presentations. Upcoming third-party protection of the information will embrace video interviews of Dr. Fleshner by UroToday, and of Dr. Aaron R. Hansen by VuMedi. Dr. Hansen is Deputy Director for the Division of Cancer Services at Metro South Health, a Medical Oncologist at Princess Alexandra Hospital, and an Associate Professor of Medicine on the University of Toronto and the University of Queensland.
The part 3 SPLASH trial is a multi-center, randomized, open label evaluation of PNT2002 in members with prostate-specific membrane antigen (PSMA)-expressing mCRPC who’ve progressed on androgen receptor pathway inhibitor (ARPI) remedy. Compared to different at the moment authorised radioligand therapies for prostate most cancers, SPLASH is evaluating PNT2002 earlier within the therapy pathway and utilizing fewer and decrease doses. The therapy routine for the lead-in cohort is identical because the routine being investigated within the randomization a part of the trial: members obtain as much as 4 cycles of 177Lu-PNT2002 at 6.8 GBq per cycle each 8 weeks. The SPLASH trial is at the moment enrolling sufferers throughout 53 websites in North America, Europe, and UK, and website activations stay ongoing to expedite accrual.
The poster is titled “Efficacy and Safety of 177Lu-PNT2002 prostate-specific membrane antigen (PSMA) Therapy in Metastatic Castration Resistant Prostate Cancer (mCRPC): Initial Results from SPLASH” (e-Poster #1400P). The poster’s newly launched information have been based mostly on a median follow-up of 11.7 months, updating the beforehand printed summary which was based mostly on a median follow-up of seven.6 months. Key findings for the lead-in cohort embrace:
- Median rPFS was 11.5 months, as in comparison with the management arm benchmarks of three.5–4.2 months for people with progressive mCRPC post-ARPI failure receiving comparable therapy1,2
- Median general survival had not been reached with an 11.7-month median length of follow-up from time of enrollment
- A radiographic goal response was achieved in 60% of the ten members with evaluable illness at baseline
- 84.8% of people imaged met PSMA eligibility standards
- From a median baseline PSA (ng/mL) of twenty-two (vary 0.3–701.0), 11 (42%) members achieved a PSA50 response
- PNT2002 was effectively tolerated with no treatment-related deaths and few treatment-related AEs of grade 3 or greater
- Treatment-related antagonistic occasions occurring in >10% of members included dry mouth (25.9% of members; all grade 1), fatigue (22.2%; grades 1-2), nausea (18.5%; grades 1-2), and anaemia (14.8%; grades 1-3)
“In this patient population, which was not as heavily pre-treated as the population studied in the published randomized trials of 177Lu-PSMA-617, PNT2002 was very well tolerated,” stated Scott Tagawa, MD, MS, FACP, Medical Oncologist at Weill Cornell Medicine, Professor of Medicine at Meyer Cancer Center, SPLASH trial investigator, and senior creator on the SPLASH poster at ESMO. “The early efficacy signals of PSA and measurable disease responses, combined with the favorable, though non-randomized, rPFS data, are encouraging for success of the phase 3 study.”
Prior to the publication of the lead-in cohort information, the Company hosted a 45-minute academic webinar on August 18, 2022 entitled “Understanding the PNT2002 SPLASH Trial Control Arm” that includes shows from Dr. Oliver Sartor and Dr. Kim Chi.
Both the poster and the webinar can be found beneath the Presentations tab of the Investors part of the Company’s web site, positioned at https://www.pointbiopharma.com/investors#investor-presentations.
1. de Bono J, Mateo J, Fizazi Ok, et al. N Engl J Med 2020;382:2091–102.
2. Powles T, Yuen KC, Gillessen S, et al. Nature 2022;28:144–53.
Potential battle of curiosity disclosure: Dr. Tagawa has obtained analysis funding and honoraria for consulting from POINT.
About the SPLASH Trial
The part 3 SPLASH trial is a multi-center, randomized, open label evaluation of PNT2002 in members with PSMA-expressing mCRPC who’ve progressed on androgen receptor pathway inhibitor (ARPI) remedy and refuse, or are usually not eligible for, chemotherapy. The randomization part of the examine is anticipated to enroll roughly 400 members throughout North America, Europe, and the United Kingdom. Participants can be randomized 2:1 with members in arm A receiving PNT2002 and members in arm B receiving both abiraterone or enzalutamide. Participants in arm B who expertise centrally assessed radiographic development and meet protocol eligibility can have the choice to crossover and obtain PNT2002. Patients can be topic to follow-up for as much as 5 years from their first PNT2002 dose. The major endpoint of the examine is radiographic progression-free survival. Key secondary endpoints embrace general response charge, general survival, and pharmacokinetics.
About POINT Biopharma Global Inc.
POINT Biopharma Global Inc. is a globally targeted radiopharmaceutical firm constructing a platform for the medical growth and commercialization of radioligands that combat most cancers. POINT is remodeling precision medication by combining a portfolio of best-in-class radiopharmaceutical property, a seasoned administration staff, an industry-leading pipeline, in-house manufacturing capabilities, and secured provide for uncommon medical isotopes like actinium-225 and lutetium-177. POINT’s lively medical trials embrace FRONTIER, the part 1 trial for PNT2004, a pan-cancer program concentrating on fibroblast activation protein-α (FAP-α), and SPLASH, the part 3 trial for PNT2002 for individuals with metastatic castrate resistant prostate most cancers (mCRPC). More details about the SPLASH trial could be discovered at https://www.splashtrial.com/. Learn extra about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/.
Forward Looking Statements
This press launch incorporates forward-looking statements throughout the that means of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. In some circumstances, you may determine forward-looking statements by the next phrases: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the unfavourable of those phrases or different comparable terminology, though not all forward-looking statements include these phrases. These statements contain dangers, uncertainties and different components that will trigger precise outcomes, ranges of exercise, efficiency or achievements to be materially completely different from the knowledge expressed or implied by these forward-looking statements. Although we consider that we’ve got an inexpensive foundation for every forward-looking assertion contained on this press launch, we warning you that these statements are based mostly on a mix of information and components at the moment recognized by us and our projections of the longer term, about which we can’t be sure. Forward-looking statements on this press launch embrace, however are usually not restricted to, statements concerning the potential attributes and advantages of POINT’s product candidates and the format and timing of POINT’s product growth actions and medical trials. We can not guarantee you that the forward-looking statements on this press launch will show to be correct. These forward-looking statements are topic to a variety of important dangers and uncertainties that would trigger precise outcomes to vary materially from anticipated outcomes, together with, amongst others, our potential to acquire funding for our operations, our potential to take care of the license agreements underlying our product candidates, competitors, the power of POINT to develop and handle development profitably and retain its key staff, the influence of COVID-19 on POINT’s business, the power to take care of the itemizing of POINT’s widespread inventory on the NASDAQ, adjustments in relevant legal guidelines or rules, the chance that POINT could also be adversely affected by different financial, business, and/or aggressive components, and different dangers and uncertainties, together with these described in POINT’s Annual Report on Form 10-Ok filed with the SEC on March 25, 2022 and subsequent filings with the SEC. Most of those components are exterior of POINT’s management and are tough to foretell. Furthermore, if the forward-looking statements show to be inaccurate, the inaccuracy could also be materials. In mild of the numerous uncertainties in these forward-looking statements, you shouldn’t regard these statements as a illustration or guarantee by us or some other particular person that we are going to obtain our goals and plans in any specified time-frame, or in any respect. The forward-looking statements on this press launch signify our views as of the date of this press launch. We anticipate that subsequent occasions and developments will trigger our views to vary. However, whereas we might elect to replace these forward-looking statements in some unspecified time in the future sooner or later, we’ve got no present intention of doing so besides to the extent required by relevant legislation. You ought to, due to this fact, not depend on these forward-looking statements as representing our views as of any date subsequent to the date of this press launch.
Investor Relations Contact:
Daniel Pearlstein
Associate Director, Corporate Strategy
[email protected]
