PSMA ADC / Lantheus - LARVOL DELTA

Progenics Pharmaceuticals announces first quarter 2013 financial results (Progenics) - "First quarter research and development expenses decreased by $2.2 million, primarily from a decline in compensation expenses partially offset by higher clinical trial expenses for PSMA ADC and including expenses for recently acquired MIP-1404."

Commercial • Oncology

Progenics: Q2 2014 Results (Progenics) - Anticipated presentation of data from P2 trial for chemo-naïve metastatic castration-resistant prostate cancer at ASCO GU (Feb 26-28, 2015)

Anticipated P2 data • Oncology • Prostate Cancer

A phase 2 study of prostate specific membrane antigen antibody drug conjugate (PSMA ADC) in patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC) following abiraterone and/or enzalutamide (abi/enz) (ASCO-GU 2015) - Abstract #144; P2, N=119; NCT01695044; Sponsor: Progenics; "In all treated pts, PSA declines of ≥30% and ≥50% were 30% and 14%, respectively (n=113); CTC counts showed a decline of ≥50% in 78% of pts and conversion from ≥5 to <5 cells/7.5 ml blood in 47% (n=77) at any time during the study. For 2.3 mg/kg pts (n=82), corresponding PSA declines were 35% and 17%; CTC declines of ≥50% were seen in 81% and conversions in 46% (n=54)."

P2 data • Oncology • Prostate Cancer

Progenics: ASCO 2014 Meeting (Progenics) - "In taxane-experienced mCRPC treated with PSMA ADC at doses of 2.3 mg/kg, reductions of PSA ≥30% are seen in ~36% and reductions of ≥50% are seen in ~15% of patients"; "CTC conversion from unfavorable to favorable occurs in ~45% of patients"; "PSMA expression both by IHC and CTC correlates well to PSA and CTC response"; "Low NE markers correlate well to PSA response with CTC reduction of >50% in 76% of patients"; "2.3 mg/kg is generally well tolerated and appears to be better tolerated than 2.5 mg/kg; most common AE’s are fatigue and neutropenia"; "A taxane-naïve cohort is ongoing" 

P2 data • Oncology • Prostate Cancer

PSMA ADC: Anticipated expiry of patents in US related to composition-of-matter in 2022, 2023 and 2026 (Progenics) - Annual Report 2016: Anticipated expiry of patent in US related to methods of use in 2031;  Anticipated expiry of patents in EU and ROW related to composition-of-matter in  2022 and 2026;  Anticipated expiry of patents in EU and ROW related to method of use in 2029

Anticipated patent expiry • Oncology

Progenics: ASCO Genitourinary Cancers Symposium (Progenics) - "Summary/Conclusions"; "In patients with progressive mCRPC following abi/enz, treatment with PSMA ADC resulted in CTC conversion from unfavorable to favorable status in 47% and CTC declines of ≥50% in 78% of all patients; chemo-naïve patients showed conversion in 53% and declines of ≥50% in 89%"; "Reductions of PSA ≥30% and ≥50% are seen in 30% and 14% of all patients, respectively, and 32% and 21% of chemo-naïve patients"; "PSA and CTC responses were more prominent in patients with high PSMA expression and low neuroendocrine biomarkers"; "Radiologic responses (complete and partial) and stable disease were seen in a majority of patients"; "2.3 mg/kg is generally well tolerated and appears to be better tolerated than 2.5 mg/kg; most common AE’s are neutropenia, fatigue, electrolyte imbalance, anemia and neuropathy"

P2 data • Oncology • Prostate Cancer

PSMA ADC: Expiry of patents in US related to composition-of-matter in 2022 and 2023 (Progenics) - Annual Report 2017: Expiry of patents in RoW related to composition-of-matter in 2022

Patent • Oncology

Progenics: Corporate Presentation (Progenics) - "PSMA ADC: Phase 2 Results"; "Strong anti-tumor activity: Complete and partial radiologic responses and stable disease seen in 93% of chemo-naïve and 86% of all patients, CTC declines of ≥50% in 89% of chemo-naïve and 78% of all patients, Conversion from unfavorable to favorable CTC status in 53% of chemo-naïve and 47% of all patients, PSA declines of ≥30% seen in 32% of chemo--naïve and 30% of all patients, Responses continue to be more prominent in patients with high PSMA expression and low neuroendocrine biomarkers,"; "Responses comparable to those seen for approved therapies"

P2 data • Oncology

Progenics: Jefferies Global Healthcare Conference (Progenics) - “PSMA ADC: CTC Responses in Chemo-Naïve Patients, CTC reductions of greater than or equal to 50% in 89% of patients”; “Biomarkers Correlate CTC Response to PSMA ADC, Evaluable chemo-naïve patients (≥ 5 CTCs at baseline)”

P2 data • Oncology • Prostate Cancer

Progenics: AACR 2014 Meeting (Progenics) - "Clinical results for PSMA ADC"; "Phase 1 and 2 studies in advanced metastatic castration-resistant prostate cancer: Taxane-refractory patients with significant prior exposure to abiraterone and/or enzalutamide"; "Tolerability: Generally well tolerated at 2.3 mg/kg q3 weeks"; "Activity: Reductions in prostate-specific antigen (PSA) and circulating tumor cells (CTC)"; "Conclusion: Clinical proof of concept in a difficult-to-treat patient population"

P2 data • Oncology • Prostate Cancer

Prostate specific membrane antigen antibody drug conjugate (PSMA ADC) in patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC) following abiraterone and/or enzalutamide (abi/enz): Results from a phase 2 study (AUA 2015) - Presentation time: May 19, 2015, 8:00 AM-10:00 AM; Abstract #MP82-09; P2, N=119; "Radiologic responses (RECIST) in 31 pts with measurable target lesions were: partial response, 27% CN; 5% TE; stable disease, 55% CN; 65% TE; progressive disease, 18% CN; 30% TE....The most common treatment-related adverse events (AEs) ≥CTCAE grade 3 were neutropenia (TE: 25%; CN: 22%), fatigue (20%; 8%), electrolyte imbalance (16%; 11%), anemia (10%; 8%), and neuropathy (8%; 8%)."

P2 data • Oncology • Prostate Cancer

Correlation of PSMA ADC exposure with reduction in tumor growth rate determined using serial PSA measurements from a Phase I clinical trial (AACR-NCI-EORTC 2013) - Abstract #B215; Presentation time: Monday, Oct 21, 2013, 12:30 PM - 3:00 PM; P1, N=52; NCT01414283; Sponsor: Progenics; "PSMA ADC, Total Ab, and MMAE exposure increased linearly with increasing PSMA ADC dose....G continuously decreased with increasing PSMA ADC exposure, suggesting an exposure dependent drug effect. There was no apparent saturation of this effect at the maximum observed exposure, and no influence of age, baseline albumin and ALT/AST levels on G was evident."

PK/PD data • Oncology • Prostate Cancer

New ADC effective against prostate cancer (Cancer Discov) - P1; N=70; PMID: 2331977; NCT01414283; "Based on the results of a phase I clinical trial announced at the 2012 Symposium on Molecular Targets and Cancer Therapeutics, an antibody-drug conjugate targeting prostate-specific membrane antigen may be an effective treatment for metastatic, hormone-refractory prostate cancer."

P1 data • Oncology

A phase 2 trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC) (ASCO 2014) - Presentation time: Saturday, May 31; 1:15 PM - 4:15 PM; Abstract #5023; P2, N=75; NCT02020135; Sponsor: Progenics Pharmaceuticals; "PSA and CTC responses were associated with higher PSMA+CTC and PSA responses with lower neuroendocrine markers. Stable disease was seen in 80% of RECIST evaluable pts (n=15). Pts with prior CAB had lower CTC responses."

P2 data • Oncology • Prostate Cancer

A phase II trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC) (ASCO-GU 2014) - Abstract #83; P2, N=70; NCT01695044; Sponsor: Progenics Pharmaceuticals; "PSA and CTC responses were associated with higher PSMA expression on CTC and lower neuroendocrine (NE) markers....PSMA ADC at 2.3 mg/kg was generally well tolerated in pts with progressive mCRPC previously treated with taxane. Anti-tumor activity, CTC and PSA reductions were observed at 2.3 and 2.5 mg/kg."

P2 data • Oncology • Prostate Cancer

Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane (ASCO-GU 2013) - P1, N=52; NCT01414283; Sponsor: Progenics; "PSMA ADC was generally well tolerated with the most commonly seen adverse events being anorexia and fatigue...Antitumor activity was seen at higher dose levels. DLTs were neutropenia and reversible LFT abnormalities. The maximum tolerated dose of PSMA ADC was determined to be 2.5 mg/kg."

P1 data • Oncology

PSMA ADC: Expiry of composition-of-matter patents in US/ex-US in 2022 (Progenics) - Annual Report 2018

Patent

Phase 1 study of PSMA ADC, an antibody‐drug conjugate targeting prostate‐specific membrane antigen, in chemotherapy‐refractory prostate cancer (Wiley Online Library) - P1, N=52; "In an extensively pretreated mCRPC population, PSMA ADC demonstrated acceptable toxicity. Antitumor activity was observed over dose ranges up to and including 2.5 mg/kg. The observed anti-tumor activity supported further evaluation of this novel agent for the treatment of advanced metastatic prostate cancer."

P1 data