In a September 10 research note, H.C. Wainwright & Co. Analyst Edward White advised that clinical stage biopharmaceutical company Mersana Therapeutics Inc. (MRSN:NASDAQ) issued "an update on the progress of its upifitamab rilsodotin (UpRi) clinical development strategy and reported positive interim data from the ovarian cancer expansion cohort of the Phase 1 study."
H.C. Wainwright explained that UpRi, a first-in-class Dolaflexin ADC targeting NaPi2b, is the lead product candidate in Mersana's pipeline which is being developed to target ovarian cancer and non-small cell lung cancer (NSCLC) adenocarcinoma. The analyst noted that UpRi has been shown to be well tolerated in clinical studies and has demonstrated consistent antitumor activity including patients who have undergone previous PARPi and Avastin (bevacizumab) treatment.
In an expansion cohort of the UpRi study, low, intermediate and high doses ranging from 36mg/m2 to 43mg/m2 were administered. The company had previously reported data for 72 patients evaluable for safety and 47 patients evaluable for RECIST response in January 2021.
The company achieved an objective response rate (ORR) of 32% a disease control rate (DCR) of 74% in the higher NaPi2b population which showed a median duration of response estimated at 5 months. In the overall population the ORR was 28% and the DCR was 68%.
H.C. Wainwright pointed out that enrollment in the ovarian cancer expansion cohort is complete having signed on 97 patients, 75 of whom are considered as RECIST-evaluable at this interim analysis. The analyst stated that recent data announced September 10, 2021 demonstrated a 34% confirmed ORR and an 87% DCR in the high NaPi2b population.
The analyst stated that safety data continues to look promising as patients who were given the lower dose of 36mg/m2 experienced fewer ≥Grade 3 adverse events. Importantly, none of the patients in the low dose group reached ≥Grade 3 fatigue levels, whereas 13% of the intermediate dose group and 23% of the higher dose group reported ≥Grade 3 fatigue. In addition, no patients in either the low or intermediate dose groups had ≥Grade 3 pneumonitis, while 10% of the high dose patients had ≥Grade 3 pneumonitis.
The report indicated that the UPLIFT study is now underway with a lower dose single-arm registration in treating platinum-resistant ovarian cancer. The company used feedback it received from the FDA to design the study which is to serve as a basis for a potential later submission to the FDA for accelerated approval.
According to the analyst, "the UPLIFT study is enrolling patients with platinum resistant high grade serous ovarian, fallopian tube, and primary peritoneal cancer with up to four prior lines of therapy and Mersana expects to enroll about 100 patients with high NaPi2b expression and up to 180 patients overall."
The report mentioned that Mersana had not previously offered enrollment guidance for UPLIFT study but now anticipates that substantial enrollment will occur by summer of 2022.
H.C. Wainwright commented that perhaps the modifications made to reduce the dosage might play a small role in accelerating enrollment and may aid in the overall success of the UPLIFT study. Patients enrolled in the trial will be observed for a period of 6-8 months and as the trial progresses more information on the timing and data from study will be released. H.C. Wainwright highlighted that it estimates that UpRi will launch commercially in 2024 with $22 million in sales increasing to $809 million in 2030.
The report stated that Mersana has announced plans for kicking off a new Phase 3 UPNEXT study for the purpose of evaluating UpRi monotherapy in the maintenance setting in platinum-sensitive recurrent ovarian cancer versus a placebo control group. The primary established endpoint in the study has been designated as progression free survival. If things go as planned and on schedule, the study's protocol and design could be revealed prior to YE/21 and the study could commence in 2022.
The company remains hopeful that the UPNEXT clinical trial could offer confirmatory support of the UPLIFT study and thus help promote accelerated approval that may be used for global registration support.
H.C. Wainwright presently rates Mersana Therapeutics as a "Buy" with a target price of $28.00/share. The firm indicated that it arrived at the $28 per share price by employing net present value calculations utilizing a 20% discount rate to 2030 revenue forecasts of $809 million for UpRi for ovarian cancer and $773 million for XMT-1592 in non-small cell lung cancer (NSCLC).
The company's shares trade on the Nasdaq exchange under the symbol "MRSN" and last closed for trading at $9.90/share on September 13, 2021.
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