Aprea Therapeutics appoints Fouad Namouni, Richard Peters to board » 07:1406/2906/29/20
Aprea Therapeutics (APRE)…
Aprea Therapeutics (APRE) announced the appointments of Fouad Namouni, M.D. and Richard Peters, M.D., Ph.D. to its Board of Directors. In addition, Guido Magni, M.D., Ph.D. will step down from the Company's Board of Directors, effective June 30, 2020. Fouad Namouni most recently serving as Senior Vice President & Head of Oncology Development at Bristol-Myers Squibb (BMY). Richard Peters currently serves as President, Chief Executive Officer and Director at Yumanity Therapeutics.
|Over a week ago|
Fly Intel: Top five analyst initiations » 09:5706/2206/22/20
NKLA, DKNG, APRE, CHX, LLNW
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Nikola (NKLA) initiated with a Neutral at JPMorgan. 2. DraftKings (DKNG) initiated with a Buy at Jefferies. 3. Aprea Therapeutics (APRE) initiated with a Neutral at H.C. Wainwright. 4. ChampionX (CHX) initiated with a Buy at BofA. 5. Limelight Networks (LLNW) initiated with a Buy at Lake Street. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Aprea Therapeutics initiated with a Neutral at H.C. Wainwright » 06:0806/2206/22/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Andrew Fein initiated coverage of Aprea Therapeutics with a Neutral rating and $30 price target. The analyst sees downside risk into the Phase 3 study of myelodysplastic syndrome, expected in Q3. The trial should likely hit its primary endpoint complete response rate, but existing evidence does not suggest elevated probability of success of increased duration of response, a key measurement required for regulatory approval, Fein tells investors in a research note.
Aprea Therapeutics presents results from Phase Ib/II clinical trial of APR-246 » 06:2606/1206/12/20
Aprea Therapeutics announced the oral presentation of updated data from its French Phase 1b/2 clinical trial at the 25th European Hematology Association Annual Meeting. The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of TP53 mutant myelodysplastic syndromes and acute myeloid leukemia. The clinical trial is sponsored by the Groupe Francophone des Myelodysplasies. As of the April 1 data cutoff, the overall response rate in 28 evaluable MDS patients was 75%, with a 57% complete remission rate, by International Working Group criteria. With a median duration of follow-up of 9.7 months, the median overall survival for all enrolled patients was 12.1 months and in MDS patients was 12.1 months. For patients who remained on treatment for 3 or more cycles of treatment the median OS was higher at 13.7 months versus 2.8 months for patients who were on treatment for fewer than 3 cycles. Relative to baseline, mutant TP53 variant allele frequency was decreased in responding patients by 3 cycles of treatment, including 20 patients who achieved mutant TP53 negativity by next-generation sequencing. "The data from this ongoing trial of eprenetapopt with azacitidine continue to be very encouraging in these most difficult-to-treat TP53 mutant MDS and AML patients, who not only have at least one TP53 mutation but the majority of whom also have high risk cytogenetic abnormalities," said Thomas Cluzeau, M.D., co-lead investigator for the GFM trial. "We continue to observe ORR and CR rates in these patients that are substantially higher than the GFM's experience with azacitidine monotherapy. Furthermore, with increased duration of follow-up, we now also see the emergence of highly encouraging overall survival that appears to be better than azacitidine alone or in combination with others agents in this very high-risk molecular group of patients with a TP53 mutation."
|Over a month ago|
Aprea Therapeutics completes enrollment of Phase 3 trial in TP53 mutant MDS » 08:1306/0306/03/20
Aprea Therapeutics announced that patient enrollment in its Phase 3 clinical trial evaluating eprenetapopt with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes has been completed. Topline results are expected by year-end 2020. Aprea plans to include the results of the trial in a New Drug Application to the U.S. FDA and a Marketing Authorization Application to the EMA in 2021. The randomized, controlled pivotal Phase 3 trial is designed to evaluate eprenetapopt with azacitidine compared with azacitidine alone as front-line therapy in intermediate, high, and very high risk TP53 mutant MDS patients. The multi-center trial enrolled 154 patients, randomized 1:1 to the two arms with a primary endpoint of CR rate. The trial has 90% power with P-value less than 0.05 to detect a difference in CR rates of 50% in the eprenetapopt-containing arm versus 25% in the azacitidine-only control arm.
Aprea Therapeutics targets submission of IND for APR-548 in 1H20 » 07:3605/1505/15/20
The Company's second…
The Company's second product candidate, APR-548, is a next-generation p53 reactivator with the potential for oral administration. APR-548 is a unique analog of APR-246 and therefore a pro-drug of MQ. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. The Company has completed Investigational New Drug, or IND, enabling preclinical studies of APR-548 and is targeting the submission of an IND in the first half of 2020.
Aprea targets first patient enrollment in Phase 1/2 solid tumor trial in 2H20 » 07:3605/1505/15/20
Based on in vivo data…
Based on in vivo data evidencing synergistic activity between APR-246 and immuno-therapy agents including anti-PD-1 antibody, the Company has designed and plans to conduct Phase 1/2 clinical trials in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing APR-246 with anti-PD-1 therapy. The Company is targeting the first patient to be enrolled in the second half of 2020.
Aprea Therapeutics targets first patient enrollment in Phase 1 NHL trial in 2H20 » 07:3505/1505/15/20
As further assessment of…
As further assessment of APR-246 in hematological malignancies, the Company has designed and plans to conduct a Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia and mantle cell lymphoma assessing APR-246 with venetoclax and rituximab, and APR-246 with ibrutinib. The Company is targeting the first patient to be enrolled in the second half of 2020.
Aprea Therapeutics expects to complete enrollment in Phase 2 MDS/AML trial in 3Q » 07:3405/1505/15/20
The Company is currently…
The Company is currently enrolling its single-arm, open-label Phase 2 trial evaluating APR-246 with azacitidine as post-transplant maintenance therapy in TP53 mutant MDS and acute myeloid leukemia patients who have received an allogeneic stem cell transplant. Though the Company had initially observed a decrease in both patient screening and patient enrollment as a result of the COVID-19 pandemic, the Company has recently observed increased patient screening activity and has currently enrolled 16 out of 31 patients in this trial with a number of additional patients scheduled for screening. The Company believes that it will complete enrollment in this trial in the third quarter of 2020.
Aprea Therapeutics expects to close enrollment in Phase 3 MDS trial in 2Q20 » 07:3305/1505/15/20
The Company is currently…
The Company is currently enrolling a pivotal Phase 3 randomized, controlled trial evaluating APR-246 with azacitidine as frontline therapy in HMA-naive TP53 mutant myelodysplastic syndromes patients with a primary endpoint of CR rate. Though the Company had initially observed a decrease in both patient screening and patient enrollment as a result of the coronavirus pandemic, the Company has recently observed increased patient screening activity and has currently enrolled 140 patients in the trial with a number of additional patients now scheduled for screening. The Company currently plans to close enrollment of this trial in the second quarter of 2020 and remains confident it will have top-line data available by year-end 2020.