AstraZeneca announced FDA granted Breakthrough Therapy Designation (BTD) to Farxiga for the treatment of chronic kidney disease in patients with and without diabetes. Below, FENIX provides thoughts on the impending DAPA-CKD regulatory review in the context of Janssen’s CREDENCE and readthrough to BI/Lilly’s EMPA-KIDNEY.
On Thursday, August 13, Precision Biosciences released their Q2 2020 financial results (press release). While no new data was presented, Precision highlighted that the first patient was dosed with PBCAR269A (an allogeneic BCMA CAR-T) for the Ph1/2 trial in r/r MM. Moreover, management confirmed that interim data from the PBCAR0191 (an allogeneic CD19 CAR-T) Ph1 study in ≥3L r/r NHL and r/r ALL will be delayed due to the COVID-19 pandemic. Below, Celltelligence provides thoughts on key competitors Precision and Allogene’s position within the allogeneic BCMA CAR-T setting and the possibility for a PBCAR0191 presentation at ASH 2020.
Provention Bio announced that yesterday, the company launched a national campaign to bring awareness to the importance of screening people with a family history of T1DM. The campaign is made of two complementary modules: Connected by T1D (for providers) and Type 1 Tested (for patients). The campaign initiation follows Provention’s announcement that the clinical module for the teplizumab BLA rolling submission has been submitted to FDA, leaving only the final CMC module to be submitted later this year. Below, FENIX provides thoughts on the campaign in the context of the FDA review of teplizumab.
Provention Bio announced it has filed the clinical module for the teplizumab rolling BLA submission. Recall, teplizumab received Breakthrough Therapy Designation for the prevention or delay of T1DM in at-risk individuals (view previous announcement). The company continues to plan for the final CMC module to be submitted in Q4 ’20. Provention Bio previously indicated they are preparing for a 2021 launch, assuming FDA grants priority review (previous FENIX insight). Below, FENIX provides brief thoughts on teplizumab and the impending FDA review.
On Friday, August 28, Legend Biotech published their Q2 2020 results (press release). Management confirmed that their BCMA CAR-T, cilta-cel (JNJ-4528), co-developed with Janssen, is expected to be filed with the FDA by YE 2020, the EMA in early 2021, and with China’s NMPA in 2021. Furthermore, by YE 2020, Legend anticipates filing an IND application for LB1901 (a CD4 CAR-T) in r/r T cell lymphoma (TCL). Below, Celltelligence provides thoughts on cilta-cel’s commercial opportunity following the anticipated approval of ide-cel (BMS) around March 2021, and Legend’s market opportunity for LB1901 in the TCL setting.
DreaMed Diabetes announced it has partnered with four US clinics to integrate DreaMed’s Advisor Pro software into the clinics’ protocols. For context, the Advisor Pro software uses cloud-based technology and AI to perform data analyses from CGM, insulin pumps, SMBG, and event data to suggest insulin treatment recommendations. Below, FENIX provides thoughts on the partnerships in the context of COVID-19 and the acceleration toward digital health management.
A series of diabetes-related news items have been observed: Dexcom published results from a study evaluating the cost-effectiveness of its G6 CGM in the UK and announced the launch of G6 in Turkey; Lifescan announced the launch of its OneTouch Amazon storefront; Daewoong Pharmaceutical announced the results of a Ph2 trial evaluating enavogliflozin; and Zucara Therapeutics announced the first patient has been dosed in a Ph1 trial of ZT-01 for insulin-induced hypoglycemia. Below, FENIX provides highlights and insights for the respective news items.
Abbott announced it has received CE Mark for the Libre 3 CGM system. Unlike the Libre 1 and 2 CGM systems which require users to scan the sensor to receive their glucose readings, Libre 3 is a true real-time CGM. Additionally, Abbott has updated the Libre form factor with Libre 3 being approximately the size of two stacked US pennies. According to the press release, Abbott is planning for an EU launch “in the coming months” with no update on a potential US timeline. Below, FENIX provides thoughts on the new Libre 3 CGM features as well as potential implications to Dexcom, Medtronic, Senseonics, and other CGM manufacturers.
On the final day of EASD 2020, no new press releases were observed; however, during the Novo Nordisk obesity session, the speaker disclosed plans to conduct a semaglutide HFpEF study. Additionally, AstraZeneca’s DAPA-MI study has been posted on CT.gov. Below, FENIX provides insights and context from the respective news items, including thoughts on why the STEP HFpEF trial appears to fit into the new paradigm of non-outcomes-based label-enabling studies.
On Day 4 of EASD 2020, four key press releases were observed from Dexcom, Novo Nordisk, Movano, and Poxel. Below, FENIX provides insights and context from each respective announcement, including what could be behind the scenes in the Dexcom-UVA research partnership.