AACR 2021 Early Readouts
American Association for Cancer Research (AACR) presentations are happening this weekend and into early next week (see image below for a few of those in our catalyst database). On first glance, CRDF's Onvansertib data in colorectal cancer and AGEN's anti-CTLA-4 antibody AGEN1181 cancer basket trial data look pretty good. Onvansertib appears to increase PFS to 5.6 months from 2-3 months, although typically the FDA and market like to see at least 6 months PFS in our experience. With biomarker segmentation (KRAS) CRDF may get there since PFS has not been reached in this subpopulations. AGEN1181 showed additional responses and a conversion of a partial response to a complete response. Our volatility/Big-mover analysis found them both to be possible single-digit to low double-digit movers on strong readouts. Let's see what the market has in store for these stocks on Monday.
The biggest mover expected by the market appears to be SYBX and its SYNB1891 cancer biologic. Early data shows some stable disease, but without any partial responses it seems too early, possibly too low of a dose. Read more about this unique anti-cancer biotherapeutic in our IQ card. Did the market expect more? We'll see what happens on Monday.
Added Monday 4/12/21:
More updates:
#SPPI presented additional results, further to their March 2021 ESMO results, on twice daily vs. once daily Poziotinib, and 16 mg (total daily) vs. 12 mg (total daily) dosing. The EGFR/HER2/HER4 oral kinase inhibitor has been a disappointment, but maybe the twice daily and lower dosing will save the day? Well, the update gave us more info from Cohort 5 (pretreated NSCLC patients with exon 20 insertion mutations) of the Zenith20 trial. 31.6% of patients (6/19) achieved a partial response in the twice daily arm, up from 30% in the prior (March 2021 update). Improved tolerability continues to be observed in the twice daily vs. once daily dosing at both the 16mg and 12mg dosing. Unfortunately, the company reported that the 12mg dosing arms, which showed improved tolerability over the 16mg dose in the March 2021 update, were not as active as the 16mg dosing arm. More data should be coming later this year on the 16 mg twice-daily arm. It will be interesting to see what this all means for the NDA that SPPI is filing this year for these NSCLC EGFR exon 20 mutant patients.
#HOOK provided immunogenicity data for its viral vector cancer vaccine biologics: HB-201 and HB-202 for treating HPV16+ cancers. The data presented support that these biologic vaccines appear to elicit an anti-HPV16 T cell response. It will be interesting to see if there is any clinical significance to this anti-HPV16+ immunological response in the coming months.
#RUBY presented a poster with updated data on its allogeneic engineered RBCs that are intended to hype up a patient's own immune system to increase its fight against an existing cancer. The market loved the initial proof of concept data from March 15, 2021. The updated data provided more details including a waterfall plot (see in POSTER) from March 15, 2021 update, which shows that no other patients experienced a decrease in tumor size from baseline other than the 1 unconfirmed and 1 confirmed responder. Increased tumor immune response observed, including an increase in PDL1 expression in 3/4 solid tumor patients. Not quite as positive news as the March 15, 2021, but still looks encouraging, especially if combined with an anti-PD1 therapy (planned for 2H'21).
Monday stock moves (11AM EST) (biopharma indices down ~2%) re: above companies:
AGEN: down ~5% - A little surprised down more than indices. Need to dig deeper into those AACR results (no new results since the April 10 PR).
SYBX: down ~0.3% - Not surprising there is no big move, but a bit surprised it is performing a little better than biopharma indices:
CRDF: up 1.19% - Market recognizing continued positive data especially with KRAS biomarker data.
SPPI: down 3% - Not surprised that market has not changed its view on companies value based on the slightly updated data.
HOOK: down ~5.5% - Market not impressed by immunogenicity data without clinical data?
RUBY: down ~3% - Market sees not much change in overall situation for RUBY from AACR data vs. March 15, 2021 update.
BPIQ catalyst search results snippet - 4/10/21
#Onvansertib #CRDF #AGEN1181 #AGEN #AACR2021 #TCRR #TC210 #SBYX #SYNB1891 #MTEM #MT5111 #immunooncology #SPPI #Poziotinib #HB201 #HB202 #HOOK #RUBY #RTX240