As the annual meeting for the American Association of Cancer Research kicks off this weekend and runs into early next week, we have been busy analyzing abstracts and company information for possible investor opportunities (i.e. catalysts), which at scientific meetings are typically updates on safety and especially efficacy from clinical trials. We don't find very many exciting small biopharma investor opportunities at AACR as the majority of presentation by small biopharma companies at AACR relate to pre-clinical studies. However, there are a few presentations worth noting/considering. Here are a few of them:
Dynavax (DVAX): We are excited about seeing an update from the efficacy data that DVAX presented at ASCO 2017 last June from the ongoing phase 1b/2 study of DVAX's TLR-9 agonist SD-101 in combination with an anti-PD1 antibody in metastatic melanoma patients. That is one reason we've been building our hypothetical DVAX position in the Amp hypothetical fund over the past month, and possibly a reason that the stock is up over 20% in that time. The data from last June was exciting for the anti-PD1/L1 naïve patient cohort in that 7 of 7 objective responses (100% ORR) with 3 complete responses were achieved. Although comparison to historical studies of anti-PD1 in melanoma need to be considered with caution because base patient characteristics, marker expression status, and prior treatments have a large effect on response rates, a 100% ORR is very exciting (e.g. Topalian et al.'s 2012 report of a large anti-PD1 melanoma study showed a response rate of 41%) if it holds up with more patients and if the responses have good durability. DVAX has indicated that at a minimum they will show more durability data. Based on other anti-PD1 studies with or without potentiators that we are aware of, including the Topalian et al. 2012 study, the durability of responses in many cases can last for over 12 months. Furthermore, DVAX will present data from the same combination therapy in head and neck cancer, where there is a low bar for success. Therefore, we are bullish on the DVAX data at AACR.
Arqule (ARQL) has a busy AACR, with 10 abstracts being presented. However, there is only one presentation that likely has clinical anti-tumor efficacy data. This presentation will focus on results of the phase 1B trial testing the combination of ARQL's AKT inhibitor miransertib with anastrozole in endometrial or ovarian cancer. The company has reported that results from this trial "identify a potential clinical path forward in this difficult to treat disease." Therefore, although there has been some generally positive data presented already for other cohorts of this trial, it is likely that the presented data from the Miransertib with anastrozole cohort will be positive. Furthermore, some preclinical and early clinical (non-efficacy we believe) data will be presented focusing on Arqule's reversible BTK inhibitor, which looks like a valuable asset that could get more investor attention even without efficacy data. At any rate, we’ve been accumulating ARQL in the Amp hypo fund for over a month because even after a recent run-up over this time, a market cap of $250M dollars is attractive for an oncology company with ARQL’s clinical assets.
Oncosec (ONCS) plans to present an update of its Intratumoral plasmid IL-12 electroporation technology. At the AACR meeting, a Stanford collaborator will present data from at least two patients in pre-treated inoperable locally advanced or recurrent triple-negative breast cancer (TNBC). The company reported that these two patients after treatment of the ONCS IL-12 technology and then an anti-PD1 antibody experienced "robust objective responses." These are noteworthy results for this difficult-to-treat patient population and may get investor attention at the meeting. Furthermore, the company plans to update its melanoma data at a company-hosted investor event held on Sunday evening outside the meeting. The last time the company presented data from this trial was last fall, when the stock price increased over 50%. Most of the upside from this trial is now likely baked in the current share price. However, with some additional positive data, this less than $100M microcap company could see another gain. Either way, it appears to be a low risk situation.
Tocagen (TOCA) plans to present preliminary clinical data for its replicating retroviral vector technology (Toca 511 & Toca FC combo) from its Toca 6 Phase 1 study in advanced solid tumors. New data from Tocagen's Phase 1 resection trial demonstrating the immune profile of the tumor microenvironment helps predict response in patients with high-grade glioma receiving Toca 511 & Toca FC will also be presented. Although it is unlikely that any new anti-tumor efficacy data will be presented in these presentations, the data will include human data for Toca's combo therapy when Toca 511 is administered by IV injection rather than locally (e.g. intracranial injection). The Toca combo has shown promising results in glioma, and this sexy technology may impress investors when they see that it can be delivered in IV/oral combo and still reach tumor and harmful immune cells near the tumor and not other tissue/cells. A recent scientific publication shows similar data in a mouse model (Yagiz et al. 2018). At any rate, there seems to be little downside from the Toca presentations.
Blueprint Medicines (BPMC) will present preliminary data from the dose escalation phase for a phase 1 trial of its targeted RET kinase inhibitor BLU-667. From the title of the abstract and information provided by the company it appears that the data will be positive and establish proof of concept for selective RET inhibition. The company has reported previously that preliminary evidence of clinical activity was observed in non-small cell lung cancer (NSCLC) in this trial. The company will also host an investor event Sunday evening. We have not analyzed BPMC or their RET asset closely, and with an over 100% run-up in stock price over the past year bringing its market cap to over $4 billion, and a growing pipeline of selective kinase inhibitors, BPMC is a complex story. For example we don’t know how much of the current market cap is attributed to this RET asset. Furthermore, the selective kinase inhibitor space is very complex (see Klaeger et al. Science 2017 for a comprehensive analysis of the specificity of 243 kinase inhibitors that are approved or in clinical trials). Therefore, we can’t comment on the opportunity or risk with the BLU-667 presentation at this time.
Going into May we have already begun our analysis of upcoming presentations at the American Society for Clinical Oncology (ASCO), which is a much more important meeting with respect to catalysts for small biopharma companies. We are excited by the potential investment opportunities both from ASCO presentations, as well as for catalysts from cancer trials with Q2 report-outs. Check out our future Amp Ups for updates going into ASCO with abstracts coming in mid-May and presentations in early June.
AACR PRESENTATIONS MENTIONED ABOVE
DVAX PRESENTATIONS:
Phase Ib/II, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Monday Apr 16, 2018, 1:00 PM - 5:00 PM CDT
Durability of responses to the combination of SD-101 and pembrolizumab in advanced metastatic melanoma: Results of a phase Ib, multicenter study
Tuesday Apr 17, 2018, 8:00 AM - 12:00 PM CDT
ONCOSEC PRESENTATIONS:
Intratumoral plasmid IL-12 and electroporation in pre-treated inoperable locally advanced or recurrent triple-negative breast cancer (TNBC)
Sunday, April 15, 2018; 1:00 PM - 5:00 PM EST
ARQL PRESENTATIONS:
A phase 1b study of Miransertib (ARQ 092) in combination with anastrozole in patients with PIK3CA or AKT1-mutant ER+ endometrial and ovarian cancer
April 15, 2018, Time: 3:00 – 5:00 p.m. CT
ARQ 531, a Novel and Reversible Inhibitor of Bruton’s Tyrosine Kinase, Displays Favorable Oral Bioavailability and Exposure in patients with B-cell malignancies
April 15, 2018, 1:00 – 5:00 p.m. CT
TOCA PRESENTATIONS: A phase 1b study of Toca 511, a retroviral replicating vector, followed by Toca FC in patients with advanced cancer
Monday, April 16, 8:00 a.m. - 12:00 p.m. CT
Immune profile of tumor microenvironment helps predict response in patients treated with an investigational immunotherapeutic consisting of a retroviral replicating vector (Toca 511) and an extended-release formulation of 5-fluorocytosine (Toca FC)
Wednesday, April 18, 8:00 a.m. - 12:00 p.m. CT
BPMC PRESENTATIONS:
Highly potent and selective RET inhibitor, BLU-667, achieves proof-of-concept in a Phase I study of advanced, RET-altered solid tumors Sunday, April 15, 3-5 p.m. CT
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