(For an even more detailed analysis of PDS0101 and HPV cancer trials, see our full BPIQ.com forum post on the topic available HERE to BPIQ subscribers. You can become a subscriber today with a 30-day free trial, by following the links on BPIQ.com. That will get you access to our ASCO21 Investor Hub forum post here on bpiq.com, as well, which includes ASCO trading strategies and big-mover stock analysis.)
PDS Biotech (PDSB) has been the highest ASCO21 gainer to date (see our ASCO21 movers post), up more than 100% on its updated data from a combination immunotherapeutic regimen to treat advanced human papillomavirus (HPV)-associated cancers. The fairly complex immunotherapeutic regimen includes the following biologics: (1) a liposomal multipeptide therapeutic vaccine against HPV positive cancers (PDS0101) delivered subcutaneously, (2) Bintrafusp-alpha, a bifunctional fusion protein checkpoint inhibitor targeting PD-L1 and TGF beta (M7824) delivered intravenously, and (3) a tumor targeted (antibody-conjugated) immunocytokine (NHS-IL12) delivered subcutaneously (https://clinicaltrials.gov/ct2/show/NCT04287868). PDS0101 (Versamune-HPV), PDS Biotech’s lead candidate, is a liposomal formulation of PDSB’s Versamune® particles (positively charged nanoparticles about the size of a viral particle) and a proprietary mix of HPV16 E6/E7 peptide antigens (More Information). It is notable that although PDS0101 is being developed by PDSB, Bintrafusp alfa is being jointly developed by Merck KGaA and GlaxoSmithKline, and NHS-IL12 is being developed by Merck KGaA. This combination therapy is a good example of next-generation immunotherapeutic combinations that have made their way into clinical trials and ASCO21 presentations.
The trial for this therapeutic combination reported on in the ASCO21 abstract (ASCO abstract 199070), which will be the subject of an ASCO21 oral presentation on June 7, is sponsored by the National Cancer Institute (NCI). Data from the first 14 patients was reported on in the abstract. Treatfment with the therapeutic combination resulted in an 83% and 63% objective response rate (ORR) in relapsed/refractory HPV-16 positive advanced cancer patients who are either checkpoint inhibitor naïve or refractory, respectively. Furthermore, 90% of the responses are ongoing after a median of 5 months of follow-up. The therapy is aggressive with 4 of the 14 treated patients experiencing a grade 3 toxicity. However, these early results are impressive since only about 15-20% of HPV-associated malignancies respond to PD-(L)1 inhibitors and for the overwhelming majority of patients who progress on these immunotherapies there is no effective standard of care therapy (PDSB press release 5/20/21).
This Phase 1/2 trial is a basket-type trial for HPV associated malignancies, and is not limited to a certain cancer type. The patients in the NCI sponsored trial include cervical, anal, oropharyngeal vaginal/vulvar and a variety of other HPV-associated cancers. NCI reports that there are more than 630,000 cases of HPV-associated malignancies including cervical, oropharyngeal and anal cancer worldwide annually. HPV 16 is responsible for most of these cases. Thus, this appears to be a large market opportunity.
As shown in FIG. 1, PDS0101 is PDSB's only clinical asset. The Phase 2 update at ASCO21 relates to 1 of 3 different cancer combinations in clinical trials for PDS0101. Of course based on PDS0101’s mechanism of action, all of the trials are related to HPV associated cancers. The other trials are also combination trials, either with Keytruda, Merck’s market-leading approved checkpoint inhibitor, or with chemotherapy and radiation therapy. It will be interesting to see how these other trials progress given the ASCO21 proof of concept data from the NCI-sponsored triple therapy trial.
FIG. 1
BPIQ.com Company asset page for PDSB
Competition for PDSB’s HPV vaccine will likely be fierce. For example, Merck has an approved HPV vaccine, Gardasil 9, which is approved for vaccination to protect individuals from developing many of the cancers in the Phase 2 NCI trial (https://www.gardasil9.com/). In fact, when we search clinicaltrials.gov we find a number of trials, including several actively recruiting clinical trials, testing Gardasil 9 (sometimes in combination with an anti-PD1 antibody) to treat cervical cancer or precursors thereof (See e.g. https://clinicaltrials.gov/ct2/show/NCT04096911).
Furthermore, when we search our BPIQ database for other HPV cancer therapeutics, we find 6 other therapeutic candidates of smid-cap companies targeting HPV cancers in active clinical trials with data report outs in 2021 or early 2022. These include HB-201 and HB-202 from HOOKIPA Pharma, SQZ-PBMC-HPV from SQZ Biotechnologies, RTX-321 from Rubius Therapeutics, CUE-101 from Cue Biopharma, and Multikine from Cel-Sci Corporation. RTX-321, SQZ-PBMC-HPV, and HB201/HB2-202 are the subject of ASCO21 presentations. CUE-101 data is expected in mid 2021, and an additional combo trial from PDSB expects data in late 2021 or early 2022. Data from Cel-Sci is expected this year for the indication HNSCC, but the indications could be expanded to include HPV. SB206 from Novan has a planned Phase 3 trial, but there is currently no indication of initiation timing.
As far as PDSB’s cash runway, the company appears to be in good shape. The company had $25 million in cash as of Q1, 2021, with a burn rate of only around $3.0 million per quarter (See FIG. 2). We expect this burn rate to increase in the coming quarters, now that the company has this proof of concept data.
FIG. 2 BPIQ.com Company page header portion for PDSB
In summary, HPV cancers appear to be a hot area of clinical actively. PDSB is one of the players in the middle of this activity. It's very early days for PDSB, but there initial results look very promising not only for investors, but especially for patients with HPV cancers. For a more detailed analysis of PDS0101 and HPV cancer trials, see our full BPIQ.com forum post on the topic available HERE to BPIQ subscribers. You can become a subscriber today with a 30-day free trial, by following the links on BPIQ.com.
The next big question for biopharma investors with respect to ASCO21, is which stocks are likely to move upon the release of the posters on June 4, or at an oral presentation or associated investor meeting for ASCO21. For example, PDSB announced that data from more patients will be presented at the ASCO oral presentation on the NCI-sponsored trial (PDSB press release 5/20/21). We analyzed the ASCO abstracts and press releases and identifies a number of ASCO21 presentations that are most likely to move their corresponding stock significantly higher or lower (our Big-Mover analysis). We include our most comprehensive and up-to-date Big-Mover analysis and other ASCO21 information in our ASCO21 Investor Hub forum post here on bpiq.com. Furthermore, you can use our BPIQ.com database to learn more about any of the drug candidates in these presentations, including mechanism of action, drug history, and more! We plan to update our database with the ASCO posters as they become available. Click here to try 30-days risk-free for full access to our full ASCO21 Investor Hub forum post and our database of information about these drug candidates.
Faith Smalley, Dominic Vacchiano, and Manny Vacchiano
Amp Biotech Research (BiopharmIQ - BPIQ.com)