ASCO-GU 2023 Coming Soon!

Summary:

• ASCO-GU is taking place from Feb 16-19 and abstracts will be released Feb 13

• This conference will focus on genitourinary cancers such as prostate cancer and ovarian cancer

• Several smid-cap biopharmas are presenting data at ASCO-GU, including final results from BTAI

• We have also determined additional upcoming late stage trials in GU cancers in the next year

ASCO-GU 2023 starts February 16 and focuses on new and innovative findings and studies for the treatment of genitourinary malignancies. Abstracts will be released February 13 at 5pm ET and late breaking abstracts will be released on the day of presentation at 7am PT. Currently we know of 5 companies in our database of smid-cap biopharmas that are presenting data at ASCO-GU 2023. These companies focus on genitourinary cancers, such as prostate cancer and ovarian cancer. See these companies as well as a summary of data to be presented in Table 1. We expect to see additional companies announce involvement when abstracts are released.

Currently BTAI's presentation of full Phase 2 BXCL701 data is a BPIQ Suspected Mover (See all February Suspected/ Big Movers HERE after subscribing. Learn more here), below is more info on this trial.

Table 1. ASCO-GU 2023 smid-cap biopharma presentations

BTAI BXCL701 Data

Data from the Phase 2 trial of BTAI's asset BXCL701 + KEYTRUDA to treat rare prostate cancer was first reported January 11, 2023. The company stated the trial showed promising topline data that demonstrated an encouraging response rate in metastatic castration-resistant prostate cancer (mCRPC). The January report was very limited and without specific data, it was stated full data would be presented at ASCO-GU, making us label it as a Suspected Mover for the month. This trial was a Phase 2a study evaluating BXCL701 in combo w/ KEYTRUDA in patients with at least 1 prior line of chemotherapy. Patients received 0.3mg BXCL701 twice daily for 14 days plus 200mg KEYTRUDA every 21 days.

The primary endpoint of this trial is the composite response rate and secondary endpoints include duration of response, progression-free survival, overall survival, and biomarker evaluation. This trial includes 28 patients in the SCNC (small cell neuroendocrine) mCRPC cohort.

Previous data from BXCL701 trial includes Phase 1b/2 data reported at SITC 2020 and ASCO-GU 2021. These presentations included updated data from the early stage trial and data included preliminary efficacy and safety data from the Phase 1b portion of the trial. Interim data from the Ph2 portion of the trial was then reported at ESMO 2021 and ASCO-GU 2022. This data showed encouraging results including a composite response rate of 33% in the SCNC cohort at the planned interim analysis. However, 17% of patients experienced serious adverse events and 22% of patients discontinued the trial due to AEs. This was a very small cohort (15 patients) so it will be interesting to compare the full results of the cohort of 28 patients. The data coming next month is also from the SCNC cohort; an adenocarcinoma cohort was previously included however there is no recent mention of data from this cohort.

On January 11, 2023, stock moved 12% upon announcement of positive topline Ph2 data, and the market seems excited for this full data.

Currently treatments for mCRPC include chemotherapy, androgen synthesis inhibitors, and androgen signal blockers. Many patients need second or third line therapies in their treatments.

BXCL701 works as an innate immune activator designed to initiate inflammation in the tumor micro-environment, which can be used to activate T-cells, such as IL-2. This treatment is helpful in "cold" tumors, where there is no inflammation triggering T-cell response. Prostate cancer is considered a cold tumor because few immune cells recognize the malignancies. Other innate immune activators include ASND TransCon (IL-2), CRIS CA-4948 (IRAK4), CDAK exoSTING, SYBX SBT6050 (TLRs), and SLS Galinpepimut-s (CD4 & 8).

Upcoming GU readouts

Some other mCRPC assets with upcoming readouts include MGNX (Ph1), LVTX (Ph1/2), AZN (PDUFA), FMTX (Ph1), RCUS (Ph1/2), EXEL (Ph3), MGNX (Ph2) and more. There are many other readouts coming in the next year and beyond in the genitourinary cancer area, as can be seen in Table 2.

Table 2. Upcoming GU cancer readouts

This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.

Article history: 1/27/23 initially published post

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