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Healthcare

Biotechnology

Onconova Therapeutics Inc.

Investment Appraisal 
Onconova Therapeutics presented data at the virtual 25th annual European Hematology Association (EHA) Congress on Friday, June 12th. The company is conducting a pivotal study (INSPIRE) of rigosertib (a RAS pathway inhibitor) for the treatment of 2nd line high-risk myelodysplastic syndrome (HR-MDS). The MDS patients (360 patients) are randomized in 2:1 fashion of rigosertib or physician&#8217;s choice plus best supportive care. The primary endpoint is overall survival rate. The trial design is summarized in Exhibit 1.
Exhibit 1. INSPIRE study design
 <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/ontx.6.14.2020.e1.png" style="width: 580px;height: 234px" />
Source: Company EHA presentation
The genomic data presented at EHA Congress was from 190 patients enrolled in the INSPIRE study. Bone marrow samples from the patients were collected at the study baseline and at months of 2, 4, and 6 and every 6 months throughout the treatment. The baseline mutational analysis was performed in 295 genes. &nbsp;A total of 55 mutations was identified at baseline with the median number of mutations per patient at 3 prior to receiving study treatment. The MDS is known to be a highly mutated disease. The most commonly mutated genes were ASXL1 37%, TP53 26%, RUNX1 26%, TET2 23%, STAG2 21%, DNMT3A 17%, SRSF2 17%, and IDH 11%.
Exhibit 2. Genomic profiling in patients with HMA failure at baseline for INSPIRE study
 <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/ontx.6.14.2020.e2.png" style="width: 519px;height: 330px" />
Source: Company EHA presentation
The correlation between mutational and baseline clinical features showed that RAS pathway mutations were observed more commonly in patients that progressed on hypomethylating agents&nbsp;(HMA) therapy versus patients that failed HMA therapy.
Exhibit 3. RAS pathway is correlated with treatment failure in patients
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/ontx.6.14.2020.e3.png" style="width: 427px;height: 421px" /> 
Source: Company EHA presentation
This current data lays out genomic information of the patient&#8217;s mutational profile at the baseline. Further data following study treatment will be meaningful to provide insight into the correlation of clinical responses of rigosertib and genetic mutations. The INSPIRE topline data readout in H2 2020 remains to be the major catalyst for the company. In our view, 2020 and early 2021 will be transformational for the company with topline readout and multiple programs (CDK 4/6 program and rigosertib in 1st line MDS and solid tumors) entering in clinic. We are reiterating our Outperform rating and $1.3 price target.

Onconova Therapeutics Inc. (ONTX)

INSPIRE Study Patients’ Genomic Profile at the Baseline

Fundamental Analysis:

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Clinical Trials Make Expected Progress In 2Q23 (ONTX)

New Leukemia Data Presented Supports Wide Range Of Action (ONTX)

1Q23 Reported With Clinical Progress Review (ONTX)

Data Presented on Narazaciclib Targets and Mechanisms (ONTX)

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