Fennec (FENC) presented the full data from SIOPEL 6, a Phase 3 study in cisplatin induced hearing loss in children with Standard Risk Hepatoblastoma (SR-HB). The study met its goal and reaffirmed what the interim data showed about a month ago.
Efficacy
The addition of Fennec’s STS significantly reduces cisplatin-induced hearing loss. Among the 99 evaluable patients, hearing loss occurred in 30/45=67% treated with Cisplatin (Cis) alone and in 20/54=37.0% treated with Cis+STS (p=0.0033). This p-value improved from 0.0069 in preliminary analysis to 0.0033 in the final data.
Safety
The combination of Cis+STS was well tolerated and showed it did not interfere with cisplatin’s anti-tumor effects.
The combination of Cis+STS was well tolerated and showed it did not interfere with cisplatin’s anti-tumor effects.
- With a follow up of 52 months, 3yr EFS is Cis 78.8% and Cis+STS 82.1%;
- 3yr OS is Cis 92.3% and Cis+STS 98.2%.
What’s Next?
We think the likelier outcome is a takeout. This data and the data from prior Phase 3 COG study (read more here), in our opinion, are strong enough to warrant an approval from the FDA. Additionally, the company’s management and board are comprised of individuals with successful exits in rare diseases. We think the company will be putting itself up for sale and expect a takeout value of around $21/share.
One or more of PropThink's contributors are Long FENC
Fennec will pursue regulatory approval with the FDA and EMA. The company will now have to decide whether to commercialize STS alone or be acquired. Cash balance should be roughly $9M, which is sufficient to take the company into an NDA. Therefore, Fennec can take the next step as a standalone company, if need be.
We think the likelier outcome is a takeout. This data and the data from prior Phase 3 COG study (read more here), in our opinion, are strong enough to warrant an approval from the FDA. Additionally, the company’s management and board are comprised of individuals with successful exits in rare diseases. We think the company will be putting itself up for sale and expect a takeout value of around $21/share.
One or more of PropThink's contributors are Long FENC
- Study met primary endpoint (p=0.0033). STS showed significant reduction in hearing loss without any evidence of tumour protection in patients with Standard Risk Hepatoblastoma
- Remain Long FENC. We think an acquisition of Fennec is likely and place a fair value of $21/share
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