Selecta Biosciences, Inc. (SELB) experienced a downfall of 12.89% in the aftermarket. However, the last trading session closed at $3.18.
Update on Phase 1/2 Clinical Trial of SEL-302 – What’s up?
SELB announced the Update on Phase 1/2 Clinical Trial of SEL-302 for the Treatment of Methylmalonic Acidemia on 24th November 2021. SELB received a letter from the FDA on November 23 ordering a clinical hold. This is done to acquire further information on the MMA-101 product candidate’s chemical, manufacturing, and controls (CMC). In the FDA letter, there were no unanswered clinical or preclinical questions. Lastly, this clinical trial has not yet begun, and no human patients would be given MMA-101.
Now what?
Patient safety is the first priority, and the company is working hard to respond to the FDA’s queries about CMC. Moreover, SELB looks forward to working together with the FDA to address any remaining issues.
Third Quarter 2021 Financial Results by SELB
SELB announced third quarter 2021 results on 9th November 2021. Selecta had $140.0 million in cash and cash equivalents. Moreover, Selecta anticipates that its cash and cash equivalents will be enough to satisfy its operating needs until the second quarter of 2023. In addition, the research and development costs were $21.0 million, compared to $14.0 million in the same time of 2020. There was a rise in preclinical program expenses, salary, staffing, and AskBio cooperation costs in the quarter ended September 30, 2021.
SELB reported general and administrative costs of $5.4 million, $4.4 million more than the same period of 2020. Salaries, professional fees, and stock compensation expenditures all contributed to the cost rise. Lastly, SELB reported a net loss of $17.9 million compared to a net loss of $9.7 million in the same period of 2020.
So what?
The third quarter of 2021 saw many great advances that further validated the comprehensiveness of the innovative ImmTOR platform, such as essential pipeline milestones and the formation of numerous collaborations that will propel SELB forward in the year ahead.
Phase I SEL-399 AAV Empty Capsid Study – Top Line Data Revealed by SELB!
On 8th November 2021, SELB released preliminary findings from research. This helped in evaluating the ImmTOR platform’s ability to prevent neutralizing antibodies. The results were as follows:
- For ImmTOR, all treatment-related side effects were predicted to be mild, manageable, and transitory.
- The immunological response to AAV8 empty capsids was significant, with peak median anti-AAV8 neutralizing antibody (NAb) titers of 1:6875.
- 6 of 6 (100%) of participants who received 0.3 mg/kg of ImmTOR had an anti-AAV8 neutralizing antibody titer of 1:25 or less, whereas 4 of 6 (67%) had a titer of 1:5 or less.
- At 30 days, 6 of 9 (67%) of participants who received 0.15 mg/kg of ImmTOR had an anti-AAV8 neutralizing antibody titer of 1:25 or less, while 2 of 9 (22%) had a titer of 1:5 or less.
- Only 1 of 8 (or 12.5%) of participants who received AAV8 empty capsid alone had a neutralizing antibody titer of 1:25 or less, and no subjects (0/8) had a titer of 1:5 or less.
