Syncona’s (SYNC’s) portfolio company Autolus Therapeutics plc has announced that it has entered into a strategic collaboration with BioNTech SE, a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The strategic collaboration is aimed at advancing both companies’ autologous CAR-T programmes towards commercialisation, pending regulatory authorisations. In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement, which can be summarised as follows:
- BioNTech has agreed to purchase US$200m of Autolus’ American Depositary Shares in a private placement. BioNTech will have a right to appoint a director to Autolus’s board.
- BioNTech will make a cash payment of US$50m and is granted the following rights in exchange:
- BioNTech is eligible to receive an up to mid-single digit royalty on obe-cel net sales. Autolus will retain full rights to and control of the development and commercialisation of obe-cel.
- BioNTech has the option to access Autolus’ commercial and clinical site network, manufacturing capacities in the United Kingdom and commercial supply infrastructure in a cost-efficient set-up in order to accelerate the development of BNT211 in additional CLDN6+ tumour types. BioNTech plans to have 10 or more ongoing potentially registrational clinical trials in the pipeline by the end of 2024, including its fully owned CLDN6 CAR-T programme BNT211 in relapsed or refractory germ cell tumours.
- Autolus will lead the development and commercialisation for AUTO1/22 and AUTO6NG in any oncology indication with BioNTech having an option to support certain development activities and co-commercialise both candidates in certain territories. If BioNTech exercises an option, it will receive a profit share with respect to such exercised product candidate worldwide while Autolus will be eligible to receive an option exercise fee, milestone payments and co-funding of development expenses.
- Autolus granted BioNTech an exclusive license to develop and commercialise therapeutics incorporating certain of Autolus’ proprietary binders along with options to license binders and cell programming technology for use in BioNTech’s in vivo cell therapy development programmes and investigational antibody-drug conjugates. If BioNTech exercises an option, Autolus will be eligible to receive exercise fees and milestones payments, with low-single digit royalties on net sales of the licensed products.
Autolus announces pricing of public offering
Separately, Autolus Therapeutics has announced the pricing of a public offering in the US of 58,333,336 of its American Depositary Shares (ADSs – representing 58,333,336 ordinary shares), at US$6.00 per ADS, generating total gross proceeds of approximately US$350.0m (£277.2m). All ADSs sold in the offering were offered by Autolus and the offering is expected to close on 12 February 2024, subject to customary closing conditions. Following this public offering and the sale of US$200m ADSs to BioNTech SE noted above, Syncona retains a stake of approximately 11.8% in Autolus, which was valued at £167.8m at close of business on 07 February 2024.
Beacon presents 12-month clinical data from Phase II trial in XLRP
Separately, Beacon Therapeutics Holdings (another SYNC portfolio) presented 12-month interim safety and efficacy results from its Phase II SKYLINE trial of its lead asset, AGTC-501, in patients with X-linked retinitis pigmentosa (XLRP) at the 47th Annual Macula Society Meeting in Palm Springs, California. Highlights from the presentation include:
- Encouraging efficacy shown by improvements in retinal sensitivity, the primary endpoint for the trial, with a 63% response rate in the higher dose cohort
- Patients also showing robust improvements in visual function, a secondary endpoint for the trial
- AGTC-501 was generally well tolerated with no clinically significant safety events associated with treatment
- Pivotal Phase II/III VISTA trial for AGTC-501 in XLRP expected to begin in H1 CY2024
Elisa Petris, Lead Partner at Syncona Investment Management Limited, said: “This 12-month data presented by Beacon from the SKYLINE trial shows a strong response from the company’s lead AGTC-501 therapy, which continues to display a favourable efficacy and safety profile. It is pleasing to see improvements in visual function amongst patients who have been treated. This underlines AGTC-501’s potential in XLRP, a disease area where there is currently no approved treatment. Key to understanding the longer term durability profile of the therapy will be 24-month data from SKYLINE, which is expected in H2 CY2024.”