BioNTech adds CAR-T manufacturing with $250m Autolus deal

Autolus Therapeutics

Germany’s BioNTech has taken a $200 million stake in Autolus in a private placement that will allow it to tap into the UK company’s manufacturing capacity for CAR-T therapies.

The main thrust of the deal is to build capacity for BNT211, BioNTech’s lead CAR-T therapy for Claudin-6-positive solid tumours, as it progresses towards late-stage clinical testing. The biotech’s chief executive, Ugur Sahin, said the alliance would allow it to “expand our BNT211 programme into trials for multiple cancer indications in a cost-efficient way.”

There is a technical element to the agreement as well, as BioNTech will be able to access cell-targeting tools developed by Autolus that could be used in the development of in vivo cell therapy and antibody-drug conjugate (ADC) products, said Sahin.

BNT-211 consists of a CAR-T directed at Claudin-6 coupled with an mRNA vaccine (CARVac) designed to amplify the activity of the cell therapy and is due to start its first pivotal trials later this year, in germ cell tumours like testicular and endometrial cancer.

At last year’s ESMO congress, phase 1/2 data revealed an overall response rate (ORR) of 45% with the therapy in a group of 38 evaluable patients with various Claudin-6-positive solid tumours that had resisted multiple prior lines of therapy, including germ cell tumours and ovarian cancer, with a disease control rate – including stabilised tumours – of 74%.

So far, CAR-Ts have disappointed as therapies for solid tumours, as the immune cells find it difficult to target cancer cells, as well as infiltrate and survive in the hostile microenvironment of the tumour.

BioNTech is also making an upfront payment to Autolus of $50 million in return for royalty rights to Autolus’ lead CD19-directed CAR-T therapy obecabtagene autoleucel (obe-cel), which is under review by the FDA relapsed/refractory adult B-cell acute lymphoblastic leukaemia, with a decision expected by 16th November.

The German biotech will also provide support for the commercial launch of obe-cel, if approved, and gets an option of joint commercial rights to Autolus’ AUTO1/22 – in early-stage clinical development for treating relapses in patients who have received a CAR T-cell therapy for B-cell acute lymphoblastic leukaemia – and neuroblastoma candidate AUTO6NG.

Autolus files $350m private placement

Alongside the BioNTech alliance, Autolus announced a public offering that it hopes will raise $350 million, putting it in line for a total cash injection of $600 million.

The company – which had around $256 million in cash reserves at the end of September last year – said it would use the proceeds to advance the clinical development of its obe-cel programme, fund manufacturing activities for the CAR-T, and develop its commercial infrastructure. It is due to close early next week.