Cell remedy developer Autolus has a lead program underneath FDA overview for a kind of blood most cancers and in scientific growth for different indications. As the corporate appears forward to a possible product launch later this yr, it has stuffed its coffers with $600 million from a pair of offers, one in all them a collaboration with BioNTech.
BioNTech is buying $200 million value of Autolus shares and making a $50 million money fee to the London-based biotech, the businesses introduced Thursday. In change, BioNTech is eligible for a royalty on gross sales of the Autolus cell remedy, obe-cel. Whereas Autolus retains full rights to this remedy, BioNTech will get the choice to entry the biotech’s scientific web site community and its manufacturing and business provide infrastructure, which can be used to advance the event of therapies in its personal pipeline.
Quickly after the BioNTech settlement was introduced, Autolus raised extra cash with a $350 million inventory providing. The corporate mentioned proceeds from each transactions will assist actions comparable to manufacturing of obe-cel and ongoing scientific growth of the cell remedy.
Obecabtagene autoleucel, or obe-cel, is a CAR T-cell remedy. Like the primary technology of CAR T-drugs, Autolus’s remedy targets the CD19 protein on most cancers cells. However Autolus engineers its remedy to supply decrease toxicity and an extended length of impact. Autolus initially developed this remedy as a remedy for adults whose acute lymphoblastic leukemia (ALL), a most cancers of the blood and bone marrow, has relapsed or has not responded to earlier strains of remedy. The FDA’s goal date for a regulatory determination is Nov. 16. Autolus expects to submit an utility in Europe within the first half of this yr.
The Autolus cell remedy can be in Section 1 growth for pediatric ALL sufferers and B-cell non-Hodgkin lymphoma. Autoimmune ailments supply further alternative. Autolus has mentioned it expects a Section 1 take a look at of obe-cel in lupus will yield preliminary knowledge in late 2024.
In the meantime, BioNTech’s pipeline contains BNT211, a CAR T-cell remedy for stable tumors. This program is at the moment in Section 1 growth, however the firm has mentioned it plans to have 10 or extra doubtlessly registrational scientific trials in its pipeline by the top of this yr. BioNTech co-founder and CEO Ugur Sahin mentioned in a ready assertion that the Autolus collaboration allows his firm to increase growth of BNT211 to a number of most cancers indications in a cost-efficient manner. He added that the choice to entry Autolus’s exact cell-targeting instruments will assist BioNTech’s growth of in vivo cell therapies and antibody drug conjugates. If BioNTech workout routines that choice, Autolus is in line to obtain train charges and milestone funds, plus royalties from gross sales of any commercialized merchandise developed with the biotech’s applied sciences.
In a word despatched to traders Thursday, William Blair analyst Matt Phipps wrote that capital from the BioNTech pact and the inventory providing will assist Autolus because it progresses the event of obe-cel past most cancers and into autoimmune indications. Autolus administration advised Phipps that the lupus research has begun enrollment, and the extra capital permits the corporate to extra broadly deploy its assets towards autoimmune illness analysis. Plans embody a “basket research,” a method extra generally utilized in most cancers. Such research take a look at a single focused most cancers drug towards many kinds of cancers to establish which of them it might deal with. This basket strategy might be used to seek out further autoimmune indications for obe-cel.
“We imagine the deal highlights the worth of Autolus’s wholly owned manufacturing facility, which we toured towards the top of final yr and the corporate’s intensive cell programming applied sciences,” Phipps mentioned. “Administration believes the capital readily available will enable the corporate to succeed in profitability on obe-cel in grownup ALL and to increase growth of your complete pipeline.”
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