Genentech, a member of the Roche Group, will partner with Adaptimmune to develop and commercialize allogeneic T-cell therapies to treat multiple cancer indications, through a collaboration that could generate more than $3 billion for the U.S./U.K. oncology drug developer, the companies said today.
Under their collaboration Genentech will work with Adaptimmune to develop “off-the-shelf” allogeneic T-cell therapies for up to five shared cancer targets, as well as a novel allogeneic personalized cell therapy platform from which personalized allogeneic T-cell therapies would be developed.
“Through this collaboration, our platform will form the basis of a personalized allogeneic cell therapy vision, where any patient can receive a T-cell product for their cancer—a significant step towards our goal of making cell therapies both curative and mainstream,” Adaptimmune CEO Adrian Rawcliffe said in a statement.
For each component, Adaptimmune has agreed to oversee development of clinical candidates by using its induced pluripotent stem cell (iPSC) derived allogeneic platform to produce T-cells (iT cells). Genentech agreed, in turn, to oversee the T-cell receptors (TCRs) as well as their subsequent clinical development and commercialization.
“We believe allogeneic cell therapies could be a game-changing approach for developing personalized therapy platforms based on individual cancer patients’ unique needs,” added James Sabry, MD, PhD, global head of Pharma Partnering, Roche. “This partnership, which combines Adaptimmune’s allogeneic platform with Genentech’s expertise in developing personalized therapies, complements our other efforts to discover and develop personalized cell therapies. It holds the promise to change how we treat cancer and brings us another step closer to making personalized healthcare a reality.”
Based in Philadelphia and Oxfordshire, U.K., Adaptimmune specializes in developing cancer immunotherapies based on its SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform, designed to enable the engineering of T-cells to target and destroy cancer across multiple solid tumors.
On Sunday, Adaptimmune announced positive results from the Phase I ADP-A2AFP trial (NCT03132792)—presented at the International Liver Cancer Association (ILCA) Conference, held September 2–5—showing that its ADP-A2AFP SPEAR T-cell product, designed to treat liver cancer by targeting alpha-fetoprotein (AFP), led to one complete response, and a disease control rate of 64% with stable disease for ≥16 weeks in two patients as of the data cutoff. Twelve patients with advanced hepatocellular carcinoma (HCC) received ADP-A2AFP in Cohort 3 and the expansion phase of the trial.
Last month in announcing second-quarter results, Adaptimmune said it was on track to file a BLA next year for its first cancer immunotherapy afamitresgene autoleucel (“afami-cel”; formerly ADP-A2M4) after presenting data at ASCO 2021 from the Phase II SPEARHEAD-1 trial (NCT04044768) showing an overall response rate for patients with at least one scan of 39.3% (13 of 33 patients)—including 41.4% (12 of 29) among patients with synovial sarcoma, including two complete responses; and 25% (1 of 4) among patients with Myxoid/round cell liposarcoma (MRCLS) from its Phase II SPEARHEAD-1 trial.
Of the 29 patients with synovial sarcoma, the disease control rate was 86.2% (25 of 29) among patients, with two complete responses and 10 partial responses.
$150M Upfront, $150M over Five Years
Investors responded to the Genentech collaboration with a buying surge that sent Adaptimmune shares soaring 25.5% in premarket trading this morning, to $6.20 as of 9:15 a.m., from Friday’s closing price of $4.94, before settling to 15% above that close, to $5.68 as of 10:38 a.m.
“Overall, we view the deal favorably given it demonstrates additional external confidence in ADAP’s early-stage allogeneic platform and provides ADAP with meaningful upfront and milestone payments,” Jonathan Chang, PhD, CFA, managing director, emerging oncology and a senior research analyst with SVB Leerink, wrote in a research note.
Chang noted that Adaptimmune has extended its cash runway guidance following the partnership to having sufficient cash to fund operations into early 2024, from into early 2023 previously. He raised SVB’s price target for Adaptimmune shares form $5 to $6, and maintained the firm’s “market perform” rating on the company.
Genentech agreed to pay Adaptimmune $150 million upfront, and another $150 million over five years unless the agreement is terminated before then. Genentech also agreed to pay Adaptimmune potentially more than $3 billion in payments tied to achieving research, development, regulatory, and commercial milestones—as well as tiered royalties in the mid-single to low-double digits to Adaptimmune on net sales of co-developed candidates.
In a regulatory filing, Adaptimmune broke down the potential milestone payments as follows:
- Research milestones of up to $50 million. The research program will run an initial eight years, which may be extended for up to two additional two year terms at Genentech’s option upon payment of an undisclosed extension fee for each two-year term.
- Development milestones of up to $100 million in relation to the development of off-the-shelf T-cell therapies per collaboration target (unless Adaptimmune exercises its right to opt-in to receive a profit share) and up to $200 million in relation to the development of personalized T-cell therapies;
- Commercialization milestones of up to $1.1 billion for off-the-shelf T-cell therapies and net sales milestones of up to $1.5 billion for off-the-shelf T-cell therapies—unless Adaptimmune exercises its right to opt-in to receive a profit share and assuming off-the-shelf T-cell therapies are developed to five targets—and for personalized T-cell therapies.
Adaptimmune has the option to opt in to a 50/50 U.S. profit/cost share on “off-the-shelf” products. If Adaptimmune opts in, it would be eligible to share half of profits and losses from U.S. sales on such products, and would also be eligible to receive ex-U.S. regulatory and sales-based milestone payments, as well as royalties on ex-U.S. net sales.
The collaboration is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.