Eli Lilly and BioNTech said today they have launched a research collaboration to discover new cancer immunotherapies, in a deal that could generate more than $360 million for the German biotech.

The companies said they will partner to identify and validate new tumor targets and their corresponding T cell receptors (TCRs) in one or more undisclosed types of cancer. The targets and TCRs would be engineered and developed into targeted cancer therapies.

BioNTech’s technologies include UniCell® fully human TCRs, designed to enable high-throughput cloning and validation of human TCRs from single antigen-reactive T lymphocytes.

According to the company, UniCell has already generated a library of TCR drug candidates covering a broad range of ideal oncology targets and various human leukocyte antigen (HLA) restrictions, opening up additional opportunities for targeted immunotherapy. Using UniCell, TCRs can be cloned from patient samples and validated in as little as 11 days, BioNTech says on its website.

BioNTech also says it plans to develop fully individualized T cell-based cancer immunotherapies using UniCell. A chimeric antigen receptor (CAR) T cell therapeutic directed against a target expressed in many types of tumors—including ovarian cancer, endometrial cancer and lung cancer—is in preclinical development and is expected to enter clinical testing in 2016, the company adds.

The immunotherapies to be co-developed with BioNTech would add to Lilly’s cancer pipeline, which includes small molecule drugs and monoclonal antibody treatments now under study for a variety of cancers.

Two Lilly compounds are under regulatory review. One is LY3012211 (necitumumab), a fully human IgG1 monoclonal antibody for squamous non-small cell lung cancer (NSCLC). Necitumumab is designed to block the ligand binding site of the epidermal growth factor receptor (EGFR). In its filing, Lilly has cited results from the Phase III SQUIRE trial, in which patients with stage IV metastatic squamous NSCLC showed a statistically significant improvement in overall survival with a median survival of 11.5 months when receiving necitumumab plus gemcitabine and cisplatin as a first-line treatment, compared to 9.9 months for those treated with chemotherapy alone.

In February, a study published in the journal The Lancet Oncology showed results for another Phase III trial involving necitumumab. The INSPIRE trial found that adding necitumumab to cisplatin and pemetrexed did not increase survival of previously untreated patients with stage IV non-squamous NSCLC: “Unless future studies identify potentially useful predictive biomarkers, necitumumab is unlikely to provide benefit in this patient population.”

The other compound under regulatory review, LY3009806 (ramucirumab), is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist initially approved for gastric cancer. Last month, Lilly received FDA approval for an additional indication for the compound of metastatic colorectal cancer (mCRC) in combination with Folfiri in patients whose disease has progressed on a first line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen. LY3009806 is designed to bind and block activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D.

Lilly’s deal with BioNTech is its fourth cancer immunotherapy-related collaboration over the past year.

Back in January, Lilly and Merck & Co. agreed to a clinical trial collaboration to evaluate the safety, tolerability and efficacy of Lilly compounds in combination with Merck’s marketed Keytruda® (lambrolizumab) in multiple clinical trials. The value of that deal was not disclosed. Lilly also agreed to join Bristol-Myers Squibb (BMS) in assessing a combination of BMS’ marketed Opdivo (nivolumab) and Lilly’s galunisertib (LY2157299) in a Phase I/II trial.

And in July 2014, Lilly agreed to use Immunocore’s cancer immunotherapy technology to co-discover and co-develop new T cell-based treatments against the disease, in a deal that could generate for Immunocore $25 million-plus per candidate developed.

In the latest collaboration, Lilly agreed to pay BioNTech a $30 million “signing fee,” as well as more than $300 million in payments tied to development, regulatory and commercial milestones for each potential treatment developed. BioNTech would also receive up-to-double-digit tiered royalties for treatments that are successfully commercialized.

Lilly also agreed to make a $30 million equity investment in BioNTech's subsidiary, Cell & Gene Therapies, which specializes in the research and development of TCR and chimeric antigen receptor immunotherapeutics. Further financial terms were not disclosed.

[This updated report corrects an earlier version by including the Phase III trial that was the basis of the regulatory filing for necitumumab, and updating the status of the metastatic colorectal cancer indication for ramucirumab.]








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