Boost for CGT market as AztraZeneca collaborates with Cellectics

The World Health Organization (WHO) ranks cancer as one of the top causes of death globally accounting for nearly 16% of all deaths even as more pharmaceutical companies now get interested in new innovative treatment options such as cell and gene therapies (CGT). (1)

Public health regulators such as the US' Food and Drug Administration (FDA) and Europe's European Medicines Agency (EMA) have in the recent past approved variations of CGT with many more applications still under consideration. This trend has catalysed business deals and collaborations among CGT solution providers especially for cancer, autoimmune or genomic medicine, to leverage their diverse strengths to expand access to affordable treatment globally and especially emerging markets.

For instance, UK-based Anglo-Swedish multinational pharmaceutical and biotechnology company, AztraZeneca Plc, announced on November 1, a deal with another company in the fast-growing CGT market.

AztraZeneca said it had struck a new collaboration and investment deal with French biopharmaceutical company, Cellectis, to scale up the development and distribution of cell therapy treatments for diseases such as "oncology, immunology and rare diseases." (2)

The agreement gives AstraZeneca the exclusive right on the French biotechnology company's gene editing technologies and standard production procedures in the subsequent design of "novel cell and gene therapy products."

Apart from cell-based therapy, AstraZeneca says, it is currently working at the development of other new options, such as antibody and nucleotide-based therapeutics, areas that have hitherto proved hard to crack with existing treatments.

The company previously indicated to shareholders nearly 30% of its early pipeline "consists of new drug modalities including oligonucleotides, mRNA and Anticalin® proteins."

Cellectis has reserved 25 genetic targets exclusively for AstraZeneca, with at least 40% of the candidate products expected to proceed to development phase. If this happens, AstraZeneca will hold an exclusive global permit for the candidate products.

By the end of Q4, 2023, AzatraZeneca will acquire a 22% stake in Cellectis at approximately US$80 million with the option to increase the share to 44% in Q1, 2024, subject to successful negotiations with Cellectis workers representatives and receiving of necessary regulatory approvals.

Moreover, AstraZeneca will, once the deal is successfully closed, become a business associate of Cellectis on account of the planned 44% stake acquisition.

"Cellectis is also eligible to receive an investigational new drug (IND) option fee and development, regulatory and sales-related milestone payments, ranging from $70m up to $220m, per each of the 10 candidate products, plus tiered royalties," AzatraZeneca said in its November 1, statement.

Previously, FDA had announced the approval of Omisirge, a brand name for Omidubicel, an allogeneic cell therapy produced by Israel's Gamida Cell Ltd, for use in adults and paediatric patients 12 years and older with blood cancer and set for an umbilical cord stem cell transplantation. (3)

Omisirge, FDA says is a blood-based cell therapy that supports fast regeneration of neutrophils, part of the white blood cells in the body and minimize chances of infections that are encouraged by a weak body immunity due to treatments such as radiation or chemotherapy.

Administering of Omisirge to patients requires a single intravenous dose. The administered amount comprises human allogeneic stem cells from umbilical cord blood, but which have been processed and cultured with nicotinamide, a water-soluble form of vitamin B3.

Other reports indicate the cell and gene therapies (CGT) market is growing, and doing so fast, in tandem with the spike in the number of genetically related ailments and diseases that are hard to treat such as cancer.

It is estimated that by the end of 2019, at least 27 CGT products were unveiled globally with an estimated 990 companies already engaged in research, development and commercialization of new therapies. (4)

By the end of the 2025, market researcher Deloitte estimates the CGT market size could surpass US$11.9 million.

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References

1. https://www.who.int/health-topics/cancer#tab=tab_1

2. https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-cell-and-gene-therapy-deal-w-cellectis.html

3. https://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell

4. https://www2.deloitte.com/us/en/insights/industry/life-sciences/cell-and-gene-therapy-and-chinas-precision-medicine-initiative.html