Halozyme Therapeutics Inc (HALO)

[biotechinvestor1]

Read the recently published meta analysis of Enhanze in the Journal of Immunotherapy (abstract below). It is inevitable that FDA will grant a much shorter path to approval (like Argenix is applying for) of all MCA’s combined with Enhanze. As I mentioned before, this will lower the cost of the combination trials significantly and open the floodgates to new partners for Halo. Note that while the efficacy remained strong in all studies, the immunogenicity (allergic reactions) profile was far better with Enhanze/SC vs. IV. FDA will grant future approvals after simple/short pharmacokinetics and biomarker data to Argenix and others.

Meta analysis: rHuPH20-facilitated subcutaneous administration of monoclonal antibodies in cancer therapy
Published Online: 17 Nov 2020 https://doi.org/10.2217/imt-2020-0204

Abstract
Aim: This meta-analysis aimed to evaluate the pharmacokinetics, efficacy, safety and immunogenicity of rHuPH20-facilitated subcutaneous (SC) administration of monoclonal antibody compared with intravenous (IV) administration for patients with cancer. Materials & methods: Outcomes included trough concentrations (Ctrough), overall response rate, adverse events, serious adverse events and antidrug antibody positivity rate. Subgroup analysis was also performed. Results: Five studies involving 1575 participants (788/787) were included. All studies met the non-inferiority criterion in Ctrough. No significant differences were observed in overall response rate (p = 0.12), adverse events (p = 0.05), and severe adverse events (p = 0.73) between SC and IV groups. The SC group also had lower immunogenicity than the IV group. Conclusion: rHuPH20-facilitated subcutaneous administration of monoclonal antibody is highly similar to IV administration in terms of pharmacokinetics, efficacy, and safety, but with lower immunogenicity.