Heavy | Binhui Bio-Clinical Cooperation Agency Announces Phase I/II Clinical Data of Oncolytic Herpes Simplex Virus Type II OH2 Injection

Recent popular reports from Yimaike ★Pharmaceutical giants have ended up with nucleic acid drugs! Come take a look at the research and development of nucleic acid drugsYimai Meng broke the news ★The world's top ten breakthrough technologies ranked first mRNA vaccine! mRNA vector technology is expected to become a hot investmentMedClub broke the news April 13, 2021/eMedClub News/--Recently, the results of a domestic multi-center clinical study led by Professor Huang Jing from the Cancer Hospital of the Chinese Academy of Medical Sciences were published in Journal for ImmunoTherapy of Cancer, the article "Intratumoral OH2, an oncolytic herpes simplex virus 2, in patients with advanced solid tumors: a multi-center, phase 1/2 clinical trial" published the oncolytic herpes simplex virus OH2 injection as The safety, tolerability and anti-tumor activity of a single drug or in combination with the anti-PD-1 antibody HX008 applied to patients with advanced solid tumors are the results of clinical trials.

This multicenter phase I/II clinical trial included patients with advanced solid tumors who had failed standard therapies and received increasing doses (106, 107, and 108CCID50/mL) of intratumoral single-dose OH2 injection or combined fixed-dose HX008 treatment.

The primary endpoint is the safety and tolerability defined by the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs), and the anti-tumor activity is evaluated according to the evaluation criteria of RECIST version 1.
1 and iRECIST for solid tumors.

From April 17, 2019 to September 22, 2020, a total of 54 patients were enrolled, of which 40 were treated with OH2 monotherapy and 14 were treated with OH2 combined with HX008.

No DLT was reported for single-agent OH2.
The most common treatment-related adverse event (AE) was fever (n=18, 45.
0%).
Except for one case of grade 3 fever in the 108CCID50/mL group, the rest were grade 1 to 2.
Serious adverse events related to treatment occurred.

In terms of anti-tumor activity, 2 patients with metastatic advanced rectal cancer and metastatic esophageal cancer from the single-drug group and 2 patients from the combined drug group obtained an immune partial response (iPR).

Among them, the response duration of the two patients who received OH2 monotherapy was 11.
25+ and 14.
03+ months, respectively, and the response duration of the two patients in the combination group was 1.
38+ and 2.
56+ months, respectively.

OH2 monotherapy caused changes in the tumor microenvironment.
In most patients, CD8+ and CD3+ cell density and PD-L1 expression levels increased compared to baseline, which fully demonstrated that OH2 can enhance the potential immunomodulatory effect of T cell infiltration in tumors.

This feature of making "cold" tumors "hot" makes the prospect of combined therapy with immune checkpoint inhibitors even more exciting.

Following the T-VEC (HSV1) Phase III clinical trial proved to be effective and approved for marketing, products developed with the same virus modification technology, such as Binhui Bio-OH2 injection, Replimune's RP series, and Japan's No.
1 Pharmaceutical G47∆.
Substantial progress has been made in the clinical stage, verifying that the virus modified by deleting the neurotoxic gene ICP34.
5 and immunosuppressive gene ICP47 from the wild-type virus genome not only enhances the oncolytic activity, but also induces a systemic anti-tumor immune response.
Drugs Safety and effectiveness are improved.

The sponsor of this clinical trial, Wuhan Binhui Biotechnology Co.
, Ltd.
, is a leading domestic oncolytic virus drug independent research and development company.
It has built an oncolytic virus technology platform and developed the first oncolytic virus injection OH2, which is mainly used for single drugs.
Treatment of multiple indications such as colorectal cancer, and can also be used in combination with traditional radiotherapy and chemotherapy and PD-1/PD-L1 monoclonal antibodies.
It is the only domestic company that has obtained clinical approval for combination with PD-1/PD-L1 monoclonal antibodies.
It is an oncolytic virus company and has obtained positive clinical data.
Currently, the company is communicating with CDE on the design of phase III clinical trials and is actively applying for the US IND.

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