"The world's richest doctor" Huang Xinxiang proposed a new combination strategy, IL-15 super agonist and NK cell therapy is expected to enhance the anti-tumor activity of TROP-2 ADC

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Click on the picture and register immediately June 17/eMedClub News/--Recently, ImmunityBio, Inc.
, a clinical-stage immunotherapy company, announced that a phase 1b/2 clinical study of a combination therapy has been authorized by the FDA
.

The combination therapy is a combination of the super agonist Anktiva (N-803, an IL-15 super agonist), PD-L1.
t-haNK, standard chemotherapy, and Trodelvy (sacituzumab govitecan-hziy).
The test mainly evaluates the combination The safety and effectiveness of the therapy in patients with advanced triple-negative breast cancer (TNBC)
.

Patrick Soon-Shiong, CEO and founder of ImmunityBio, said: “Antibody drug conjugates like Trodelvy have made great progress in providing more and higher quality time to TNBC patients, but we believe that the increase in Anktiva will Patients bring more and provide more hope
.

At present, we are conducting a number of studies on Anktiva, in combination with NK cells, to determine whether they can enhance the activity of antibodies such as Trodelvy, and ultimately provide patients with longer Survival
.

 " Combination therapy strategy ImmunityBio is a leading late-stage clinical treatment company dedicated to developing next-generation immunotherapies to drive immunogenic mechanisms to overcome cancer and infectious diseases
.

Triple-negative breast cancer is a particularly aggressive disease.
It is a serious cancer with a high mortality rate, accounting for 10% to 15% of breast cancers
.

Based on the data of Anktiva and haNK cells in the phase 1 trial, the company proposed that Anktiva, PD-L1.
t-haNK and Trodelvy may show a synergistic effect when used in combination, which is likely to increase the response rate and durability
.

Trodelvy is a TROP-2 ADC drug of Gilead, which was approved by the US FDA in April 2020 for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who had previously received at least two treatments
.

ImmunityBio's Anktiva (N-803) is a new type of IL-15 super agonist complex
.

Compared with the natural non-composite IL-15 in the body, N-803 has improved pharmacokinetic properties, longer persistence in lymphatic tissues and enhanced anti-tumor activity
.

Previously, N-803 was granted a breakthrough therapy designation by the FDA for use in combination with Bacille Calmette-Guerin (BCG) to treat patients with non-muscular invasive bladder cancer in situ (CIS) who had previously poorly responded to BCG
.

PD-L1.
t-haNK cells are a human-derived allogeneic NK cell line, which is engineered to express a CAR targeting PD-L1, which originated from NantKwest's proprietary NK-92 (aNK) master cell bank
.

In addition to targeting PD-L1, PD-L1.
t-haNK is also engineered to express a high-affinity variant of the CD16 receptor (V158 FcγRIIIa), which is attached to a monoclonal antibody previously bound to cancer cells to mediate Antibody-dependent cellular cytotoxicity (ADCC) promotes the elimination of cancer cells
.

This means that the therapy can be used in combination with other targeted methods
.

Based on the above results, the company will launch a new clinical trial to confirm the efficacy of this combination strategy in triple-negative breast cancer
.

Combination therapy brings new hope.
At present, the strategy behind the combination therapy is to use two different complementary methods to attack tumors
.

Trodelvy targets the protein TROP-2 displayed by many different TNBC cells to target the initial blow to the tumor and provide a payload of chemotherapy
.

At the same time, Anktiva wakes up key cells of the immune system, including NK and T cells, to continue fighting tumors
.

In order to further release the power of the immune system, PD-L1.
t-haNK will be introduced
.

In this phase 1b/2 open-label combination therapy study, Trodelvy's combined chemotherapy and immunotherapy (cyclophosphamide, N-803, and PD-l1.
t-haNK) will be evaluated after at least two treatments for metastatic disease After the safety and effectiveness of TNBC patients
.

The study is divided into two phases, with 79 subjects: Phase 1b of the study will be divided into two parts: Part 1 will be designed to use a 3+3 dose escalation, and Part 2 will expand the recommended second Phase dose (RP2D) to further evaluate the safety and effectiveness of Trodelvy+ chemical and immunotherapy
.

In Phase 1b and Phase 2 clinical studies, all subjects will receive Trodelvy + chemical and immunotherapy for a period of 3 weeks
.

The dose of Trodelvy depends on the 1b dose level cohort and will be set in Phase 2 of RP2D.
The dose of this combination therapy will remain the same in all dose level cohorts and stages
.

According to statistics, 2.
3 million women worldwide were diagnosed with breast cancer last year, of which 685,000 died of breast cancer
.

The TNBC tests for estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) proteins were all negative
.

Therefore, TNBC does not respond to hormone therapy or drugs that target ER, PR, and HER2, and other treatment options are limited, especially after initial treatment failure
.

This innovative combination of chemistry and immunotherapy by Trodelvy may bring new hope to these patients with advanced TNBC
.

Reference materials: 1.
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