Invenra Highlights Exelixis’ Announcement: Initiation of Phase 1 Clinical Trial Evaluating XB010 in Patients with Advanced Solid Tumors

Rhea-AI Summary

Exelixis (NASDAQ: EXEL) has initiated the dose-escalation stage of the first-in-human phase 1 clinical trial of XB010 in patients with locally advanced or metastatic solid tumors. XB010 is an antibody-drug conjugate (ADC) targeting the tumor antigen 5T4, developed through Exelixis' biotherapeutics collaboration network. The trial will evaluate XB010 as a single agent and in combination with pembrolizumab. The study includes a dose-escalation stage followed by expansion cohorts to assess tolerability and activity in specific indications. XB010 was constructed using Catalent's SMARTag site-specific bioconjugation platform, with its 5T4-targeting mAb discovered in collaboration with Invenra.

Positive

• Initiation of first-in-human phase 1 clinical trial for XB010
• XB010 is the first custom ADC from Exelixis' biotherapeutics collaboration network
• Trial design includes both single agent and combination therapy evaluations
• Expansion cohorts planned to assess tolerability and activity in specific indications

Negative

• None.

Insights

Oncology Research Specialist

The initiation of the Phase 1 clinical trial for XB010 is a significant milestone in the development of this novel antibody-drug conjugate (ADC). As an oncology expert, I find several aspects particularly noteworthy:

• XB010 targets the tumor antigen 5T4, which is expressed in various solid tumors, potentially offering a broad therapeutic application.
• The use of Catalent's SMARTag bioconjugation platform suggests a potentially improved safety profile and more consistent drug-to-antibody ratio compared to traditional ADCs.
• The trial's design, evaluating XB010 both as monotherapy and in combination with pembrolizumab, is strategically sound. It allows for assessment of the ADC's efficacy alone and potential synergistic effects with immunotherapy.

While promising, it's important to remember that Phase 1 trials primarily assess safety and efficacy data will be preliminary. The true potential of XB010 will become clearer as the trial progresses to expansion cohorts.

Biotech Industry Analyst

This announcement carries significant implications for Exelixis and its collaborators:

• It marks Exelixis' entry into the ADC space, a rapidly growing segment of oncology therapeutics with high market potential.
• The successful progression of XB010 to clinical trials validates Exelixis' biotherapeutics collaboration strategy, potentially leading to more partnerships and pipeline expansion.
• For Invenra, this milestone likely triggers a financial payment and enhances its credibility in antibody discovery.
• The involvement of multiple partners (Invenra, Catalent) showcases a trend towards specialized collaborations in biotech drug development.

Investors should note that while this news is positive, ADC development is highly competitive. The long-term value will depend on XB010's performance in later-stage trials and its differentiation from other ADCs in development or on the market.

Clinical Trials Expert

The design of this Phase 1 trial for XB010 is well-structured and forward-thinking:

• The dose-escalation stage is important for determining the maximum tolerated dose and initial safety profile.
• Including a combination arm with pembrolizumab early in development is strategic, as combination therapies are increasingly becoming standard of care in oncology.
• The planned expansion cohorts will provide valuable indication-specific data, potentially accelerating the path to Phase 2 for promising indications.

However, it's important to note that the trial is in its early stages. Typical Phase 1 timelines suggest we might not see significant data for 12-18 months. The global nature of the study could accelerate recruitment but may also introduce variability in results. Investors and the medical community should temper expectations and await initial safety data before drawing conclusions about XB010's potential.

MADISON, Wisc.--(BUSINESS WIRE)-- Invenra’s collaboration partner, Exelixis, Inc. (NASDAQ: EXEL) has announced the initiation of the dose-escalation stage of the first-in-human phase 1 clinical trial of XB010 in patients with locally advanced or metastatic solid tumors.

XB010, an antibody-drug conjugate (ADC) consisting of a monomethyl auristatin E payload conjugated to a monoclonal antibody targeting the tumor antigen 5T4, is the first custom ADC generated through Exelixis’ biotherapeutics collaboration network. XB010 was constructed using Catalent’s SMARTag site-specific bioconjugation platform, and its 5T4-targeting mAb was discovered in collaboration with Invenra.

Exelixis further announced that the dose-escalation stage of their phase 1, global, open-label study will evaluate XB010 as a single agent and in combination with pembrolizumab to inform the cohort-expansion stage. The expansion cohorts are designed to further assess the tolerability and activity of monotherapy and of the combination in specific indications.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240807872964/en/

608-441-8319 or BD@invenra.com

Source: Invenra

FAQ

What is XB010 and what is its target in Exelixis' (EXEL) new clinical trial?

XB010 is an antibody-drug conjugate (ADC) targeting the tumor antigen 5T4. It's being evaluated in a phase 1 clinical trial for patients with locally advanced or metastatic solid tumors.

What stage of clinical development has XB010 (EXEL) entered?

XB010 has entered the dose-escalation stage of a first-in-human phase 1 clinical trial, as announced by Exelixis (EXEL).

How will XB010 be evaluated in Exelixis' (EXEL) phase 1 trial?

XB010 will be evaluated as a single agent and in combination with pembrolizumab in the dose-escalation stage, followed by expansion cohorts to assess tolerability and activity in specific indications.

Which companies collaborated in the development of XB010 for Exelixis (EXEL)?

XB010 was developed through collaborations with Catalent (using their SMARTag bioconjugation platform) and Invenra (who discovered the 5T4-targeting mAb).