Avelas - Model AVB-620 - Pegloprastide - Cell-Penetrating Peptides
Pegloprastide (AVB-620) is based on the science of activatable cell-penetrating peptides and is designed to deliver a fluorescent marker specifically to cancer cells to enable surgeons to identify cancerous tissue in real-time and thus, avoid repeat surgeries and improve patient outcomes. Pegloprastide is the only fluorescence-based clinical cancer detection product that uses the ratio of two fluorophores within the same molecule (ratiometric imaging) to provide more accurate and actionable information during a procedure.
Products Details
Pegloprastide is currently an investigational product under development in human clinical trials. A recent Phase 2 registration study of the use of pegloprastide during breast cancer surgery met its primary endpoint of detecting cancer in margin specimens in real time (p < 0.001).
Additional top-line data analysis found:
- Use of pegloprastide during surgery correctly identified cancer in up to 75% of patients who may have otherwise been candidates for a repeat (re-excision) surgery
- Overall accuracy of pegloprastide in detecting true positive or true negative patients was ~81%
- While the current typical re-excision rate among initial lumpectomies is estimated at 20-40%, the observed re-excision rate in this prospective study was ~6%
In clinical studies, pegloprastide has been administered by intravenous (IV) injection between ~3-20 hours prior to surgery. In more than 150 patients dosed to date, no drug-related serious adverse events have been reported.
Given the potential broad applicability of pegloprastide due to its MMP-driven mechanism of action, Avelas plans to explore the use of pegloprastide to improve outcomes in a variety of other non-breast cancer surgeries, such as ovarian, colorectal, head and neck, melanoma, and sarcoma.
Pipeline
Pegloprastide has the potential to become part of standard-of-care treatment for a variety of cancer surgeries
Our Science
The pioneering science behind pegloprastide was developed in the lab of Nobel Laureate Dr. Roger Y. Tsien at the University of California, San Diego. The initial motivation behind the invention was to enable systemic delivery of cell-penetrating peptides (CPP) and attached cargo to cancer cells. Avelas has utilized this approach by designing pegloprastide to deliver a fluorescent marker specifically to cancer cells for real-time cancer detection during surgery.
The approach involves activatable CPPs (ACPPs) which exploit cancer’s inherent biochemical pathology using enzyme activation to selectively deliver imaging cargo to target tissue. Protease enzymes associated with cancers activate the ACPP molecules, allowing the cargo to be delivered locally to malignant cells.
In the case of pegloprastide, the novel peptide is cut by a subset of matrix metalloproteinases (MMPs) on cancer cells’ surface. This cleavage activity results in the unmasking of the molecule’s CPP and is also accompanied by a fluorescent color change. The CPP enters the surrounding cancer cells where it emits at this new wavelength. Avelas’ differentiated method of imaging measures the ratio of “active” CPP in cancer cells to that of “inactive” pegloprastide in surrounding tissue to provide surgeons an accurate image of cancer margins.
Avelas’ ACPP technology has several distinctive advantages:
- Using enzyme activity as the targeting mechanism provides molecular and biological amplification and results in high sensitivity
- The activatable agent masks the CPP until near target tissue, which enhances bio-distribution
- The cargo containing CPP triggers cellular binding and internalization resulting in enhanced cargo retention and extended imaging window
- The platform is general and modular allowing for broad applications
Expanded Access Policy
At Avelas Biosciences, we are committed to developing products that bring new, innovative therapies, like pegloprastide (AVB-620), to patients with serious or life-threatening illnesses or conditions. Avelas is developing pegloprastide to improve the ability of surgeons to identify cancerous tissue on the surface of tissue during breast cancer surgery. Pegloprastide must be used in conjunction with a specific imaging device to visualize potentially cancerous tissue during surgery.
At this time, Avelas does not offer an expanded access program and is not accepting expanded access requests for investigational products, such as pegloprastide.
Avelas’ current focus and priority is to complete the product development program for its investigational product(s), such as pegloprastide, in order to obtain the required safety and efficacy data needed for regulatory approval. We believe that focusing our resources on our clinical trial program is the best path forward to bring our investigational product(s) to patients as quickly and safely as possible.
As we continue to develop investigational product(s), we will review our expanded access policy for investigational product(s) and may make updates to this policy.
Patients can gain access to our investigational product(s), such as pegloprastide, by participating in a clinical trial. If you or someone you know would like to learn more about Avelas Biosciences’ clinical trials, we encourage you to view our trials at www.clinicaltrials.gov.
If you have additional questions about Avelas’ expanded access policy, please email us at info@avelasbio.com.
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