Goodwin Biotechnology, Inc., a biological contract development and manufacturing organization or  CDMO specialized in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing mammalian cell culture expression systems and bioconjugation technologies, has partnered with Aspyrian Therapeutics to complete process development, scale-up, and cGMP manufacturing of the Aspyrian’s novel Antibody Drug Conjugate (ADC).

San Diego-based start-up biotechnology company Aspyrian Therapeutics recently submitted – and received – U.S Food and Drug Administration’s (FDA) acceptance of an Investigational New Drug (IND) Application for RM-1929, their first-in-class, precision targeted therapy for cancer.  The company is now recruiting patients to participate in a clinical study.[1]

The current trials is a two-part, multicenter, open-label, dose-escalation, combination Phase I study of patients with recurrent Head and Neck Cancer (HNC), who, in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy. The estimated study completion date is September 2016.

Part I of this study is a drug dose-escalation, fixed low fluency light application study to determine the drug dose that can be safely given to saturate the epidermal growth factor receptor (EGFR) at the tumor.

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Part II of this trial is a light dose-escalation, fixed drug dosing infusion study to determine the optimal light application. In combination with the Part I drug dose, an optimal light application is needed to achieve clinical response with an acceptable safety profile. Interim analysis will be performed after completion of Part I and prior to initiation of Part II. [1]

Dual specificity
Aspyrian’s first-in-class therapy uses an antibody conjugate is designed to precisely target cancer cells after which it is locally activated to elicit rapid anticancer responses. The dual specificity resulting from in-tumor activation of a tumor-selective conjugate promises to deliver oncologists the ability to achieve locoregional tumor control with minimal damage to surrounding healthy tissues and structures.

“This clinical trial is the first of its kind to evaluate a novel therapy with a two-step targeting approach designed to deliver unparalleled tumor specificity,” explained Merrill Biel, M.D. Ph.D., Chief Medical Officer of Aspyrian. “Recurrent head and neck cancer patients who have failed standard treatments of surgery, radiation, and chemotherapy currently have no further treatment options available. RM-1929 offers hope to these difficult-to-treat patients and has the added advantage that it targets their cancer while sparing damage to adjacent normal and healthy tissues that are critical to their health related quality of life, such as those required for normal speech and swallowing.”

RM-1929 was developed in collaboration with Hisataka Kobayashi, MD, Ph.D, and Peter L. Choyke at the National Cancer Institute (NCI), the inventors of the photoimmunotherapy platform. [2] “Activation of RM-1929 at the tumor triggers very rapid tumor destruction with exquisite specificity,” explained Miguel Garcia-Guzman, Ph.D., President and Chief Scientific Officer at Aspyrian. “RM-1929 provides oncologists a new, precision-targeted approach for the effective locoregional management of cancer either alone or in combination with other anticancer therapies.”

Solid tumors
RM-1929 targets a specific cancer antigen that is highly expressed in carcinomas allowing treatment of a number of different cancer types, including cancers of the head and neck, esophagus, lung, colon, and pancreas. “The initiation of this clinical study marks a key milestone for Aspyrian, as we continue to develop a pipeline of precision-targeted therapies for the treatment of solid tumors. The broad therapeutic potential of our lead product candidate gives us the opportunity to expand the clinical program for RM-1929 into a range of cancer indications during 2016,” noted Scott Salka, Chief Executive Officer of Aspyrian.

Precision oncology
Aspyrian Therapeutics is developing a novel class of precision oncologic drugs for the treatment of solid tumors based on the photoimmunotherapy platform licensed exclusively from the National Cancer Institute. The Near-Infrared Photoimmunotherapy (PIT) technology uses a target-specific photosensitizer based on a near-infrared (NIR) phthalocyanine dye, IR700  (IRDye® 700DX), conjugated to monoclonal antibodies targeting epidermal growth factor receptors. The molecule is activated with a laser at the tumor site to induce rapid cancer cell destruction.[2]

Inert payload
The new ADC technology platform permits highly efficient and selective ablation of tumor cells while sparing damage to critical structures adjacent to the tumor. Because the payload in this unique ADC is inert until it is both in the tumor and activated by a laser using visible light, it overcomes the dose-limiting adverse effects that have hindered the development of conventional, toxin-loaded ADC systems.

Benefiting patients is the fact that laser activation can be accomplished on an outpatient basis by either external illumination or by needle placement of an optical fiber to illuminate a deep-seated tumor from within. As part of their development program, Aspyrian is currently working with a number of monoclonal antibodies with the potential to treat various types of cancers, including head and neck, esophageal, lung, brain, pancreatic, colorectal, breast and ovarian.


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