On June 23, 2020 InxMed (Shanghai) Co., Ltd. ("InxMed" or "Company"), a clinical stage biotech company dedicated to developing innovative, individualized medicines with international impact, reported that the company has released the research data of "FAK inhibitor IN10018 overcomes drug resistance of KRAS G12C inhibition" at "Late Breaking Research" session of 2020 AACR (Free AACR Whitepaper) virtual meeting II (Press release, InxMed, JUN 23, 2020, View Source [SID1234561421]).

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KRAS G12C inhibitors are under clinical phase II development. Even though it has shown anti-tumor effect on KRAS G12C mutant tumor types, its drug resistance problem, similar to other target therapies, has caught increasing awareness by research community. InxMed’s IN10018 is a potent and selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor under clinical development stage in United States, Australia, and China. Early clinical data of IN10018 has demonstrated a favorable safety profile and promising efficacy signals against different tumor types. Emerging science also showed that IN10018 potentially overcomes fibrotic barrier and immune tolerance, boosting multi-modalities including targeted therapy, chemotherapy, immune-therapy and radiation therapy.

The combination of KRAS G12C inhibitors and IN10018 was evaluated in both in vitro and in vivo. The data released showed that FAK signaling is significantly induced by KRAS G12C inhibition, serving as one predominant mechanism of drug resistance of KRAS G12C inhibition, and IN10018 can significantly decrease the FAK signaling induced by KRAS G12C inhibition, rendering synergistic anti-tumor effects on various types of cancer. Furthermore, our data has shown KRAS G12C inhibitors can induce significant generation of fibrosis in tumor tissues – one important adaptive drug resistance mechanism, and IN10018 can decreases the level of fibrosis induced by KRAS G12C inhibitors and therefore overcome drug resistance. Our pioneering research indicates the synergistic effect between IN10018 and KRAS G12C inhibitors, which can support the continuous clinical exploration of this combination treatment regimen.

On June 23, 2020 SkylineDx reported that it signed the 10th collaboration agreement with an academic partner for research under the extensive Falcon R&D Program to further validate both melanoma (skin cancer) tests (Press release, SkylineDx, JUN 23, 2020, View Source [SID1234561420]). The 10 clinical centers represent 6 countries on 3 continents with data on over 3,500 cutaneous melanoma patients. The data generated will be used in the validation of the Merlin and Peregrine assay. The Merlin assay has been developed to predict a patient’s risk of having metastasis in the sentinel lymph node. If a patient is identified as low-risk, the surgery that removes the sentinel lymph node can be safely avoided. The Merlin assay is developed on a US patient dataset[2] and validated in a European dataset[3]. The group of patients without metastasis in their sentinel lymph nodes, are currently considered low risk, although a significant number of patients will see their melanoma returning within 5 years. The Peregrine assay has been developed to identify patients at high risk of disease recurrence within this group of patients now considered low-risk, so treatment options can be discussed[4-5].

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"I am very pleased that we are continuing our research with global partners for retrospective validation studies. Even more clinical groups have expressed interest to collaborate and are likely to be added in the near future to this research initiative. Processing of the biobanked samples is in full swing and we expect to have all the results for analyses by the end of 2020. The peer reviewed publication will follow shortly in 2021," explains Dharminder Chahal, CEO SkylineDx.

About Merlin & Peregrine

Both assays are using the CP-GEP model, a powerful algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes (predictive use) and the risk of the melanoma returning (prognostic use). The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age. The model has been previously published in JCO Precision Oncology[2]. The predictive use of the CP-GEP model is the main focus of the Merlin Study Initiative. The prognostic use of the CP-GEP model is the main focus of the Peregrine Study Initiative. Both are developed under the wings of the Falcon R&D Program. More information on www.falconprogram.com.

On June 23, 2020 Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., reported that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L, its melanoma cancer vaccine for the adjuvant treatment of stage IIB/IIC melanoma patients post-resection to improve recurrence-free survival (Press release, Polynoma, JUN 23, 2020, View Source [SID1234561419]).

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"The Fast Track designation by the FDA provides further validation of seviprotimut-L as a potential new and important cancer vaccine for patients with localized melanoma," said Alan Yu, Chairman of Polynoma and Vice President & Chief Operating Officer at CK Life Sciences. "We look forward to advancing seviprotimut-L in a pivotal trial as an adjuvant treatment of melanoma."

Fast Track is designed to facilitate the development and expedite the review of drugs which treat serious or life-threatening conditions and fill an unmet medical need. The FDA defines filling an unmet medical need as "providing a therapy where none exists or providing a therapy which may be potentially better than available therapy,"1 based on criteria such as:

Showing superior effectiveness, or improved effect on serious outcomes;
Avoiding serious side effects of an available therapy;
Decreasing a clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment;
Ability to address anticipated public health need.
Benefits of Fast Track designation include more frequent communication with the FDA, a rolling submission of the marketing application, and eligibility for Priority Review and Accelerated Approval, if relevant criteria are met.

The interval between progression from Stage II to Stage III/IV melanoma marks a critical therapeutic intervention point to improve survival. Treatment of Stage IIB/IIC melanoma is primarily limited to surgery, coupled with a "wait and see" approach. However, recurrence of the disease can occur following definitive resection of the melanoma. Many patients progress to more advanced stages following resection and five-year survival rates fall sharply after a patient passes from localized Stage II melanoma into regional Stage III disease (98.4% to 63.6%). Five-year survival rates are distinctly lower (22.5%) for metastatic Stage IV.2

Final analysis of clinical data from Part B1 of MAVIS (Melanoma Antigen Vaccine Immunotherapy Study), a Phase III study of seviprotimut-L was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, held online May 29-31, 2020.

Highlights of the presentation are as follows:

Improved outcomes in Stage IIB/C patients: Final analysis of subgroups confirmed the findings from the interim analysis, suggesting enhanced RFS for seviprotimut-L in patients with AJCC Stage IIB/IIC melanoma, particularly those under age 60, and those with ulceration, whose lesions are considered more serious because they have a greater risk of metastasis.3
Early evidence of survival benefit in Stage IIB/C patients: For Stage IIB/IIC melanoma patients under 60, there was a trend toward improved overall survival for those treated with seviprotimut-L.
Favorable adverse event profile: Seviprotimut-L was well-tolerated with treatment-emergent adverse events (AEs) similar to patients given placebo. There were no treatment-related serious adverse events.
About MAVIS
MAVIS (Melanoma Antigen Vaccine Immunotherapy Study) is a multicenter, double-blind, placebo-controlled adaptive Phase III trial to assess the safety and efficacy of seviprotimut-L, with primary endpoints of recurrence-free survival (RFS) and overall survival (OS) in patients with melanoma at high risk of recurrence after definitive surgical resection. MAVIS is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. For additional information about the trial, please visit View Source

About Seviprotimut-L
Seviprotimut-L is an allogeneic, polyvalent, partially purified shed melanoma antigen vaccine derived from three proprietary human melanoma cell lines. Seviprotimut-L stimulates humoral and cellular immune responses. Melanoma-associated antigens (MAAs) found in seviprotimut-L are taken up by antigen-presenting cells (e.g., dendritic cells) which then activate the production of antigen-specific cytotoxic T-lymphocytes (CTLs) as well as develop antibody responses against MAAs. These CTLs and antibodies then recognize and act on tumor cells expressing the MAAs on their surfaces, causing cell death. Seviprotimut-L is currently in development for the adjuvant treatment of patients with Stages IIB to IIIC melanoma, following definitive resection.

On June 23, 2020 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported their participation at the Third Annual Next-Gen Immuno-oncology Congress occurring virtually June 25-26, 2020 (Press release, Applied BioMath, JUN 23, 2020, View Source [SID1234561418]).

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John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath, will present "Targeting Bispecific Antibodies and Developing Systems Disease Models in Immuno-oncology" Thursday, June 25th at 12:55 p.m. US EST. In this presentation, Dr. Burke will highlight mathematical modeling efforts that have de-risked projects, accelerated the discovery and development of best-in-class therapeutics, and impacted critical decisions or provided deep biological insights in the continuum from preclinical exploration to clinical research. Examples will include: T cell engager at the new target through lead generation stage, GITR-mediated T cell dynamics, species translation to make human predictions, and mechanistic predictions in checkpoint inhibitors.

"We are excited to present at the Next-Gen Immuno-Oncology Congress for the first time this year," said John Burke, PhD, Co-Founder, President and CEO of Applied BioMath. "This presentation establishes how developing and interrogating a systems pharmacology model earlier in the project helps project teams make informed decisions that can provide better mechanistic prediction into humans and help identify the winners, screen for the best candidates possible, and accelerate the winner into the clinic."

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis

On June 23, 2020 VerdePharmHealth reported the signing of an exclusive national agreement with HAI Health for the HealthyDose product line formulated by a highly respected oncologist, Dr. Alberto Bessudo (Press release, VerdePharmHealth, JUN 23, 2020, View Source [SID1234561416]).

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"There is growing evidence that medical cannabis may be effective in helping patients manage certain types of cancers at various stages, in conjunction with and as an alternative to traditional medical treatments. Medical cannabis may also be effective in managing the side effects of cancer therapies and the symptoms of the disease. Unfortunately, most people wait too long after diagnosis to begin cannabis therapies. They begin looking for alternative therapy when conventional treatments haven’t worked, and the disease is already advanced, sometimes with a terminal diagnosis," said Dr. Alberto Bessudo, founder & chief executive officer at HAI Health. "After careful consideration and diligence, we selected VerdePharmHealth given our alignment of mission and values for patient care, their solid commitment towards innovation in integrative medicine, and robust offering to healthcare providers and their patients."

"Dr. Alberto Bessudo has been on the cutting edge of medicinal cannabis in patient care, developing integrative plans with cannabinoids targeted towards specific symptoms, without the numerous side effects of conventional pharmaceuticals and procedures. Dr. Bessudo and his team have designed synergistic formulations, which are comprised of curated ingredients that are specifically designed to work and support the body’s own functions and accelerate health," said Dr, Ralph Boccia, oncologist, board member, & medical director at VerdePharmHealth. "As part of their ongoing commitment to quality medical cannabis products, the ingredients are grown without pesticides or herbicides, and several in the product line are organic. Furthermore, several tests are conducted, including testing for heavy metals, pesticides, mold and yeast, microbes, and cannabinoid potency, instilling a higher level of confidence for our provider member network and their patients."

Both companies will further partner around systematic, structured real-world observational studies to better understand and improve the appropriate use of cannabinoids, support cost of care, improve quality of life, and treatment optimization paradigms, with HealthyDose Clinical Premium product made available through HAI Health and the clinical research platform and services, decision-support tools, patient engagement app, and data analytics provided by VerdePharmHealth.