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Molecular Targeting Technologies, Inc. Receives Global Rights From NIH for Integrin-Targeting Radiotherapeutics to Treat GBM and Lung Cancer

On October 28, 2019 Molecular Targeting Technologies, Inc. (MTTI) reported that the NIBIB (an Institute within the National Institutes of Health (NIH)) has granted MTTI an exclusive worldwide license to commercialize patented technology invented by Drs. Xiaoyuan Chen and Orit Jacobson (Press release, Molecular Targeting Technologies, OCT 28, 2019, View Source [SID1234549932]). This patent portfolio covers a targeted radiotherapeutic 177Lu-EBRGD for integrin expressing cancers including treating Glioblastoma multiforme (GBM) and Non-Small Cell Lung cancer (NSCLC).

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The key feature of this technology is the incorporation of a derivative of Evans Blue into RGD peptide radiopharmaceutical which binds to both albumin and integrin thus extends residence time, enabling smaller and less frequent dosing.

"Integrin is highly expressed in both tumor blood vessels and tumor cells in glioblastoma patients. Based on our study using Ga-68 PRGD2, we believe that Lu-177 EBRGD could be the next innovative radiotherapeutic in treating GBM," said Deling Li, MD. Vice Director of Brain Tumor and International Translational Molecular Imaging Center for Brain Tumor (ITMIC-BT), Beijing Tiantan Hospital.

"We are privileged to receive the exclusive global license from NIH," said Chris Pak, President & CEO of MTTI. "Currently, we are already advancing NIH’s EBTATE for treating neuroendocrine tumors and we look forward to moving EBRGD to tackle hard-to-treat cancers such as GBM and NSCLC."

MTTI is a privately held biotechnology company focused on the acquisition and development of novel technologies for treatment and diagnosis of disease. More information: www.mtarget.com.

*Chen H et al. Novel "Add-On" Molecule Based on Evans Blue Confers Superior Pharmacokinetics and Transforms Drugs to Theranostic Agents. J Nucl Med 2017;58:590-597.

KSQ Therapeutics to Present First Data from its Proprietary CRISPRomics Discovery Engine

On October 28, 2019 KSQ Therapeutics, a biotechnology company using CRISPR technology to enable the company’s powerful discovery engine to achieve higher probabilities of success in drug development, reported two upcoming presentations at leading scientific immuno-oncology congresses (Press release, KSQ Therapeutics, OCT 28, 2019, View Source [SID1234549931]). The data demonstrate the capabilities of the company’s proprietary CRISPRomics discovery engine, which allows genome-scale, in vivo validated, unbiased drug discovery.

"There is a significant need for next-generation immuno-oncology therapies as the majority of cancer patients today experience an insufficient response to PD-1/PD-L1 therapies. The data we will be sharing demonstrate the potential of our CRISPRomics discovery platform to systematically identify and validate new cancer therapies for patients with PD-1 refractory solid tumors," said Frank Stegmeier, Ph.D., Chief Scientific Officer at KSQ Therapeutics. "KSQ was founded on the premise that CRISPR-enabled functional genomics can improve on current approaches to drug discovery and, taken together, these poster presentations describing the output of our genome-scale in vivo T-cell screens show that our platform can do this with a high degree of precision and quality, pointing the direction towards promising avenues of drug development."

Presentations include:

At the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper): Comprehensive identification of novel therapeutic targets for treatment of PD-1 resistant solid tumors via a genome-scale CRISPR/Cas9 in vivo T-cell screen – Poster # C101 – Tuesday, October 29 – 3:30-4:00 p.m. – Level 2 Hall D
At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting: An immune-CRISPRomics platform enabling genome-scale and pair-wise combination in vivo T-cell function screens enables comprehensive identification of novel therapeutic targets – Poster # P550 – Saturday, November 9 – 12:35–2:05 p.m. and 7:00-8:35 p.m.

PierianDx Closes Series B Financing Round to Facilitate the Democratization of Clinical Next-Generation Sequencing

On October 28, 2019 PierianDx, the leading clinical genomics informatics company, reported that it has closed a $27 million Series B funding round led by ATW Partners and SJF Ventures that also includes existing investors Health Catalyst Capital, Inova Health Systems, RTI International, and ARUP Laboratories (Press release, PierianDx, OCT 28, 2019, View Source [SID1234549930]).

PierianDx provides a SaaS platform that enables the practice of clinical genomics as a standard of care and empowers the world’s most advanced molecular diagnostic labs. Founded in 2014 out of Washington University in St. Louis, PierianDx is focused on advancing cancer diagnostics and making targeted therapeutics more accessible to healthcare systems, laboratories, and patients worldwide.

Dr. Rakesh Nagarajan, Founder and Executive Chairman of PierianDx, said, "PierianDx has grown tremendously over the past 18 months and is continuing to add the clinical expertise and resources necessary to execute on our vision. Our team is uniquely skilled and dedicated to the adoption of clinical NGS around the globe."

Michael L. Sanderson, CEO of PierianDx, said, "Our new capital infusion will accelerate the commercial expansion of PierianDx’s leading clinical genomics platform in the U.S. and global markets throughout Europe, Asia, Australia, Latin America, and North America, as we continue to work with leading sequencer, assay and pharma partners in our explosive space. PierianDx is fueled by making the most advanced clinically actionable cancer care accessible to everyone, regardless of location or ability to pay."

"We are excited about leading the Series B investment in PierianDx. We believe PierianDx will change the way cancer is treated worldwide and we are proud to be investors," said Mr. Kerry Propper, Co-Founder and Managing Partner of ATW Partners.

Inflammatory Breast Cancer (IBC) Research Foundation, Susan G. Komen®, and Milburn Foundation® Raise More Than $850,000 to Take on Aggressive Breast Cancer

On October 28, 2019 Inflammatory Breast Cancer (IBC) Research Foundation, Susan G. Komen, and the Milburn Foundation reported that they have again come together to become a powerful force against inflammatory breast cancer (IBC) – an aggressive subtype of breast cancer that is challenging to diagnose and treat (Press release, IBC Research Foundation, OCT 28, 2019, View Source [SID1234549929]). Together, the organizations raised more than $850,000 for research aimed at finding new, innovative diagnostic tools and treatment options for IBC.

Earlier this year, IBC Research Foundation and Milburn matched all donations to Komen up to $50,000, and far exceeded their goal to raise $250,000 in funds specifically for research into IBC.

IBC is a particularly aggressive form of breast cancer because it can be missed on a mammogram, doesn’t usually present with a lump, is often misdiagnosed, and spreads quickly. In fact, about 30 percent of those diagnosed with IBC are initially diagnosed with metastatic disease, meaning their cancer has already spread to other parts of the body. Clinical trials for new therapies often either restrict enrollment of IBC patients or combine their outcomes with non-IBC patients, limiting our understanding of this form of breast cancer.

Through this partnership, a focus group of clinicians, researchers and advocates who are experts in the field of IBC convened to identify the most critical questions in IBC and IBC research. Through this patient directed conversation, several vital challenges were identified, including how inflammatory breast cancer is defined in the clinic and for research. The group has developed a set of recommendations to address the challenge of diagnosis, which will be presented at the San Antonio Breast Cancer Symposium in December.

"In our twenty years of IBC research and patient advocacy, we have consistently stressed the need for better definition and diagnostic guidelines for IBC," said Ginny Mason, Executive Director of the IBC Research Foundation. "We are very pleased that this year’s impressive matching campaign will support continued collaborative work to resolve these long-standing issues, resulting in more timely diagnosis and hopefully saving lives that would have been stolen by IBC."

"We know treatment options for IBC are lacking, and with few clinical trials focused solely on IBC, there have been few improvements in treatment," said Paula Schneider, President and CEO of Susan G. Komen. "We must continue to make IBC and metastatic breast cancer a research priority in order to help save the more than 42,000 lives lost each year in the U.S. to metastatic breast cancer. Partnerships like this help us make an even greater impact than we ever could alone."

"By working hard together, this partnership has amplified the strengths of each organization to bring a potentially significant advancement in IBC to fruition," said Bryon Davis, President and CEO of the Milburn Foundation. "Our collective work being presented at the San Antonio Breast Cancer Symposium is the first of multiple critical milestones aimed at changing the research landscape in IBC."

The partnership between the three organizations has now raised more than $2.44 million to date, thanks to earlier matching gift campaigns beginning in 2016. Funds raised have made it possible to invest in breakthrough research, including studies in IBC, aggressive and metastatic breast cancers.

Castle Biosciences Presents Second Study Confirming Ability of DecisionDx-Melanoma to Inform Sentinel Lymph Node Biopsy Decisions at the 8th International Congress on Cancer Metastasis

On October 28, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of data supporting clinical use of the DecisionDx-Melanoma test to inform decisions of whether to discuss or recommend the sentinel lymph node biopsy (SLNB), a surgical procedure used to provide additional prognostic information (Press release, Castle Biosciences, OCT 28, 2019, View Source [SID1234549927]). The study found that DecisionDx-Melanoma test results can be used with clinicopathologic factors to identify patients at low risk of sentinel lymph node (SLN) positivity. This information can inform patient discussions and recommendations regarding the SLNB surgical procedure in line with national melanoma clinical practice guidelines.

The study titled, "Identification of T1-T2 melanoma patients at low risk for a positive sentinel lymph node using the 31-gene expression profile test," was presented during an Oral Abstract session at the 8th International Congress on Cancer Metastasis (ICCM) in San Francisco, October 25-27.

Study Background:

National guidelines recommend the SLNB surgical procedure to assess prognosis of melanoma patients whose tumor features suggest at least a 5% likelihood of sentinel lymph node (SLN) positivity. The guidelines do not recommend the procedure if a patient has a likelihood of SLN positivity of less than 5%.
Among all patients with T1-T2 melanoma (tumor depth of 2 mm or less), only 5-10% have a positive SLNB, with the likelihood of a positive SLN decreasing with age.
The DecisionDx-Melanoma test is a 31-gene expression profile prognostic test for cutaneous melanoma that predicts 5-year risk of metastasis as low risk (Class 1, 1A lowest risk) or high risk (Class 2, 2B highest risk), as well as metastasis to the sentinel lymph node.
The DecisionDx-Melanoma test has been previously validated to identify patients with T1-T2 melanoma with SLN positivity rates below 5%, thus helping guide SLNB discussions and recommendations.
This study was designed to further evaluate the ability of the DecisionDx-Melanoma test to identify T1-T2 melanoma patients with low risk for a positive SLN, using the combination of the previously published cohort with a novel cohort, totaling 1,905 prospectively tested consecutive T1-T2 melanoma patients. The cohort had a median age of 64 years, median Breslow depth of 1.2 millimeters and 13% had ulceration present.
Key Findings:

In patients with T1-T2 tumors of any age (DecisionDx-Melanoma intended use population) and a Class 1A test result, SLN positivity was 4.9%, significantly less than patients with a Class 1B-2A result (p<0.01) or a Class 2B result (p<0.0001) and below the 5% threshold at which guidelines do not recommend the procedure.
In SLNB-assessed patients with T1-T2 tumors 65 years of age or older and a Class 1A test result, SLN positivity was 2.7%, significantly less than patients with a Class 1B-2A (p<0.01) or Class 2B result (p<0.0001), and below the 5% threshold at which guidelines do not recommend the procedure.
In SLNB-assessed patients with T1 tumors (tumor depth of 1 mm or less) 65 years of age or older and a Class 1A test result, SLN positivity was 1.0%, significantly less than patients with a Class 1B-2A (p<0.01) or a Class 2B result (p<0.001), and below the 5% threshold at which guidelines do not recommend the procedure.
Use of the DecisionDx-Melanoma test to guide SLNB decisions in patients with T1-T2 melanoma could reduce SLNB surgical procedures by 58% in patients 65 years of age or older, as 367 of 629 patients who underwent this procedure had a Class 1A result.
In a multi-center, retrospective dataset of 576 T1-T2 patients with long-term follow-up (median 7.5 years) Class 1A patients with T1-T2 melanoma had melanoma-specific survival of 99.7%, overall survival of 97.3%%, distant metastasis-free survival of 94.9% and recurrence-free survival of 92.9% at five years, supporting that this population can safely avoid the SLNB surgical procedure.
In a multi-center, prospective dataset of 246 T1-T2 patients with long-term follow-up (median 3.2 years), Class 1A patients with T1-T2 melanoma had overall survival of 99.4%, distant metastasis-free survival of 98.7% and recurrence-free survival of 96.6% at three years, adding further support that this population can safely avoid the SLNB surgical procedure.
"The data presented at the ICCM show the DecisionDx-Melanoma test, in combination with patient age and clinical features, can identify T1-T2 melanoma patients who are at low risk for a positive sentinel lymph node and can avoid the SNLB surgical procedure, based on thresholds established by national clinical melanoma guidelines," said Federico A. Monzon, M.D., FCAP, chief medical officer at Castle Biosciences. "Additionally, T1-T2 melanoma patients with a DecisionDx-Melanoma Class 1A result show very low rates of metastatic recurrence and melanoma specific death."

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 3,900 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and five prospective risk of recurrence studies including more than 780 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included more than 2,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.