On July 15, 2020 SYSPRO, a global provider of industry-built enterprise resource planning (ERP) software, reported that Freenome Holdings, Inc., a biotechnology company dedicated to early cancer detection, has chosen SYSPRO ERP Software to streamline and enhance its business for optimal growth (Press release, Freenome, JUL 15, 2020, View Source [SID1234561883]).

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Freenome has pioneered the most comprehensive multiomics platform for early cancer detection with a routine blood draw, beginning with a colorectal cancer screening test. The company is integrating actionable insights through a machine learning feedback loop with healthcare providers, to leverage real-world data and improve patient care through early detection.

To continue on a path of innovation and growth, Freenome looks to SYSPRO and its specialized technology partner, Operations Resource Group (ORG), to strengthen and streamline its processes through integrations and modular capabilities. Areas of focus include accounting, financial reporting, controls, workflow, compliance, and security.

"Our team has implemented SYSPRO with another company and have found the experience very easy, collaborative, and informative. The urgency at Freenome to have an ERP system in place is similar to our last experience. The SYSPRO and ORG teams have delivered thus far to our expectations," said William Quirk, Freenome Chief Financial Officer.

"I speak on behalf of the entire SYSPRO team when I say that we are proud to be part of Freenome’s journey in fighting cancer," said Scott Hebert, SYSPRO USA Chief Sales Officer. "Freenome is a prime example of how SYSPRO’s manufacturing and distribution customers are changing the world by integrating new technologies and streamlining business practices."

"We are thrilled to partner with a company as forward-thinking and innovative as Freenome," said Julia Maynard, Project Manager, Operations Resource Group. "Any support that we can provide to help further Freenome’s cause to save lives is of upmost importance to us."

On July 15, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of a multicenter, prospective study demonstrating that DecisionDx-UM test results significantly impacted treatment plan recommendations for patients with uveal melanoma (UM) (Press release, Castle Biosciences, JUL 15, 2020, View Source [SID1234561882]).

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The article titled, "Gene expression profiling in uveal melanoma: five-year prospective outcomes and meta-analysis," was published in the peer-reviewed journal Ocular Oncology and Pathology.

DecisionDx-UM is Castle’s 15-gene expression profiling (GEP) test developed to identify patients at low risk (Class 1) or high risk (Class 2) of metastasis, based on the unique biology of their primary tumor, and is the current standard of care for UM patients. It is estimated that nearly 8 in 10 patients diagnosed with UM in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. UM patients face up to a 50% risk of metastasis, despite successful control of the primary tumor.

The multicenter CLEAR Registry Study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to prospectively evaluate management plans and five-year clinical outcomes for UM patients tested with DecisionDx-UM as part of their clinical care. The median follow-up time for patients who did not develop metastasis was 4.9 years, reflecting the longest follow-up reported to date for any prognostic tool for UM.

"The accurate and reliable identification of a patient’s metastatic risk is critical for clinical planning and decision-making," commented first author, Thomas Aaberg, Jr., M.D., associate clinical professor at Michigan State University Medical School and ocular oncologist with Retina Specialists of Michigan. "As with previously published studies, the results of the CLEAR study demonstrate the high-level of accuracy of DecisionDx-UM for prediction of metastatic risk and further support its use in guiding patient management."

Study Background and Highlights:

Eighty-nine patients with DecisionDx-UM results were prospectively enrolled at four centers. Sample size calculations indicated that 29 patients would be sufficient to demonstrate a statistically significant difference in metastatic rates between Class 1 and Class 2 patients, while 47 patients would be sufficient to detect differences in melanoma-specific mortality.
Physician-recommended management plans were collected, and clinical outcomes tracked every six months.
Five-year DecisionDx-UM Class 1 and DecisionDx-UM Class 2 metastasis-free survival rates were 90% and 41% (p<0.0001), respectively, and melanoma-specific survival rates were 94% and 63% (p=0.0007), respectively.
In multivariate analysis with clinicopathologic features, including age, ciliary body involvement, largest basal diameter and tumor thickness, the DecisionDx-UM Class 2 result was the only statistically significant predictor of metastasis, with a hazard ratio (HR) of 7.53 (p<0.0001).
A meta-analysis with published cohorts found that patients with a Class 2 result had a HR of 8.70 (p<0.0001) for metastasis and 7.21 (p<0.0001) for mortality.
All patients with DecisionDx-UM Class 2 (high-risk) test results were managed with high-intensity surveillance (imaging and/or liver function tests every 3-6 months), while 80% of Class 1 (low-risk) patients were managed with low-intensity surveillance (annual imaging and/or liver function tests, p<0.0001).
The results of this study support that DecisionDx-UM is used to appropriately guide metastatic surveillance in UM patients. High-risk Class 2 patients were managed more intensely, in accordance with an observed metastatic rate of greater than 50%, while low-risk Class 1 patients were managed with low-intensity surveillance, resulting in appropriate utilization of healthcare resources.
About DecisionDx-UM

DecisionDx-UM is a 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is the standard of care in the management of uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.

On July 15, 2020 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported entering into an agreement with a fund affiliated with institutional investors providing for a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, pursuant to which Idera has sold shares of common stock (or common stock equivalents), together with accompanying warrants to purchase an additional shares of common stock, for aggregate gross proceeds of $5.1 million (Tranche 1) (Press release, Idera Pharmaceuticals, JUL 15, 2020, View Source [SID1234561880]). The combined purchase price per share of common stock (or common stock equivalent) and accompanying full warrant was $1.845. The common stock warrants have an exercise price of $2.58 per share and a term of three years and are exercisable at any time or times, provided that the investors will be prohibited from exercising a common warrant for shares of common stock to the extent that the investors would beneficially own in excess of 19.99% of the total number of shares of common stock then issued and outstanding (Beneficial Ownership Limitation).

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Pursuant to the agreement, the investors may, at their option, make a further investment of an additional $5.1 million to purchase shares of common stock equivalents, together with accompanying common stock warrants to purchase additional shares of common stock with 35% warrant coverage (Tranche 2). The combined purchase price per share of common stock (or common stock equivalent) and accompanying 0.35 warrant will be $6.50 per share. The common stock warrants, if issued, will have an exercise price of $9.75 per share, a term of three years and are exercisable at any time or times, provided that the investors will be prohibited from exercising a common warrant for shares of common stock to the extent that the investors would beneficially own in excess of the Beneficial Ownership Limitation.

The investors’ option to invest in Tranche 2 must occur no later than the tenth business day following the announcement of overall response rate data from the Company’s ILLUMINATE-301 trial of its lead product, tilsotolimod, in combination with ipilimumab for the treatment of anti-PD-1 refractory advanced melanoma. To the extent Tranche 2 is closed and inclusive of proceeds from the exercise of warrants issuable in this private placement, the Company may receive up to $20.0 million in gross proceeds.

The Company plans to use the initial proceeds and, if exercised, subsequent proceeds from the financing for the ongoing clinical development of tilsotolimod, its potential NDA filing and commercial launch, and for general corporate purposes.

The shares of common stock (or common stock equivalents) and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.clinicaltrials.gov.

On July 15, 2020 Novocure (NASDAQ: NVCR) reported it has entered into a clinical trial collaboration agreement with MSD (a tradename of Merck & Co., Inc.), through a subsidiary, to develop Tumor Treating Fields together with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for treatment of non-small cell lung cancer (NSCLC) (Press release, NovoCure, JUL 15, 2020, View Source [SID1234561879]). Novocure’s Tumor Treating Fields use electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die.

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The two companies plan to conduct a phase 2 pilot study of Tumor Treating Fields concomitant with KEYTRUDA for first-line treatment of intrathoracic advanced or metastatic, PD-L1 positive NSCLC. The study is designed to enroll approximately 66 patients in the United States and is expected to begin in the second half of 2020. Objective response rate (ORR) is the primary endpoint of the study. Secondary endpoints include overall survival, progression free survival (PFS), PFS at six months, one-year survival rate, duration of response, disease control rate at 18 weeks and safety.

"We are very pleased to collaborate with MSD, a global leader in oncology, in this important combination study as we strive to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields," said William Doyle, Novocure’s Executive Chairman. "Multiple preclinical studies suggest that the use of Tumor Treating Fields together with anti-PD-1 therapy can potentially augment the immune response resulting in improved tumor control. We look forward to generating clinical data demonstrating the effect of Tumor Treating Fields concurrent with KEYTRUDA in first-line NSCLC."

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die from lung cancer than from colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85 percent of all cases. The five-year survival rate for patients diagnosed in the U.S. with NSCLC is approximately 24 percent.

About Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the U.S. for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Use of Tumor Treating Fields for the treatment of NSCLC is investigational only.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On July 15, 2020 BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, reported closing of a Series D financing round raising $72.5 million (Press release, BioAtla, JUL 15, 2020, View Source [SID1234561878]). The financing was led by Soleus Capital and joined by several new investors including HBM Healthcare Investments as co-lead, Cormorant Asset Management, Farallon Capital, Pappas Capital, funds managed by Janus Henderson, Boxer Capital, and one other institutional investor. Current investor Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE), also participated in the financing.

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"The funding provided by this group of highly respected investors strongly supports the execution of BioAtla’s current and future product and strategic plans. The proceeds of this financing greatly enhance our ability to design, implement, and execute clinical programs evolving from our CAB platform that uniquely yields tumor-targeting antibodies with the potential for an enhanced benefit risk profile" said Jay M. Short, Ph.D., chairman and chief executive officer of BioAtla. "We look forward to driving Phase 2 trials addressing high unmet medical needs in oncology for our innovative CAB-AXL-ADC (BA3011) and CAB-ROR2-ADC (BA3021) product programs, as well as advancing clinical studies for CAB-CTLA-4 (BA3071)," stated Scott Smith, president of BioAtla. "In addition, we are pursuing development of several T cell-recruiting CAB-bispecific candidates."

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.