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Enzo Biochem, Inc. Announces Issuance of United States Patent for Advanced Nucleic Acid Hybridization Probe Technology for Clinical and Research Applications

On August 5, 2019 Enzo Biochem, Inc. (NYSE:ENZ), an integrated diagnostics and therapeutics company, reported the issuance of U.S. Patent No. 10,323,272 entitled Nucleic Acid Probes for In Situ Hybridization (Press release, Enzo Biochem, AUG 5, 2019, View Source [SID1234538144]). The patent is related to a new probe technology developed by Enzo and transformative methods of testing using the probes, which allow for significantly more cost effective, simple and scalable processes across the multi-billion dollar diagnostic testing, drug development and academic research marketplace.

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These new probes can be used to detect clinically relevant genomic targets with high-sensitivity in cell samples and biopsy tissue obtained from patients. Significantly, the new probe design permits the detection of such targets without the disadvantages encompassed in competing high-sensitivity methods such as nucleic acid amplification-based detection and branched DNA (bDNA) probe technologies, which can involve high cost, high complexity, time consuming processes and disruptions of sample integrity.

Elazar Rabbani, Ph.D., CEO of Enzo stated: "This is a transformative advance for Enzo and the industry. We are pleased to receive a U.S. patent for this new probe technology as we rapidly integrate it across our line of cytology and pathology products and services. With its superior sensitivity, simplicity of manufacturing and use, and superb performance in combination with Enzo’s PolyView line of detection reagents, we believe this new probe design will further drive Enzo’s business in existing in situ hybridization markets, such as HPV testing. We also believe it will enable a whole new range of applications for Enzo and its customers in the areas of tissue analysis, cancer diagnostics and liquid biopsy, as well as drug development and basic research."

The company is currently developing a next-generation, liquid cytology, Pap testing product as part of its women’s health platform, that employs the new probe technology for detecting genes of human papilloma viruses (HPV-16 and HPV-18) associated with cervical cancer. As the same viruses are also responsible for a growing number of oral and anal cancers, in both women and men, there may also be substantial further applications for these HPV probes.

Dr. Rabbani continued: "Because of its high-sensitivity signal amplification feature, we are also exploring non-in situ uses of this new probe design for the direct detection and quantification of nucleic acids of interest, including very low quantity targets where previously only nucleic acid amplification based techniques that copy the target, such as the Polymerase-mediated Chain Reaction (PCR), were practical."

Eureka Therapeutics Announces Initiation of Phase 1/2 Clinical Trial of ET140202 ARTEMIS™ T-Cell Therapy in Liver Cancer

On August 5, 2019 Eureka Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel T-cell therapies that harness the evolutionary power of the immune system, reported initiation of Phase 1/2 clinical trial of ET140202 ARTEMIS T-Cell therapy in liver cancer at City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, based in Duarte, California (Press release, Eureka Therapeutics, AUG 5, 2019, View Source [SID1234538143]).

The Phase 1/2 study is a multicenter, open-label, dose-escalating clinical trial of ET140202 ARTEMIS T-Cell therapy for the treatment of advanced hepatocellular carcinoma (HCC), the predominant type of liver cancer.

Patients with advanced HCC have a very poor prognosis and limited treatment options. The rate of liver cancer diagnosis has more than tripled since 1980, according to the American Cancer Society. About 42,030 new cases are expected, and about 31,780 people are expected to die from the disease in 2019.

ET140202 utilizes Eureka’s proprietary ARTEMIS antibody T-cell receptor (AbTCR) platform engineered with a proprietary human TCR-mimic (TCRm) antibody to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex on HCC cancer cells. Data presented in September 2018 from Eureka’s ongoing proof-of-concept first-in-human study of ET140202 in China demonstrated a favorable safety profile with no observed cytokine release syndrome or drug-related neurotoxicity.

"The novel T cell platform has the potential to transform T cell therapy into an outpatient procedure," said Yuman Fong, M.D., director of the Center for Surgical Innovation at City of Hope and co-investigator of the ongoing clinical trial. "We, Eureka Therapeutics and others are designing T cell therapies with low toxicity."

The patients who are selected for the clinical trial have metastatic or locally advanced, inoperable liver cancer and have progressed or have not been able to tolerate at least one line of treatment for their disease. The clinical trial tests for safety and proper dosing levels. If the initial study participants react favorably, the trial will move into drug efficacy testing.

"Traditional immunotherapy such as checkpoint inhibitors releases the breaks on the immune system, which allows it to sometimes attack the tumor but can also lead to attacks on other parts of the human body," said Daneng Li, M.D., principal investigator of the ongoing study and a medical oncologist at City of Hope. "This approach engineers immune cells to directly attack a protein that is expressed on liver cancer. We are trying to individualize treatment for patients with advanced liver cancer."

"We are pleased to work with City of Hope on bringing ET140202 therapy to patients with advanced HCC. Our approach has been to use our ARTEMIS T-cell platform with higher target specificity to address the safety and other challenges in the treatment of solid tumors," said Dr. Cheng Liu, Founder and CEO of Eureka Therapeutics. "HCC is a devastating disease, and we are delighted that City of Hope is using their broad expertise to potentially accelerate our efforts and provide additional opportunities to combat this and other diseases."

UroGen Pharma to Report Second Quarter 2019 Financial Results on Friday, August 9, 2019

On August 5, 2019 UroGen Pharma Ltd. (Nasdaq:URGN) reported that it will report second quarter 2019 financial results on Friday, August 9, 2019, prior to the open of the market (Press release, UroGen Pharma, AUG 5, 2019, View Source [SID1234538142]). The announcement will be followed by a live audio webcast and conference call on Monday, August 12, 2019 at 8:30AM Eastern Time.

Audio Webcast

The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately two weeks.

Dial-In Information

Live (U.S. / Canada): 1 (888) 771-4371
Live (International): 1 (847) 585-4405
Confirmation number: 48773603

Gossamer Bio to Announce Second Quarter 2019 Financial Results and Host Conference Call and Webcast on August 8, 2019

On August 5, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it will report its second quarter 2019 financial results on Thursday, August 8, 2019 (Press release, Gossamer Bio, AUG 5, 2019, View Source [SID1234538141]).

In connection with the earnings release, Gossamer’s management team will host a live conference call and webcast at 4:30 p.m. ET on Thursday, August 8, 2019, to discuss the Company’s financial results and provide a corporate update.

The live audio webcast may be accessed through the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source Alternatively, the conference call may be accessed through the following:

Conference ID: 1393207
Domestic Dial-in Number: (866) 221-1654
International Dial-in Number: (470) 495-9466
Live Webcast: View Source

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.

SFA Therapeutics, Inc. Requests FDA Orphan Drug Designation (ODD) for SFA001 for Treatment of Hepatocellular Carcinoma (HCC)

On August 5, 2019 SFA Therapeutics, Inc. reported that the company has filed an FDA application requesting Orphan Drug Designation (ODD) for SFA001, the company’s novel microbiome-based treatment for human hepatocellular carcinoma (HCC) (Press release, SFA Therapeutics, AUG 5, 2019, View Source [SID1234538140]).

"In seeking Orphan Drug Designation (ODD) for this patented new human-microbiome-based drug, we are asking FDA to grant special status to the treatment of the most prevalent form of liver cancer. ODD status would provide significant drug development and tax advantages as well as expanded market exclusivity," stated Ira Spector, PhD, SFA Therapeutics’ CEO. "These advantages would undoubtedly speed the drug’s availability for a disease that kills hundreds of thousands of patients annually world-wide and has a low survival rate."

While hepatocellular carcinoma afflicts 54,000 patients per year in the US (Cancer.net), the World Health Organization estimates the disease causes as many as 700,000 deaths per year globally –especially in China and other parts of Asia. SFA Therapeutics has already been granted two patents recognizing the uniqueness of SFA001 treatment. In validated transgenic HBX animal models, SFA001 has been shown to block the progression of hepatitis B to HCC and has been shown to treat HCC with a non-chemotoxic mechanism in two forms of human HCC.