OncoCell MDx, Now Immunis.AI, to Present at Biotech Showcase

On January 9, 2020 OncoCell MDx, a privately held immunogenomics company with a patented liquid biopsy platform, reported it has changed its name to Immunis.AI (Press release, OncoCell MDx, JAN 9, 2020, View Source [SID1234552940]). The name was chosen to better reflect the power and breadth of application of the company’s novel Intelligentia platform, which assesses and stratifies risk of disease on an individualized basis, earlier in the process, at the cellular level. Intelligentia combines the power of the immune defense system, RNAseq technology and machine learning for the development of proprietary disease-specific algorithms to detect and grade disease with a simple blood test. The company will present as Immunis.AI at the 2020 Biotech Showcase, being held January 13-15, 2020 in San Francisco, California.

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Date: Tuesday, January 14, 2020

Time: 10:30 AM

Track: Franciscan D (Ballroom Level)

Venue: Hilton San Francisco Union Square, 333 O’Farrell Street, San Francisco, CA 94102

"Our name change reflects the expanded potential of the technology as well as a new stage in the company’s growth and development," said Mark McDonough, President and CEO of Immunis.AI. "Our Intelligentia platform is unique in leveraging the immune system’s surveillance apparatus to overcome the limitations of cfDNA and circulating tumor cells to improve early stage disease detection, at the point of immune-escape, when there is the best opportunity for cure. We’re continuing to develop the platform in multiple cancer types, where there is a significant opportunity to change the diagnostic paradigms, and we’re now also focusing development in other needed disease states. We’re looking forward to sharing details of our expanded platform and focus areas at Biotech Showcase next week."

Over the past year, Immunis.AI has built out a new leadership team, convening top executives in life sciences with years of experience leading companies towards commercialization and acquisition. In September 2019, the company announced a series B funding of $22.2 million to help advance their novel platform towards commercialization. The company’s novel technologies were created at Harvard University by co-founder, Professor Amin I. Kassis, in 2012. Through 2019, the company advanced its internal discovery studies, intellectual property portfolio, and patient databases. In 2020, the company plans to launch its first noninvasive diagnostic test for early prostate cancer detection, and to further advance development of tests in other diseases.

To schedule a meeting with Mark McDonough during the conference, or for additional details, please contact [email protected].

Danaher To Present At J.P. Morgan Healthcare Conference

On January 9, 2020 Danaher Corporation (NYSE: DHR) reported that President and Chief Executive Officer, Thomas P. Joyce, Jr., will be presenting at the J.P. Morgan Healthcare Conference in San Francisco, California on Tuesday, January 14, 2020 at 8:00 a.m. PT (Press release, Danaher, JAN 9, 2020, View Source [SID1234552957]). The audio will be simultaneously webcast on and the presentation will be archived on www.danaher.com.

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Agenus Announces the Appointment of Dr. Jennifer Buell to the position of President and COO

On January 9, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents that activate immune response to cancers, is reported the appointment of Dr. Jennifer Buell to President and COO (Press release, Agenus, JAN 9, 2020, View Source [SID1234552914]).

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Dr. Jennifer Buell, President & COO of Agenus

"Jen’s tenure with Agenus, her exceptional leadership and cultural attributes, and her deep understanding of our science and operations makes her the top candidate for this newly created position," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. He added, "I am very excited to partner with Jen as we set to realize Agenus’ vision of defeating cancer in the coming years."

After her tenure at Harvard Clinical Research Institute, Dr. Buell rejoined Agenus in 2013 as the Head of Global R&D operations. She was subsequently appointed as Chief Communications and External Affairs Officer, and then, to the position of Chief Operating Officer.

Dr. Buell brings over 20 years of biopharmaceutical industry experience and knowledge. Her efforts in the rapid advancement of discovery candidates through development has resulted in Agenus’ record of advancing 13 I-O candidates to the clinic in the past four years. Her experience also includes extensive communication with internal and external constituencies, regulators, investors, and collaborators. Dr. Buell’s previous operational and research experience include her tenures at Bristol-Myers Squibb and Harvard Clinical Research Institute. Dr. Buell obtained her PhD in Cellular, Biochemical, and Molecular Biochemistry with an MS in Biostatistics from Tufts University in Boston.

CStone announces first patient dosed in the Phase III trial of CS1001 in combination with chemotherapy in first-line esophageal squamous cell carcinoma

On January 8, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the first patient has been dosed in the Phase III GEMSTONE-304 study of the Company’s anti-PD-L1 antibody CS1001 in combination therapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC) (Press release, CStone Pharmaceauticals, JAN 8, 2020, View Source [SID1234552811]). The GEMSTONE-304 trial is a multicenter clinical study designed to evaluate the efficacy and safety of CS1001 in combination with 5-fluorouracil plus cisplatin (FP) doublet chemotherapy in the first-line treatment of unresectable locally advanced, relapsed, or metastatic ESCC.

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According to the GLOBOCAN data released in 2018, there are approximately 307,000 new incidences of esophageal cancer and 283,000 cases of esophageal cancer-related deaths in China annually. The incidence and mortality rates of esophageal cancer are ranked 5th and 4th respectively among all tumor types nationwide. Epidemiological data indicate that 90% of all esophageal cancer cases in China are ESCC, and around 70% of ESCC cases were locally advanced or metastatic at the time of diagnosis. The platinum-based doublet chemotherapy is the current standard of care first-line treatment for patients with advanced ESCC, but it has limited efficacy. Existing data on this first-line treatment for advanced ESCC suggest an objective response rate (ORR) of 35%, a median progression-free survival (PFS) of less than six months, and a median overall survival (OS) of less than one year. There are no alternative treatments for ESCC patients who have failed the first-line treatment.

CS1001 is an investigational anti-PD-L1 antibody developed by CStone. Results released at the 2019 Chinese Society of Clinical Oncology (CSCO) Annual Meeting have shown that, as of July 1, 2019, the Phase Ib trial of CS1001 in combination with the FP chemotherapy regimen in first-line treatment of ESCC achieved an ORR of 77.8% with durable response as well as good overall safety and tolerability.

"Esophageal cancer is one of the tumor types that are particularly prevalent in China, with over 50% of the world’s new esophageal cancer cases and related deaths occurring in the country. Furthermore, the lack of more effective treatments for this patient population has long represented an urgent unmet clinical need," said Dr. Frank Jiang, Chairman and CEO of CStone. "I am glad that we have dosed the first patient in the GEMSTONE-304 trial. I hope CS1001 will continue to demonstrate its clinical promise in its development programs, and soon be proven as a new treatment option for ESCC patients in China."

"Early symptoms of esophageal cancer are relatively silent; as a result, esophageal cancer patients are commonly diagnosed at advanced stages for which there are very limited treatment options. Furthermore, no immunotherapy has been approved for the first-line treatment of ESCC. Recent results from the Phase Ib trial of CS1001 have already demonstrated promising preliminary antitumor efficacy in advanced ESCC. We will continue accelerate this Phase III trial with our best effort. Should this clinical program lead to successful outcomes, it will be a major breakthrough for advanced ESCC patients who are in urgent need of effective therapies," noted Dr. Jason Yang, Chief Medical Officer of CStone.

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase 1 dose-escalation study in China, in which the drug showed good tolerability. During Phase 1a and 1b stages of the study, CS1001 produced sustained clinical benefits in multiple tumor types.

CS1001 is being investigated in a number of ongoing clinical trials, including one Phase 1 bridging study in the U.S. In China, its clinical program includes one multi-arm Phase 1b study, two pivotal Phase 2 studies, and four Phase 3 studies for several tumor types.

Intensity Therapeutics to Participate in East/West CEO Conference

On January 8, 2020 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary intratumoral immunotherapy products to kill tumors and increase immune system recognition of solid cancers, reported that Lewis H. Bender, President and CEO, will be a featured panelist on the "Developments in The Oncology Landscape" panel at East/West CEO (Press release, Intensity Therapeutics, JAN 8, 2020, View Source [SID1234552851]). The conference will take place January 11-12, 2020, the weekend before the 38th Annual J.P. Morgan Healthcare Conference, at the Four Seasons Hotel in San Francisco.
The panel, which will examine the next wave of innovations and developments in oncology, will be held on Sunday, January 12, 2020 from 1:45 p.m. to 2:15 p.m. PST.

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