On August 21, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that the company will present at the 2018 Baird Global Healthcare Conference on Wednesday, September 5, 2018, at 11:25AM ET (Press release, NewLink Genetics, AUG 21, 2018, View Source [SID1234530680]).

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A live webcast of the presentation will be available on the Company’s website at www.newlinkgenetics.com in the "Investors & Media" section under "Events and Presentations." An archived edition of the presentation will be available on the Company’s website later that day.

On August 21, 2018 Ichor Medical Systems, Inc. (Ichor) reported that its investigational TriGrid Delivery System (TriGrid) is being utilized in a Phase 1b/2 clinical trial to administer GX-188E, an investigational therapeutic HPV DNA vaccine developed by Genexine, Inc (Press release, Ichor Medical Systems, AUG 21, 2018, View Source [SID1234529014])., in patients with human papilloma virus (HPV)-induced advanced non-resectable cervical cancer, in combination with an anti-PD-1 therapy (NCT03444376).

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Cervical cancer is the fourth most common cancer affecting women worldwide and is almost always caused by infection with HPV. Preventative vaccines for cervical cancer are ineffective in women who are already infected with HPV, and despite advances in screening and HPV vaccination, a significant number of women develop advanced disease. Although chemotherapy is the standard first-line treatment for advanced cervical cancer, the prognosis remains poor and effective second line options are still needed.

Ichor’s patented TriGrid Delivery System uses electroporation to open pathways into cells to facilitate entry of a DNA vaccine into its intracellular site of action. The TriGrid has been utilized in >25 clinical studies, including randomized comparative studies demonstrating that administration of DNA vaccines with the TriGrid device significantly enhanced immune responses to the vaccines compared to conventional injection. A Phase 1 study using the TriGrid to deliver GX-188E in patients with high grade cervical intraepithelial neoplasia (CIN), a precancerous stage of cervical cancer, showed promising results with GX-188E demonstrating the ability to induce a tumor-specific immune response with evidence of lesion clearance (Nat Commun. 2014 Oct 30; 5: 5317).

Immuno-oncology is a rapidly evolving field of medicine designed to improve the ability of a patient’s immune system to detect and destroy tumors. The study has been initiated in Korea with plans to enroll up to 46 patients and was recently announced by Genexine.

Robert Bernard, Ichor Founder and CEO, stated, "Ichor’s TriGrid Delivery System is a platform technology used by an increasing number of Ichor partners for clinical delivery of their DNA vaccines where T-cell generation is a critical aspect of the prescribed immunotherapy. We are pleased through our Genexine partnership to expand TriGrid’s use into additional areas of immuno-oncology around the world."

On August 21, 2018 Sensei Biotherapeutics, Inc., a privately-held biopharmaceutical company developing immuno-oncology therapies that teach the immune system to recognize and attack cancer, reported the appointment of Ildiko Csiki, M.D., Ph.D., as Chief Medical Officer (Press release, Sensei Biotherapeutics, AUG 21, 2018, View Source [SID1234529015]). Dr. Csiki brings nearly two decades of leadership experience in oncology drug development and research, most recently serving as Vice of President of Immuno-Oncology Clinical Development at Inovio Pharmaceuticals.

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"It is with great excitement that we welcome such an accomplished oncologist and clinical leader to Sensei. Ildiko brings an outstanding intellect, expertise and passion for patients to our team," said John Celebi, CEO of Sensei Biotherapeutics. "She is joining Sensei at a time when we are taking bold steps in discovering and developing the next generation of cancer immunotherapies, and we look forward to her contributions to building our oncology drug development capabilities and developing the clinical strategies for SNS-301 and the other programs in our pipeline."

Dr. Csiki joins Sensei at a pivotal time with promising clinical data from the Phase I trial of its lead drug candidate SNS-301 expected in the fall of 2018, and the continued development of its proprietary SPIRIT drug development platform that is generating a pipeline of innovative immuno-oncology therapies.

"I am excited to join Sensei and have the opportunity to play a leadership role in advancing innovative immuno-oncology drug candidates and bring new medicines to cancer patients," said Ildiko Csiki, CMO of Sensei Biotherapeutics "Our SPIRIT platform offers an innovative mechanism for detecting and eliminating cancer. I am eager to move forward with the clinical program for Sensei’s lead drug candidate, SNS-301, as well as creating the clinical strategy for the company’s pipeline of immuno-oncology therapies with the potential to have a profound impact for cancer patients."

In her most recent role, Dr. Csiki served as Vice of President of Immuno-Oncology Clinical Development at Inovio Pharmaceuticals where she led the advancement of Inovio’s DNA-based cancer immunotherapies based on T cell immunotherapeutic vaccines, including responsibility for overseeing clinical programs, clinical strategy, medical monitoring and regulatory submissions. Previously, Dr. Csiki was a Senior Director of Oncology Clinical Development at Merck, as a clinical development lead for pembrolizumab (Keytruda), and she was Director of Clinical Development at GSK focused on a lymphoma and other oncology programs. Before that, Dr. Csiki was an Assistant Professor in the Perelman Cancer Center at the University of Pennsylvania where she had an active clinical practice and a translational science laboratory focused on thoracic malignancies. She holds an M.D. and Ph.D. from Vanderbilt University School of Medicine. Her postdoctoral training included an internship in Internal Medicine and residency in radiation oncology at Vanderbilt and subsequently, a Holman Pathway Research Fellowship.

On August 21, 2018 Genprex, Inc. (NASDAQ: GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that company management will present at the following upcoming investor and industry conferences (Press release, Genprex, AUG 21, 2018, View Source [SID1234529016]):

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Event: H.C. Wainwright 20th Annual Global Investment Conference
Date: September 6, 2018
Time: 5:30 PM EDT
Location: New York, NY
Presenter: Dr. Julien Pham, President and COO
Event: Newsmakers in the Biotech Industry
Date: September 7, 2018
Time: 1:30 PM EDT
Location: New York, NY
Presenter: Dr. Julien Pham, President and COO

On August 21, 2018 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma (Press release, Agilent, AUG 21, 2018, View Source [SID1234529017]).

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The assay is now approved to identify patients with urothelial carcinoma who may benefit from KEYTRUDA, an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada), as a first-line treatment option. KEYTRUDA is approved for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to identify patients with urothelial carcinoma for treatment with KEYTRUDA. This follows previous FDA approvals for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, and cervical cancer.

"Anti-PD-1 therapies are a promising treatment class for many cancer types, and early PD-L1 testing can provide critical information to physicians managing urothelial carcinoma patients," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "By expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent strives to address the unmet need for treatment options in patients who are ineligible for cisplatin-containing chemotherapy. Through these efforts, we maintain our commitment to bringing companion diagnostics to the market in support of groundbreaking immuno-oncology therapeutics."

Urothelial carcinoma is the fifth most common cancer in the United States, with an estimated incidence of 81,000 new cases in 2018 alone.1 For patients with advanced/metastatic urothelial carcinoma, cancer-related mortality has not improved in the past 30 years and the five-year survival rate is approximately 15%.2 Additionally, age- and disease-associated comorbidities affect patient eligibility for standard cisplatin-containing chemotherapy.3-5 For patients ineligible for cisplatin-containing chemotherapy, there is a significant unmet need for new, effective treatments.3,4

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, and their therapeutic value is being demonstrated across a growing list of cancer types.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck. PD-L1 IHC 22C3 pharmDx also helps physicians identify NSCLC, cervical cancer, and gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA. PD-L1 expression in urothelial carcinoma, cervical cancer, and gastric or GEJ adenocarcinoma tissues is interpreted using Combined Positive Score (CPS). PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS).

References: 1. Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA, eds. SEER Cancer Statistics Review, 1975-2015. National Cancer Institute. View Source November 2017 SEER data submission. Published April 2018. Accessed August 16, 2018. 2. Gupta S, Gill D, Poole A, Agarwal N. Systemic immunotherapy for urothelial cancer: current trends and future directions. Cancers. 2017;9(15):1-14. 3. Bellmunt J, Mottet N, De Santis M. Urothelial carcinoma management in elderly or unfit patients. EJC Suppl. 2016;14(1):1-20. 4. Balar AV, Castellano D, O’Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): A multicentre, single-arm, phase 2 study. Lancet. 2017;18(11):1483-1492. 5. Galsky MD, Hahn NM, Rosenberg J, et al. Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.