On October 9, 2019 Debiopharm (www.debiopharm.com) reported the first patient enrolment in a Phase I study initiated by Dr. Phillippe Cassier, combining the oral, IAP (Inhibitor of Apoptosis Proteins) antagonist, Debio 1143, with Merck Sharpe & Dohme’s (MSD) anti-PD1 Keytruda (pembrolizumab) (Press release, Debiopharm, OCT 9, 2019, View Source [SID1234540136]). The CATRIPCA study focuses on two cancer patient populations with conditions that are intrinsically resistant to Immune Checkpoint Inhibitors (ICI). More specifically, the trial will recruit patients without other available therapeutic options in Non-microsatellite instability (non-MSI)-high colorectal cancer (CRC) and pancreatic ductal adenocarcinoma cancer (PDAC). Up to 46 patients will be included in the dose-escalation and expansion parts, to assess the safety and preliminary efficacy of the combination, with the primary endpoint of the study extension being the Objective Response rate.

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Expected to become one of the leading causes of overall cancer mortality by 2025, pancreatic cancer is characterized by early metastasis and resistance to currently available agents including recent immunotherapies.1 In CRC, the fourth highest cause of cancer-related death, the newly developed ICIs have not demonstrated a substantial benefit as single agents.2,3 The CATRIPCA study focuses on these two cancer types to address the high unmet need by potentially enhancing ICI efficacy in these settings. As preclinical models have demonstrated synergy between Debio 1143 and immunotherapy, the compound is expected to offer an immune-sensitizing effect.

"With this combination trial, we’re aiming to evaluate if the addition of Debio 1143 can stimulate the host immune system to revert primary resistance to ICIs in advanced non-MSI-high CRC or in PDAC patients."
Dr. Philippe Cassier, Principal Investigator

"This study is the third of a series of Immuno-oncology studies investigating the effect of Debio 1143 in combination with ICIs. The study will evaluate a particularly difficult patient population, primarily in the immune-refractory setting with hopes that the Debio 1143-pembrolizumab combination will open up new possibilities for these patients."
Dr. Angela Zubel, Chief Development Officer, at Debiopharm

About Debio 1143
Debio 1143 is an IAP antagonist with a dual mode of action, promoting programmed cell death and fostering anti-tumor immunity. Currently in clinical development in a broad range of cancer types, the compound is being tested in combination with chemo-radiotherapy or with ICIs (PD-1/PD-L1), with reported data consistently showing a favorable and manageable safety profile. Over 200 patients have been treated so far with Debio 1143, in indications such as non-small cell lung cancer (NSCLC) and Head & Neck cancer (SCCHN).

About CATRIPCA
Initiated by Dr. Philippe Cassier at the Léon Bérard Center in France, this Phase I study was designed to test the hypothesis that combining IAP inhibition and PD1 blockade therapy could induce responses in non-MSI-high advanced/metastatic PDAC or CRC, conditions that are intrinsically resistant to ICIs alone.

On October 9, 2019 Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, reported its operating results for the quarter ended September 30, 2019 after the market closes on Wednesday, October 23, 2019, and will host a conference call at 5:00 p.m. ET that day to discuss those results (Press release, Edwards Lifesciences, OCT 9, 2019, View Source [SID1234540134]).

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To participate in the conference call, dial (877) 704-2848 or (201) 389-0893. For 72 hours following the call, an audio replay can be accessed by dialing (877) 660-6853 or (201) 612-7415 and using conference number 13694541. The call will also be available via live or archived webcast on the "Investor Relations" section of the Edwards web site at ir.edwards.com.

On Ocotober 9, 2019 Boehringer Ingelheim, a leading provider of animal health products for pets and livestock, reported the completion of work Wednesday after a $76 million investment in its site in Athens, Ga (Press release, Boehringer Ingelheim, OCT 9, 2019, View Source [SID1234540133]). The investment doubled the company’s capacity to produce vaccines for pets in the United States and around the world.

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U.S. Senator David Perdue (R-GA), on left, visited Boehringer Ingelheim’s site in Athens, Georgia.
U.S. Senator David Perdue (R-GA), on left, visited Boehringer Ingelheim’s site in Athens, Georgia.
"Today’s announcement is representative of the growth and investment Boehringer Ingelheim is making around the United States. It also signals our commitment to a world in which no animal suffers from a preventable disease," said Everett Hoekstra, president of Boehringer Ingelheim Animal Health USA Inc. "We are excited about what’s in store for our company and our communities, and for the future of animal health."

U.S .Senator David Perdue (R-GA) visited Boehringer Ingelheim’s site in Athens on Wednesday to help mark the occasion.

"Boehringer Ingelheim continues to be a strong contributor to our economy," Perdue said. "Their investment in Georgia is a testament to our outstanding universities, growing biosciences industry, and business-friendly climate."

Headquartered in Duluth, Ga., Boehringer Ingelheim’s U.S. Animal Health Business has increased its manufacturing capacity in recent years at several sites in Georgia and in St. Joseph, Mo., where the company has maintained operations for more than a century.

Since 2017, the company has been delivering on its commitment to invest more than $124 million in Georgia and create 225 jobs in Athens, Duluth, and Gainesville.

Boehringer Ingelheim employs about 440 people in Athens. The site produces more than 150 vaccines for pets, poultry and wildlife sold in more than 80 countries, protecting animals from diseases like rabies. The site produces several hundred million doses of vaccines a year.

"Boehringer Ingelheim’s products help support Georgia’s critical agriculture industry and I personally want to congratulate the company and its employees on completing this expansion in Athens," Perdue said.

On Ocotober 9, 2019 Danaher Corporation (NYSE: DHR) reported that it will webcast its quarterly earnings conference call for the third quarter 2019 on Thursday, October 24, 2019 beginning at 8:00 a.m. ET and lasting approximately 1 hour (Press release, Danaher, OCT 9, 2019, View Source [SID1234540132]).

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The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher’s website, www.danaher.com, under the subheading "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

You can access the conference call by dialing 866-503-8675 within the U.S. or +1 786-815-8792 outside the U.S. a few minutes before 8:00 a.m. ET and notifying the operator that you are dialing in for Danaher’s earnings conference call (access code 6177645). A replay of the conference call will be available shortly after the conclusion of the call until October 31, 2019. You can access the replay dial-in information on the "Investors" section of Danaher’s website under the subheading "Events & Presentations."

Danaher’s earnings press release, the webcast slides and other related presentation materials will be posted to the "Investors" section of Danaher’s website under the subheading "Quarterly Earnings" beginning at 6:00 a.m. ET on the date of the earnings call and will remain available following the call.

On October 9, 2019 City of Hope reported that it has opened a first-in-human clinical trial for patients with recurrent glioblastoma – the trial is the first to combine City of Hope’s chimeric antigen receptor (CAR) T cells that target the IL13Rα2 antigen common on brain tumor cells in combination with nivolumab (commercial name: Opdivo), an anti-PD1 antibody, and ipilimumab (commercial name: Yervoy), also a checkpoint inhibitor that blocks the CTLA-4 protein (Press release, City of Hope, OCT 9, 2019, View Source [SID1234540131]).

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To launch the randomized trial, National Institutes of Health (R01CA236500) awarded $3.3 million over five years to Behnam Badie, M.D., The Heritage Provider Network Professor in Gene Therapy and chief of City of Hope’s Division of Neurosurgery, and Christine Brown, Ph.D., City of Hope’s The Heritage Provider Network Professor in Immunotherapy, and deputy director of City of Hope’s T Cell Therapeutics Research Laboratory; Brown and Badie also received $800,000 from Gateway for Cancer Research.

"Our hope is that by combining two powerful immunotherapies – CAR T cell therapy and checkpoint inhibitors – we can find additional treatments for patients with malignant glioma, who currently have few options," Brown said. "In addition, the trial will allow us to conduct liquid biopsies of the cerebrospinal fluid throughout the treatment time to query the central nervous system, furthering our understanding of how checkpoint inhibitors alter the function and persistence of CAR T cells, as well as how it potentially promotes endogenous immune responses in the brain."

The trial will deliver CAR T cells that target IL13Rα2 locally to the brain, by direct injection to the tumor site and through infusion into the ventricular system. City of Hope was the first to use this type of delivery for glioblastoma patients receiving CAR T treatment, as well as the first to investigate CAR T cells targeting IL13Rα2. A 2016 case study in the New England Journal of Medicine outlined how a City of Hope patient’s brain cancer regressed for 7.5 months after receiving CAR T therapy to effectively attack cells with IL13Rα2.

With product provided by Bristol-Myers Squibb, patients will also receive nivolumab and ipilimumab. Nivolumab is an immune checkpoint inhibitor that can prevent the PD-1 protein from doing its job, which is to suppress the immune system from fighting cancer. By putting PD-1 in check, the body’s immune system can better fight cancerous cells. Ipilimumab blocks the CTLA-4 protein in a similar way.

For the trial, all patients will receive the IL13Rα2 CAR T cells weekly, combined with nivolumab every other week. Patients on the experimental arm will additionally receive ipilimumab and nivolumab, each dosed once 14 days prior to the start of combination therapy with CAR T cells plus nivolumab.

The U.S. Food & Drug Administration (FDA) has approved the use of nivolumab for patients with various cancers, including metastatic melanoma, nonsmall cell lung cancer, classical Hodgkin’s lymphoma, and head and neck cancer. Clinical trials are underway at City of Hope and other institutions to expand the use of nivolumab for other cancers or for use with other therapies. The FDA has approved the use of ipilimumab for metastatic melanoma or in combination with nivolumab for renal cell carcinoma and colorectal cancer.

Mustang Bio Inc. (NASDAQ: MBIO) is the exclusive licensee of City of Hope patents covering its IL13Rα2-specific CAR T cell therapy.