Calidi Biotherapeutics Secures Series A Investments to Advance Manufacturing

On January 21, 2020 Calidi Biotherapeutics, Inc., a clinical‐stage immuno-oncology company at the forefront of cell-based oncolytic virus immunotherapies for cancer, reported Series A investments from two South Korean firms to advance manufacturing in preparation for Calidi’s pre-IND and IND filings (Press release, Calidi Biotherapeutics, JAN 21, 2020, View Source [SID1234553376]).

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The investment efforts were led by Heehyoung Lee, Ph.D., co-founder and managing partner of LumeBio, advisor to Calidi Biotherapeutics and a fifteen-year veteran in the biopharmaceutical space. Dr. Lee facilitated the relationships between Calidi Biotherapeutics and the South Korean investment firms: Won & Partners and Greentable Co., Ltd.

"We are excited to grow Calidi Biotherapeutics and further our mission to bring lifesaving treatments to cancer patients." said Allan Camaisa, CEO of Calidi Biotherapeutics. "Dr. Lee and Lumebio have been instrumental in helping us close out our series A raise. This funding will allow us to continue advancing our manufacturing processes as we prepare our pre-IND and IND package for Supernova 1 (SNV1c), a tumor-selective vaccinia virus combined with allogeneic adipose-derived mesenchymal stem cells (AD-MSC). We are excited to advance this asset into the clinic to target multiple cancer types."

"The promise of oncolytic viral therapy has yet to be fulfilled," said Heehyoung Lee, Ph.D., "Calidi’s unique allogeneic stem cell delivery platform utilizing adipose tissue will revolutionize the field of oncolytic viruses."

Dr. Lee previously held positions at Hanmi Pharmaceuticals, Sorrento Therapeutics, and City of Hope. Upon completing her Ph.D. in Pathology & Molecular Medicine in 2002, Dr. Lee received the American Heart Association Fellowship and held a postdoctoral position at Moffitt Cancer Center. Dr. Lee became an Assistant Professor at City of Hope, where she focused on tumor immunobiology and cancer. She led the seminal findings in linking lipid metabolism to JAK-STAT-driven cancer, which is published in Nature Medicine and Nature Reviews Cancer. Her extensive background also includes global strategic planning and alliance management with Sanofi, Genentech, and Eli Lilly.

Vertex to Announce Full-Year and Fourth-Quarter 2019 Financial Results on January 30

On January 21, 2020 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its full-year and fourth-quarter 2019 financial results on Thursday, January 30, 2020 after the financial markets close (Press release, Vertex Pharmaceuticals, JAN 21, 2020, View Source [SID1234553413]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

Scientists study zebrafish in search of melanoma-fighting drugs

On January 21, 2020 Northern Arizona University reported that melanoma is the most lethal type of skin cancer and unusually common in Arizona, where residents are exposed to higher-than-average amounts of ultraviolet radiation (Press release, Northern Arizona University, JAN 21, 2020, View Source [SID1234553361]). However, Northern Arizona University scientists believe the formula for a combination of melanoma-fighting drugs is within reach.

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Matthew Salanga, an assistant professor in NAU’s Department of Biological Sciences, is leading an 18-month project funded through a Flinn Foundation grant of $100,000. His team, which includes experts in experimental biology, computational systems biology and translational medicine, will study melanoma tumors on zebrafish, a small minnow-sized fish that has 70 percent of the same genes that are found in humans. Physiologically, zebrafish also have pigment cells in their skin, called melanocytes, which give them their stripes and their name. In humans, these cells are responsible for creating a tan when exposed to the sun, and if dysregulated can give rise to melanoma.

The majority of melanoma skin cancers are the result of a specific mutation in the BRAF gene (BRAF V600E). BRAF is a type of enzyme known as a protein kinase that adds a phosphate group to other proteins in cell signaling pathways. For this project, zebrafish that express the human form of mutated BRAF are employed to test strategies for treating melanoma.

"Fish don’t often get cancer," said Salanga, an expert in cell and developmental biology, "but in the lab, we can engineer fish to contain human genes that we know are associated with cancer. Essentially, it’s a way to use non-human vertebrates as though they were human. We call this humanization."

Currently there are around 30 zebrafish carrying the BRAF V600E human oncogene in Salanga’s lab that have visible melanoma tumors, and that number will grow as the study progresses. Activated BRAF acts to promote cell growth and proliferation. Salanga explains that the V600E mutation of BRAF leaves it stuck in the "on" position. This can result in unrestricted cell growth and proliferation. Drugs have been developed that specifically target and suppress tumor cells that have aberrant BRAF kinase activity. These drugs are in a class of drug called protein kinase inhibitors (PKIs), and are currently used clinically. However, not all patients respond and many relapse after a few months of therapy.

Researchers try to predict best drug combinations for inhibiting kinase activity

Salanga believes that there is a combination and dosage of PKIs recognizing distinct conformations of the BRAF kinase that can shut down the misfiring proteins and kill tumor cells dependent on oncogenic BRAF activity.

"The crux of the project is trying to predict which set of currently available drugs will work the best at inhibiting BRAF’s ability to turn things on inappropriately," he said. "Molecular profiling of tumor cells might be used to guide the drug selection for individual patients."

Critical to the NAU-based pilot project team is Richard Posner, a professor in NAU’s Department of Biological Sciences and William Hlavacek, a scientist at Los Alamos National Laboratory. Posner and Hlavacek are computational systems biologists who have developed mathematical models for predicting optimal strategies to target mutations in BRAF. In recent work, they and their collaborators predicted that two-drug combinations will be able to effectively suppress mutant BRAF (V600E) signaling. These predictions were validated in melanoma cell lines. The researchers are leveraging this computation pipeline to predict therapeutic responses to novel combinations of U.S. Food and Drug Administration-approved drugs in humanized zebrafish harboring melanoma skin cancer.

Also involved in the project is Haiyong Han, a scientist in the Molecular Medicine Division at the Translational Genomics Research Institute (TGen). His specialty is pancreatic cancer, which could potentially be treated using similar therapeutic strategies that are being proposed for melanoma.

The researchers, including undergraduate and graduate students, will be adding various combinations of inhibitors to see if they can find combinations that are most effective in targeting mutated RAF proteins.

Salanga says taking the melanoma-fighting research from the lab to medical facilities could happen quickly, as 150 PKIs are already in various stages of safety testing, and many are approved by the FDA.

"TGen and its partners can carry out these PKI clinical trials fairly routinely through its patient network and its scientists, who assist in these human studies. We could see humans receiving treatments like this within the next year or two," he said.

Although early detection of melanoma contributes to an 89 percent, five-year survival rate, metastatic melanoma is often lethal, with less than a 20 percent survival rate.

NAU’s grant for the project was awarded by the Flinn Foundation under its Seed Grants to Promote Translational Research initiative.

Novocure Announces National Reimbursement in Israel for Optune® in Combination with Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

On January 21, 2020 Novocure (NASDAQ: NVCR) reported that the State of Israel Ministry of Health has added Optune in combination with temozolomide to the Israeli medical services basket for the treatment of patients with newly diagnosed glioblastoma (Press release, NovoCure, JAN 21, 2020, View Source [SID1234553377]). The medical services basket includes the entire range of services, medications and devices that the insured public in Israel is entitled to receive under the National Health Insurance Law.

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"We are extremely pleased that the Ministry of Health has established national reimbursement for Optune in Israel," said Anat Bin, Novocure’s Country Manager of Israel. "Access to our therapy continues to grow throughout the world, demonstrating health insurers’ increasing recognition of Optune. We are committed to bringing Optune to as many patients who may benefit."

Gilead Sciences to Release Fourth Quarter and Full Year 2019 Financial Results on Tuesday, February 4, 2020

On January 21, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its fourth quarter and full year 2019 financial results will be released on Tuesday, February 4, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s fourth quarter and full year 2019 financial results and will provide a business update (Press release, Gilead Sciences, JAN 21, 2020, View Source [SID1234553414]).

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The live webcast of the call can be accessed at the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 9634129 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, February 6, 2020. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 9634129. The webcast will be archived on www.gilead.com for one year.