On January 27, 2020 The Mark Foundation for Cancer Research reported the creation of The Mark Foundation Center for Advanced Genomics and Imaging at the Johns Hopkins University (JHU), which will receive initial funding of $5 million over 2 years (Press release, The Mark Foundation For Cancer Research, JAN 27, 2020, View Source [SID1234553565]).

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Bringing together the tools of astronomy image analysis, pathology, computer science, cancer genomics, and immunogenomics to solve problems in oncology, the new center will find innovative solutions that can expand the number of cancer patients who benefit from immunotherapy.

Scientists from The Mark Foundation will collaborate with JHU researchers as part of a joint steering committee that will review scientific progress and facilitate the success of the center.

"It takes a village of diverse disciplines and areas of expertise to confront the vast challenges presented by cancer, and the work of this center is the perfect embodiment of this reality," said Michele Cleary, PhD, CEO of The Mark Foundation. "One focus of the center is especially imaginative, as it involves developing a new platform that takes a model used in astronomical nighttime sky analysis and turns it into one that can be used to analyze cancer tumors."

The Mark Foundation Center for Advanced Genomics and Imaging will be led by Drew Pardoll, MD, PhD, Director of the Bloomberg-Kimmel Institute for Cancer Immunotherapy and co-Director of the Cancer Immunology Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, together with Janis Taube, MD, MSc, Professor of Dermatology and Pathology and Director of the Division of Dermatopathology and co-Director of the Tumor Microenvironment Laboratory of the Bloomberg-Kimmel Institute for Cancer Immunotherapy.

On January 27, 2020 PharmaCyte Biotech (OTCQB: PMCB) reported that its clinical trial product, which will be employed during the company’s upcoming Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC), has passed each of the U.S. Food and Drug Administration’s (FDA) required "release tests" for safety and functionality (Press release, PharmaCyte Biotech, JAN 27, 2020, View Source [SID1234553588]). With a clinical trial product that has proven to be safe and functional, PharmaCyte is now "on-the-clock" for its submission of an Investigational New Drug application or "IND" package to the U.S. FDA requesting a Phase 2b clinical trial in LAPC at trial sites throughout the United States.

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In a series of 10 "release tests" over two batches of the company’s clinical trial product for a total of 20 "release tests," PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box, performed admirably and proved to be both safe to place into humans in a clinical trial, and to function properly. During the tests, the more than 20,000 genetically modified live cells that fully fill each Cell-in-a-Box capsule were functioning as expected after being manufactured, placed into syringes, frozen, thawed and then tested for enzymatic activity, cell viability, and biologic activity among a host of other tests.

And now that "release testing" has ended successfully, Austrianova will issue 2 Certificates of Analysis to PharmaCyte—1 for each manufactured and tested batch of the company’s clinical trial product. Additionally, Austrianova will turn over all of the completed batch records to PharmaCyte from both production runs and the subsequent "release testing." The data generated from these tests are necessary information that must be entered into the company’s IND application.

PharmaCyte has methodically taken extra steps to position the company for a greater chance at success once the IND is submitted to the FDA. One such step is the manufacture and testing of two batches of its clinical trial product, which was requested by cGMP Validation, the company taking responsibility for releasing the clinical trial product into the U.S. for use in PharmaCyte’s upcoming clinical trial.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commenting on manufacturing a second batch of the company’s clinical trial product, said, "Our GMP consultant, cGMP Validation, has informed us that while two successful manufacturing runs are not required by the FDA to request a Phase 2b clinical trial, it could go a long way in demonstrating to the FDA that our manufacturing process is robust and reproducible – manufacturing qualities that are highly embraced by the FDA."

Successfully completing the manufacturing process of PharmaCyte’s clinical trial product, conducting and successfully completing "release testing" on both batches of the company’s product, and the data being generated from those tests are all critical to the completion of PharmaCyte’s IND package. With the announced success of the "release tests," PharmaCyte has essentially conquered what was the greatest hinderance in the company’s ability to move forward with completing its IND application.

Because pancreatic cancer is the third leading cause of cancer-related deaths, this work for PharmaCyte is important and necessary, and the company has painstakingly endured a process of perfection to land it on the precipice of engaging with the FDA in an opportunity to enter into a clinical trial. In 2020 alone, an estimated 57,600 Americans will be diagnosed with pancreatic cancer, and approximately 47,050 Americans are expected to die from the disease this year.

PharmaCyte hopes to better those dismal numbers by using its targeted chemotherapy—Cell-in-a-Box plus low doses of the anticancer drug ifosfamide—in patients with LAPC who no longer see any benefit after being treated for 4-6 months with one of the two first-line therapies offered to this patient population. Its stated goal is to make inoperable tumors operable and give these patients a second chance at life. Needless to say, PharmaCyte is closer than ever to submitting its IND, so the countdown to this momentous milestone for the company’s shareholders should be "officially" underway and is certainly highly anticipated.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, watch the company’s documentary video complete with medical animations at: View Source

On January 27, 2020 Tempe, Ariz.-based Gt Medical Technologies Inc. reported that it has won the U.S. FDA’s nod for an expanded indication for Gammatile therapy. With this decision, patients with newly diagnosed malignant brain tumors now are eligible to receive the FDA-cleared surgically targeted radiation therapy (Press release, GT Medical Technologies, JAN 27, 2020, View Source [SID1234553566]).

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Matthew Likens, president and CEO of Gt Medical, noted that the company was excited to offer the therapy to those who are newly diagnosed with malignant brain tumors. Previously, the therapy was available for individuals with recurrent ones.

"Patients receiving Gammatile therapy immediately after the removal of a brain tumor will have the peace of mind that they are accelerating their radiation treatment and targeting residual tumor cells where treatment is most needed to help prevent recurrence," he added.

Gammatile therapy offers an option vs. waiting several weeks for surgical wound healing before beginning treatment. It protects healthy brain tissue while delivering a targeted dose to any remaining tumor cells. In addition, it limits certain side effects, such as hair loss.

"The neurosurgeon is handed these tiles by the radiation oncologist. They’re literally tiling the inner wall of the cavity and the base of the cavity and then closing the patient up," Likens told BioWorld last year. "It’s a five-minute procedure right at the end of the resection process." As a result, it does not disrupt the workflow of the operating suite.

With this indication in hand, this new group of patients will not have to wait long for treatment. "Patients will be eligible to receive Gammatile therapy immediately at the 15 centers where the treatment is currently available," Likens told BioWorld.

When asked about other markets, he noted that the U.S. remained the company’s immediate focus. "[B]ut we consider Gammatile to be a global technology, and we plan to deploy it outside the U.S. in the future."

Looking to improve the space

The company placed the number of people in the U.S. living with some type of brain tumor each year at roughly 700,000, citing figures from the American Brain Tumor Association. It also noted that despite the attempts by surgeons, outcomes for patients with brain tumors have not improved very much over the past 30 years. The FDA has approved four drugs and cleared two devices in that time period to help these patients. Now, Gammatile looks to advance the field and is the most recent treatment cleared or approved.

"Approximately 400,000 Americans are newly diagnosed with some type of brain tumor each year, including gliomas, meningiomas and brain metastases," Likens told BioWorld. "This expanded indication more than triples the number of patients who can benefit from Gammatile therapy."

In a clinical study, Gammatile therapy gave the average patient about an extra 10 months without a local recurrence with extended overall survival. Clark Chen, head of the Department of Neurosurgery at the University of Minnesota Medical School, presented data from his first patients treated with Gammatile at the 2019 Society of Neuro-Oncology Annual Meeting.

Consistent with data published in a peer-reviewed article, Chen noted that local control was achieved in about 90% of patients who underwent gross total resection. This result was achieved without an increase in wound complications or length of hospital stay.

For his part, Vincent DiNapoli, neurosurgeon and director of the Brain Tumor Center at The Jewish Hospital in Cincinnati, has been treating patients with Gammatile therapy since August 2019. "Having been encouraged by the outcomes for recurrent brain tumor patients treated with Gammatile therapy in my practice, I am excited by the FDA’s decision to expand this technology to the many patients who can benefit from the treatment during their initial diagnosis," DiNapoli said. "This could potentially create a more meaningful impact on patient outcomes, treatment compliance, and quality of life."

Patients also have been enthusiastic, as they have not had to come back for repeated hospital visits.

Working with Isoray

Gt Medical and its collaborator Isoray Inc., of Richland, Wash., reported July 9, 2018, the receipt of FDA clearance of Gammatile therapy for the treatment of recurrent brain tumors. In January 2018, Isoray revealed the signing of an exclusive manufacturing and supply agreement with Gt Medical for Cesium-131 seeds embedded in the product’s collagen tiles. The term of the agreement was 10 years.

For its part, during its Nov. 12, 2019, first-quarter earnings call, Isoray CEO Lori Woods discussed the potential for the now-realized expanded indication for Gammatile. "We are very interested in how this effort for expanded indication proceeds with the FDA because of its implications for Cesium-131 and Isoray," she said. She noted that the product remained in active review, with revenues for Gt Medical remaining nominal as the company continued to introduce the Gammatile centers around the U.S.

$10M series A

The news regarding the FDA’s decision comes about a year after the company reported that it had raised $10 million in a series A financing to support the commercialization of Gammatile therapy.

At the time, Likens said his company had the intellectual property for use of the therapy in extra-cranial applications, but due to its resources, it planned to concentrate totally on the brain for the immediate future.

"Gammatile therapy was specifically designed with the brain’s delicate environment in mind and our current focus is on improving the lives of patients with brain tumors," told BioWorld in the wake of the expanded clearance. Because of its IP protection beyond the brain "we are currently collecting feedback on other potential indications for the future," Likens concluded.

On January 27, 2020 AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. reported the presentation of results from an investigator-sponsored Phase 1b trial of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, AVEO, JAN 27, 2020, View Source [SID1234553589]). The results were presented during a poster session at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium. A copy of the presentation, titled "Phase 1b Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab in Patients with Advanced Pancreatic Cancer" (abstract 693), is available in the Publications & Presentations section of AVEO’s website.

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The study, which was based on preclinical findings demonstrating a synergistic effect of the combination in a preclinical model of PDAC, was designed to determine the maximum tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel. Secondary outcome measures included response rate and progression free survival. A total of 24 patients were enrolled. The average number of 28-day cycles received was 7.5 (range 1-15), with 3 patients remaining on active treatment. The combination was associated with a promising durable response rate relative to expectations for gemcitabine and nab-paclitaxel alone. This included a 29% partial response (PR) rate and 92% rate of disease control (PR + stable disease). Treatment with this regimen was associated with significant hypoalbuminemia and edema, and therefore a follow up safety study is under consideration of ficlatuzumab in combination with an alternate cytotoxic regimen.

"Pancreatic cancer remains among the most challenging diseases to treat, owing to late diagnoses, rapid progression and early mortality," said Kimberly Perez, MD, Dana-Farber Cancer Institute. "By targeting the c-MET pathway, ficlatuzumab inhibits the Prrx1b-HGF signaling associated with pancreatic development, pancreatitis, and carcinogenesis. These Phase 1b results show encouraging responses that support the further study of ficlatuzumab in pancreatic cancer."

"Ficlatuzumab continues to emerge as a promising clinical candidate, with these results adding to a growing body of clinical data in acute myeloid leukemia and head and neck cancer," said Michael Bailey, president and chief executive officer of AVEO. "As we continue to execute on our tivozanib Phase 3 clinical and U.S. registration strategy and move closer to its potential commercialization, we look forward to seeing ficlatuzumab progress in multiple clinical studies, with the goal of determining a pivotal strategy, assuming favorable study outcomes."

"Ficlatuzumab continues to demonstrate the potential for major clinical utility in areas of significant unmet need," said Scott Hutton, Chief Executive Officer of Biodesix. "We look forward to continuing our diagnostic development work alongside AVEO to help realize the full potential of this promising therapeutic candidate."

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (SCCHN), metastatic pancreatic ductal cancer (PDAC), and acute myeloid leukemia (AML).

On January 27, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the closing of its previously announced underwritten public offering of 24,523,750 shares of its common stock at a price of $4.25 per share, which included the exercise in full by the underwriters of their option to purchase up to 3,198,750 additional shares of common stock (Press release, ImmunoGen, JAN 27, 2020, View Source [SID1234553568]). ImmunoGen received total gross proceeds from the offering (before deducting the underwriting discounts and offering expenses) of $104.2 million.

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ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization activities, capital expenditures, and working capital.

Jefferies, Cowen and William Blair acted joint book-running managers for the offering.

The securities described above were offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by e-mail at [email protected] or by telephone at (800) 621-0687.