On December 7, 2020 KaliVir Immunotherapeutics LLC (CEO: Helena Chaye, Ph.D., J.D., "KaliVir") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that they entered into a worldwide licensing agreement for the research, development, and commercialization of VET2-L2, an intravenously administered oncolytic virus for Immuno-Oncology, as well as a research collaboration to generate a Second Product, a follow-on virus (Press release, Astellas, DEC 7, 2020, View Source [SID1234572335]).

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KaliVir holds its unique technology platform based on genetically modified vaccinia virus, and is developing VET2-L2, an oncolytic vaccinia virus as their lead program. VET2-L2, which is delivered by intravenous administration, reaches and destroys cancer cells and activates anti-cancer immunity through expression of therapeutic transgenes. KaliVir’s vaccinia virus-based oncolytic viral immunotherapies can be delivered intravenously to cancer patients, eliminating the need for complicated procedures of the direct intra-tumoral administration and enables access for a broader patient population. VET2-L2 is in preclinical stage.

This collaboration, which combines KaliVir’s expertise in the development of oncolytic viruses with Astellas’ capabilities in advanced drug development and its global business experience, will enable both parties to develop new Immuno-Oncology therapies.

Under the terms of the agreement, Astellas will pay to KaliVir up to US$56 million in the form of an upfront payment and other payments to support research and preclinical activities related to VET2-L2 and the Second Product. Additionally, Astellas may pay up to US$307 million and up to US$271 million for development, regulatory and commercialization of VET2-L2 and Second Product, respectively. Astellas also may make royalty payments on net sales of each licensed product.

"We are thrilled that Astellas has chosen KaliVir, and specifically VET2-L2, our lead product candidate, to add to their oncology program. VET2-L2, a multi-mechanistic, intravenously-delivered oncolytic vaccinia virus, has demonstrated strong precinical data prompting us to plan our initial clinical trial for VET2-L2," said KaliVir CEO Helena Chaye, Ph.D., J.D. "With Astellas’ excellent track record for drug development and commercialization, we believe that their commitment to collaborating with KaliVir represents strong third-party validation for our VET platform. We are commited to bringing this exciting product to cancer patients and believe that our collaboration with Astellas will expedite our ability to do this."

Naoki Okamura, Representative Director, Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer, at Astellas said, "We, at Astellas, have positioned Immuno-Oncology as one of the Primary Focuses of our R&D strategy, and we are committed to developing the next generation of Immuno-Oncology therapies through new modalities and technologies. Oncolytic viruses are one of the therapies in which we are particularly focused as we strive to provide new options for patients who have no effective treatment options. We expect this KaliVir collaboration to enhance our pipeline and further expand our cancer treatment options as we work to develop innovative medical solutions that turn innovative science into VALUE for patients."

On December 7, 2020 Researchers from SWOG Cancer Research Network, a cancer clinical trials group funded by the National Cancer Institute (NCI), part of the National Institutes of Health, reported that have shown that isatuximab, a monoclonal antibody approved for the treatment of multiple myeloma, can effectively treat relapsed refractory AL amyloidosis, findings to be announced at the 2020 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, SWOG Cancer Research Network, DEC 7, 2020, View Source [SID1234572334]).

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AL amyloidosis is a rare disease, with about 4,500 cases diagnosed each year in the United States. Like its cancerous cousin, multiple myeloma, AL amyloidosis involves plasma cells, in this case causing them to produce abnormal protein fibers that build up in tissues and organs, leading to vital organ dysfunction, failure, and death. Many drugs that work for multiple myeloma also work for people with AL amyloidosis. However, many AL amyloidosis patients see their disease return after initial treatment, creating a need for new therapy options. The SWOG team wanted to put isatuximab to the test with these relapsed refractory patients.

Emma Scott, MD, a medical director at the pharmaceutical company GSK and an adjunct associate professor in the Division of Hematology and Medical Oncology at Oregon Health & Science University (OHSU), designed the phase II trial while working full-time at OHSU. The trial is now led by Terri Parker, MD, of Yale Cancer Center, and Vaishali Sanchorawala, MD, of Boston Medical Center. The trial, S1702, enrolled 43 patients from 32 hospitals and clinics. All patients had previously been treated for AL amyloidosis, and 35 were eligible to receive the study drug. Patients received isatuximab intravenously every week for one 28-day cycle, then every other week for as many as 24 cycles. The median treatment time was about 12 months.

Researchers’ main objective was to determine patients’ hematologic response – a blood cell count that can be a good indicator of how well the treatment is working. Of the 35 patients who took isatuximab on S1702, there was an overall response rate of 77 percent. Of the 35 patients, hematological complete response was observed in one patient, very-good-partial response was found in 19 patients, and partial response was found in seven patients.

"This is encouraging news for patients who’ve already been treated for AL amyloidosis and who are looking for another, more effective treatment," Parker said. "This is the first study of isatuximab in this disease population, and if a phase III study confirms our results, we’ve opened up another treatment option for patients with this rare disease."

The SWOG team also gathered important safety information. Overall, 19 of the 35 patients stopped treatment, the most common reasons being adverse events, disease progression, sub-optimal response, and concerns related to COVID-19. The most common drug-related side effects were generally mild. They included infusion related reactions in 17 patients, or 49 percent of those taking the study drug, along with anemia and lymphopenia. Overall, researchers found a good safety profile, one similar to other monoclonal antibodies tested in AL amyloidosis.

Parker will share results of the SWOG study in an oral presentation on Dec. 7 at 1:30 p.m. PT at the 200 ASH (Free ASH Whitepaper) meeting. The ASH (Free ASH Whitepaper) abstract number is 728, and can be found here.

S1702 was supported by the National Institutes of Health through National Cancer Institute awards CA180888, CA180819, CA180820, and CA180821 and in part by Sanofi US.

Along with Parker and Sanchorawala, the SWOG team also includes Adam Rosenthal, MS, of the SWOG Statistics and Data Management Center; Heather J. Landau, MD, of Memorial Sloan Kettering Cancer Center; Erica L. Campagnaro, MD, of University of Michigan Rogel Cancer Center; Prashant Kapoor, MD, of Mayo Clinic; Natalia Neparidze, MD, of Yale University School of Medicine; Patrick Hagen, MD, of Loyola University Medical Center; Shayna Sarosiek, MD, of Boston University Medical Center; Emma C. Scott, MD, of GSK; Antje Hoering, PhD, the SWOG Statistics and Data Management Center; Brian G.M. Durie, MD, of Cedars-Sinai Medical Center; Saad Z. Usmani, MD, of Levine Cancer Institute; and Robert Z. Orlowski, MD, PhD, of The University of Texas MD Anderson Cancer Center.

On December 7, 2020 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported it has entered into a research collaboration and license agreement with Janssen Biotech, Inc. (Janssen) (Press release, Xencor, DEC 7, 2020, View Source [SID1234572333]). The research and license agreement is focused on the discovery of XmAb bispecific antibodies against CD28, an immune co-stimulatory receptor on T cells, and an undisclosed prostate tumor target, for the potential treatment of patients with prostate cancer. Additionally, Xencor has a right to access select, predefined agents from Janssen’s portfolio of clinical-stage drug candidates and commercialized medicines to evaluate potential combination therapies in prostate cancer with agents in its own pipeline in non-registrational clinical studies. Janssen has the same right with Xencor’s portfolio of clinical-stage drug candidates to evaluate potential combination therapies in prostate cancer, as well.

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"Our XmAb bispecific Fc domains enable the creation of a wide range of multi-specific antibody and protein structures, such as bispecific antibodies in our new CD28 platform. These antibodies can co-stimulate T cells in a tumor-target dependent manner and can synergize with both checkpoint inhibitor therapies and other tumor-targeted agents, like CD3 bispecific antibodies, in order to enhance anti-tumor activity," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "In addition, the ability to study combinations of therapies from both companies’ prostate cancer portfolios leverages Xencor’s broad clinical pipeline and the leading prostate cancer therapeutics portfolio at Janssen. This collaboration with Janssen expands the use of our CD28 platform and complements our first wholly owned internal candidate, a B7-H3 x CD28 bispecific antibody designed to treat a range of solid tumors, which is currently advancing through preclinical development."

Under the terms of the agreement, Xencor will apply its XmAb bispecific Fc technology to create and characterize XmAb CD28 bispecific antibody candidates against the tumor target specified by Janssen. Preclinical activities and all clinical development, regulatory and commercial activities will be conducted by Janssen, which has exclusive worldwide rights to develop and commercialize the novel drug candidates. Xencor will receive an upfront payment of $50 million and will be eligible to receive development, regulatory and sales milestone payments and high-single digit to low-double digit percent royalties on net sales.

Upon clinical proof of concept for a bispecific antibody candidate, Xencor has the right to opt-in to fund 20 percent of development costs and to perform up to 30 percent of the detailing efforts in the United States; Xencor would be eligible for milestone payments and low-double digit to mid-teen percent royalties on net sales.

The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and closing is expected to occur by year end.

On December 7, 2020 Helix BioPharma Corp. (TSX: "HBP") ("Helix" or the "Company"), an immunooncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a private placement financing for gross proceeds of $1,100,000 (Press release, Helix BioPharma, DEC 7, 2020, View Source [SID1234572332]).

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The terms of the placement are for the purchase of units at $0.50 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $0.70 and have an expiry of five years from the date of issuance. Helix intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

On December 7, 2020 Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology therapeutics, reported that new data showing monotherapy treatment with PT-112, the company’s lead clinical agent, was feasible and well tolerated in heavily pre-treated, relapsed / refractory multiple myeloma patients (Press release, Phosplatin, DEC 7, 2020, View Source [SID1234572331]). The study entitled, "A Phase I Dose Escalation Study of PT-112 in Patients with Relapsed or Refractory Multiple Myeloma," was presented in a narrated slide presentation on December 5 at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually from December 5-8, 2020.

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"The patients enrolled in this study have exhausted all currently available treatment options," said Taxiarchis Kourelis, M.D., Division of Hematology, Assistant Professor of Medicine, Mayo Clinic College of Medicine Rochester, Minnesota, who presented the study. "We are encouraged by these results, which show a well-tolerated safety profile and preliminary evidence of clinical activity that support further evaluation of PT-112 in a Phase II setting."

The study enrolled 24 patients using a 3+3 dose escalation design to determine the recommended Phase II dose. Patients received PT-112 as a monotherapy on a 28-day dosing cycle. All of the patients enrolled in the study were heavily pre-treated, having exhausted all available therapies. Key findings included the following:

PT-112 monotherapy treatment was feasible and well tolerated in this heavily pre-treated, relapsed / refractory multiple myeloma patient population, with one dose-limiting toxicity (grade 4 neutropenia, 420mg/m2) and no grade 4 non-hematological treatment-related adverse event observed.

The recommended Phase II dose (RP2D) of PT-112 was determined to be 360 mg/m2 given on days 1, 8, and 15 of a 28-day cycle.

Evidence of drug activity included a confirmed partial response in 1 of 4 patients treated at the RP2D, and a confirmed minimal response in a non-responding patient to prior BCMA-CAR-T therapy.

The study (NCT03288480) was designed and launched following translational work conducted in the Cancer Genetics Laboratory of P. Leif Bergsagel, M.D., at the Mayo Clinic in Scottsdale, Arizona.

"This evidence is very encouraging and supports our continued development of the PT-112 multiple myeloma program," said Robert Fallon, co-founder and Chief Executive Officer, Phosplatin Therapeutics. "We believe that PT-112’s immunogenic cell death induction, and osteotropic biodistribution, offers a compelling hypothesis for patients who have exhausted available treatment options. We look forward to expanding our study in the near future."

The presentation was part of "Session 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I" and is available on the ASH (Free ASH Whitepaper) Annual Meeting and Exposition site through the conclusion of the conference.

About PT-112

PT-112 is a novel small molecule conjugate of pyrophosphate that possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents the best-in-class small molecule inducer of this immunological form of cancer cell death and is currently under Phase II development. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase Ib study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase I study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) is the third completed Phase I study of PT-112.