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Be The Match BioTherapies® Announces Strategic Collaboration with Kiadis Pharma to Accelerate Patient Access to Haploidentical Stem Cell Therapies

On May 22, 2019 Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies, and Kiadis Pharma N.V. ("Kiadis") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, reported a strategic collaboration to support clinical evaluation of an innovative cell therapy product with potential to make haploidentical hematopoietic stem cell transplantations (HSCT) safer and more effective for patients (Press release, Be The Match BioTherapies, MAY 22, 2019, View Source [SID1234536533]).

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Under the terms of the collaboration agreement, Be The Match BioTherapies will provide logistical and technological solutions to support Kiadis’ Phase III clinical trial for ATIR101, an adjunctive immunotherapeutic designed to address key risks and limitations of HSCT in the treatment of blood cancers.

Kiadis’ multinational Phase III clinical trial is evaluating the safety and efficacy of ATIR101 as an adjunctive treatment to HSCT from a half-matched (haploidentical) family donor compared to post-transplant cyclophosphamide (PTCy or "Baltimore" protocol) in adult patients with blood cancers. The Phase III study is currently enrolling patients in the EU, Canada, Israel and the U.S.

The collaboration will leverage Be The Match BioTherapies’ industry-leading expertise in cell delivery logistics and supply chain case management, including the company’s MatchSource end-to-end supply chain management software, to manage the transport and processing of cellular products for use at Kiadis’ clinical trial sites in the U.S. and Canada.

"Kiadis’ quest to provide better treatment outcomes for patients receiving stem cell transplants is one we deeply share, given the foundational role that our parent company, the National Marrow Donor Program/Be The Match, has played in improving stem cell transplantation for more than three decades," said Chris McClain, vice president of Sales and New Business Development, Be The Match BioTherapies. "We look forward to utilizing our cell therapy expertise to advance Kiadis’ important work."

"We’re pleased to partner with Be The Match BioTherapies to progress our clinical investigation of ATIR101 and to expedite its availability to patients," said Andrew Sandler, chief medical officer of Kiadis Pharma. "We believe this therapeutic approach could allow family members to serve as stem cell donors for those patients who would otherwise not find a matching donor in time, ultimately saving lives."

Merck Foundation Announces Grant to American Cancer Society to Improve Access to Cancer Care in Resource-Limited Settings

On May 22, 2019 The Merck Foundation (the Foundation) and the American Cancer Society (ACS) reported that the Foundation awarded a $1.99 million, five-year grant to ACS to improve support and access to care for people living with cancer in low-and-middle-income countries, particularly in sub-Saharan Africa (Press release, Merck & Co, MAY 22, 2019, View Source [SID1234536532]). This funding will help ACS further develop its capacity development approach to expanding patient navigation to countries with a growing burden of cancer.

More than 70% of the 9 million cancer-related deaths worldwide are in resource-limited settings, where patients face many barriers in seeking a timely diagnosis and receiving high-quality cancer care. Patient navigators—whether nurses providing cancer education or lay health workers linking patients to transportation services in the community—play a vital role in supporting patients from the point of diagnosis at a health facility through their treatment journey.

With support from the Foundation, ACS will fortify its patient navigation program in Kenyatta National Hospital (KNH), a national referral hospital in Kenya, and adapt it for a high need facility in Uganda – The Uganda Cancer Institute (UCI), which serves about 200 patients daily.

"We are excited about the American Cancer Society’s program to bring patient navigation services to cancer patients in areas of the world where care coordination is especially challenging" says Dr. Julie Louise Gerberding, chief patient officer, Merck and vice chair, Merck Foundation Board of Trustees. "Cancer patients deserve quality care delivered with compassion, regardless of where they live."

This grant is a first step toward broad expansion of patient navigation programs to help more patients in resource-limited settings receive timely, high-quality cancer care. As part of this effort, ACS will develop a comprehensive guide and toolkit to develop and implement patient navigation programs, designed specifically for health facilities in low- and middle-income countries. Lessons learned from collaborating with hospitals in Kenya and Uganda will be incorporated into this guide, which ACS will pilot in health institutions in Asia and Latin America.

ACS hopes to demonstrate that resource-limited health care institutions can use patient navigation as an effective tool to improve cancer care. Looking ahead, ACS will help KNH and UCI integrate patient navigation services into the way they deliver cancer care, with the goal of transforming the patient experience so patients continue to receive the timely, high-quality cancer care they need.

"Over the last 30 years, patient navigation has become a standard of care across the U.S. to address the myriad hurdles that cancer patients – especially the most vulnerable – confront across the complicated continuum of cancer care," says Sally Cowal, senior vice president of Global Cancer Control, American Cancer Society. "We are eager to bring our expertise in this area to countries where health system challenges prevent patients from getting timely diagnoses and treatment."

"Uganda has a population of 43 million, but there are only 20 oncologists in the entire country. That’s one of the reasons why patient navigators are so important in helping patients manage the day-to-day challenges that prevent them from receiving care and empowering them to seek treatment and stay in care," says Dr. Jackson Orem, Executive Director of the Uganda Cancer Institute.

ACS will work with the Rollins School of Public Health at Emory University in Atlanta to evaluate the implementation of the patient navigation programs in Kenya and Uganda as well as the pilot of the program design guide and implementation toolkit. The evaluation team will disseminate its findings to the global cancer community and other interested stakeholders to advance the field’s knowledge of how to effectively support cancer patients in resource-limited settings.

AngioDynamics Receives FDA Approval to Initiate Pilot Study for the Use of NanoKnife® to Treat Prostate Cancer

On May 22, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that the United States Food and Drug Administration (FDA) approved the Company’s investigational device exemption (IDE) application for its NanoKnife Irreversible Electroporation pilot study for the ablation of prostate cancer tissue in low-risk patients (Press release, AngioDynamics, MAY 22, 2019, View Source [SID1234536531]).

The prospective, non-randomized pilot study includes six subjects at up to three clinical sites. The pilot study is intended to inform the design of a pivotal clinical study in the United States to support the approval of a future Premarket Approval Application (PMA).

"On the heels of our first patient enrollment in our Stage III pancreatic cancer IDE, we are excited to receive approval to conduct a separate pilot IDE for the treatment of prostate cancer," said Brent Boucher, AngioDynamics Senior Vice President and General Manager of Oncology. "This pilot study represents the next step in our comprehensive approach to establish NanoKnife as a platform technology to treat numerous cancers and conditions."

Prostate cancer is the second leading cause of cancer death in American men1. Approximately one man out of every nine will be diagnosed with prostate cancer during his lifetime1. Traditional treatment options have focused on standard whole-gland therapies, such as active surveillance, radical prostatectomy, and external beam radiation2. However, over the last decade, focal therapy has been evaluated as an alternative for select patients diagnosed with localized prostate cancer in order to minimize treatment-related toxicity2.

The NanoKnife System is a unique, minimally invasive technique that has been used to successfully treat focal prostate lesions through irreversible electroporation.

Exicure to Present at TIDES 2019 on Preclinical and Clinical Development of AST-008

On May 22, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported a presentation at TIDES: Oligonucleotide and Peptide Therapeutics, the world’s largest meeting to accelerate oligonucleotide and peptide products from early discovery to late-stage development and commercialization (Press release, Exicure, MAY 22, 2019, View Source [SID1234536530]).

The talk, "Preclinical and Clinical Development of AST-008, A Toll-like Receptor Agonist 9 Spherical Nucleic Acid for Immuno-oncology Applications," will be presented by Weston Daniel, Exicure Senior Director of Program Management, at the conference, May 20-23 at Manchester Grand Hyatt in San Diego.

Presentation Date/Time: Wednesday, May 22, 12:45 – 4:35 p.m. PT
Room: Seaport A
Session: Oligonucleotide Discovery, Preclinical and Clinical

OncoSec Provides Encouraging Interim Data from Ongoing KEYNOTE-890 Study of TAVO in Combination with KEYTRUDA® for the Treatment of Heavily Pretreated Chemotherapy/Radiotherapy Refractory Metastatic Triple Negative Breast Cancer

On May 22, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a late-stage cancer biotechnology company developing gene-based intratumoral immunotherapies, reported interim data from KEYNOTE-890, an ongoing Phase 2 study of TAVO (intratumoral IL-12) in combination with KEYTRUDA in patients with heavily pretreated, metastatic, chemotherapy refractory triple negative breast cancer (mTNBC) (Press release, OncoSec Medical, MAY 22, 2019, View Source [SID1234536528]). Patients who previously failed an average of 3.5 prior lines of chemotherapy were enrolled in KEYNOTE-890 to evaluate if the addition of TAVO (IL-12) could provide meaningful clinical activity when combined with KEYTRUDA, an anti-PD-1 checkpoint inhibitor.

Heavily pretreated patients with refractory mTNBC (average of 3.5 prior lines of chemotherapy) showed a rapid tumor reduction of 20% or greater at the initial 3-month evaluation in the first five of 10 patients. Two patients had a partial response, one with a 66% tumor reduction, including a significant reduction of liver lesions, and four patients had stable disease, three of which reported a 20% or greater tumor reduction. These preliminary findings, when compared to the results of KEYNOTE-086, which demonstrated a 5.3% response rate in mTNBC patients treated with KEYTRUDA monotherapy1, suggest TAVO’s ability to unlock KEYTRUDA’s potential anti-cancer efficacy in this very difficult to treat patient population. Four of the six patients who experienced tumor reductions have an ongoing response as of May 9, 2019.

"These interim data are impressive, especially when considering that all of the patients received numerous prior rounds of chemo/radiation with no success, and the safety profile associated with this platform continues to be unparalleled. Metastatic TNBC is a heterogeneous cancer with a poor prognosis where less than five percent of pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint treatments," explained Alain Algazi, M.D., Associate Professor of Clinical Medicine at UCSF and Clinical Strategic Advisor to OncoSec. "Therefore, the marked synergy shown in these patients adds even more support for our earlier findings demonstrating that TAVO primes the tumor microenvironment, dramatically improving the clinical results that would have been anticipated with PD-1/PD-L1 checkpoint treatment alone. The combination of TAVO and KEYTRUDA represents a highly promising new therapeutic approach for TNBC and warrants expedited evaluation."

Of the four patients who progressed following treatment, two received only one cycle of combination treatment prior to rapid clinical deterioration. Importantly, treatment was very well-tolerated, with only three patients reporting Grade 1 TAVO-related adverse events (AE’s). No TAVO-related Grade 2 or above AE’s/SAE’s were reported.

Patients demonstrated encouraging immunological responses in tumor and blood consistent with an IL-12-associated mechanism of action, including on-treatment reduction of the peripheral gMDSC suppressors, which aligns with observed clinical responses. Biomarker analysis of patient tumor and blood samples are ongoing.

The Company has enrolled over half of the targeted enrollment of 25 patients, and expects to complete enrollment and present the clinical data at the San Antonio Breast Cancer Symposium later this year.

Additional details can also be found at www.clinicaltrials.gov here.

To learn more about the trial, visit www.oncosec.com.

About Triple Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. As a result, TNBC does not respond to therapies targeting these markers, making it more difficult to treat. Approximately 10-20% of patients with breast cancer are diagnosed with TNBC.

About KEYNOTE-890

KEYNOTE-890 is designed as a multicenter Phase 2 open-label trial focusing on patients with a histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least 1 prior line of approved systemic chemotherapy or immunotherapy. 25 patients are expected to be enrolled. Each patient will undergo 3-week treatment cycles with pembrolizumab administered as a 30-minute IV infusion day 1 of every cycle (flat dose of 200 mg) and treated with TAVO on days 1, 5 and 8 every six weeks.