On October 17, 2019 Biocure Technology Inc. (CSE: CURE OTCQB: BICTF) (the "Company" or "Biocure") reported that Biocure Pharm Corp.("BPK"), a subsidiary of the Company has appointed CLIPS (Clinical Professional Services) as the CRO (Contract Research Organization) to proceed with a Clinical Trial for CAR-T products in Korea (Press release, Biocure Technology, OCT 17, 2019, View Source [SID1234628815]). After reviewing multiple competent CRO’s in Korea and multiple meetings with them, BPK has selected CLIPS who has outstanding experience as well as expertise in gene therapies and cell therapies. In addition, their knowledge of the clinical trials convinced BPK it could achieve a successful clinical trial for CAR-T products within the given timeline.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Sang Mok Lee, a CEO and President of Biocure as well as BPK states, "I am pleased to appoint CLIPS as our CRO to proceed to a clinical trial for CAR-T products in Korea, where our Company targets the first commercialization of our CAR-T products. Biocure has successfully completed there pre-clinical trial in Korea last October 2018 and now is fully geared to speed up the process of clinical trial in Korea through this CRO appointment. We should be able to start a clinical trial in Korea no later than January 2020 and in Germany within 2Q, 2020. Biocure will continue to make every effort to commercialize CAR-T products as soon as possible to meet the expectations of our shareholders."

On October 17, 2019 ADC Therapeutics SA, a clinical-stage oncology-focused biotechnology company pioneering the development of highly potent and targeted antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors, reported that the first patients have been dosed in a 100-patient pivotal Phase 2 clinical trial evaluating the efficacy and safety of ADCT-301 (camidanlumab tesirine) in patients with relapsed or refractory Hodgkin lymphoma (HL) (Press release, ADC Therapeutics, OCT 17, 2019, View Source [SID1234596054]). The trial is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Alex Herrera, MD, Assistant Professor, Department of Hematology/Hematopoietic Cell Transplantation at City of Hope Medical Center and an investigator for the trial, said, "Approximately 15 to 25 percent of the 16,500 patients diagnosed with HL each year in the U.S. and Europe have relapsed or refractory HL. While advances have been made in the treatment of HL, a significant unmet medical need remains in the relapsed or refractory HL patient population, especially patients who have progressed following treatment with other novel agents. I believe ADCT-301 has the potential to fill this important medical need."

The primary objective of the Phase 2, multi-center, open-label, single-arm clinical trial is to evaluate the efficacy of ADCT-301 in patients with relapsed or refractory HL, measured by overall response rate based on the 2014 Lugano Classification Criteria. Patients with pathologically confirmed relapsed or refractory HL who have failed three prior lines of therapy, including brentuximab vedotin and a checkpoint inhibitor approved for HL such as nivolumab or pembrolizumab, are eligible for enrollment in the clinical trial.

Jay Feingold, MD, PhD, Senior Vice President, Chief Medical Officer and Head of Oncology Clinical Development at ADC Therapeutics, said, "In our large Phase 1 clinical trial, ADCT-301 demonstrated an overall response rate of 86.5 percent in patients with HL at the dose we are using in the pivotal Phase 2 clinical trial, with more than half of those being complete responses. We look forward to continuing the evaluation of ADCT-301 in this pivotal Phase 2 trial and, if successful, submitting a BLA to the FDA for accelerated approval of ADCT-301 for the treatment of relapsed or refractory HL in patients who have failed or were intolerant to brentuximab vedotin and a checkpoint inhibitor approved for HL."

For more information about the pivotal Phase 2 clinical trial of ADCT-301, please visit View Source (identifier NCT04052997).

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a human monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. Once bound to a CD25-expressing tumor cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead killing the cell with an immunogenic cell death. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring tumor cells. The ADC also depletes CD25-positive regulatory T cells in the tumor environment. All of these properties of ADCT-301 may enhance immune-mediated anti-tumor activity. ADCT-301 is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (NCT04052997), as well as ongoing Phase 1a/1b clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235) and a Phase 1b clinical trial in solid tumors (NCT03621982).

On October 17, 2019 ArsenalBio reported that its debut backed by $85 million Series A financing to build a programmable cell therapy company to create highly effective and accessible immune cell therapies (Press release, Arsenal Bio, OCT 17, 2019, View Source [SID1234567863]). The company will integrate technologies such as CRISPR-based genome engineering, scaled and high throughput target identification, synthetic biology, and machine learning to advance a new paradigm to discover and develop immune cell therapies, initially for cancer. ArsenalBio’s foundation stems from the contributions of scientific leaders from a consortium of academic medical and research institutions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Investors include Westlake Village BioPartners, the Parker Institute for Cancer Immunotherapy (PICI), Kleiner Perkins, the University of California, San Francisco (UCSF) Foundation Investment Company, Euclidean Capital, and Osage Venture Partners.

"Our goal is to address the unmet need and suffering of patients with cancer, and ultimately other diseases, by developing and advancing a new paradigm of human immune cell therapy design and treatment," said Ken Drazan, MD, ArsenalBio’s founding Chief Executive Officer. "The integrated technology approach we’re embarking upon will create a new arsenal of tools and medicines for researchers, patients and their physicians to reduce cancer morbidity and mortality."

Today’s commercialized, first-generation T cell therapies are designed and manufactured with the goal of inserting into T cells a single cell-targeting transgene, a chimeric antigen receptor or a new T cell receptor through viral delivery. ArsenalBio seeks to exponentially advance this process by precisely inserting, without viral vectors, significantly larger DNA payloads, designed with proprietary tools and encoding a broader set of biological "software" instructions to enable immune cells to effectively target and destroy solid organ and hematologic cancers. ArsenalBio’s approach will move beyond the current model of tumor-targeting strategies to enable the rewiring of immune cell circuitry through computationally driven design. The company aspires to evolve critical metrics of success for immune cell therapies, including enhanced and broader efficacy, increased patient safety, reduced provider costs, and expanded market access.

"The technology ArsenalBio is developing represents a significant advance in how cancer could be treated. The experience leaders such as Jane Grogan, Michael Kalos and Tarjei Mikkelsen bring, combined with Dr. Drazan’s results-oriented management approach, will help rapidly advance this transformational platform to benefit patients," added Beth Seidenberg, MD, co-founding Managing Director of Westlake Village BioPartners, a Los Angeles area-based venture capital firm focused on incubating and building life sciences companies.

"ArsenalBio is taking different approaches to gene editing, target selection, cell circuit engineering, and computation to reimagine dosing, delivery, persistence, and affordability of cell therapy. The networks of pharma, science, and talent relationships of PICI, Westlake and Kleiner Perkins is a booster to ArsenalBio’s remarkable team and R&D progress," said Brook Byers, Founding Partner of Kleiner Perkins of Menlo Park, CA.

"ArsenalBio allows us to rewrite vast stretches of code to give T cells dramatic new functions–that means they can be made to be more effective at killing cancer and a broad spectrum of other diseases," said Sean Parker, founder and Chairman of PICI. "It’s also very rewarding to see ArsenalBio born from the deep collaboration of PICI investigators—who worked together across research centers, hospitals and universities on the science behind these technologies. The company’s very existence demonstrates how much faster and better we can get therapies from bench to bedside when we collaborate and put patients first."

Experienced Management Team

ArsenalBio’s management team includes seasoned industry executives who bring immuno-oncology, cell therapy and genomic expertise:

Ken Drazan, MD, who most recently served as President of GRAIL, Inc.
Jane Grogan, PhD, Chief Scientific Officer (formerly Principal Scientist, Head of Adaptive Tumor Immunity and Cell Therapy, Genentech)
Michael Kalos, PhD, Executive Vice President, Head of Research & Development (formerly Vice President, Immuno-Oncology and Cell Therapies, Janssen Oncology)
Tarjei Mikkelsen, PhD, Chief Technology Officer (formerly Vice President, Biology at 10x Genomics)
Board of Directors with Proven Track Record

ArsenalBio’s board brings together industry leaders who have proven track records building successful companies:

Ken Drazan, MD, Founding CEO, ArsenalBio
Beth Seidenberg, MD, Managing Director, Westlake Village BioPartners
Brook Byers, Founding Partner, Kleiner Perkins
Sean Parker, Chairman and Founder, PICI
Alexander Marson, MD, PhD, Associate Professor of Microbiology/Immunology, UCSF and PICI Investigator
Scientific Founders

The company’s scientific founders comprise a bi-coastal, multi-disciplinary consortium of leading academic researchers:

Bradley Bernstein, MD, PhD, Professor of Pathology, Massachusetts General Hospital / Broad Institute
W. Nicholas Haining, BM BCh, Vice President, Discovery Oncology at Merck Research Laboratories, previously Associate Professor of Pediatrics, Dana-Farber Cancer Institute
Alexander Marson, MD, PhD, Associate Professor of Immunology, UCSF and PICI Investigator
Theodore Roth, PhD, UCSF School of Medicine, ArsenalBio’s founding interim Chief Scientific Officer
Kole Roybal, PhD, Assistant Professor of Immunology, UCSF and PICI Investigator
E. John Wherry, PhD, Chairman and Distinguished Presidential Professor of Systems Immunology, UPenn and PICI Investigator, Chair Arsenal Science Advisory Board

On October 17, 2019 OncoCyte reported that it has entered into a First Amendment to Loan and Security Agreement (the "Amended Loan Agreement") with Silicon Valley Bank (the "Bank") pursuant to which Oncocyte obtained a new $3 million secured credit facility ("Tranche 1"), a portion of which was used to repay the remaining balance of approximately $400,000 on outstanding loans from the Bank, plus a final payment of $116,000, under the February 21, 2017 Loan Agreement with the Bank (Filing, 8-K, Oncocyte, OCT 17, 2019, View Source [SID1234551120]). The credit line under the Amended Loan Agreement may be increased by an additional $2 million ("Tranche 2") if OncoCyte obtains at least $20 million of additional equity capital, as was the case with the original Loan Agreement, and a positive final coverage determination is received from the Centers for Medicate and Medicaid Services for the Razor lung cancer test at a specified minimum price point per test (the "Tranche 2 Milestone"), and OncoCyte is not in default under the Amended Loan Agreement.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Payments of interest only on the principal balance will be due monthly from the draw date through March 31, 2020 followed by 24 monthly payments of principal and interest, provided, however, that if the Tranche 2 Milestone is achieved the interest only payment period will be extended through September 30, 2020 followed by 18 equal monthly payments of principal plus interest. The outstanding principal balance of the loan will bear interest at a stated floating annual interest equal to (a) the greater of 0.75% above the prime rate or 4.25% for Tranche 1 loans, or (b) the greater of the prime rate or 5% per annum for Tranche 2 loans.

The principal amount of all loans plus accrued interest will be due and payable to the Bank at maturity on March 31, 2022. At maturity, OncoCyte will also pay the Bank an additional final payment fee of $200,000. Any amounts borrowed and repaid may not be reborrowed.

OncoCyte may prepay in full the outstanding principal balance at any time, subject to a prepayment fee equal to 3.0% of the outstanding principal balance if prepaid within one year after October 17, 2019, 2.0% of the outstanding principal balance if prepaid more than one year but less than two years after October 17, 2019, or 1.0% of the outstanding principal balance if prepaid two years or more after October 17, 2019.

The outstanding principal amount of the loan, with interest accrued, the final payment fee, and the prepayment fee may become due and payable prior to the applicable maturity date if an "Event of Default" as defined in the Amended Loan Agreement occurs and is not cured within any applicable cure period. An Event of Default includes, among other events, failure to pay interest and principal when due, material adverse changes, which include a material adverse change in OncoCyte’s business, operations, or condition (financial or otherwise), failure to provide the bank with timely financial statements and filings with the Securities and Exchange Commission, as required, legal judgments or pending or threatened legal actions of $50,000 or more, insolvency, and delisting from the NYSE American. OncoCyte’s obligations under the Amended Loan Agreement are collateralized by substantially all of its assets other than intellectual property such as patents and trade secrets that OncoCyte owns.

On October 17, 2019 in conjunction with Tranche 1 becoming available under the Amended Loan Agreement, OncoCyte issued a common stock purchase warrant to the Bank (the "Bank Warrant") entitling the Bank to purchase 98,574 shares of OncoCyte common stock at the initial Warrant Price of $1.69 per share through October 17, 2029. The number of shares of common stock issuable upon the exercise of the Bank Warrant will increase on the date of each draw, if any, on Tranche 2. The number of additional shares of common stock issuable upon the exercise of the Bank Warrant will be equal to 0.02% of OncoCyte’s fully diluted equity outstanding for each $1 million draw under Tranche 2. The Warrant Price for Tranche 2 warrant shares will be determined upon each draw of Tranche 2 funds and will be closing price of OncoCyte common stock on the NYSE American or other applicable market on the date immediately before the applicable date on which OncoCyte borrows funds under Tranche 2. The Bank may elect to exercise the Bank Warrant on a "cashless exercise" basis and receive a number of shares determined by multiplying the number of shares for which the Bank Warrant is being exercised by (A) the excess of the fair market value of the common stock over the applicable Warrant Price, divided by (B) the fair market value of the common stock. The fair market value of the common stock will be last closing or sale price on a national securities exchange, interdealer quotation system, or over-the-counter market.

On October 17, 2019 SurgiMab, a late-stage biotechnology company pioneering a new antibody-based fluorescence-guided approach with the aim to improve cancer surgery and clinical outcomes for patients, reported that the first US patient has been recruited into its on-going pivotal Phase 3 clinical trial evaluating its investigational imaging agent SGM-101 in patients undergoing colorectal cancer (CRC) surgery (Press release, Surgimab, OCT 17, 2019, View Source [SID1234542349]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The randomized Phase 3 trial, designed following discussions with the FDA and other regulators, aims to enroll 300 CRC patients in ten clinical centers in Europe and the US. The trial will assess the safety and clinical benefit of using fluorescence-guided surgery (FGS) with SGM-101 as an intraoperative imaging agent to better identify cancer lesions during the surgical procedure. Patients are injected with 10mg of SGM-101 four days prior to the scheduled CRC surgical procedure. Preliminary clinical data from the Phase 3 trial is expected in 2020. (ClinicalTrials.gov Identifier: NCT03659448)

SGM-101 is a tumor-specific antibody conjugated to a dye (fluorophore) that fluoresces under near-infra-red light; it selectively targets a marker on the cancer cell surface known as carcinoembryonic antigen (CEA), which is overexpressed by more than 95% of colorectal cancer cells. SGM-101 is being developed to provide cancer surgeons with a novel intraoperative imaging tool designed to improve the visualization of tumor tissues overexpressing CEA in real-time during surgery. The aim of the study is to demonstrate that SGM-101 could be used to enable surgeons to more clearly delineate the margin between tumor tissue and healthy tissue. If this is the case, it could allow a more accurate and complete resection of tumor tissue beyond what can currently be achieved with standard procedures. The Phase 3 trial is also seeking to determine if the use of SGM-101 could minimize or prevent removal of healthy tissue adjacent to tumor cells in order to better preserve functional outcomes.

SurgiMab is advancing SGM-101 into a pivotal Phase 3 trial based on compelling results from a Phase 2 study (n=75) in which residual and otherwise invisible tumor tissue was detected using SGM-101 during FGS. The Phase 2 study, published in The Lancet Gastroenterology & Hepatology[1], has shown that the use of SGM-101 during surgery leads to a modification of surgery in 35% of patients with recurrent or peritoneal metastases of CRC by allowing either more aggressive resection of tumor tissue or by preserving healthy tissue.

Dr Françoise Cailler, SurgiMab’s CEO, commented, "We are delighted to have started recruiting US patients into our pivotal Phase 3 study testing SGM-101 as a novel intraoperative imaging tool in CRC surgery. If this Phase 3 trial successfully demonstrates that the use of SGM-101 improves tumor resection, we believe that this could provide a new approach for the close to 150,000 patients diagnosed with CRC every year in the United States, most of whom undergo surgery. We look forward to reporting the preliminary data from our Phase 3 study in 2020."

Participating centers in the US in the Phase 3 study include:

Cleveland Clinic Florida, Weston, FL
Massachusetts General Hospital , Boston, MA
Moores Cancer Center – UC San Diego Health, La Jolla, CA
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA