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.

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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.

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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]).

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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

On October 17, 2019 Kymera Therapeutics Inc., a biotechnology company pioneering targeted protein degradation to discover breakthrough medicines for patients, reported the company will present preclinical data showing the discovery and characterization of novel, selective, and potent degraders of STAT3, a transcriptional regulator linked to numerous cancers and other diseases (Press release, Kymera Therapeutics, OCT 17, 2019, View Source [SID1234542348]). Data will be shared during a poster presentation (Abstract #C054) at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston on Tuesday, October 29 at 12:30 PM EST.

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STAT3 is an oncogenic transcription factor that is regulated by multiple signaling events including the IL-6-JAK pathway and growth factor receptors. Activating mutations and aberrant activation of STAT3 have been directly linked to the promotion of cancer cell survival and proliferation and immune evasion, making it a highly attractive target for hematologic malignancies and solid tumors.

"STAT3 has historically been considered an ‘undruggable’ transcription factor. Over the past few decades, some of the key challenges for this target have been the lack of small molecule binders, additional functions beyond transcriptional regulation, and sequence homology with other SH2 domain-containing STAT family members," said Nello Mainolfi, PhD, Founder, President & CSO of Kymera Therapeutics. "Using our drug discovery engine, especially our understanding of ternary complex structure and function, we rationally designed specific STAT3 degraders with excellent in vivo properties. Our data using these degraders have shown disruption of signaling downstream of STAT3 and promising antitumor activity in multiple cancer models, supporting the transformative therapeutic potential of this modality. With these unique molecules we are expanding the understanding of the biological impact of STAT3 degradation in tumor and immune contexts."

AACR-NCI-EORTC Study Highlights
ABSTRACT #C054, "Discovery of KYM-003, a Potent and Selective STAT3 Degrader with Anti-Tumor Activity in Heme Malignancies," presented by Fred Csibi, Associate Director, Oncology Biology at Kymera Therapeutics.
in vitro

KYM-003 cooperatively formed a high-affinity STAT3-KYM003-E3 ligase ternary complex.
KYM-003 potently induced ubiquitination of endogenous STAT3.
KYM003-induced degradation was highly selective for STAT3 versus >10,000 other detected proteins (including all other STAT family members) in tumor cell lines and hPBMCs.
KYM003-induced degradation of STAT3 resulted in downregulation of STAT3 target-gene expression, including the PIM1 oncogene.
in vivo

Total STAT3 levels in tumors were reduced by >90% for at least 24 hours after a single dose of KYM-003.
Repeated dosing of KYM-003 showed dose-dependent antitumor activity in xenograft models of heme malignancies with good tolerability.

On October 17, 2019 Accelerate Diagnostics, Inc. (NASDAQ: AXDX) reported that it will report financial results for the third quarter of 2019 after the market close on Thursday, November 7, 2019 (Press release, ACCELERATED MEDICAL DIAGNOSTICS, OCT 17, 2019, View Source [SID1234542347]). The company’s management will host a conference call at 4:30 p.m. ET that same day to review the results.

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Listen to the audio webcast online by visiting ir.axdx.com and selecting the event. A replay of the audio webcast will be available until November 28, 2019.

To listen by phone, dial +1.877.883.0383 and enter the conference ID: 2508360

International participants may dial +1.412.902.6506. Please dial in 10-15 minutes prior to the start of the conference. A replay of the call will be available by telephone at +1.877.344.7529 (U.S.) or +1.412.317.0088 (international) using the replay code 10136055 until November 28, 2019.