On October 3, 2019 Biodesix, Inc., reported it has been issued U.S. Patent Number 10,422,729, which covers the Biodesix Collection Device (BCD) (Press release, Biodesix, OCT 3, 2019, View Source [SID1234540040]). The new device offers improved ease of use in blood sample collection for diagnostic testing, compared to current standard methods.

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"This device is intuitive and very easy to use," remarked Susan Garwood, M.D., Pulmonary and Advanced Bronchoscopy Lung Cancer Specialist with Centennial Medical Center in Nashville, part of the HCA TriStar division. "The Biodesix Collection Device enables the opportunity for a fast, simple collection process. Enhancing patient comfort while retaining accuracy is of top concern for all professionals drawing patient blood samples."

The BCD, currently in use with the Biodesix Nodify XL2 test, replaces the need for processing samples used for proteomic testing on-site and shipping blood tubes, which often requires cold-chain logistics during transit to the testing laboratory. This reduces the need for processing equipment such as centrifuges in the clinic, improves sample stability during transit and eliminates the need for single-use, bulky shipping containers containing materials such as Styrofoam that are not only costly but also have a negative environmental impact.

"The BCD is designed for exceptional laboratory test performance and surpasses similar collection methods by combining multiple sample processing steps, including specimen collection and reproducible sample separation with ambient shipping. Specimen stability has been demonstrated with analytic measures of proteins using highly sensitive mass spectrometry methods," said Gary Pestano, Ph.D., chief development officer at Biodesix.

"Our commitment to innovation continues to improve the customer experience," commented Scott Hutton, chief operating officer at Biodesix. "We are as focused as ever on supporting healthcare professionals and their patients by providing increasingly valuable information to physicians using a noninvasive blood collection. The new BCD significantly reduces cost and environmental impact over current sample collection practices, and we are excited to not only use this for our own tests but to make it available for broad use across the industry."

Biodesix is planning to use the new BCD in all current and future proteomic testing and also make the device available for purchase by labs and diagnostic companies wishing to use this novel technology for their own sample processing and testing. To see how the BCD is used to collect specimens for the Nodify XL2 test visit this link.

On October 3, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has opened for enrollment a Phase 1b expansion cohort of its Phase 1/2 clinical trial of cirmtuzumab, a ROR1-targeted monoclonal antibody, combined with ibrutinib, in patients with mantle cell lymphoma (MCL) (Press release, Oncternal Therapeutics, OCT 3, 2019, View Source [SID1234540042]). The decision to open an expansion cohort in MCL of the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial was based on favorable interim results from the dose-finding cohort of the trial, including that the combination was well-tolerated and that complete responses were observed in two heavily pre-treated patients who had received and failed multiple chemotherapy regimens and an autologous transplant, as well as either an allotransplant or CAR-T therapy, prior to participating in this clinical trial.

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In June, the Company presented interim data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, including the preliminary results from the first six patients with MCL treated in the CIRLL clinical trial. One patient with MCL, who had relapsed following an allogeneic stem cell transplant, experienced a confirmed complete response (CR) after three months of cirmtuzumab plus ibrutinib treatment, including complete resolution of a large mediastinal mass. This CR appears to be sustained and has been confirmed to be ongoing after completing 12 months of cirmtuzumab plus ibrutinib treatment. Following ASCO (Free ASCO Whitepaper), a second confirmed CR occurred in a patient who had progressive disease after failing several different chemotherapy regimens, autologous transplant and CAR-T therapy. Additional data from this clinical trial will be presented at a future medical conference.

"It is encouraging to see that the drug has been well tolerated as well as the early signal of efficacy of cirmtuzumab with ibrutinib in MCL, particularly the rapid and durable complete responses of the heavily pre-treated patients after three months of therapy, which is an unusually fast response in this patient population," said Hun Lee, M.D., Assistant Professor of Medicine in the Department of Lymphoma & Myeloma at the University of Texas MD Anderson Cancer Center, who is an investigator on the CIRLL clinical trial.

The CIRLL clinical trial is supported by a grant from the California Institute for Regenerative Medicine (CIRM) and is being conducted in collaboration with the University of California San Diego (UC San Diego).

"We are pleased to be opening the expansion cohort portion of the CIRLL clinical trial for patients with MCL, and continue to be encouraged by the interim results from this study for both patients with MCL and patients with chronic lymphocytic leukemia, for whom a randomized Phase 2 portion of the trial was opened in August," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.

About the CIRLL Clinical Trial

The CIRLL clinical trial (CIRM-0001) is a Phase 1/2 trial evaluating cirmtuzumab in combination with ibrutinib in separate groups of patients with chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL). Part 1 of the clinical trial was a Phase 1 dose-finding portion designed to determine the Phase 2 dose, or recommended dosing regimen (RDR). Part 2 is a Phase 1b expansion cohort to confirm the RDR. Additional information about the CIRM-0001 clinical trial and other clinical trials of cirmtuzumab may be accessed at ClinicalTrials.gov.

About Cirmtuzumab

Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL and MCL, in a collaboration with the University of California San Diego School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with metastatic breast cancer is being conducted at the UC San Diego School of Medicine. CIRM has also provided funding to support development programs for cirmtuzumab and a CAR-T therapy that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors.

ROR1 is a potentially attractive target for cancer therapy because it is an oncofetal antigen – a protein that confers a survival and fitness advantage when reactivated and expressed by tumor cells. When expressed by hematologic malignancies such as CLL and MCL, ROR1 acts as a receptor for the tumor growth factor Wnt5a. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to inhibiting Wnt5a activation, specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. Cirmtuzumab is in clinical development and has not been approved by the U.S. Food and Drug Administration for any indication.

On September 27, 2019, Rigel Pharmaceuticals, Inc., a Delaware corporation (the "Company") reported that entered into a Credit and Security Agreement, dated as of September 27, 2019 (the "Closing Date") by and among the Company, the lenders party thereto from time to time and MidCap Financial Trust, as administrative agent and collateral agent ("Agent") (the "Term Loan Credit Agreement"), which provides for a $60 million term loan facility (Filing, 8-K, Rigel, OCT 2, 2019, View Source [SID1234540009]). The Term Loan Credit Agreement provides for (i) on the Closing Date, $10.0 million aggregate principal amount of term loans, (ii) at the Company’s option, until December 31, 2020, an additional $10.0 million term loan facility, (iii) at the Company’s option, until March 31, 2021, an additional $20.0 million term loan facility subject to the satisfaction of certain conditions ("Tranche Three") and (iv) at the Company’s option, until March 31, 2022, an additional $20.0 million term loan facility subject to the satisfaction of certain conditions ("Tranche 4") (collectively, the "Term Loans"). The Company used the proceeds of the Term Loans for general corporate purposes

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The obligations under the Term Loan Credit Agreement are secured by a perfected security interest in all of the Company’s assets except for intellectual property and certain other customary excluded property pursuant to the terms of the Term Loan Credit Agreement.

The Term Loans are subject to an origination fee of 0.25% of each funded tranche of Term Loans. The Company will pay the Agent an annual administrative fee of 0.25% of the amount borrowed under the Term Loans, payable annually. The Term Loans may be prepaid in full or in part through September 27, 2020 with payment of a 2.5% prepayment premium, after which they may be prepaid in full or in part through September 27, 2021 with payment of a 1.5% prepayment premium, after which they may be prepaid in full or in part through September 27, 2022 with payment of a 1.0% prepayment premium, after which they may be prepaid in full or in part with no prepayment premium. An additional 2.5% of the amount of Terms Loans advanced by the lenders will be due upon prepayment or repayment of the Term Loans in full.

The interest rate applicable to the Term Loans is LIBOR plus 5.65%, subject to a LIBOR floor of 1.50%. Commencing October 1, 2019, the Company initially will make interest-only payments for 24 months, followed by 36 months of amortization payments. The interest-only period will be extended to 36 months and again to 48 months upon the satisfaction of certain conditions set forth in the Term Loan Credit Agreement. All unpaid principal and accrued interest is due and payable in full no later than September 1, 2024.

The Term Loan Credit Agreement requires that the Company (i) upon both of (x) the draw of Tranche 3 or Tranche 4 and (y) cash falling below 1.25x Term Loans outstanding, maintain U.S. Tavalisse Net Revenue (as defined in the Term Loan Credit Agreement) in amounts set forth in the Term Loan Credit Agreement and (ii) upon the draw of Tranche 3 or Tranche 4, maintain cash and cash equivalents of at least $10.0 million. The Term Loan Credit Agreement also contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions.

Events of default under the Term Loan Credit Agreement include: (i) failure by the Company to timely make payments due under the Term Loan Credit Agreement; (ii) material misrepresentations or misstatements in any representation or warranty by the Company when made; (iii) failure by the Company or its subsidiaries to comply with the covenants under the Term Loan Credit Agreement and other related agreements; (iv) certain defaults under a specified amount of other indebtedness of the Company or its subsidiaries; (v) insolvency or bankruptcy-related events with respect to the Company or any of its subsidiaries; (vi) certain undischarged judgments against the Company or its subsidiaries; (vii) certain ERISA-related events with respect to the Company or its subsidiaries above a specified amount; (viii) certain security interests or liens under the loan documents ceasing to be, or being asserted by the Company not to be, in full force and effect; (ix) the institution of criminal proceedings against the Company; (x) an event of default under the guarantee of the obligations under the Term Loan Credit Agreement; (xi) the prepayment of any subordinated debt other than as specifically permitted by the terms of such subordination; (xii) the occurrence of a Material Adverse Change (as defined in the Term Loan Credit Agreement); (xiii) certain adverse actions by the FDA or DEA with respect to certain products or which could be reasonably expected to result in a Material Adverse Change (as defined in the Term Loan Credit Agreement); (xiv) a default or material breach under certain specified material contracts and (xv) any loan document ceasing to be, or any challenge or assertion by the Company that such loan document is not, in full force and effect. If one or more events of default occurs and continues beyond any applicable cure period, the Agent may, with the consent of the lenders holding a majority of the loans and commitments under the facilities, or will, at the request of such lenders, terminate the commitments of the lenders to make further loans and declare all of the obligations of the Company under the Term Loan Credit Agreement to be immediately due and payable.

On October 2, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that it will be presenting clinical biomarker data from its ongoing ALX148 phase 1 clinical program at the SITC (Free SITC Whitepaper) 34th Annual Meeting, November 6-10, 2019 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland (Press release, ALX Oncology, OCT 2, 2019, View Source [SID1234540025]).

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Poster Presentation Information
Title: Pharmacodynamic biomarker characterization of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy (Abstract P449)
Date: Friday, November 8, 2019
Time: 7:00 am – 8:00 pm

On October 2, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported planned poster presentations at upcoming scientific meetings highlighting new preclinical data on the Company’s lead programs: ALPN-101, a first-in-class dual CD28/ICOS inhibitor for the treatment of autoimmune diseases, and ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor for the treatment of cancers (Press release, Alpine Immune Sciences, OCT 2, 2019, View Source [SID1234540010]).

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2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting – National Harbor, MD

Abstract Title: ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Utilizes Multiple Mechanisms to Elicit Potent Anti-Tumor Immunity Superior to Checkpoint Blockade Alone
Poster #: P793
Date: Friday, November 8, 2019
Time: 7:00 a.m. – 8:00 p.m. ET

Abstract Title: ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Enhances the Activity of Multiple Standard of Care Modalities
Poster #: P467
Date: Friday, November 8, 2019
Time: 7:00 a.m. – 8:00 p.m. ET

American College of Rheumatology 2019 ACR/ARHP Annual Meeting – Atlanta, GA

Abstract Title: ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Underlying Rheumatoid and Psoriatic Arthritis
Session Title: Spondyloarthritis Including PsA–Clinical Poster II: Treatment of Axial Spondyloarthritis and Psoriatic Arthritis
Date: Monday, November 11, 2019
Time: 9:00 a.m. – 11:00 a.m. ET

Abstract Title: ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Associated with Sjögren’s Syndrome
Session Title: Sjögrenʼs Syndrome–Basic & Clinical Science Poster I
Date: Tuesday, November 12, 2019
Time: 9:00 a.m. – 11:00 a.m. ET