On December 3, 2019 ArcherDX, Inc., a growth-stage molecular diagnostics company dedicated to developing breakthrough solutions that advance personalized genomic medicine, reported a non-exclusive partnership with Illumina, Inc. (NASDAQ: ILMN) to develop in-vitro diagnostic (IVD) tests for Archer’s planned portfolio of next-generation sequencing (NGS)-based companion diagnostics (Press release, ArcherDX, DEC 3, 2019, View Source [SID1234551898]).

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The scope of the agreement includes ArcherDX’s future portfolio of IVD tests used to facilitate targeted therapy selection and monitoring of Minimal Residual Disease for the management of patients with solid tumor and blood cancers. The planned IVD tests will empower commercial laboratories, hospitals and health systems to run these assays in their local laboratories worldwide.

Under the agreement, ArcherDX will develop IVD tests to run on Illumina’s NextSeq 550Dx System. ArcherDX will be responsible for obtaining necessary regulatory approvals for each IVD kit and for their subsequent commercialization. ArcherDX and Illumina entered into a similar agreement for the MiSeq Dx System in 2016.

"We are pleased to expand our development partnership with Illumina, whose large install base and highly accurate sequencing systems will accelerate our efforts to democratize access to high-quality genomic testing by developing distributable diagnostic assays that can be used to identify targeted therapy options, as well as monitor for the recurrence of disease across a wide variety of cancers," said Jason Myers, Chief Executive Officer and co-founder of ArcherDX. "These IVD tests will provide important new options for providers and patients around the world."

"Partnerships that bring exceptional clinical content to customers and patients represent an exciting opportunity in clinical genomics," said Dr. Phil Febbo, Chief Medical Officer of Illumina. "By enabling ArcherDX to develop IVD tests, we are ensuring health care providers and patients have access to a growing menu of important distributable diagnostic tests that will improve patient outcomes."

On December 3, 2019 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT drug candidate for prostate cancer (Press release, Advaxis, DEC 3, 2019, View Source [SID1234551866]).

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"We are pleased to announce continued clinical progress of our ADXS-HOT program," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Results from our ADXS-NEO program provided important proof-of-concept data demonstrating the generation of CD8+ T cells against hotspot mutations. Based on these encouraging results, and the convenient and broadly accessible off-the-shelf approach of our HOT therapies, we are focused on expanding the HOT program to additional cancer-specific trials through various, capital-efficient avenues. In addition, we look forward to reporting immune data from the monotherapy arm of our ongoing Phase 1/2 HOT clinical trial in non-small cell lung cancer (NSCLC) in early 2020."

ADXS-504 is part of the company’s ADXS-HOT off-the-shelf immunotherapy platform which targets hotspot neoantigens, allowing for the development of multiple cancer-type specific clinical candidates. Advaxis has designed over ten ‘HOT’ drug candidates that are in various stages of development, with the company’s Phase 1/2 clinical trial for ADXS-503 in NSCLC currently enrolling patients at five centers. Advaxis anticipates reporting the immune data from the first dose level of ADXS-503, Part A, in monotherapy, and expects to dose the first patient in Part B, which is studying ADXS-503 in combination with the checkpoint inhibitor pembrolizumab, in early 2020.

About ADXS-HOT

ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other cancer-testes and oncofectal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment approach designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.

On December 3, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that clinical data updates for cirmtuzumab, its investigational anti-ROR1 monoclonal antibody, will be presented at upcoming medical conferences (Press release, Oncternal Therapeutics, DEC 3, 2019, View Source [SID1234551883]).

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Interim data from the ongoing Phase 1/2 clinical study of cirmtuzumab in combination with ibrutinib in patients with chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting that will be held December 7-10, 2019, in Orlando, FL.

Abstract: Cirmtuzumab, a ROR1 Targeted mAb, Reverses Cancer Stemness, and Its Combination with Ibrutinib Is Safe and Effective: Planned Analysis of the CIRLL Phase 1/2 Trial for CLL and MCL (abstract #1755)
Session Name: 642. CLL: Therapy, excluding Transplantation: Poster I
Session Date: Saturday, December 7, 2019
Session Time: 5:30 PM – 7:30 PM
Location: Hall B, Level 2 (Orange County Convention Center)
Initial data from the ongoing, investigator-sponsored Phase 1 clinical study of cirmtuzumab in combination with paclitaxel in patients with Her2 negative, metastatic or locally advanced unresectable breast cancer will be presented at the San Antonio Breast Cancer Symposium (SABCS) that will be held December 10-14, 2019, in San Antonio, TX.

Abstract: Phase 1b Trial of Cirmtuzumab and Paclitaxel for Locally Advanced, Unresectable and Metastatic Breast Cancer
Session Name: PS3. Poster Session 3
Session Date: Thursday, December 12, 2019
Session Time: 5:00 PM – 7:00 PM
Location: Hall 1 (Henry B. Gonzalez Convention Center)
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 December 3, 2019 Boston Biomedical, Inc. reported that the company has entered into an alliance in oncology research with three world-leading oncology centers of excellence – Columbia University, Harvard University and The Wistar Institute (Press release, Boston Biomedical, DEC 3, 2019, View Source [SID1234551899]).

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The Sumitomo Dainippon Pharma Group, which consists of Sumitomo Dainippon Pharma and its subsidiaries, Boston Biomedical and Tolero Pharmaceuticals, Inc., will have access to novel targets and platform technologies that may be discovered by the three United States institutions in the course of research projects supported by this alliance for the development of cancer drugs. Leveraging each institution’s unique technologies and therapeutic insights, specific research areas will be pursued over the five-year agreement, with input from Joint Steering Committees at each institution as well as representation from companies within the Sumitomo Dainippon Pharma Group.

"We are thrilled to be collaborating with the distinguished scientists at Columbia University, Harvard University and The Wistar Institute," said Dr. Mahmoud Mahmoudian, Senior Vice President, Head of Global Oncology External Innovation, Sumitomo Dainippon Pharma Global Oncology. "We will leverage this commitment to innovation to bring together the wealth of expert knowledge housed in these academic institutions and our Group to work on unique themes, with the goal of delivering innovative new drugs to patients."

The Sumitomo Dainippon Pharma Group positions oncology as one of its priority areas of research and is seeking new opportunities for network-based drug discovery with universities and biotech companies in Japan and the U.S. The Group has also established a Global Oncology External Innovation Hub in Cambridge, Mass., a leading hub of oncology research, to enhance collaboration with external organizations. This framework for research alliances with globally renowned U.S. academic institutions marks a significant advance in propelling drug discovery by the Group.

In a joint statement, Orin Herskowitz, Executive Director of Columbia Technology Ventures at Columbia University, Isaac Kohlberg, Chief Technology Development Officer and Senior Associate Provost at Harvard University, and Dr. Heather Steinman, Vice President of Business Development and Executive Director of Technology Transfer at The Wistar Institute, said: "We are deeply appreciative of the investment Boston Biomedical has made to establish this strategic research alliance, which aims to advance discovery and innovation in oncology for patients’ benefit. This foundational support furthers our institutions’ commitment to drive innovation for tomorrow’s discoveries and advancements in oncology."

On December 3, 2019 Applied DNA Sciences reported that LineaRx, the Company’s majority-owned subsidiary focused on next-generation biotherapeutics and diagnostics, it has signed a definitive agreement with Tyme Technologies, to supply the Company’s Vita-Assay invasive Circulating Tumor Cell (iCTC) capture assay and associated services for use in the pivotal stage of the TYME-88-PANC clinical trial for patients with third-line pancreatic cancer (the "Agreement") (Press release, Applied DNA Sciences, DEC 3, 2019, View Source [SID1234551867]).

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Under the terms of the Agreement, TYME has the option to purchase from the Company up to 3,000 Vita-Assay kits and associated iCTC analytical and storage services over the course of treatment of up to 250 patients. The potential value of the Agreement is the largest contract to-date for LineaRx, and the largest in the development history of the iCTC assay.

The Company and TYME have previously announced a study demonstrating correlation between the number of iCTCs in a patient’s blood and their disease status, as observed in TYME’s SM-88 Phase II trial for recurrent prostate cancer. The study demonstrated that SM-88 had very encouraging efficacy and safety outcomes for prostate cancer patients where sparing testosterone was important. The study also showed that reduction of CTCs, an important prognostic indicator, may prove to be a better surrogate for patient outcomes than PSA, particularly for SM-88 and other non-hormonal agents.