On December 3, 2019 IONTAS Limited (IONTAS), a leader in the discovery and optimisation of fully human antibodies, reported it has entered into a collaboration agreement with Adaptate Biotherapeutics, developers of antibody-based therapeutics for modulation of gamma delta T-cells (Press release, Iontas, DEC 3, 2019, View Source [SID1234551885]). The agreement is to generate and optimise antibodies for novel immuno-oncology targets, including access to IONTAS’ proprietary Mammalian Display technology to select antibodies with optimal biophysical properties.

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IONTAS’ proprietary technology enables the construction of large libraries of stable cell lines displaying human antibodies on their surface. As well as generating an abundance of therapeutic antibody leads, the technology also addresses "developability" issues early in discovery; increasing the likelihood of successful progress through the development process. Under the terms of the collaboration, the project provides Adaptate Biotherapeutics with access to IONTAS’ proprietary Mammalian Display technology, allowing the selection of high affinity antibodies based on their function, stability, expression and developability thereby facilitating a speedy transition through Chemistry, Manufacturing and Controls (CMC) and eventual manufacturing.

Dr John McCafferty, Founder and Chief Executive Officer of IONTAS, commented: "Recently spun out of GammaDelta Therapeutics, Adaptate Biotherapeutics is already a leading company in the field of gamma delta T cell therapeutics and it is a privilege to be working with such an innovative team. This collaboration is further validation of our platform, including our Mammalian Display technology, and adds to an expanding portfolio of partners that enjoy the benefit of combining selection for affinity with developability during the initial steps of drug discovery. Subsequently, the resulting panels of "developable" antibodies facilitate manufacture and reduce the risk of delays and potential product failure by detecting and avoiding problematic clones at the outset. Our aim is to ensure the right lead is selected first time, every time."

Dr Natalie Mount, Chief Executive Officer of Adaptate Biotherapeutics, said: "IONTAS has developed an impressive track record in delivering therapeutic antibodies. We selected them as our partner because of their extensive experience in overcoming antibody project challenges using their industry-leading platforms. We anticipate that the combination of IONTAS’ antibody discovery capabilities and our innovative approach to gamma delta T cell-targeted therapeutics will facilitate the accelerated entry of our oncology portfolio to the clinic."

Dr Neil Butt, Chief Business Officer of IONTAS, will be at Antibody Engineering & Therapeutics, 9–13 December 2019, San Diego, CA.

Dr John McCafferty and Dr Neil Butt will attend the 38th Annual J.P.Morgan Healthcare Conference, 13–16 January 2020, San Francisco, CA.

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On December 3, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported that Alan Joslyn, Ph.D., president and CEO of Oragenics, Inc. will be a featured presenter at the LD Micro Main Event on Tuesday, December 10, 2019 at 1:00 PM Pacific Time at the Luxe Sunset Boulevard Hotel in Los Angeles, CA (Press release, Oragenics, DEC 3, 2019, View Source [SID1234551884]).

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Dr. Joslyn will provide an overview of the company’s business model and growth strategy and will be available for one-on-one meetings.

For those interested in attending or for registered attendees who wish to request meetings, please contact David Scher at [email protected] or visit www.ldmicro.com for more information.

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 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that Matt Coffey, President & CEO of Oncolytics Biotech, will be presenting on a panel as well as delivering a corporate presentation on systemic delivery tomorrow at the Oncolytic Virotherapy Conference (Press release, Oncolytics Biotech, DEC 3, 2019, View Source [SID1234551882]). The panel presentation, "To IT or IV? Intra-Tumoral vs. Intra-Venous Administration," will discuss what indications require IT versus IV, the risks and challenges associated with IT delivery and the views of physicians. Dr. Coffey’s corporate presentation will focus on a recently announced metanalysis of 13 clinical studies and how this intravenous-related data is driving the clinical programs of Oncolytics. The conference takes place December 4 – 5 at the Westin Waterfront Hotel in Boston, MA.

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"Our proven ability to systemically deliver pelareorep through intravenous delivery is a key value driver for Oncolytics," said Dr. Coffey. "I’m excited to see this topic gaining the exposure it deserves and thrilled to be a part of the conversation on this panel at the Oncolytic Virotherapy Conference. I’m also looking forward to presenting data to our peers that outlines pelareorep’s ability to target and infect a majority of tumors, triggering effective immune recruitment following intravenous administration."

Presentations

December 4, 1:40 pm ET

Clinical development of the oncolytic reovirus, pelareorep, for breast cancer

A meta-analysis from 13 different clinical studies on the efficiency of IV delivery
Combination therapy with checkpoint blockade in breast cancer.
Adaptive immune activation following IV delivery and the development of a potential biomarker
December 4, 3:10 pm ET

Panel Presentation: To IT or IV? Intra-Tumoral vs. Intra-Venous Administration

Decide whether OV treatments are most effective when injected directly into the tumour or systemically
Weigh the risks of IT administration with the benefits of a more targeted approach
Consider the views of physicians
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On December 3, 2019 (the "Closing Date"), Veracyte, Inc. (the "Company") reported that it has entered into a License and Asset Purchase Agreement (the "LAPA") with NanoString, Inc. ("NanoString"), pursuant to which the Company (the "Transaction") (i) obtained an exclusive worldwide license to NanoString’s nCounter FLEX Analysis System (the "FLEX System") for in vitro diagnostic use and for the development and commercialization of in vitro diagnostic tests, including in vitro diagnostic devices (IVDs) or laboratory developed tests (LDTs), for use on the FLEX System (collectively, the "License") and (ii) acquired certain assets, including NanoString’s rights with respect to the Prosigna Breast Cancer Prognostic Gene Signature Assay ("Prosigna"), the LymphMark Lymphoma Subtyping Test ("LymphMark") and the assay software modules that operate together with the FLEX System (Filing, 8-K, Veracyte, DEC 3, 2019, View Source [SID1234551880]). In connection with the Transaction, the Company will assume certain liabilities associated with the assets purchased under the LAPA, including ongoing third-party royalty obligations related to Prosigna and LymphMark. As part of the Transaction, the Company will also offer certain employees of NanoString employment. In connection with entering into the LAPA, the Company and NanoString also entered into various service and supply agreements relating to the manufacture and supply of Prosigna, LymphMark, and other in-vitro diagnostic tests that may be developed by or on behalf of the Company for use on the FLEX System and for the manufacture and supply of the FLEX System.

As consideration under the LAPA, the Company will pay NanoString $40,000,000 in cash. NanoString is also entitled to receive 376,732 shares of the Company’s common stock (the "Equity Consideration"), which shares represent a value of approximately $10,000,000 based on the average closing price of the Company’s common stock for the ten consecutive trading days ending on the third trading day prior to the Closing Date. The Company is required under the LAPA to register the Equity Consideration for resale within 90 days of the Closing Date as set forth in the registration rights schedule to the LAPA (the "Registration Rights Schedule").

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Pursuant to the terms of the LAPA, NanoString may not sell the Equity Consideration for the first 90 days following the Closing Date. Thereafter, NanoString may, subject to limited exceptions, not sell Equity Consideration representing more than 10% of the average daily trading volume of the Company’s common stock for the 30-day period preceding any such sale.

Pursuant to the LAPA, NanoString is also eligible to receive three additional payments, based upon the achievement of certain commercialization milestones, totaling $10,000,000 in the aggregate (the "Milestone Payments"). The individual Milestone Payments of $3,500,000, $3,500,000 and $3,000,000 will be due, respectively, upon the Company’s commercial launch of the first, second and third diagnostic test for use on the FLEX System, other than Prosigna or LymphMark, in each case as measured by the processing of the first commercial patient sample.

The foregoing summaries of the LAPA and Registration Rights Schedule are not complete and are qualified in their entirety by reference to the LAPA and Registration Rights Schedule, copies of which are filed as Exhibits 2.1 and 4.1 to this Current Report on Form 8-K and are incorporated herein by reference. The LAPA contains customary representations and warranties, covenants and indemnities. The representations, warranties and covenants contained in the LAPA were made only for the purposes of the LAPA, were made as of specific dates, and were made solely for the benefit of the parties to the LAPA, and may not have been intended to be statements of fact but, rather, as a method of allocating risk and governing the contractual rights and relationships among the parties. The assertions embodied in those representations and warranties may be subject to important qualifications and limitations agreed to by the parties in connection with negotiating their respective terms. Moreover, the representations and warranties may be subject to a contractual standard of materiality that may be different from what may be viewed as material to the Company’s stockholders. For the foregoing reasons, none of the Company’s stockholders or any other person should rely on such representations and warranties, or any characterizations thereof, as statements of factual information at the time they were made or otherwise.