On April 23, 2020 Immunomic Therapeutics, Inc., ("ITI") a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported the close of a $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs (Press release, Immunomic Therapeutics, APR 23, 2020, View Source [SID1234556532]). This represents the second closing in the investment process for the HLB Consortium, ($10M was placed in February 2020), and substantially increases their holding in Immunomic Therapeutics to 47.6% of the common stock. HLB also secured an option to make further investment into the company in the months ahead.

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"We are pleased to welcome HLB as a significant shareholder of Immunomic Therapeutics and look forward to working with them within the framework of the HLB Bio family of companies. They have a proven track record of success in Asia and share our commitment and passion for developing best-in-class therapies for cancer and other serious diseases," said Dr. William Hearl, CEO of Immunomic Therapeutics. "With HLB’s support, we are well-positioned to accelerate our efforts in immuno-oncology, in particular glioblastoma multiforme, and rapidly advance other key candidates in our pipeline, including our most recent initiative into infectious diseases with development of our vaccine candidate for COVID-19."

Proceeds from the financing will support the acceleration of ITI’s Phase II clinical trial of ITI-1000 for the treatment of glioblastoma multiforme (GBM), advance its emerging pipeline, and expand upon the current applications of its UNITE platform. The financing will also enable Immunomic to expand its team and infrastructure to support the future growth of the company.

In addition, ITI and HLB intend to establish an Asian Brain Cancer Research Center in Seoul that will bring together the world’s leading experts and cutting-edge science to advance research in the GBM field and to deploy ITI-1000 to the Asian population. ITI-1000 is a cell therapy powered by ITI’s UNITE platform that is currently being evaluated in a Phase II clinical trial (ATTAC-II) in collaboration with researchers at the University of Florida (Dr. Duane Mitchell) and Duke University (Dr. John Sampson). ITI-1001 is an alternative, cell-free approach to treating GBM. The company held a successful pre-IND meeting earlier this year for ITI-1001 and expects to be able to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) by the end of 2020.

Concurrent with the financing, five (5) members from HLB Co., LTD will be joining the Immunomic Therapeutics Board of Directors.

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On April 23, 2020 Paige, the leader in computational pathology which is transforming the diagnosis and treatment of cancer, reported it has received additional funding from Goldman Sachs Merchant Banking Division, which will be added to the recently announced Series B financing round (Press release, Paige AI, APR 23, 2020, View Source [SID1234556548]). Paige will use this new capital to further develop the company’s diagnostic and test products for the biopharma industry, while strengthening its leadership position in clinical AI for pathologists and development of the Paige platform for remote viewing and routine clinical practice. Additionally, Paige has added David Castelblanco, Managing Director at Goldman Sachs, to its Board of Directors. David brings with him a wealth of experience as an investor and board member working with leading cancer treatment centers internationally.

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"We’re thrilled to be working with David Castelblanco and the team at Goldman Sachs as we build our platform and further develop our computational pathology infrastructure," said Leo Grady, CEO at Paige. "With our new funding and leadership additions, we’ll focus on building network effects based on our clinical-grade digital pathology and AI platform."

"Paige is transforming pathology and translational research in the cancer field and is working closely with biopharma companies to create custom diagnostic solutions and drug development technologies to improve patient care," said David Castelblanco. "We look forward to supporting the Company’s important mission of improving cancer care through its AI technology."

Paige is continuing its mission to accelerate the future of pathology by translating cutting-edge cancer research into solutions that help physicians and patients arrive at an accurate diagnosis faster and more cost effectively.

"Paige’s leadership is doing a fantastic job in building a stellar team and seizing opportunities in this exciting market," said Jim Breyer, founder and CEO of Breyer Capital, who invested in both series A and B for the company.

Recent company milestones for Paige include the appointment of R. Martin Chavez, a former Goldman Sachs executive to the board, and a partnership with Invicro LLC, a Konica Minolta company, to provide integrated pathology solutions to support pharmaceutical and biotechnology sponsors with their drug discovery and development initiatives.

ABOUT GOLDMAN SACHS MERCHANT BANKING

Founded in 1869, The Goldman Sachs Group, Inc. is a leading global investment banking, securities and investment management firm. Goldman Sachs Merchant Banking Division (MBD) is the primary center for the firm’s long-term principal investing activity. MBD is one of the leading private capital investors in the world with investments across private equity, growth equity, infrastructure, private debt and real estate.

On April 23, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it will release its first-quarter 2020 financial results on Thursday, May 7, 2020 (Press release, Bausch Health, APR 23, 2020, View Source [SID1234556564]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EDT to discuss the results and provide a business update . All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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Conference Call Details

Date:

Thursday, May 7, 2020

Time:

8:00 a.m. EDT

Webcast:

View Source
presentations

Participant Event Dial-in:

+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)

Participant Passcode:

2149923

Replay Dial-in:

+1 (877) 344-7529 (North America)

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)

Replay Passcode:

10143142 (replay available until May 14, 2020)

On April 23, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported publication of an invited review in Frontiers in Oncology: Tumor Necrosis Factor α Blockade: an Opportunity to Tackle Breast Cancer, by Dr. Roxana Schillaci, in the Lab of Molecular Mechanisms, Instituto de Biología y Medicina Experimental-CONICET, Argentina (Press release, INmune Bio, APR 23, 2020, View Source [SID1234556533]).

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This publication is part of the evolving body of work by Dr. Schillaci and her team in the role of soluble TNF in resistance to oncology immunotherapies including trastuzumab and other therapies. Trastuzumab is the leading therapy for women with HER2+ breast cancer. Dr. Schillaci’s has previously reported that women with MUC4 expressing HER2+ breast cancers are resistant to trastuzumab.

"This novel work was first presented at the San Antonio Breast Cancer Symposium in 2018," said RJ Tesi MD, Chief Executive Officer of INmune Bio. "Dr. Schillaci showed that MUC4 expression is driven by soluble TNF. When soluble TNF is neutralized with INB03, MUC4 expression is decreased and the cancer becomes sensitive to trastuzumab."

"This review is one of the first to address the impact of TNFɑ on breast cancer subtypes progression and metastasis and to discuss the participation of soluble and transmembrane TNFɑ in breast cancer," said Dr. Schillaci. "We demonstrate the potential efficacy of TNF blocking agents in the treatment of breast cancer because soluble TNF is involved in resistance to most of the breast cancer therapies, ranging from chemotherapy, hormone therapy to anti-checkpoint inhibitors."

Dr. Schillaci’s work in MUC4 induced resistance to trastuzumab in women with HER2+ breast cancer is the basis for INMB’s planned Phase II trial in women with metastatic HER2+ breast cancer. The article is part of a three article Research Topic in this issue of Frontiers in Oncology entitled, The Tumor Necrosis Factor Superfamily: an Increasing Role in Breast Cancer.

On April 23, 2020 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer who are appropriate for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform (Press release, Agilent, APR 23, 2020, View Source [SID1234556549]).

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"Our PD-L1 IHC 22C3 pharmDx assay is used by thousands of laboratories around the globe, and now customers in the U.S. can add PD-L1 to their routine IHC workflow on Dako Omnis."

Dako Omnis is Agilent’s fully automated, walk-away solution for staining tumor samples that provides a flexible, high-throughput diagnostic service integrated into the core of the laboratory workflow.

The FDA approval of this CDx demonstrates that Agilent is continuing to enable metastatic NSCLC patients, who previously had few and inefficient therapy options, to gain access to first-line treatment monotherapy with the targeted immunotherapy, KEYTRUDA, providing new hope for patients and their families.

"We are delighted to add the first FDA approval of this important companion diagnostic on Dako Omnis," said Simon Østergaard, Agilent vice president, and general manager of the company’s pathology division. "Our PD-L1 IHC 22C3 pharmDx assay is used by thousands of laboratories around the globe, and now customers in the U.S. can add PD-L1 to their routine IHC workflow on Dako Omnis."

Thanks to extensive clinical validation on NSCLC through concordance with PD-L1 IHC 22C3 pharmDx for Autostainer Link 48, laboratories can implement PD-L1 testing on Dako Omnis with complete diagnostic confidence.

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. Manufactured by Merck, KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

Lung cancer is the leading cause of cancer-related mortality in the United States, with an estimated incidence of 142,000 deaths in 2019 alone. Among these cases, NSCLC accounts for nearly 85% of all diagnoses.2

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.