On August 18, 2021 Illumina, Inc. (NASDAQ: ILMN) reported that it has acquired GRAIL, a healthcare company focused on life-saving early detection of multiple cancers, but will hold GRAIL as a separate company during the European Commission’s ongoing regulatory review (Press release, Illumina, AUG 18, 2021, View Source [SID1234586722]).

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Illumina, the global leader in DNA sequencing, first announced its intention to acquire GRAIL nearly a year ago, reuniting Illumina with GRAIL four years after it was spun off. GRAIL’s Galleri blood test detects 50 different cancers before they are symptomatic. Illumina’s acquisition of GRAIL will accelerate access and adoption of this life-saving test worldwide.

Regulators in the EU are reviewing the transaction, but a decision is projected after the deal expires. GRAIL has no business in the EU, and the company believes that the European Commission does not have jurisdiction to review the merger as the EU merger thresholds are not met, nor are they met in any EU member state. The General Court of the European Union will hear Illumina’s jurisdictional challenge later this year. By holding GRAIL separate while proceedings are ongoing, Illumina is positioned to abide by whatever final decision is reached in these legal processes.

There is no legal impediment to acquiring GRAIL in the US. Illumina is committed to working through the ongoing FTC administrative process, and as always, will abide by whatever outcome is ultimately reached in the US courts.

The reasons to reunite the two companies are compelling:

The deal will save lives. Cancer kills around 10 million people annually worldwide and 600,000 people in the US alone. Cancers responsible for nearly 71% of cancer deaths have no recommended early detection screening, and most cancers are detected when chances of survival are lower. Illumina feels there is a moral obligation to have the deal decided by a thoughtful and full review by the EU regulators and the US courts. This can only be done if Illumina acquires GRAIL now. Otherwise, the company is locked into a situation where the deal terms will expire before there is a chance for full review; the clock will just run out.

Right now, the Galleri test is available but costs $950 because it is not covered by insurance. Reuniting the two companies is the fastest way to make the test broadly available and affordable. Illumina’s expertise in market development and access has resulted in coverage of genomic testing for over 1 billion people around the world already. This experience will help lead to coverage and reimbursement for the Galleri test.

GRAIL and Illumina have a long history. Illumina formed GRAIL and spun it out in 2016. GRAIL’s first employees were part of Illumina, which still owns 12 percent of the company. GRAIL and Illumina are not competitors—this is a vertical acquisition.

Based on past experience, when Illumina enters a market, the market expands. When Illumina entered the non-invasive prenatal testing space, prices dropped, reimbursement expanded, the number of providers increased, and more expectant parents had access to testing.

Illumina’s acquisition of GRAIL is driven by the belief that this test should be available to as many people as possible as quickly as possible. From fighting the COVID-19 pandemic to matching cancer patients to therapies, Illumina’s mandate is to save lives and transform healthcare. The first COVID-19 viral sequence was on an Illumina machine and now genomic surveillance has emerged as a critical tool in the global fight against the pandemic, with over 70 countries now using Illumina platforms for COVID-19 variant tracking.
"Just as we are now able to screen for early-stage diabetes and high cholesterol, we will soon be able to conduct multi-cancer early detection with a simple blood test in your doctor’s office," said Francis deSouza, Chief Executive Officer of Illumina. "Since early detection of cancer saves lives, this new genomic test will be nothing short of transformational for human health and the economics of healthcare."

"The merger with Illumina will get the Galleri test to people far faster. We aim to accelerate this process so the test will be available in doctors’ offices everywhere, fully reimbursed," said Hans Bishop, Chief Executive Officer of GRAIL. "A one-year acceleration of access to the Galleri test for the US population has the potential to save 10,000 lives over a 9-year period."

"The decision to make the acquisition and hold the companies separate permits the regulatory processes to proceed while safeguarding the life-saving, pro-competitive benefits of this vertical transaction without the deal expiring. We will abide by any outcome ultimately reached by the courts," said Charles Dadswell, General Counsel of Illumina.

On August 18, 2021 Exscientia, a clinical-stage, artificial intelligence (AI)-driven pharmatech company, reported that Bristol Myers Squibb has elected to in-license an immune-modulating drug candidate created by Exscientia (Press release, Exscientia, AUG 18, 2021, View Source [SID1234586721]). Exscientia has two active collaborations with Bristol Myers Squibb, which together focus on multiple therapeutic areas, including oncology and immunology. A significant expansion of the relationship was announced earlier this year.

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The in-licensed candidate targets a critical immunological kinase that historically has proven difficult to target due to the need for a combination of potency, selectivity, and overall drug-like properties. To design a novel candidate that overcame these issues, Exscientia utilized its end-to-end platform to drive the discovery process, including AI-driven design, structural biology, chemistry, and pharmacology, as well as late-stage preclinical studies. Exscientia’s precision design approach focused on solving, in parallel, parameters important to overall therapeutic performance for the target, such as potency, selectivity, safety, and physicochemical characteristics. Exscientia’s platform is ideally suited for solving multi-objective design problems to efficiently and rapidly discover novel drug candidates with superior properties.

Andrew Hopkins, Chief Executive Officer of Exscientia commented, "We are focused on using our patient-first AI technology to design precision engineered drugs against challenging drug product profiles. We are seeing great efficiency from our platform. This drug candidate molecule was just the 150th novel compound to be designed and tested and it was identified within 11 months of starting drug design. In partnership with Bristol Myers Squibb and its world-class research, clinical and commercialization capabilities, we look forward to advancing this candidate into the next stage of development."

Rupert Vessey, President of Research & Early Development at Bristol Myers Squibb said, "We are pleased to in-license our first drug candidate resulting from our strategic collaboration with Exscientia. Artificial intelligence and machine learning continue to play important roles in drug discovery and Exscientia has delivered a promising development candidate in the field of immunology. We look forward to our continued collaboration and further advancing this candidate for the potential benefit of patients with unmet medical need."

Bristol Myers Squibb will be responsible for clinical and commercial development of the drug candidate. Under the terms of the agreement, Exscientia will receive a $20 million option exercise fee with the potential for additional development milestones as well as tiered royalties on any product sales.

On August 18, 2021 Immunitas Therapeutics ("Immunitas"), a single cell genomics-based therapeutics company, reported the completion of a $58 million Series B financing led by Agent Capital with participation from Medical Excellence Capital (MEC), 120 Capital, Solasta Ventures, Mirae Asset, Ono Venture Investment, The Mark Foundation for Cancer Research, NS Investment, BrightEdge (American Cancer Society), and The Leukemia & Lymphoma Society Therapy Acceleration Program (LLS TAP) (Press release, Immunitas Therapeutics, AUG 18, 2021, View Source [SID1234586720]). Existing investors Alexandria Venture Investments, Evotec, Leaps by Bayer, M Ventures, Novartis Venture Fund (NVF), and founding investor Longwood Fund also joined the round. As part of the financing, Geeta Vemuri, PhD, MBA, Managing Partner and Founder of Agent Capital, and Brian Halak, PhD, on behalf of MEC will join the Immunitas Board of Directors.

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"Immunitas has made tremendous strides in the past year. This Series B financing is a key inflection point for the company and will enable us to drive IMT-009 rapidly into the clinic, while continuing to build and validate our pipeline of novel oncology programs," said Jeffrey Goldberg, Chief Executive Officer of Immunitas Therapeutics. "Our single cell technology platform allows our team to incorporate insights from human biology throughout the discovery and development process, enabling us to rapidly move towards serving patients in need."

The Series B funding will be used to advance Immunitas’ lead program, IMT-009, a CD161 inhibitor, into the clinic to treat both solid tumors and hematological malignancies. Both blockade and knockout of CD161 in preclinical systems have shown enhanced tumor-killing, increases in critical cytokines, and increased survival. The company expects to file its first Investigational New Drug application (IND) in 1H 2022 for IMT-009. This financing builds on the $39 million Series A financing secured in 2019. Immunitas Therapeutics was founded by Kai Wucherpfennig, MD, PhD, Dana-Farber Cancer Institute, K. Dane Wittrup, PhD, the Massachusetts Institute of Technology (MIT), Mario Suvà, MD, PhD, Massachusetts General Hospital (MGH), and Aviv Regev, PhD, MIT.

"Immunitas is focused on creating impactful therapies that modulate oncology targets, driven by a cross-functional platform that combines single cell analysis computation and molecular and cellular biology to rapidly identify and validate new targets," said Geeta Vemuri of Agent Capital. "This approach is well suited to provide powerful translational insights into biomarker and indication selection with long-term potential beyond IO."

In addition, Amanda Wagner, MBA, has been appointed Chief Business Officer in recognition of her significant contributions to the company’s business and corporate development. Ms. Wagner was one of the earliest employees of Immunitas, joining the company in October 2019 as Vice President of Strategy. Ms. Wagner has more than 15 years of experience in drug discovery, drug development, and medical technology, and has led teams to identify, research, and develop novel immune-modulating therapies. At Immunitas, Ms. Wagner has led the structuring and negotiation of multiple strategic collaborations and driven the progression of the lead program and pipeline. Prior to joining Immunitas, she was Vice President of Corporate Development at Q32 Bio, where she contributed to the company’s $46 million Series A. Previously, Ms. Wagner was at Concert Pharmaceuticals, where she managed a $250 million asset sale, directly contributed to the Initial Public Offering, and identified and led the development of a preclinical therapeutic for autoimmune disease, now in Phase 3. Prior to Concert, Ms. Wagner was an early member of the team at UpToDate, Inc. Ms. Wagner also sits on the Board of Directors of the National Alopecia Areata Foundation.

On August 18, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Patent and Trademark Office has issued the first U.S. patent for its novel ovarian cancer vaccine technology (Press release, Anixa Biosciences, AUG 18, 2021, View Source [SID1234586719]). This technology was invented and developed at Cleveland Clinic and Anixa is the worldwide licensee. A European patent covering this technology was issued earlier this year.

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The patent is titled, "Ovarian Cancer Vaccines," and the inventors are Drs. Vincent K. Tuohy, Suparna Mazumder, and Justin M. Johnson, all of Cleveland Clinic.

"The ovarian cancer vaccine targets a protein (the Extracellular Domain of the Anti-Mullerian Hormone Receptor 2, AMHR2-ED) that is normally expressed only in the ovaries of pre-menopausal women. After menopause, the target protein is no longer expressed in normal tissues and is only found again in ovarian cancer cells. Our vaccine targets the AMHR2-ED protein and trains the immune system to destroy ovarian cancer cells as they arise," said Dr. Tuohy of the Department of Inflammation and Immunity at Cleveland Clinic’s Lerner Research Institute. "We are looking forward to working together to further develop this technology."

Dr. Amit Kumar, President and CEO of Anixa Biosciences, said, "We are pleased that the U.S. Patent and Trademark Office has issued this patent. This technology is now patented in Europe and the U.S., and we continue to prosecute the intellectual property in other jurisdictions." Dr. Kumar continued, "This ovarian cancer vaccine has the potential to prevent one of the deadliest malignancies in women. Ovarian cancer is often diagnosed after it has reached stage 3 or 4, when it is difficult to effectively treat. Outcomes for ovarian cancer patients are poor, so if this vaccine is able to eliminate the onset of ovarian cancer, the impact for women and for our healthcare system would be significant. We are also pleased that the National Cancer Institute’s PREVENT program will collaborate and financially support the development of this vaccine."

On August 18, 2021 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported the pricing of its previously announced public offering (the "Offering") (Press release, ProMIS Neurosciences, AUG 18, 2021, View Source [SID1234586717]). Pursuant to the Offering, the Company will issue up to 93,750,000 units (the "Units") at a price of US$0.16 per Unit (the "Issue Price") for aggregate gross proceeds of US$15 million, exclusive of the Agent’s Option (as defined herein) and before deducting the Agent’s Cash Commission (as defined herein) and estimated Offering expenses payable by the Company. Each Unit consists of one common share of the Company (a "Common Share") and one quarter of one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share (each, a "Warrant Share") at a price of US$0.21 per Warrant Share at any time up to 60 months following the issuance date thereof, subject to acceleration.

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The Offering will be conducted on a commercially reasonable efforts basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and Leede Jones Gable Inc. (the "Agent"). In connection with the Offering, the Agent will be paid a cash commission equal to 7.0% of the gross proceeds of the Offering (including any gross proceeds raised on exercise of the Agent’s Option) (the "Agent’s Cash Commission") and it will be issued that number of broker warrants exercisable for Common Shares (the "Compensation Warrant Shares") equal to 7.0% of the number of Units sold in the Offering (including any additional Units issued on exercise of the Agent’s Option). The Company will also grant the Agent an option (the "Agent’s Option"), exercisable, in whole or in part, at the sole discretion of the Agent, to increase the size of the Offering by up to 15%. The Agent’s Option is exercisable, in whole or in part, at any time until the date that is two business days prior to the Closing Date (as defined herein).

The Offering is expected to close on or about August 24, 2021, or such other date as may be mutually agreed to by the Company and the Agent (the "Closing Date"), subject to satisfaction of customary closing conditions, including the approval of the listing of the Common Shares, Warrant Shares and Compensation Warrant Shares on the Toronto Stock Exchange (the "TSX").

The Offering is being made pursuant to a prospectus supplement to the Company’s short form base shelf prospectus dated June 30, 2021 (the "Base Prospectus"), which the Company will file with the securities commissions or other security regulatory authorities in each of the provinces and territories of Canada (other than Québec). Additionally, the Offering is expected to be conducted by way of private placement in other jurisdictions where the Offering can lawfully be made.

The Company intends to use the net proceeds from the Offering (including additional proceeds from the possible exercise of the Agent’s Option) to advance its lead Alzheimer’s therapy PMN310 to the filing of an Investigational New Drug application to enable a first clinical trial, expanding the ProMIS portfolio of antibodies and patents, and general corporate purposes, as more fully described in the preliminary prospectus supplement of the Company dated August 17, 2021 (the "Preliminary Prospectus Supplement").

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This news release does not constitute an offer for sale of securities nor a solicitation for offers to buy any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.