On January 19, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC) (Press release, Regeneron, JAN 19, 2022, View Source [SID1234605583]). The target action date for the FDA decision is September 19, 2022.

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The sBLA is supported by results from a randomized, multicenter Phase 3 trial that investigated Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone. Enrolled patients (n=466) had locally advanced or metastatic NSCLC, irrespective of PD-L1 expression level or tumor histology, and with no ALK, EGFR or ROS1 aberrations. A regulatory filing has also been recently submitted to the European Medicines Agency.

The Phase 3 trial supporting the sBLA was stopped early after the Libtayo combination demonstrated a significant overall survival improvement compared to chemotherapy alone. Results were presented at the European Society for Medical Oncology Virtual Congress in 2021. Among patients in the Libtayo combination (n=312) and chemotherapy alone (n=154) groups, treatment discontinuations due to adverse events (AEs) occurred in 5% and 3% of patients, respectively. Immune-mediated AEs occurred in 19% of patients in the Libtayo combination group.

Notably, the Phase 3 trial was designed to include baseline characteristics seen in everyday clinical practice. Among those enrolled, 43% had tumors with squamous histology, 67% had tumors with <50% PD-L1 expression, 15% had inoperable locally advanced disease not eligible for definitive chemoradiation, and 7% had pretreated and clinically stable brain metastases. In addition, 84% of patients had an ECOG 1 performance status, which indicates the presence of cancer-related symptoms. ECOG performance status assesses patient ability to conduct daily living activities and prognosis on a scale of increasing severity ranging from 0 (no symptoms) to 5 (death).

In 2021, Libtayo was approved in the U.S. and European Union as first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

Libtayo, which was invented using Regeneron’s proprietary VelocImmune technology, is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. The use of Libtayo in combination with chemotherapy for advanced NSCLC is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority.

About Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer death worldwide. In recent years, more than 235,000 and 2.2 million annual new cases have been diagnosed in the U.S. and globally, respectively. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages. Additionally, 70% of all NSCLC cases will have <50% PD-L1 expression, making it the most common treatment setting.

About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo is indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced NSCLC.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat people with:

A type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
A type of skin cancer called basal cell carcinoma (BCC):
That cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog inhibitor (HHI), or cannot receive treatment with an HHI.
That has spread (metastatic BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC). Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1" and your tumor does not have an abnormal "EGFR", "ALK" or "ROS1" gene.
It is not known if Libtayo is safe and effective in children.

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent (dupilumab), Libtayo (cemiplimab-rwlc), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb) and Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn).

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat certain cancers by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Libtayo. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling.

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Libtayo. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious.
Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Libtayo if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Libtayo can harm your unborn baby

Females who are able to become pregnant:
Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include muscle or bone pain, tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.

On January 19, 2022 Duality Biologics reported a strategic cooperation agreement with Harbour BioMed (Press release, DualityBio, JAN 19, 2022, View Source [SID1234649926]). According to the agreement, Harbour BioMed will grant the self-developed preferred monoclonal antibody for specific tumor targets to Duality Biologics for the exclusive development of ADC medicines in the world. Based on the DITAC (Duality Immune Toxin Antibody Conjugate) technology platform with its independent intellectual property rights, Duality Biologics will rapidly develop the world’s first-in-class ADC medicines to benefit patients all over the world. And Harbour BioMed will receive the down payment, milestone payments and sales-based royalties paid by Duality Biologics.

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Harbour BioMed and Duality Biologics always maintain a strategic win-win cooperative relationship. After signing the agreement, both parties will continue to uphold the common goal of rapid research and development of high-quality ADC: Duality Biologics will be responsible for the preclinical research, clinical development, clinical registration, production and commercialization of the ADC candidate molecule; Harbour BioMed will continue to pay close attention to the relevant follow-up research of this molecule and provide necessary support.

"Previously, fully human antibodies developed from Harbour Mice have been used in multiple company’s ADCs development projects, demonstrating the advantages of our fully human antibodies in ADC development. With Duality Biologics’ strong R&D advantages in ADC development, this strategic collaboration will further strengthen our overall strategy in the field of ADC, maximize the value of Harbour Mice, develop more high-quality and differentiated new ADC drugs to meet global patients’ needs." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

"I’m very pleased to achieve strategic collaboration with Harbour BioMed, and we are both very excited and confident about this new target of ADC drug. The combination of our proprietary ADC platform in next-generation and tumor-specific antibody will optimize the value of our DITAC platform, a leading 3rd generation toxin ADC platform with significantly improved therapeutic window, and rapidly enrich our pipeline to generate original innovative products. The signing of this agreement is the beginning of our platform-based strategic win-win cooperation. In the future, Duality Biologics hopes to maintain the close cooperation with Harbour BioMed and continue to propel more product development, jointly bringing better therapeutics to patients." said Dr. John Zhu, founder and CEO of Duality Biologics.

On January 14, 2022, Sorrento Therapeutics, Inc. (the "Company") entered into an Agreement and Plan of Merger (the "Merger Agreement") with Virex Health, Inc., a Delaware corporation ("Virex"), VH Merger Sub I, Inc., a Delaware corporation and wholly owned subsidiary of the Company ("Merger Sub"), VH Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company ("Merger LLC"), and Fortis Advisors LLC, as representative of the equityholders of Virex (the "Stockholders’ Representative") (Filing, 8-K, Sorrento Therapeutics, JAN 19, 2022, View Source [SID1234605584]). Pursuant to the terms of the Merger Agreement, Merger Sub will merge with and into Virex (the "Initial Merger"), with Virex continuing as the surviving corporation in such merger, and subsequent to the Initial Merger, Virex will merge with and into Merger LLC, with Merger LLC surviving as a wholly owned subsidiary of the Company (the "Subsequent Merger" and together with the Initial Merger, the "Merger"). At the effective time of the Subsequent Merger, the name of Merger LLC as the surviving company in the Subsequent Merger will change to Virex Health, LLC.

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As consideration for the Merger, upon completion of the Initial Merger, the equityholders of Virex (the "Virex Equityholders") will be entitled to receive the following amounts (to be paid in cash and stock as further described below): (i) $12,000,000, subject to certain adjustments pursuant to the terms of the Merger Agreement for indebtedness, transaction expenses and cash (the "Closing Consideration") and (ii) subject to achievement of certain regulatory milestones, up to $10,000,000 in additional consideration (the "Milestone Payment" and together with the Closing Consideration, the "Merger Consideration").

Pursuant to the Merger Agreement, the Merger Consideration shall be paid as follows: (i) 59% in cash; and (ii) 41% in shares of common stock of the Company, par value $0.0001 per share ("Common Stock"). At any time shares of Common Stock are issued in respect of the Merger Consideration (the "Shares"), the number of shares to be issued will be based on a price per share equal to the volume weighted average closing price per share of the Common Stock, as reported on The Nasdaq Stock Market LLC for the eleven consecutive trading days ending on the date that is three trading days prior to the applicable issuance date. The aggregate number of shares of Common Stock issuable pursuant to the Merger Agreement as Merger Consideration shall not exceed 19.99% of the total number of shares of Common Stock issued and outstanding immediately prior to the effective time of the Merger. In the event the Company determines in its reasonable discretion that a Virex Equityholder is not an "accredited investor" as defined in Rule 501(a) of Regulation D promulgated under the Securities Act of 1933, as amended (the "Securities Act"), the Company shall pay the portion of the Merger Consideration payable to such Virex Equityholder in the form of cash only and shall be entitled to proportionately decrease the amount of cash, and increase the number of shares of Common Stock, payable to the "accredited investors" so as to maintain the 59% cash and 41% stock allocation referenced above. Ten percent of the Closing Consideration will be deposited into an escrow account (in the form of cash and stock) as partial security for the indemnification obligations of the Virex Equityholders under the Merger Agreement and $150,000 will be set aside for expenses that may be incurred by the Stockholders’ Representative.

The closing of the Merger is subject to customary conditions, including the accuracy of the representations and warranties contained in the Merger Agreement (subject to certain materiality qualifiers) and compliance with covenants and agreements in the Merger Agreement in all material respects.

The Merger Agreement contains customary representations, warranties and covenants of the Company and Virex. Subject to certain customary limitations, following the closing of the Merger, the Virex Equityholders shall indemnify the Company and its officers, directors, employees and agents against certain losses related to, among other things, breaches of Virex’s representations and warranties, certain specified liabilities and the failure to perform covenants or obligations under the Merger Agreement.

Pursuant to the terms of the Merger Agreement (and subject to the limitations set forth therein), the Company has agreed to prepare and file one or more registration statements with the Securities and Exchange Commission (the "SEC") following the closing of the Merger, for the purpose of registering for resale the shares of Common Stock issued as Merger Consideration. Under the Merger Agreement, the Company is required to file such registration statement with the SEC within 30 days of the issuance of such shares of Common Stock.

The foregoing description of the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Merger Agreement, which is filed herewith as Exhibit 2.1.

The representations, warranties and covenants contained in the Merger Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to the Merger Agreement, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Merger Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Merger Agreement, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the SEC.

Item 3.02. Unregistered Sale of Securities.

The information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference into this Item 3.02 in its entirety. The Shares will be issued to accredited Virex Equityholders in a transaction exempt from registration under the Securities Act, in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder. Each Virex Equityholder that receives any shares of Common Stock as Merger Consideration will represent that such equityholder is an "accredited investor," as defined in Regulation D, and will acquire such shares of Common Stock for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof.

Except for the registration rights contemplated by the Merger Agreement, the Shares will not be registered under the Securities Act and such Shares may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws. Neither this Current Report on Form 8-K nor the exhibits attached hereto is an offer to sell or the solicitation of an offer to buy shares of Common Stock or any other securities of the Company.

On January 19, 2022 Pierian, the global leader in clinical genomics knowledge, reported that it has partnered with Biodesix to provide its interpretation technology platform for use with the Biodesix newly launched GeneStrat NGS genomic test, a blood-based tumor profiling test to detect actionable mutations in patients with non-small cell lung cancer (NSCLC) (Press release, PierianDx, JAN 19, 2022, View Source [SID1234611225]). Biodesix (Nasdaq: BDSX) will use the Pierian platform to provide clear, up-to-date clinical interpretations for mutations detected by the GeneStrat NGS test as part of patient test results used by physicians to help inform a personalized treatment strategy and facilitate monitoring in lung cancer.

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The GeneStrat NGS test is a key part o f the IQLung testing strategy, designed to measure tumor-specific mutations and patient immune profiles with results in an unprecedented 72 hours so that physicians can assess overall prognosis and personalize treatment plans. The IQLung strategy uses genomic profiling to detect actionable mutations in lung cancer, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.

The GeneStrat NGS test data will be analyzed and interpreted using the most current therapy approvals and oncology guideline recommendations and delivered in a physician-ready report. The technology is backed by a comprehensive clinical knowledgebase and adaptive learning algorithms that take disparate inputs and translate them into concise interpretations with supporting evidence. As a result, characteristics of patient variants, even though rare or novel, are leveraged to present the most optimal treatment possibilities.

"We are helping to meet an unmet need in the continuum of care for lung cancer," said Scott Hutton, CEO of Biodesix. "Partnering with Pierian not only helps to deliver rapid results to physicians, but it also gives them information that can be easily interpreted and actioned, supporting them in providing precision care for their patients."

"We are thrilled to provide our interpretation technology to support the outstanding testing solution from Biodesix to treat patients with lung cancer," states Mark McDonough, CEO of Pierian. "We are committed to democratizing clinical genomics globally and this partnership with Biodesix supports our vision to broaden access to genomic testing and provide precision care to patients everywhere."

On January 19, 2022 Engitix reported that With the close of its Series A round at €48M ($54M), the tissue models company has shifted its business from providing drug discovery services to developing its own treatment pipeline for liver diseases (Press release, Engitix, JAN 19, 2022, View Source [SID1234610299]).

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When Engitix was spun out of University College London in 2016, the startup primarily aimed to provide tissue models to pharmaceutical companies for speeding up drug discovery in liver disease. As the company closes a €48M Series A round and drug discovery partnership with the Milan-based Dompé Farmaceutici this week, Engitix is reinforcing its plans to become a drug developer in its own right.

Drug candidates are typically tested in the lab using cell cultures, which are easy to grow and screened in large numbers. However, they don’t well resemble the structures of human organs, which are made up of cells and the extracellular matrix between them.

Engitix is developing drug testing models that are a closer imitation of real organs than cell cultures. The company sources extracellular matrix scaffolds from diseased and healthy organs from biobanks and grows cells on the scaffold to simulate a real organ.

Many companies are working on ways to screen drug candidates using more informative methods than cell cultures. Earlier this week, the Swiss startup EraCal deployed a high-throughput drug screening model based on zebrafish in a drug discovery collaboration with Novo Nordisk. There are also many firms that bioprint organs using polymer gels and cells.

By using human tissue scaffolds, Engitix’s models can shed light on local conditions influencing the behavior of tumor cells, such as blood vessels and immune cells, known as the microenvironment.