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Natera to Present at the UBS Virtual Global Healthcare Conference

On May 13, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported that it will webcast a live presentation at the UBS Virtual Global Healthcare Conference on Monday, May 18, 2020 at 12:50 p.m. PT (3:50 p.m. ET) (Press release, Natera, MAY 13, 2020, View Source [SID1234557955]).

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Mike Brophy, Chief Financial Officer, will provide an overview of the company and discuss recent business activities.

Access to the live webcast and subsequent archived presentation will be available at investor.natera.com.

Mylan to Present at the 2020 RBC Capital Markets’ Virtual Global Healthcare Conference

On May 13, 2020 Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) reported that Executive Chairman Robert J. Coury and President Rajiv Malik will present at the 2020 RBC Capital Markets’ Virtual Global Healthcare Conference on Tuesday, May 19, 2020 at 8 a.m. ET (Press release, Mylan, MAY 13, 2020, View Source [SID1234557954]).

Interested parties can access a live webcast of the presentation via the investor relations section of Mylan’s website at investor.mylan.com. An archived version also will be available following the live presentation and can be accessed at the same location for a limited time.

Biocept Reports First Quarter 2020 Financial Results

On May 13, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading provider of molecular technologies designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported financial results for the three months ended March 31, 2020 and provides an update on its business progress (Press release, Biocept, MAY 13, 2020, View Source [SID1234557953]).

"Revenue for the first quarter was $1.4 million, representing a 41% increase over the prior-year period driven by a 27% increase in revenue per commercial accession," said Michael Nall, President and CEO of Biocept. "We increased revenues even with the headwinds of the COVID-19 pandemic, which we estimate led to an approximate 15-25% decline in commercial volume from current customers and also impacted opportunities for us to gain new customers with the closing of many physician offices and labs. Operational efficiencies contributed to progress toward our goal of positive gross margin resulting in a 50 percentage point improvement versus the prior-year period. These efficiencies are primarily related to automation of our lab, with additional actions yet to be taken this year.

"Importantly, we believe we are well positioned to weather the pandemic, which is impacting testing volume industrywide, and for a return to growth as shelter-in-place restrictions are lifted and physician offices and labs reopen," he added. "We are an established leader in liquid biopsy and our Target Selector assays and products provide critical information to physicians in treatment decision-making. We expect that when it is safe for patients diagnosed with cancer to continue to seek treatment, our commercial volume will return to a more normal level. We are particularly pleased with our strengthened balance sheet, having raised approximately $36.3 million in net proceeds since the beginning of December 2019. While we believe that based on historical and planned cash usage, our current funding is expected to support operations through most of 2021; however, with the uncertainty introduced by the impact of COVID-19 on revenue and collections, our cash runway may be shorter."

First Quarter 2020 and Recent Highlights

Commercial Launches

Announced the availability of Target Selector assays to evaluate cerebrospinal fluid (CSF) for the presence of circulating tumor cells (CTCs) and biomarkers, which may be indicators of brain metastases. Of patients diagnosed with breast and lung cancer, up to 30% and 36%, respectively, will develop brain metastases. The validations study for our CSF assay was conducted in collaboration with Providence St. Joseph Health, Southern California, and its wholly owned affiliates Providence St. John’s Health Center and John Wayne Cancer Institute.
Launched the availability of research-use-only (RUO) kits that allow molecular laboratories worldwide to detect oncogene mutations through the analysis of both Formalin-Fixed Paraffin-Embedded (FFPE) tissue gained from surgical biopsies as well as circulating tumor DNA (ctDNA) gained from blood-based liquid biopsies. The first RUO kit with the ability to use tissue and liquid biopsy samples is designed for the detection of EGFR mutations that are among the most frequently evaluated biomarkers of lung cancer. RUO kits for other oncogene mutations are planned for future launches.
Awarded CE-IVD Mark for the Target Selector molecular assay EGFR Kit. The CE Mark confirms that Target Selector kits meet the requirements of the European In-Vitro Diagnostic Devices Directive and allows Biocept to commercialize these kits throughout the European Union and other CE Mark geographies. Molecular assay kits detect key oncogene mutations through the analysis of both FFPE tissue as well as ctDNA. The EGFR pathway can include mutations that are among the most frequently evaluated biomarkers for lung cancer.
Announced the validation for COVID-19 testing. Biocept operates a high-complexity, CLIA-certified, CAP-accredited and BSL-2 safety level laboratory in San Diego, with specialized, licensed molecular lab staff who have been trained in performing the COVID-19 testing. The lab will be using ThermoFisher Scientific’s FDA-approved for EUA (Emergency Use Authorization) testing TaqPath molecular diagnostic platform and kit for SARS-CoV-2 (COVID-19). Due to the national shortage, Biocept’s clients have had difficulty gaining specimen collection kits to send to Biocept for testing and to date, we have not been able to perform any COVID 19 testing. In order to address this and provide needed testing, Biocept intends to manufacture its own collection kits for distribution to clients and expects those kits to be available in June.
Commercial Agreements

Signed laboratory services agreements with two large California-based independent physician associations (IPAs) to provide Biocept’s Target Selector liquid biopsy testing services.
Peer-reviewed Journal Publications

Announced publication of clinical data in the Journal of Clinical Pathology that further validates Biocept’s Target Selector qPCR Assay using Switch Blocker technology to identify cancer-related mutations in liquid biopsy samples. Study results showed a very high concordance between Biocept’s liquid biopsy testing and tissue biopsy and best-in-class detection of alterations down to a single mutant copy in both analytical and clinical settings.
Intellectual Property

Awarded U.S. patent covering antibody and microchannel technology and enhanced detection of cancer cells. This new patent expands Biocept’s intellectual property estate for capturing and detecting rare cells of interest, including CTCs, to aid in the management of patients with cancer.
Granted Australian and Brazilian patents providing intellectual property protection for its Primer Switch technology that is useful for ctDNA analysis using reverse-transcription PCR and associated methods, including next-generation sequencing (NGS).
Corporate Developments

Promoted Cory J. Dunn to Senior Vice President of Commercial Operations. Ms. Dunn joined Biocept as Vice President of Marketing in October 2018.
First Quarter Financial Results

Revenues for the first quarter of 2020 were $1.4 million, a 41% increase from $1.0 million for the first quarter of 2019. Revenues for the first quarter of 2020 included $1.3 million in commercial test revenue, $60,000 in development services test revenue, and $69,000 in revenue for distributed products, Target Selector RUO kits and CEE-Sure blood collection tubes. Revenues for the first quarter of 2019 included $976,000 in commercial test revenues, $42,000 in development services test revenues and $5,000 from RUO kits and blood collection tubes.

Biocept accessioned 1,306 total samples during the first quarter of 2020, compared with 1,325 total samples during the first quarter of 2019. The Company accessioned 1,141 billable samples during the first quarter of 2020 compared with 1,155 billable samples during the first quarter of 2019. We believe that the decline in total samples and billable samples was due to the impact of the COVID-19 pandemic.

Cost of revenues for the first quarter of 2020 was $2.9 million, compared with $2.6 million for the first quarter of 2019. Cost of revenues increased 13% while revenues increased by 41% as Biocept continued to leverage its fixed costs.

Research and development (R&D) expenses for the first quarter of 2020 were $1.3 million, compared with $1.2 million for the first quarter of 2019, with the increase primarily due to development and validation costs related to additional offerings, such as validation of CSF and COVID-19 assays. General and administrative (G&A) expenses for the first quarter of 2020 were $1.9 million, compared with $1.7 million for the first quarter of 2019, with the increase due mainly to a reclassification of certain customer service and related expenses from sales and marketing to G&A. Sales and marketing expenses for the first quarter of 2020 were $1.5 million, compared with $1.4 million for the first quarter of 2019, with the increase primarily attributed to commission on higher revenue.

Other expense, net for the first quarter of 2020 was $2.2 million, compared with $62,000 for the first quarter of 2019, with the increase mainly due to $2.1 million in warrant inducement expense. In January 2020, Biocept completed a Warrant Exercise Inducement offering for net proceeds of approximately $2.3 million.

The net loss attributable to common shareholders for the first quarter of 2020 was $8.3 million, or $0.11 per share on 79.0 million weighted-average shares outstanding and included $2.1 million in non-cash warrant inducement expense and the impact of the COVID-19 pandemic. The net loss attributable to common shareholders for the first quarter of 2019 was $6.0 million, or $0.61 per share on 9.8 million weighted-average shares outstanding.

Biocept reported cash and cash equivalents as of March 31, 2020 of $21.5 million, compared with $9.3 million as of December 31, 2019. The increase included approximately $17.7 million in net proceeds from two registered direct offerings and the overallotment of warrants from a December 2019 financing. In April 2020, the Company raised net proceeds of approximately $9.6 million from a registered direct offering.

Conference Call and Webcast

Biocept will hold a conference call today at 4:30 p.m. Eastern time to discuss these results and answer questions. The conference call can be accessed by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4109 for other international callers. A live webcast of the conference call will be available on the investor relations page of the company’s website at http://ir.biocept.com/events.cfm.

A replay of the call will be available for 48 hours following its conclusion and can be accessed by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers or (412) 317-0088 for other international callers. Please use event passcode 10143445. A replay of the webcast will be available for 90 days.

Polynoma Presenting Final Analysis of MAVIS Phase III Part B1 Data of Its Investigational Melanoma Vaccine, Seviprotimut-L, at ASCO20 Virtual Scientific Program

On May 13, 2020 Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., reported final analysis of clinical data from Part B1 of MAVIS (Melanoma Antigen Vaccine Immunotherapy Study), a Phase III study of seviprotimut-L, an investigational melanoma vaccine candidate, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, to be held online May 29-31, 2020 (Press release, Polynoma, MAY 13, 2020, View Source [SID1234557952]). The study abstract is one of 12 abstracts selected for discussion in the Melanoma/Skin Cancers poster discussion session.

MAVIS is a multicenter, double-blind, placebo-controlled adaptive Phase III trial to assess the safety and efficacy of seviprotimut-L, with primary endpoints of recurrence-free survival (RFS) and overall survival (OS) in patients with American Joint Committee on Cancer (AJCC) Stage IIB/C, IIIA, IIIB/C melanoma at high risk of recurrence after definitive surgical resection.

Highlights of the data presented include:

Improved outcomes in Stage IIB/C patients: Final analysis of subgroups confirmed the findings from the interim analysis, suggesting enhanced RFS for seviprotimut-L in patients with AJCC Stage IIB/IIC melanoma, particularly those under age 60, and those with ulceration, whose lesions are considered more serious because they have a greater risk of metastasis.1
Early evidence of survival benefit in Stage IIB/C patients: For Stage IIB/IIC melanoma patients under 60, there was a trend toward improved overall survival for those treated with seviprotimut-L.
Favorable adverse event profile: Seviprotimut-L was well-tolerated with treatment-emergent adverse events (AEs) similar to patients given placebo. There were no treatment-related serious adverse events.
Melanoma is the most diagnosed cancer among 25 to 29 year-olds in the United States, and passage from Stage II to Stage III melanoma marks a critical therapeutic intervention point to improve survival. Treatment of Stage IIB/IIC melanoma is primarily limited to surgery, coupled with a "wait and see" approach. However, recurrence of the disease can occur following definitive resection of the melanoma. Many patients progress to more advanced stages following resection and 5-year survival rates fall sharply after a patient passes from localized Stage II melanoma into regional Stage III disease (98.4% to 63.6%). Five-year survival rates are distinctly lower (22.5%) for metastatic Stage IV.2

"The final analysis of this part of the study reinforces the findings from our interim analysis last year, suggesting improved outcomes with seviprotimut-L in Stage IIB/IIC melanoma patients, particularly in those aged under 60. Furthermore, the latest findings extend the benefit to include disease with ulceration," said Melvin Toh, Chief Technology Officer at Polynoma and Vice President & Chief Scientific Officer at CK Life Sciences. "With a median patient follow-up of more than 48 months, the data show a durable RFS clinical benefit of seviprotimut-L in Stage IIB/IIC melanoma. We believe seviprotimut-L will be an important new option for the adjuvant treatment of patients with localized melanoma and look forward to advancing seviprotimut-L into the definitive part of the MAVIS Study."

"These data show promise for seviprotimut-L as a vaccine-based treatment of melanoma," said Craig L. Slingluff Jr., MD, Professor of Surgery and Director of the Human Immune Therapy Center and co-leader of the Cancer Therapeutics Program of the UVA Cancer Center. "These findings support moving forward with a pivotal trial testing seviprotimut-L as an adjuvant treatment for patients with Stage IIB/C melanoma, with stratification by age."

FURTHER DETAILS ON POSTER PRESENTATION AND DISCUSSION SESSION:

Abstract 10017: Final analysis of relapse-free survival in a multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine after resection of high-risk melanoma.

Poster: 366
Authors: Craig L. Slingluff, Jr., MD; Brent A. Blumenstein, PhD; Karl D. Lewis, MD; Robert H. Andtbacka, MD, CM, FACS, FRCSC; John Hyngstrom, MD; Mohammed Milhem, MBBS; Svetomir N. Markovic, MD, PhD; Omid Hamid, MD; Leonel Hernandez-Aya, MD PhD; Tawnya L. Bowles, MD; Prejesh Philips, MD; Sekwon Jang, MD; Jose Lutzky, MD, FACP; Anna Bar, MD; Peter D. Beitsch, MD
Poster Discussion Session

Session Title: Melanoma/Skin Cancers
Presentation Title: Adjuvant/Neoadjuvant Approaches
Discussant: Kenneth F. Grossmann, MD, PhD | Huntsman Cancer Institute, University of Utah
Poster and Discussion: will be available "on demand" on the ASCO (Free ASCO Whitepaper) website starting May 29 at 8:00 am EDT
The data being presented assessed the treatment effects of seviprotimut-L in patients with AJCCv7 Stage IIB-III cutaneous melanoma after surgical resection. 347 patients ages 18-75, ECOG PS 0-1, were enrolled and randomized 2:1 to seviprotimut-L 40 mcg or placebo, administered intradermally every 2 weeks x 5, then monthly x 4, then every 3 months to month 24. Patients were stratified by Stage (IIB/C, IIIA, IIIB/C).

By intent-to-treat (ITT) analysis, RFS was not significantly enhanced for seviprotimut-L in the full study population but trended toward benefit (Hazard Ratio "HR" = 0.88). Subgroup analysis based on planned stratification revealed the HR for the Stage IIB/IIC subset to be 0.65 (number of patients, "N" =111, 95% CI [0.37, 1.17]), favoring seviprotimut-L.

Age has been identified as a cause of decreased immune competence;3 thus, outcomes were assessed as a function of age as an effect modifier. Final efficacy analysis of subgroups confirmed treatment with seviprotimut-L enhanced RFS for patients less than 60 years overall (N=191, HR=0.64, 95% CI [0.38, 1.08]) and among Stage IIB/IIC melanoma patients (N=52, HR=0.32, 95% CI [0.12, 0.86]).

Furthermore, in a multivariable RFS model, for Stage IIB/IIC patients less than 60 years with ulceration, the HR was 0.209 (N=38, 95% CI [0.07,0.61]). For OS, for patients less than 60, HR = 0.41 [0.33,1.14] (n=191, 19 deaths) and for those ≥60, HR = 0.92 [0.39,2.12] (n = 156, 24 deaths).

In the study, seviprotimut-L was well-tolerated with treatment-emergent adverse events (AEs) similar to placebo patients. There were no treatment-related serious adverse events (SAEs) in the 347 patients studied, and the vast majority of events were Grade 1-2 injection site reactions that were managed by topical cream/s or an over-the-counter antihistamine.

About MAVIS
MAVIS (Melanoma Antigen Vaccine Immunotherapy Study) is a multicenter, double-blind, placebo-controlled adaptive Phase III trial to assess the safety and efficacy of seviprotimut-L, with primary endpoints of recurrence-free survival (RFS) and overall survival (OS) in patients with melanoma at high risk of recurrence after definitive surgical resection. MAVIS is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. For additional information about the trial, please visit View Source

About Seviprotimut-L
Seviprotimut-L is an allogeneic, polyvalent, partially purified shed melanoma antigen vaccine derived from three proprietary human melanoma cell lines. Seviprotimut-L stimulates humoral and cellular immune responses. Melanoma-associated antigens (MAAs) found in seviprotimut-L are taken up by antigen-presenting cells (e.g., dendritic cells) which then activate the production of antigen-specific cytotoxic T-lymphocytes (CTLs) as well as develop antibody responses against MAAs. These CTLs and antibodies then recognize and act on tumor cells expressing the MAAs on their surfaces, causing cell death. Seviprotimut-L is currently in development for the adjuvant treatment of patients with Stages IIB to IIIC melanoma, following definitive resection.

Regeneron Presentations at ASCO 2020 Showcase Diverse Clinical Oncology Portfolio

On May 13, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the company will share updates from its diverse clinical oncology portfolio at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29-31 taking place virtually (Press release, Regeneron, MAY 13, 2020, View Source [SID1234557951]).

Among the accepted abstracts are new, longer-term data for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in advanced cutaneous squamous cell carcinoma (CSCC). The data published today, which will be updated during ASCO (Free ASCO Whitepaper), add to the most mature dataset for any therapy in advanced CSCC and show that median overall survival and median duration of response have yet to be reached for Libtayo-treated patients with no new safety signals observed. Additional abstracts outline the clinical trial designs for Regeneron’s first costimulatory bispecific REGN5678 (PSMAxCD28) in metastatic castration-resistant prostate cancer and the company’s first tumor-targeted bispecific REGN5093 (METxMET) in MET-altered advanced non-small cell lung cancer (NSCLC).

"Regeneron is committed to advancing an oncology program to potentially transform treatment paradigms across multiple solid tumors and blood cancers where there are significant unmet needs," said Israel Lowy, M.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "We’ve already made significant progress. Libtayo is the standard of care for advanced cutaneous squamous cell carcinoma, and we recently announced clinically meaningful outcomes from our pivotal Libtayo trials in advanced non-small cell lung cancer and advanced basal cell carcinoma. At ASCO (Free ASCO Whitepaper), we will build on these milestones with three-year data from Libtayo in advanced cutaneous squamous cell carcinoma and updates from our expanding bispecific antibody platform."

Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on Regeneron’s oncology portfolio on Monday, June 1 at 4:30 pm ET. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International). A link to the webcast may be accessed from the "Investors and Media" page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days.

Regeneron presentations and publications at ASCO (Free ASCO Whitepaper)

Libtayo (PD-1 inhibitor) & Skin Cancer (jointly presented and published with Sanofi)

Phase 2 study of cemiplimab in patients (pts) with advanced cutaneous squamous cell carcinoma (CSCC): Longer follow-up (Abstract 10018, Poster 367; Danny Rischin, M.D.; Poster Discussion)
Health-related quality of life (HRQL) in patients with advanced cutaneous squamous cell carcinoma (CSCC) treated with cemiplimab: Post hoc exploratory analysis of a Phase 2 clinical trial (Abstract 10033, Poster 382; Michael Migden, M.D.; Poster)
Assessing the value of cemiplimab for adults with advanced cutaneous squamous cell carcinoma (CSCC): A cost-effectiveness analysis (Abstract e19397; Eleanor Paul; Online Publication)
A Phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation therapy (RT) in patients (pts) with high-risk cutaneous squamous cell carcinoma (CSCC) (Abstract TPS10084, Poster 433; Danny Rischin, M.D.; Trial in Progress Poster)
Patterns of hedgehog inhibitor (HHI) treatment interruptions and re-initiations among patients with basal cell carcinoma (BCC) in real-world clinical practice (Abstract e19349; Jessica Jalbert, Ph.D.; Online Publication)
REGN5678 (PSMAxCD28 Costimulatory Bispecific)

A Phase 1/2 study of REGN5678 (Anti-PSMAxCD28, a costimulatory bispecific antibody) with cemiplimab (anti-PD-1) in patients with metastatic castration-resistant prostate cancer (Abstract TPS5592, Poster 173; Charles Drake, M.D., Ph.D.; Trial in Progress Poster)
REGN5093 (METxMET Tumor-targeted Bispecific)

A Phase 1/2 study of REGN5093, a METxMET bispecific antibody, in patients with MET-altered advanced non-small cell lung cancer (NSCLC) (Abstract TPS9628, Poster 394; Tracey Rowlands, Ph.D.; Trial in Progress Poster)
Diffuse Large B-Cell Lymphoma

Real-world treatment patterns among patients with diffuse large B-cell lymphoma (DLBCL) treated with CD19-directed chimeric antigen receptor T-cell therapy (CAR T) (Abstract e19351; Jessica Jalbert, Ph.D.; Online Publication)
About the Regeneron Bispecific Antibody Platform
All of Regeneron’s bispecifics are designed to closely resemble natural human antibodies and bind to two different targets. They are derived from a next-generation version of Regeneron’s proprietary VelocImmune technology and created using the company’s Veloci-Bi platform. These allow for the creation of bispecifics with no linkers or artificial sequences. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human antibody medicines, with similar pharmacokinetics.

There are six Regeneron investigational bispecific antibodies currently in ongoing clinical trials for multiple blood cancers and solid tumors. These bispecifics fall into three categories:

CD3 bispecifics are designed to bridge T-cells and tumor cells. At the tumor site, they activate T-cells via their CD3 receptors and promote T-cell killing of the cancer cells. Investigational candidates include:
CD20xCD3 (odronextamab) for B-cell non-Hodgkin lymphoma;
Two distinct BCMAxCD3s (REGN5458 and REGN5459) for multiple myeloma;
MUC16xCD3 (REGN4018) for ovarian cancer.
CD28 costimulatory bispecifics are also designed to bridge T-cells and tumor cells. At the tumor site, they costimulate T-cells via their CD28 receptors and may synergize with PD-1 inhibitors and/or CD3 bispecifics. Investigational candidates include:
PSMAxCD28 (REGN5678) in combination with Libtayo for prostate cancer.
Tumor-targeted bispecifics are designed to target proteins only on the cancer cell. In this way, they may affect various signaling pathways to hamper the cancer cells’ ability to survive and proliferate. Investigational candidates include:
METxMET (REGN5093) for NSCLC that is driven by MET mutations and/or amplifications. REGN5093 targets two different parts of the MET receptor on cancer cells to degrade the receptor and block its ability to trigger cell proliferation.
The bispecifics mentioned in this release are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Libtayo in combination with REGN5678 is currently under clinical development for metastatic castration-resistant prostate cancer, and its safety and efficacy have not been evaluated by any regulatory authority for this use.

As part of a global collaboration agreement, Regeneron and Sanofi are jointly developing the BCMAxCD3 and MUC16xCD3 bispecific programs.

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 the first and only immunotherapy approved in the U.S., European Union, and other countries for adults with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., the generic name for Libtayo in its approved indication is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes a potentially registrational Phase 2 trial in basal cell carcinoma and additional trials in adjuvant and neoadjuvant CSCC. Libtayo is also being investigated in potentially registrational Phase 3 trials in NSCLC and cervical cancer, as well as in trials combining Libtayo with novel therapeutic approaches for both solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

Libtayo was invented using Regeneron’s proprietary VelocImmune technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. VelocImmune technology has been used to create multiple antibodies including Dupixent (dupilumab), Praluent (alirocumab) and Kevzara (sarilumab), which are approved in multiple countries around the world. Regeneron previously used these technologies to rapidly develop a treatment for Ebola virus infection, which is currently under review by the FDA, and is now being used in efforts to create preventative and therapeutic medicines for COVID-19.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is Libtayo?
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.

It is not known if Libtayo is safe and effective in children.

What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat a type of skin cancer 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. 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 symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain.
Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky or that have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
Liver problems (hepatitis). Signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.
Hormone gland problems (especially the adrenal glands, pituitary, thyroid and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, deeper voice, very low blood pressure, urinating more often than usual, nausea or vomiting, stomach-area (abdomen) pain, and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
Kidney problems, including nephritis and kidney failure. Signs of these problems may include decrease in your amount of urine, blood in your urine, swelling in your ankles, and loss of appetite.
Skin problems. Signs of these problems may include rash, itching, skin blistering, and painful sores or ulcers in the mouth, nose, throat, or genital area.
Problems in other organs. Signs of these problems may include headache, tiredness or weakness, sleepiness, changes in heartbeat (such as beating fast, seeming to skip a beat, or a pounding sensation), confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, seizures (encephalitis), swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis), seeing or hearing things that are not there (hallucinations), severe muscle weakness, low red blood cells (anemia), bruises on the skin or bleeding, and changes in eyesight.
Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs of these problems may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling of passing out, back or neck pain, and facial swelling.
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 delay or completely stop treatment 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 had an organ transplant;
have lung or breathing problems;
have liver or kidney problems;
have diabetes;
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 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.