Regeneron and Sanofi Provide Regulatory Update on Libtayo® (cemiplimab-rwlc) in Advanced Cervical Cancer

On January 28, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi reported the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer (Press release, Regeneron, JAN 28, 2022, View Source [SID1234607482]). The decision was made after the companies and the U.S. Food and Drug Administration (FDA) were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside of the U.S. are ongoing.

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About Cervical Cancer
It is estimated that approximately 570,000 people are diagnosed with cervical cancer worldwide each year, with deaths exceeding 250,000. In the U.S. there are 14,500 new cases diagnosed annually and approximately 4,000 die each year. Since we filed our sBLA, another PD-1 inhibitor was approved as first-line treatment for patients with persistent, recurrent or metastatic cervical tumors that express PD-L1. The use of Libtayo in advanced cervical cancer is not approved by the FDA.

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 (BCC), advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell lung cancer (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.

Libtayo, which was invented using Regeneron’s proprietary VelocImmune technology, is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

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

A type of skin cancer called advanced CSCC that has spread or cannot be cured by surgery or radiation.
A type of skin cancer called 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 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.

Cardinal Health earns perfect score on Human Rights Campaign Foundation’s Corporate Equality Index for the 14th consecutive year

On January 27, 2022 Cardinal Health reported that it has earned the perfect score of 100% on the Human Rights Campaign Foundation’s Corporate Equality Index (CEI), a national benchmarking tool to measure corporate policies and practices related to LGBTQ+ (lesbian, gay, bisexual, transgender, queer and other) workplace equity (Press release, Cardinal Health, JAN 28, 2022, View Source [SID1234607466]). Organizations that have earned a 100% rating on the CEI have satisfied all criteria for the year and are recognized as a "Best Place to Work for LGBTQ+ Equality." This is the 14th year in a row that Cardinal Health has received a perfect score.

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"Diversity, equity and inclusion (DE&I) are core values of Cardinal Health. Employees at all levels of the company are committed to creating an inclusive workplace culture where every employee can bring 100% of themselves to work every day," said Steve Mason, CEO of Cardinal Health’s Medical segment and Executive Sponsor of the company’s PROUD employee resource group. "Earning 100% on the Corporate Equality Index for so many years tells us that we are on the right path and that what we are doing makes a difference."

A diverse, equitable and inclusive culture is also key to Cardinal Health’s innovation transformation, Mason said. "An inclusive culture is a kind of supercharger: it brings more creativity and innovation. Diverse teams find new ways to get things done, and solve problems more quickly, with better results."

Jay Brown, Human Rights Campaign senior vice president of programs, research and training, said, "We are proud that the Corporate Equality Index has paved the way for countless LGBTQ+ workers in America and abroad. But there is still more to do, which is why we are raising the bar yet again to create more equitable workplaces and a better tomorrow for LGBTQ+ workers everywhere. Congratulations to Cardinal Health for achieving the title of ‘best places to work for LGBTQ+ equality’ and working to advance inclusion in the workplace."

This is the 20th year of the CEI. This year’s CEI reflects growth across every measurement category, from the adoption of inclusive non-discrimination policies to equitable healthcare benefits for transgender employees.

The CEI rates companies on detailed criteria falling under four central pillars:

Non-discrimination policies across business entities;
Equitable benefits for LGBTQ+ workers and their families;
Supporting an inclusive culture; and,
Corporate social responsibility.
You can download the CEI report here, and read more about Cardinal Health’s DE&I work here.

Issue of Warrants

On January 28 2022 Sareum Holdings plc (AIM: SAR), the specialist drug development company, reported that it has issued warrants over 29,000,000 new ordinary shares of 0.025p each in the capital of the Company to individuals who provided introductory services leading to the share subscriptions announced by the Company during 2021 (Press release, Sareum, JAN 28, 2022, View Source [SID1234607483]). The warrants have an exercise price of 5p per share, with exercise being conditional on the shares having traded at or above 7p for five consecutive days, and a subscription period that ends on 31 May 2026.

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Epizyme Announces Pricing of Public Offering of Common Stock

On January 27, 2022 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported the pricing of an underwritten public offering of 56,666,667 shares of its common stock at a price to the public of $1.50 per share, before underwriting discounts (Press release, Epizyme, JAN 27, 2022, View Source [SID1234607451]). In addition, Epizyme has granted the underwriters a 30-day option to purchase up to an additional 8,500,000 shares of common stock at the public offering price, less the underwriting discount. All of the shares in the offering are to be sold by Epizyme.

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Epizyme anticipates the total gross proceeds from the offering (before deducting underwriting discounts and offering expenses) will be approximately $85.0 million, excluding any exercise of the underwriters’ options to purchase additional shares.

Epizyme anticipates using the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to fund global development and commercialization costs of tazemetostat outside of Japan, including the costs of conducting the Company’s ongoing and planned clinical trials of tazemetostat, including the Company’s confirmatory Phase 1b/3 trials in epithelioid sarcoma and follicular lymphoma (FL), the Company’s clinical trials of tazemetostat in additional FL populations and the Company’s clinical trials of tazemetostat across multiple types of hematological malignancies and solid tumors; to fund the Company’s Phase 1/1b trial of its SETD2 inhibitor, EZM0414 and the discovery and identification of additional product candidates to expand the Company’s pipeline of novel epigenetic therapies; to fund initiatives to accelerate commercial adoption of TAZVERIK; and for working capital and other general corporate purposes, which may include the acquisition of companies or businesses or licensing of other products, businesses or technologies, and repayment and refinancing of debt.

Jefferies and Barclays are acting as joint bookrunning managers for the offering. Wedbush PacGrow and H.C. Wainwright & Co. are acting as co-lead managers. The offering is expected to close on January 31, 2022, subject to the satisfaction of customary closing conditions.

The shares are being offered by Epizyme pursuant to a shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on May 6, 2021 and declared effective by the SEC on May 13, 2021. The offering is being made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on January 26, 2022 and copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected] or by telephone at (888) 603-5847. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

InnovHeart raises $55 million in Series C financing to further develop the Trans-septal Saturn Transcatheter Mitral Valve Replacement System

On January 27, 2022 InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of mitral valve disease, reported the closing of its Series C financing with granting an exclusive licensing agreement to Grand Pharmaceutical Group Limited, (Grand Pharma) for its proprietary Saturn device in Greater China (Press release, China Grand Pharmaceutical, JAN 27, 2022, https://www.innovheart.com/innovheart-raises-55-million-in-series-c-financing-to-further-develop-the-trans-septal-saturn-transcatheter-mitral-valve-replacement-system/ [SID1234607467]).

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The transaction pulled in more than $55 million in equity, upfront licensing fees, milestone payments and structured royalties.

Series C equity round was led by Grand Pharma, together with the existing investors Genextra, Panakes Partners and Indaco Venture Partners confirming their ongoing support by joining this investment round. Under the license agreement, Grand Pharma is entitled to develop, manufacture and commercialize the Saturn device in Mainland China, Hong Kong, Macau and Taiwan.

‘Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential, estimated to reach $17.4 billion globally in future years. This strategic agreement will provide InnovHeart with resources that will accelerate the development of the trans-septal version of the Saturn system into First-in-Human clinical trials, as well as access to the dynamic Chinese structural heart market’, said Keith D. Dawkins MD, Chairman of InnovHeart Board of Directors.

Commenting on this new collaboration, Shawn Chen, Senior management of the Medical Device Division of Grand Pharma, said, ’We are very excited about this collaboration. The successful closing of this transaction demonstrates that Grand Pharma has completed the strategic layout in our cerebro-cardiovascular high-end medical devices sector. InnovHeart Saturn technology is one of the most promising TMVR technologies in the market. I am confident that with InnovHeart’s expertise in this field and Grand Pharma’s strong capability and resources, we will bring this innovative clinical solution to Chinese patients soon’.

’InnovHeart has already demonstrated excellent mid-term (>1 year) results with the trans-apical version. This low profile, adaptive valve design decreases the risk of LVOT obstruction and will be implanted transeptally in FIH in 2022’, said Paolo Denti MD, Cardiac Surgeon, San Raffaele University Hospital, Milan, Italy.