Maruho Co., Ltd.

Another inflammation and immunology startup has attracted big bucks. On Thursday, Evommune announced a $115 million raise to back a pipeline anticipated to have multiple Phase 2 readouts in the next 18 months. The Series C gives fresh momentum to the Palo Alto startup’s pipeline after it stopped development of its Phase 2a drug, an IRAK4 inhibitor, in atopic dermatitis last September. The biotech quickly rebounded and has a mid-stage test ongoing — with more planned soon — for its MRGPRX2 inhibitor codenamed EVO756. The once-daily oral drug is being explored for chronic inducible urticaria, chronic spontaneous urticaria, atopic dermatitis and other indications. Evommune has a partnership with Maruho for development and commercialization of the asset in certain Asian regions. (Septerna, which went public last week , is also working on MRGPRX2.) The startup also has an IL-18-targeted fusion protein dubbed EVO301 for atopic dermatitis. It will enter Phase 2 in the first three months of next year, CEO Luis Peña told Endpoints News . The California startup licensed the asset from South Korean company AprilBio this summer for $15 million upfront and about $475 million in potential payments, an Evommune spokesperson confirmed to Endpoints at the time of the June announcement . Meanwhile, Evommune could still return to the shelved IRAK4 inhibitor, known as EVO101. An investigator-initiated trial is now testing the drug for hidradenitis suppurativa, a chronic skin condition that has attracted interest in recent years. If those data look good, Evommune might restart development. RA Capital and Sectoral Asset Management co-led the Series C, which comes 18 months after a $50 million Series B . While the new raise gives Evommune multiple years of runway, it could entertain the idea of going public, and its investor syndicate “could easily support an IPO,” Peña said. Around the middle of next year — after releasing its first batch of Phase 2 data for EVO756 in chronic inducible urticaria — could be a good time to explore the public market, Peña said. The biotech might also attract the interest of pharma acquirers, Peña said. Evommune is led by former Dermira executives, who helped take the autoimmune drug developer to a $1.1 billion sale to Eli Lilly in early 2020. “We’re more amenable to that kind of partnership as opposed to actually doing a co-development deal with a company,” Peña said. “We have such deep development expertise that we don’t really need help on that front, but if someone wants to come and bid on our programs or our company at some point, they can.” He declined to comment on whether Evommune has already received takeover proposals. He added that “you should never set up your company that way.” Peña, who was chief development officer of Dermira when Lilly bought it, formed his new startup a week after he left the Indianapolis drugmaker in 2020. The main drug from that buyout, lebrikizumab , was approved by the FDA for eczema last month. Evommune licensed the IRAK4 inhibitor and EVO756, among other programs, from Lilly.

Board-certified dermatologist, Dr. Sandra Lee , widely known as Dr. Pimple Popper , among others, details her journey with mild-moderate atopic dermatitis, the most common form of eczema, and her experience on Opzelura® (ruxolitinib) cream 1.5% WILMINGTON, Del. --(BUSINESS WIRE)--Oct. 10, 2024-- Incyte (Nasdaq:INCY) announced today the expansion of its Moments of Clarity program, an educational initiative highlighting stories of people living with mild to moderate atopic dermatitis (AD) and their paths to finding relief. Building on last year’s program launch in partnership with Mandy Moore , the Moments of Clarity program will now feature several additional real-life patient perspectives, including that of Dr. Sandra Lee and Emily, a mom of three, who share their emotional experiences and the impact AD has had on their lives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241009443934/en/ In the new program content, each patient shares defining moments throughout their journeys including how they finally found relief with Opzelura® (ruxolitinib) cream 1.5%. Opzelura is a nonsteroidal, twice-daily cream that is indicated for the short-term and non-continuous treatment of mild to moderate eczema in certain people 12 and older whose disease is not well-controlled with topical prescription therapies or when those therapies are not recommended. Use of Opzelura in combination with biologics, other JAK inhibitors or potent immunosuppressants is not recommended. “While many people know me as a dermatologist from my TV show, most probably don’t know that I live with eczema and have struggled with symptoms like persistent itch and skin inflammation throughout my life,” said Dr. Lee . “I started using Opzelura, a non-steroidal topical option, to treat my eczema flares, which helped alleviate some of my worst symptoms like itch. In the pivotal clinical trial for mild to moderate AD, 54% of patients had clear to almost clear skin at 8 weeks and 52% of patients had a significant reduction in their itch, compared to 15% of patients who used a cream that did not contain medication. I partnered with Incyte on their Moments of Clarity program to share my story and to empower others to seek out a treatment that is right for them.” AD – the most common type of eczema – is a chronic condition characterized by inflammation of the skin, which can manifest as persistent itch, dry and scaly patches or red lesions on the body1. AD affects more than 21 million people aged 12 years and older in the U.S. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. “We understand the impact eczema can have on daily life, which furthers the need for patients to find a treatment to address their individual symptoms,” said Matteo Trotta , Executive Vice President, General Manager, U.S. Dermatology, Incyte . “We are proud to elevate the patient voice and share the real, lived experience with Opzelura as part of our commitment to patients and to providing a treatment that can help address some of the most burdensome symptoms of AD. Our hope is that the Moments of Clarity program helps those living with eczema connect with others and inspires them to have conversations with their doctor.” OPZELURA is not for everyone. See below for IMPORTANT SAFETY INFORMATION including boxed Warning for Serious Infections, Increased Risk of Death, Lymphoma and other Cancers, Major Cardiovascular Events and Blood Clots. To hear more visit MyMomentsofClarity.com. All individuals were compensated for their participation. About Opzelura® (ruxolitinib) Cream Opzelura® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States . Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. In April 2022 , Incyte entered into a strategic alliance agreement with Maruho Co., Ltd. for the development, manufacturing and exclusive commercialization of ruxolitinib cream for treatment of autoimmune and inflammatory dermatology indications in Japan . Opzelura is a registered trademark of Incyte . IMPORTANT SAFETY INFORMATION OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. OPZELURA may cause serious side effects, including: Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA. OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA. Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth. Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen. Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers. Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth. Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen. Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides. Before starting OPZELURA, tell your healthcare provider if you: After starting OPZELURA: 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 OPZELURA in people treated for atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea). The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever. These are not all of the possible side effects of OPZELURA. 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 Incyte Corporation at 1-855-463-3463. INDICATIONS AND USAGE OPZELURA is a prescription medicine used on the skin (topical) for: The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. It is not known if OPZELURA is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo. Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA. About Incyte Dermatology Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need. We strive to identify and develop therapies to modulate immune pathways driving uncontrolled inflammation to help restore normal immune function and bring the body closer to homeostasis. Specifically, our efforts in dermatology are focused on a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen planus, lichen sclerosus and prurigo nodularis To learn more, visit the Dermatology section of Incyte.com. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware , Incyte has operations in North America , Europe and Asia . For additional information on Incyte , please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the partnership between Incyte and Dr. Sandra Lee Incyte’s goal of improving the lives of patients, whether and when Opzelura might provide a successful treatment option for patients with atopic dermatitis, and Incyte’s dermatology program generally, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other regulatory authorities outside of the United States ; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission , including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2024 . Incyte disclaims any intent or obligation to update these forward-looking statements. 1 National Eczema Association . What is atopic dermatitis? https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/ View source version on businesswire.com: https://www.businesswire.com/news/home/20241009443934/en/ Media media@incyte.com Investors ir@incyte.com Source: Incyte

Upstream Bio is joining a recent swell of biotechs going public. The fall flurry of biotech IPOs shows no signs of abating, with Upstream Bio becoming the latest company to express an intention to go public.The Waltham, Massachusetts-based biotech has yet to set expectations on the size of its proposed offering, but said in a Securities and Exchange Commission filing yesterday that the proceeds would be directed toward its lead asset verekitug.The company has pitched verekitug as the “only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin (TSLP).” This cytokine is a known driver of the inflammatory response, affecting a range of immune-mediated diseases.Proceeds from the IPO will go in part to completing an ongoing phase 2 trial of the drug in severe asthma, as well as launching a phase 3 study in the same indication. Funds will also be used to continue an ongoing phase 2 study of verekitug in chronic rhinosinusitis with nasal polyps, with plans for a phase 3 to follow. In addition, the biotech has its eye on a potential phase 2 study in COPD.Any remaining cash will be spent on further R&D for verekitug, including expanding into other indications, as well as for working capital and general business costs, according to the filing.The company’s recent clinical efforts have been funded by a $200 million series B last year, which saw Enavate Sciences and Venrock Healthcare Capital Partners lead a group of investors including the likes of Bain Capital Life Sciences, Wellington Management and OrbiMed. That round came just a year after the company hauled in $200 million from a series A as part of its launch in June 2022. The Upstream story can be traced back to 2021, when lead backers OrbiMed and Maruho began building the company around verekitug, an asset won in an auction from Japanese pharma Astellas. Rather than put up a small amount to start off with, OrbiMed, Maruho and other investors provided the new biotech with significant cash to get through its initial stages.The company began with what it described to Fierce Biotech at the time as a “lean and mean” team of 13 people, but yesterday’s filing shows that this workforce had increased to 38 full-time employees by last month.Upstream’s C-suite also received a shake-up (PDF) in April, when Rand Sutherland, M.D., took on the CEO role after having headed up Seeker Biologics—which closed last year—and previously serving as president of Translate Bio prior to its acquisition by Sanofi.Upstream’s intentions are the latest indication that after a summer lull, the biotech IPO scene has picked up pace, with a trio of clinical-stage companies all going public with nine-figure offerings last Friday. They were followed by the smaller-scale IPO of Kairos Pharma on Monday.