Dupilumab

If approved, Dupixent would be the first treatment in the U.S. indicated for adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell Current treatment options for adolescents with CRSwNP leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps May 13, 2024 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The target action date for the FDA decision is September 15, 2024. Dupixent is currently approved as an add-on maintenance treatment for adults with CRSwNP whose disease is not adequately controlled. The sBLA in adolescents is supported by an extrapolation of efficacy data from two positive pivotal trials (SINUS-24 and SINUS-52) in adults with CRSwNP. These trials demonstrated that Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, while also reducing the need for systemic corticosteroids or surgery, at 24 weeks compared to placebo. The sBLA was also supported by the safety data of Dupixent in its currently approved indications for adolescents. Safety results in both SINUS-24 and SINUS-52 were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥3%) compared to placebo in SINUS-24 and SINUS-52 (24-week safety pool) were injection site reactions and arthralgia. Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. The potential use of Dupixent in adolescents with CRSwNP has not been fully evaluated by any regulatory authority. CRSwNP is a chronic, recurring disease of the upper airway driven in part by type 2 inflammation that obstructs the sinuses and nasal passages. It can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, facial pressure, sleep disturbance, and overall reduction in quality of life. Many patients with CRSwNP have other type 2 inflammatory diseases, such as asthma that is often more severe and difficult to treat. These co-morbid diseases can lead to an increased risk of asthma attacks, high symptom burden and a substantial adverse impact on health-related quality of life. In the pivotal adult Dupixent CRSwNP trials, 59% of patients also had asthma. Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis (EoE), prurigo nodularis and chronic spontaneous urticaria (CSU) in different age populations. More than 850,000 patients are being treated with Dupixent globally. 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 co-Founder, 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 a substantial portion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn). Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. 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Initiated a Phase 2 clinical trial of APG777, a subcutaneous half-life extended monoclonal antibody targeting IL-13, in patients with moderate-to-severe atopic dermatitis, with 16-week proof-of-concept data from Part A of the trial expected in 2H 2025 First participant dosed in Phase 1 healthy volunteer clinical trial of APG808, a subcutaneous half-life extended monoclonal antibody targeting IL-4Rα, for the treatment of chronic obstructive pulmonary disease and other inflammatory diseases with interim Phase 1 data expected in 2H 2024 Nominated development candidate for APG990, a subcutaneous half-life extended monoclonal antibody targeting OX40L, with a Phase 1 trial in healthy volunteers expected to initiate in 2H 2024 $816 million cash, cash equivalents and marketable securities with runway into 2028 SAN FRANCISCO and WALTHAM, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology (I&I) indications, today reported pipeline highlights and first quarter financial results. “I am proud of the continued momentum our team has achieved this quarter, executing against our goals and successfully bringing our programs forward ahead of schedule,” said Michael Henderson, MD, Chief Executive Officer of Apogee. “We continue to maintain that pace of progress with the selection of our development candidate for APG990 and now plan to initiate a Phase 1 trial in healthy volunteers by the end of the year. We commenced dosing of the first healthy participants in our second clinical program, APG808, and expect an interim readout in the second half of this year. Following that readout, we're planning a Phase 1b readout for APG808 in asthma to follow in the first half of 2025 that is designed to determine the doses to then take into a Phase 2 trial in COPD in the same year. We are on track to dose the first patient in the APG777 Phase 2 trial in patients with moderate-to-severe AD in the first half of this year. Additionally, on the heels of our successful interim Phase 1 APG777 data readout, we raised $483 million in an upsized public offering providing capital into 2028.” Pipeline and Corporate Highlights and Upcoming Milestones Initiated Phase 2 APG777 clinical trial: APG777 is a novel, subcutaneous (SQ) half-life extended monoclonal antibody (mAb) targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. The company has commenced enrollment of patients for the Phase 2 clinical trial of APG777 in patients with moderate-to-severe AD in the first half of 2024, with 16-week proof-of-concept data from Part A of the trial expected in 2H 2025.The trial is designed to combine the typical Phase 2a and 2b portions of a clinical trial into a single protocol. The primary endpoint of each part of the study is mean percentage changes in EASI score from baseline to Week 16.Initiation of a Phase 2 APG777 trial in asthma is expected to commence in 2025. First participant dosed in APG808 Phase 1 trial: Apogee’s second program, APG808, is a novel, SQ half-life extended mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. APG808 has similar binding and femtomolar affinity for IL-4Rα compared to picomolar affinity in the first generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays that measure downstream functional inhibition of the IL-13/IL-4 pathway (pSTAT6 induction, inhibition of TF-1 proliferation, and inhibition of TARC secretion). In March 2024, Apogee initiated dosing of healthy volunteers in its Phase 1 clinical trial. The company expects to share initial data in the second half of 2024 followed by a Phase 1b clinical trial in asthma with data expected in the first half of 2025 and initiation of a COPD trial in the same year. APG990 development candidate selected: Apogee has selected a development candidate for its APG990 program, a novel, SQ half-life extended mAb targeting OX40L, initially being developed for AD. OX40L is located further upstream in the inflammatory pathway than IL-13 or IL-4Rα and targeting it could potentially have broader impact on the inflammatory cascade by inhibiting both Type 1 and Type 2 inflammation. With current approved biologics only targeting Type 2 inflammation (IL-13/IL4Rα) in AD, OX40L could represent another therapeutic option for patients, especially the portion of patients who do not benefit from currently available treatments. APG990 has been engineered to have differentiated attributes, including an extended half-life, which we expect will result in a more favorable dosing schedule of every three or six months. The company is also interested in testing the hypothesis that combining APG990 with APG777 will result in more extensive inhibition of the inflammatory cascade (Type 1 and Type 2 inflammation) than either approach alone. The company plans to present additional data on this at its R&D Day in the fourth quarter of this year. Initiation of a Phase 1 APG990 trial in healthy volunteers is expected to begin ahead of schedule and is now expected in the second half of 2024. Completed $483 million upsized public offering: In March, the company closed on an upsized public offering of 7,790,321 shares of common stock, including the full exercise of the underwriters’ option to purchase up to 1,016,128 additional shares, at a public offering price of $62.00 per share. The aggregate gross proceeds to Apogee from the offering were approximately $483.0 million before deducting underwriting discounts and commissions and other offering expenses payable by Apogee. First Quarter Financial Results Cash Position: As of March 31, 2024, Apogee had cash, cash equivalents and marketable securities of $816.2 million. Apogee expects that its existing total cash will enable it to fund its current operating expenses into the first quarter of 2028.Research & Development (R&D) Expenses: R&D expenses for the first quarter of 2024 were $28.7 million, compared to $8.5 million for the first quarter of 2023. R&D expenses increased primarily due to further development of the company’s APG777 and APG808 programs and advancement of its pipeline into clinical trials, as well as increases in personnel costs, including equity-based compensation expense, associated with the growth of its R&D team.General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2024 were $9.5 million, compared to $4.2 million for the first quarter of 2023. G&A expenses increased primarily due to increases in personnel costs, including equity-based compensation, associated with the growth of the company’s G&A team, as well as increased costs related to being a public company, including for legal, IT and professional services, and to support the growth of the business.Net Loss: Net loss for the first quarter of 2024 was $32.1 million, compared to $12.5 million net loss for the first quarter of 2023 . Net loss increased primarily as a result of higher R&D and G&A expenses as described above, partially offset by higher interest income. About ApogeeApogee Therapeutics is a clinical-stage biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology indications with high unmet need. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. The company’s two most advanced programs are APG777 and APG808, which are being initially developed for the treatment of AD, COPD, and asthma, respectively. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit www.apogeetherapeutics.com. Forward Looking StatementsCertain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s expectations regarding plans for its current and future product candidates and programs, its plans for Apogee’s current and future clinical trials, including a Phase 2 trial for APG777 in asthma, Phase 1 trials of APG808, and a Phase 1 trial for APG990, Apogee’s plans for clinical trial design, the anticipated timing of the initiation of and results from Apogee’s clinical trials, including data from Apogee’s Phase 2 trial of APG777 and Apogee’s Phase 1 trial of APG808, the potential clinical benefit and half-life of APG777, APG808, APG990 and any other potential programs, Apogee’s expected timing for future pipeline updates and expectations regarding the time period over which Apogee’s capital resources will be sufficient to fund Apogee’s anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Annual Report on 10-K for the year period ended December 31, 2023, filed with the SEC on March 5, 2024, and subsequent disclosure documents we may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. APOGEE THERAPEUTICS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED)(In thousands, except unit/share data) MARCH 31, DECEMBER 31, 2024 2023Assets Current assets: Cash and cash equivalents$485,457 $118,316 Marketable securities 330,739 277,143 Prepaid expenses and other current assets 4,412 2,950 Total current assets 820,608 398,409 Property and equipment, net 699 377 Right-of-use asset, net 1,951 2,217 Other non-current assets 401 401 Total assets$823,659 $401,404 Liabilities and stockholders' equity Current liabilities: Accounts payable$4,302 $2,143 Lease liability 1,141 1,101 Accrued expenses 16,108 17,314 Total current liabilities 21,551 20,558 Long-term liabilities: Lease liability, net of current 630 933 Total liabilities 22,181 21,491 Stockholders’ Equity: Common Stock; $0.00001 par value, 400,000,000 authorized, 58,456,027 issued and 56,367,802 outstanding as of March 31, 2024; 400,000,000 authorized, 50,655,671 issued and 48,338,769 outstanding as of December 31, 2023 1 - Additional paid-in capital 957,518 503,354 Accumulated other comprehensive (loss) income (177) 329 Accumulated deficit (155,864) (123,770)Total stockholders’ equity 801,478 379,913 Total liabilities and stockholders’ equity$823,659 $401,404 APOGEE THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS(UNAUDITED)(In thousands, except share and per share data) THREE MONTHS ENDED MARCH 31, 2024 2023Operating expenses: Research and development$28,716 $8,455 General and administrative 9,465 4,203 Total operating expenses 38,181 12,658 Loss from operations (38,181) (12,658)Other income, net: Interest income, net 6,087 133 Total other income, net 6,087 133 Net loss$(32,094) $(12,525) Investor Contact:Noel KurdiVP, Investor RelationsApogee Therapeutics, Inc.Noel.Kurdi@apogeetherapeutics.com Media Contact:Dan Budwick1AB dan@1abmedia.com