A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris

To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.

开始日期2019-06-27

申办/合作机构

Sol-Gel Technologies Ltd.

NCT03761784

/ Completed临床3期

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris

To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

开始日期2018-12-21

申办/合作机构

Sol-Gel Technologies Ltd.

NCT03761810

/ Completed临床3期

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris

To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

开始日期2018-12-14

申办/合作机构

Sol-Gel Technologies Ltd.

100 项与过氧苯甲酰/维A酸相关的临床结果

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100 项与过氧苯甲酰/维A酸相关的转化医学

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100 项与过氧苯甲酰/维A酸相关的专利（医药）

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项与过氧苯甲酰/维A酸相关的文献（医药）

2023-09-01·ANNALS OF PHARMACOTHERAPY

Tretinoin 0.1% and Benzoyl Peroxide 3% Cream for the Treatment of Facial Acne Vulgaris

Review

作者: Feldman, Steven R. ; Kontzias, Christina ; Zaino, Mallory

Objective::

To assess the efficacy, safety, and clinical application of tretinoin 0.1%-benzoyl peroxide 3% cream for the topical treatment of acne vulgaris.

Data Sources::

A systematic review of the literature was performed using the terms Twyneo OR tretinoin and benzoyl peroxide OR S6G5T-3 in MEDLINE (PubMed) and EMBASE. ClinicalTrials.gov was searched to obtain completed clinical trial results not published elsewhere.

Study Selection and Data Extraction::

All human studies published in English prior to November 2022 related to pharmacology, clinical trials, safety, and efficacy were evaluated for inclusion.

Data Synthesis::

In two 12-week, phase 3, randomized, vehicle-controlled clinical trials, tretinoin 0.1%-benzoyl peroxide 3% cream significantly reduced inflammatory and noninflammatory facial acne lesions and significantly improved Investigator Global Assessment (IGA) rating to clear or almost clear. The cream has a suitable safety profile, with application site pain and dryness as the most common adverse events.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Agents::

Tretinoin-BPO had similar IGA success compared to other topical retinoid and retinoid-BPO treatments for acne vulgaris. Compared to individual tretinoin and benzoyl peroxide therapy, the combination product streamlines application, which will improve medication adherence; however, the cost of tretinoin-BPO cream may be prohibitive.

Conclusions::

Tretinoin 0.1%-benzoyl peroxide 3% cream is safe and effective for the treatment of moderate-to-severe acne. Long-term trial data on efficacy and tolerability are not yet available.

2021-02-01·CLINICAL CANCER RESEARCH

The Changing Landscape of Therapeutic Cancer Vaccines—Novel Platforms and Neoantigen Identification

Review

作者: Jou, Jessica ; Zocca, Mai-Britt ; Harrington, Kevin J. ; Cohen, Ezra E.W. ; Ehrnrooth, Eva

Abstract:

Therapeutic cancer vaccines, an exciting development in cancer immunotherapy, share the goal of creating and amplifying tumor-specific T-cell responses, but significant obstacles still remain to their success. Here, we briefly outline the principles underlying cancer vaccine therapy with a focus on novel vaccine platforms and antigens, underscoring the renewed optimism. Numerous strategies have been investigated to overcome immunosuppressive mechanisms of the tumor microenvironment (TME) and counteract tumor escape, including improving antigen selection, refining delivery platforms, and use of combination therapies. Several new cancer vaccine platforms and antigen targets are under development. In an effort to amplify tumor-specific T-cell responses, a heterologous prime-boost antigen delivery strategy is increasingly used for virus-based vaccines. Viruses have also been engineered to express targeted antigens and immunomodulatory molecules simultaneously, to favorably modify the TME. Nanoparticle systems have shown promise as delivery vectors for cancer vaccines in preclinical research. T-win is another platform targeting both tumor cells and the TME, using peptide-based vaccines that engage and activate T cells to target immunoregulatory molecules expressed on immunosuppressive and malignant cells. With the availability of next-generation sequencing, algorithms for neoantigen selection are emerging, and several bioinformatic platforms are available to select therapeutically relevant neoantigen targets for developing personalized therapies. However, more research is needed before the use of neoepitope prediction and personalized immunotherapy becomes commonplace. Taken together, the field of therapeutic cancer vaccines is fast evolving, with the promise of potential synergy with existing immunotherapies for long-term cancer treatment.

2020-01-01·Skinmed

Microencapsulated Benzoyl Peroxide and Tretinoin for the Treatment of Acne Vulgaris: Results from a Phase 2 Multicenter, Double-Blind, Randomized, Vehicle-Controlled Study.

Article

作者: Sugarman, Jeffrey ; Webster, Guy F ; Levy-Hacham, Ofra ; Toledano, Ofer

This phase 2, 12-week, multicenter, randomized, double-blind, active- and vehicle-controlled (VC), parallel-group trial assessed the efficacy and safety of silica encapsulated benzoyl peroxide BP (E-BP), two concentrations of silica encapsulated tretinoin (E-ATRA) and their combinations (TWIN high and low) vs VC in 726 males and females ≥9 years of age with moderate-to-severe inflammatory facial acne. The co-primary efficacy endpoints were Investigators Global Assessment (IGA) success rate ("clear" or "almost clear") and changes from baseline in inflammatory and non-inflammatory lesion counts. TWIN high and low were each significantly superior vs VC for IGA success at 12 weeks (39.7% and 27.4%, respectively, vs 12.3%, P < 0.001 and P < 0.01). TWIN high and low resulted in mean reductions in inflammatory lesions of -16.9 (64%) and -17.0 (60.8%) vs -11.5 (42%) for VC. Reductions in non-inflammatory lesions were -23.7 for TWIN low (54.9%) and -23.6 for TWIN high (53.3%) vs -13.7 (32.4%) for VC (all P < 0.001 vs VC). Results for TWIN were also numerically superior to E-BP and E-ATRA. All treatments were safe with comparable skin tolerability. The significant superiority of both combinations over VC and numerical superiority over E-BP and E-ATRA were achieved without an increase in adverse events or reduced skin tolerability.

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项与过氧苯甲酰/维A酸相关的新闻（医药）

2025-11-20

·ir.sol-gel.com

Sol-Gel Reports Third Quarter 2025 Financial Results and Provides Corporate Updates

Sol-Gel intends to pursue high-frequency BCC as an additional indication for its lead drug candidate SGT-610, which, if approved, could at least double the drug’s commercial potential In September 2025 , Sol-Gel announced Health Canada approval of EPSOLAY Sol-Gel signed an additional agreement with Viatris covering Australia and New Zealand for both EPSOLAY and TWYNEO NESS ZIONA, Israel , Nov. 20, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today announced financial results for the third quarter ending September 30, 2025 , and provided a corporate update. Q3 2025 and Recent Corporate Developments Sol-Gel’s ongoing Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, for which top-line results are expected in the fourth quarter of 2026, has led to growing physician interest in its potential use in patients with severe, high-frequency basal cell carcinoma (BCC). One such case, a non-Gorlin patient in France with a devastating form of high-frequency BCC, was found to have a lesion harboring a PTCH-1 mutation, and Sol-Gel agreed to provide SGT-610 for compassionate use. Sol-Gel plans to supply the drug to additional high-frequency BCC patients with at least one PTCH-1 mutated lesion and is evaluating the initiation of a feasibility study in this new indication to further substantiate the rationale for a Phase 3 trial in 2027, subject to the successful completion of the Phase 3 Gorlin syndrome trial. High-frequency BCC is also a rare disease; however, its prevalence is estimated to be at least ten times higher than that of Gorlin syndrome. Even if clinical development focuses only on patients with the most severe forms of high-frequency BCC, a successful outcome is expected to at least double the commercial potential of SGT-610. For many of these patients, there is a significant unmet need for an effective and well-tolerated treatment, as frequent and potentially disfiguring Mohs surgeries are often no longer sustainable. Sol-Gel’s vehicle-controlled Phase 1b clinical trial (Stage 1) investigating SGT-210 (topical erlotinib) in patients with Darier disease has been challenged by the limited number of eligible patients in Israel . As a result, only seven subjects who completed the treatment were enrolled so far. Consequently, Sol-Gel has decided to conclude the current phase of the trial and to proceed with an open-label extension in which all enrolled patients will receive active treatment with SGT-210. Sol-Gel will release the results of Stage 1 of the trial in December 2025 . On September 4, 2025 , Sol-Gel announced Health Canada marketing approval of EPSOLAY for the treatment of inflammatory lesions of rosacea in adults. On August 19, 2025 , Sol-Gel signed an additional license agreement for the commercialization of TWYNEO and EPSOLAY in Australia and New Zealand with Viatris Pty Ltd , a subsidiary of Viatris Inc. (NASDAQ: VTRS). This agreement is in addition to the seven agreements Sol-Gel signed during 2024 in various territories covering most European countries, South Africa and South Korea . These already signed agreements, together with agreements we anticipate signing in the future covering Latin American countries, Spain and Portugal , are expected to provide upfront and regulatory milestone payments of up to $3.7 million .Based on the forecasts received from Sol-Gel’s current and potential partners, Sol-Gel now expects that TWYNEO and EPSOLAY will launch in the majority of these new territories in 2028 and 2027 respectively, and following launch, these transactions are anticipated to provide Sol-Gel with an annual royalty revenue stream with the potential to grow gradually to approximately $10 million for the year 2031 and further. Mr. Mori Arkin , Executive Chairman of Sol-Gel , stated: " Sol-Gel continued to make steady progress in the third quarter as we advance our late-stage pipeline in dermatologic rare diseases. Our pivotal Phase 3 trial of SGT-610 for Gorlin syndrome is ongoing, and we remain focused on executing this study to deliver top-line results in the fourth quarter of 2026. We are particularly excited about the opportunity of at least doubling the potential of this important drug by adding the unmet need of high-frequency BCC." Mr. Arkin further commented "The recently announced Health Canada approval of EPSOLAY, alongside our existing ex- U.S. partnerships for TWYNEO and EPSOLAY, underscores our ability to unlock the value of our approved products through collaborations that provide non-dilutive revenue streams. We are delighted that additional companies with strong market presence in their territories have joined our growing partnership network. The number of territories and the identity of our partners make us confident about reaching our target of $10 million EBITDA from this business alone, by 2031. As we look ahead, we remain committed to advancing SGT-610 and SGT-210 to support our strategy of becoming a leader in rare dermatological diseases and to create long-term value for patients and shareholders." Financial Results for the Third Quarter 2025 Total revenue for the third quarter was $0.4 million , which primarily consisted of license revenue from ex-US licensing agreements, compared to total revenue of $5.4 million for the same period in 2024, which primarily consisted of $0.4 million royalty revenue from Galderma, $0.6 royalty revenue from Searchlight, $3.8 million under the agreement with Padagis and $0.5 million under the ex-US licensing agreements. Research and development expenses were $5.7 million compared to $4.8 million for the same period in 2024. The increase of $0.9 million was primarily attributed to an increase of $0.8 million in manufacturing development expenses related to SGT-610 and an increase of $0.7 million in clinical trial expenses for SGT-610, offset by a decrease of $0.4 million in professional expenses related to ex-US activities in EPSOLAY and TWYNEO and a decrease of $0.3 million in professional expenses related to a generic product candidate. General and administrative expenses were $1 million compared to $1.4 million for the same period in 2024. The decrease is mainly attributed to a decrease in payroll and expenses due to the adoption of cost saving measures during 2024. Sol-Gel reported a net loss of $5.9 million for the third quarter of 2025 and loss of $2.13 per basic and diluted share, compared to a net loss of $0.4 million and loss of $0.13 per basic and diluted share for the same period in 2024. As of September 30, 2025 , Sol-Gel had $6.8 million in cash, cash equivalents, and deposits and $14.1 million in marketable securities for a total balance of $20.9 million . The Company expects its cash resources to fund cash requirements into the first quarter of 2027. About TWYNEO and EPSOLAY TWYNEO is a topical cream containing a fixed-dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, cream for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the cream. EPSOLAY is a topical cream containing benzoyl peroxide (BPO), 5%, for the treatment of bumps and blemishes (inflammatory lesions) of rosacea in adults. EPSOLAY utilizes a proprietary, patented technology to encapsulate BPO within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release BPO over time to provide tolerable and effective treatment. About Gorlin Syndrome and SGT-610 SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors. About Sol-Gel Technologies Sol-Gel Technologies Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. The Company’s pipeline also includes Phase 3 clinical trial of Orphan and breakthrough drug candidate SGT-610, which is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors as well as topical drug candidate SGT-210 under investigation for the treatment of rare hyper keratinization disorders. For additional information, please visit our new website: www.sol-gel.com Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to the amounts expected to be received under our current and future licensing agreements our expected cash runway, the size of the markets for SGT-610 and SGT-210, the timeline for advancing SGT-610 and SGT-210, including the timing for top-line results and the timing for payments from Mayne Pharma. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, lower than anticipated annual revenue from our current and future licensing agreements or a delay in generating revenue, the risk that the market for SGT-610 and SGT-210 will not be as anticipated, including with respect to High-Frequency BCC for SGT-610, our ability to enter into further collaborations, a delay in the timing of our clinical trials, top-line results and regulatory filings, a delay in receipt of payments from Mayne Pharma and others, the success of our clinical trials, and an increase in our anticipated costs and expenses, as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States , China , Europe or Israel ; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 13, 2024 , and our other reports filed with the SEC , could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release. Sol-Gel Contact: Eyal Ben-Or Chief Financial Officerinfo@sol-gel.com+972-8-9313429 Source: Sol-Gel Technologies Ltd. *All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. Source: Sol-Gel Technologies Ltd.

临床1期临床3期引进/卖出上市批准财报

2025-11-14

·GlobeNewswire-Health Care

IO Biotech Reports Third Quarter 2025 Financial Results and Provides Business Highlights

Topline data from Phase 3 (IOB-013) clinical trial in advanced melanoma presented at ESMO; data highlights improvements in PFS achieved in overall population and across virtually all subgroups, although statistical significance on the PFS primary endpoint was narrowly missedMeeting scheduled with FDA in December to align on the design of a potential new Phase 3 registrational trial for IO102-IO103 in patients with advanced melanomaPre-clinical data for additional T-win platform pipeline candidates IO112 targeting arginase 1 and IO170 targeting transforming growth factor (TGF)-β were presented at the Society for Immunotherapy of Cancer’s (SITC) Annual MeetingEnded the third quarter with approximately $31 million in cash and cash equivalents, which is expected to support operations through the first quarter of 2026Corporate presentations planned for the Jefferies Global Healthcare Conference in London on November 18, 2025, and the Piper Sandler 37th Annual Piper Sandler Healthcare Conference on December 3, 2025 NEW YORK, Nov. 14, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today reported financial results for the third quarter of 2025 and recent business highlights. “We remain keenly focused on our mission to develop novel, immune-modulatory, off-the-shelf cancer therapies for the treatment of multiple types of tumors including melanoma, lung, and head and neck cancer,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “Although the IOB-013 study narrowly missed statistical significance on the primary PFS endpoint, the results of the study support the mechanism of action of our therapeutic cancer vaccines and, we believe, have significantly de-risked the program. We look forward to discussing the next Phase 3 study design for Cylembio with the FDA in December and remain committed to bringing Cylembio to cancer patients seeking alternative treatment options as quickly as possible.” Recent Business Highlights The company presented topline results of its Phase 3 pivotal trial (IOB-013/KN-D18) evaluating the company’s lead investigational vaccine, Cylembio® (imsapepimut and etimupepimut, adjuvanted), in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of advanced melanoma in an oral presentation at the 2025 European Society for Medical Oncology (ESMO) congress. The trial evaluated Cylembio in combination with pembrolizumab vs. pembrolizumab alone as a first-line treatment in 407 patients with unresectable or metastatic (advanced) melanoma. In the study, Cylembio plus pembrolizumab demonstrated a clinically relevant improvement in progression free survival (PFS) compared to pembrolizumab alone, which was also observed in virtually all subgroups, but the trial narrowly missed statistical significance.The company has a meeting with the United States (US) Food and Drug Administration (FDA) scheduled in December to align on the design of a potential new Phase 3 registrational trial for the treatment of advanced melanoma.The company also presented a poster at ESMO of final data from the Phase 2 basket trial (IOB-022/KN-D38) of IO102-IO103 plus pembrolizumab for 1L treatment of advanced non-small cell lung cancer (NSCLC) and recurrent/metastatic squamous cell carcinoma of head and neck (SCCHN) highlighting encouraging landmark PFS and overall survival (OS) rates.The company presented two posters at the SITC annual meeting with pre-clinical data for two additional T-win vaccine candidates. Data presented in a poster for its next therapeutic vaccine candidate expected to enter clinical development, IO112 targeting arginase 1, demonstrated anti-tumor activity with dynamic changes in the tumor microenvironment (TME) driven by the vaccine-targeted modulation of immunosuppressive myeloid cells, including tumor-associated macrophages (TAMs). Data presented in the poster for an additional candidate, IO170 targeting Transforming Growth Factor (TGF)-β, demonstrated induction of immune responses that could inhibit tumor growth and reduce lung metastasis. Investor Conferences Participation Jefferies Global Healthcare Conference in London: Mai-Britt Zocca, PhD, President and CEO, will give a company presentation beginning at 3:00 PM GMT on November 18, 2025.Piper Sandler 37th Annual Piper Sandler Healthcare Conference: Mai-Britt Zocca, PhD, President and CEO, and Amy Sullivan, CFO, will participate in a fireside chat beginning at 3:00 PM ET on December 3, 2025. The webcasts for these two upcoming conferences will be available from the Investors section of the company’s website at https://investors.iobiotech.com. Third Quarter 2025 Financial Results Total operating expenses for the three months ended September 30, 2025, were $19.4 million, compared to $26.5 million for the three months ended September 30, 2024.Research and development expenses were $13.7 million for the three months ended September 30, 2025, compared to $20.2 million for the three months ended September 30, 2024. The company recognized $0.6 million in research and development equity-based compensation for the three months ended September 30, 2025 and 2024, respectively.General and administrative expenses were $5.6 million for the three months ended September 30, 2025, compared to $6.3 million for the three months ended September 30, 2024. The company recognized $0.9 million in general and administrative equity-based compensation for the three months ended September 30, 2025 and $1.0 million for the three months ended September 30, 2024.Cash and cash equivalents as of September 30, 2025 were $30.7 million, compared to $60.0 million at December 31, 2024. During the three months ended September 30, 2025, the company increased cash, cash equivalents and restricted cash by $2.5 million primarily due to the draw down of €12.5 million in gross proceeds from our Tranche B loan with the European Investment Bank on July 4, 2025 and net proceeds of $6.6 million from the issuance of common stock in connection with our at-the-market program. The company now expects that it will have sufficient cash to run the company through the first quarter of 2026. About Cylembio® Cylembio® (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 clinical trials is now complete. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio. Cylembio® is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada). About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression-free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) or recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) at sites in the United States, Spain, and the United Kingdom. IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, Cylembio®, in clinical trials, and additional pipeline candidates through preclinical development. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech). Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including statements regarding the timing or outcome of communications and meetings with regulatory authorities including the FDA, the timing or outcome of the submission of marketing applications, including a BLA, for Cylembio, the timing or outcome of the launch of Cylembio, and statements regarding other current or future clinical trials, their timing, progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Contact: Investors and Media: Maryann Cimino, Director of Investor Relations & Corporate CommunicationsIO Biotech, Inc.617-710-7305mci@iobiotech.com IO BIOTECH, INC.Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share amounts)(unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2025 2024 2025 2024 Operating expenses Research and development $13,742 $20,178 $46,769 $50,337 General and administrative 5,613 6,326 18,340 17,897 Total operating expenses 19,355 26,504 65,109 68,234 Loss from operations (19,355) (26,504) (65,109) (68,234)Other (expense) income Currency exchange gain (loss), net 98 1,630 (381) 1,078 Interest income 255 1,068 954 3,996 Interest expense (886) — (1,139) — Change in fair value of warrants 9,846 — 7,259 — Total other income (expense), net 9,313 2,698 6,693 5,074 Loss before income tax expense (credit) (10,042) (23,806) (58,416) (63,160)Income tax (credit) expense (1,664) 209 (1,400) 998 Net loss (8,378) (24,015) (57,016) (64,158)Net loss attributable to common shareholders (8,378) (24,015) (57,016) (64,158)Net loss per common share, basic and diluted $(0.13) $(0.36) $(0.86) $(0.97)Weighted-average number of shares used in computing net loss per common share, basic and diluted 66,941,964 65,880,914 66,238,484 65,880,914 Other comprehensive loss Net loss $(8,378) $(24,015) $(57,016) $(64,158)Foreign currency translation (353) (1,374) (314) (1,331)Total comprehensive loss $(8,731) $(25,389) $(57,330) $(65,489) IO BIOTECH, INC.Consolidated Balance Sheets(In thousands, except share and per share amounts)(unaudited) September 30,2025 December 31,2024 Assets Current assets Cash and cash equivalents $30,664 $60,031 Prepaid expenses and other current assets 6,167 4,920 Total current assets 36,831 64,951 Restricted cash 268 268 Property and equipment, net 544 638 Right of use lease asset 1,302 1,725 Other non-current assets 1,011 117 Total non-current assets 3,125 2,748 Total assets $39,956 $67,699 Liabilities and stockholders’ equity Current liabilities Accounts payable $5,587 $4,661 Lease liability - current 788 717 Accrued expenses and other current liabilities 11,936 14,108 Total current liabilities 18,311 19,486 Lease liability - non-current 667 1,198 Term loan debt, net 16,664 — Common stock warrants 3,403 — Total non-current liabilities 20,734 1,198 Total liabilities 39,045 20,684 Commitments and contingencies Stockholders’ equity Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and outstanding as of September 30, 2025 and December 31, 2024 — — Common stock, par value of $0.001 per share; 300,000,000 shares authorized at September 30, 2025 and December 31, 2024; 69,692,179 shares issued and outstanding as of September 30, 2025 and 65,880,914 shares issued and outstanding as of December 31, 2024. 70 66 Additional paid-in capital 424,335 413,113 Accumulated deficit (416,329) (359,313)Accumulated other comprehensive loss (7,165) (6,851)Total stockholders’ equity 911 47,015 Total liabilities and stockholders’ equity $39,956 $67,699

临床2期疫苗临床3期临床结果财报

2025-11-14

·CPHI制药在线

青春痘治疗格局恐生变

关注并星标CPHI制药在线日前，威斯克生物1类新药WSK-V108E的临床试验申请获CDE批准，用于治疗寻常痤疮。据公开资料，WSK-V108E是国内首个重组蛋白痤疮疫苗。此次WSK-V108E获批临床，意味着国内痤疮疫苗从“实验室概念”迈入“临床验证”阶段，未来有望改写目前以抗生素、维A酸、激素为主的长期对症模式，提供一种更针对病因、疗程更短、并可望减少抗生素使用的全新手段。值得一提的是，国外早就有药企/机构在开发痤疮疫苗，其中Origimm公司开发的ORI-001是一种基于重组蛋白的治疗性寻常痤疮候选疫苗，通过中和CAMP毒素阻断中性粒细胞趋化及IL-8释放，理论上可降低由该毒素介导的炎症反应。 2021年12月，赛诺菲通过收购Origimm公司将ORI-001纳入囊中。此外，赛诺菲在基础上开发出了一款mRNA疫苗SP0268。SP0268靶向抑制痤疮丙酸杆菌的CAMP毒素，阻断炎症信号，目前处于1/2期临床试验阶段。此外，美国加州大学研究团队还开发出了针对痤疮丙酸杆菌透明质酸酶变体（HylA）的疫苗。在小鼠模型中，使用疫苗选择性靶向HylA ，可以成功地减少了炎症，并缓解痤疮病理。痤疮治疗进展寻常痤疮（简称痤疮），俗称青春痘，是一种慢性炎症性皮肤病，临床表现为粉刺、丘疹、脓疱、结节或囊肿等一系列损害，常见于青少年。据统计，痤疮全球范围内人群发病率为9.4%，位居全球第八大慢性疾病，是全球非致命疾病负担的主要原因之一。痤疮的发生主要与皮脂腺分泌增多、毛囊口上皮异常角化、细菌感染、免疫与炎症等因素相关。此外，重型痤疮的发生还与遗传因素有关。其中，细菌感染主要是指痤疮丙酸杆菌的感染，痤疮丙酸杆菌的分泌型毒素（CAMP）是一种具有打孔能力的细菌毒力因子，可以杀伤角质形成细胞、巨噬细胞或皮脂腺细胞，并刺激这些细胞产生白介素(IL)-8、IL-1β、肿瘤坏死因子α等炎症因子促进局部炎症发生。痤疮好发于面部等暴露部位，影响患者容貌并可能诱发心理健康问题。根据痤疮严重度选择治疗方式的分级治疗是国内外痤疮治疗指南常规采用的方法，其中轻中度痤疮治疗以局部治疗为主，中重度痤疮需要系统药物治疗。目前，疮治疗主要围绕外用药物联合口服抗生素，但这一疗法对中重度痤疮的长期控制效果有限，约30%-50%患者可能复发。此外，物理疗法，如光动力疗法（PDT）、红蓝光照射、激光治疗及强脉冲光（IPL）治疗在痤疮管理中亦占有重要地位。这类疗法既可作为系统或外用药物的辅助治疗，也可作为替代方案应用于部分患者。而且，物理疗法在痤疮后遗症管理方面同样具有价值，可用于瘢痕及色素沉着的干预。随着对痤疮市场的关注，据不完全统计，近十年来全球监管机构还批准了几款痤疮新药，详见下表。值得一提的是，这几款药物均为外用制剂。 Winlevi是40年来第一款具有全新作用机制的外用痤疮新药，其活性成分Clascoterone是一种雄激素受体拮抗剂，可以有效地在毛囊皮脂腺单元内竞争性抑制雄激素(尤其是二氢睾酮DHT)与雄激素受体结合。2020年8月，该药获FDA批准，用于治疗 12 岁及以上患者的痤疮。 Aklief的活性成分曲法罗汀是一种化学稳定的三苯基酸衍生物，具有类维甲酸的作用，属于第四代维A酸，通过调节皮肤细胞分化、抑制炎症反应发挥作用。2019年10月，Aklief获FDA批准，用于治疗9岁及以上寻常痤疮， Twyneo通过创新性运用Sol-Gel二氧化硅微囊包封技术，将过氧苯甲酰和维A酸分别用二氧化硅包封，在两种药物间以及药物与皮肤间形成屏障，阻断两种药物的接触，从而提高药物的稳定性，并同时减少药物与皮肤的直接接触，降低药物对皮肤的刺激性，提高患者的耐受性。2021年7月，Twyneo获FDA批准，用于治疗成人和9岁及以上儿童寻常痤疮。 Amzeeq是Foamix采用专有MST分子稳定技术开发的一种浓度为4%的米诺环素泡沫疗法，2019年10月获FDA批准，用于治疗非结节性中重度痤疮患者的炎症性病变（成年和9岁以上儿科患者），成为首款获FDA批准的外用米诺环素疗法。2020年4月，科笛集团与Foamix公司签订协议，获得泡沫剂在内的米诺环素系列3个产品在大中华区（包括中国大陆、中国台湾、中国香港及中国澳门地区）的权益，其中包括Amzeeq。2024年11月，该药在国内获批。整体来看，相较国外，国内监管机构批准的痤疮新药相对较少。不过国内药企并未放弃痤疮药物市场，除了痤疮疫苗，国内药企还积极开发其他痤疮新药，如GT20029、地尼法司他。 GT20029：首个完成2期临床的外用PROTAC化合物 GT20029是开拓药业基于自有的PROTAC平台自主开发的一款外用靶向雄激素受体（AR）的PROTAC疗法。2025年8月，GT20029治疗痤疮的中国2期临床试验读出顶线数据，成为全球范围内首款完成2期临床试验的外用PROTAC化合物。数据显示：该2期临床试验成功达到主要研究终点，结果具有统计学显著性及临床意义，且有效性、安全性和药代动力学特征均表现出色，并确定3期临床试验的推荐剂量为0.5%。地尼法司他：正在进行上市前沟通地尼法司他是Sagimet Biosciences研发的一种口服小分子脂肪酸合成酶（FASN）抑制剂，歌礼制药拥有其在大中华区的独家权益。FASN是人体内脂肪酸从头合成（DNL）途径中的关键酶。在痤疮患者的皮脂腺细胞中，FASN的活性异常高，导致皮脂分泌过多。过多的皮脂不仅为痤疮丙酸杆菌提供了繁殖的温床，还加剧了毛囊口的堵塞和炎症反应，从而形成粉刺、丘疹和囊肿等痤疮皮损。通过抑制FASN，地尼法司他能够直接抑制人皮脂细胞中脂肪酸的合成，从而减少面部皮脂生成。 2025年6月，地尼法司他治疗中重度寻常性痤疮的3期临床试验达到所有主要、关键次要及次要终点，与安慰剂相比显著改善中重度痤疮。图片来源：歌礼制药官方公布数据具体数据为：第12周时，地尼法司他治疗组治疗成功百分比为33.2%，显著高于安慰剂组的14.6%。地尼法司他治疗组的总皮损和炎性皮损计数相对基线百分比下降分别为57.4%和63.5%，均优于安慰剂组的35.4%和43.2%。此外，第12周时，地尼法司他治疗组非炎性皮损计数相对基线百分比下降为51.9%，而安慰剂组为28.9%。安全性方面，地尼法司他安全性和耐受性良好，不良事件（TEAE）发生率与安慰剂组相当，且所有与地尼法司他相关的不良事件（AE）均为轻度或中度。目前，歌礼制药正在与NMPA进行地尼法司他的上市申请前沟通（Pre-NDA），计划在完成沟通后提交新药上市申请。总结作为全球高发慢性皮肤病，痤疮治疗以抗生素、维A酸等对症手段为主，但复发率高、耐药等局限。值得期待的是，痤疮治疗格局正迎来多维度突破。疫苗研发方面，国内威斯克生物WSK-V108E获批临床，成首个重组蛋白痤疮疫苗，国外赛诺菲ORI-001、SP0268及美国加州大学HylA靶向疫苗也在推进，有望从病因层面革新治疗。新药开发上，开拓药业GT20029、歌礼制药地尼法司他等表现亮眼，国外多款新药也已获批。 END 智药研习社近期活动来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

疫苗信使RNA并购临床结果临床2期

100 项与过氧苯甲酰/维A酸相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
寻常痤疮	美国	Mayne Pharma Ltd.	2021-07-26

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03664752 (CTgov)	临床3期	寻常痤疮	585	IDP-120 (IDP-120 Gel)	膚觸鹽鏇繭鹹鹹襯壓壓(糧憲網簾網鏇獵觸遞鹹) = 構築齋獵糧蓋齋範願廠鑰簾餘壓積鬱夢鏇衊夢 (簾築製願壓構簾構衊願, 9.50) 更多	-	2023-03-29
				IDP-120 (IDP-120 Vehicle Gel)	膚觸鹽鏇繭鹹鹹襯壓壓(糧憲網簾網鏇獵觸遞鹹) = 膚淵鹽製選衊糧壓餘網鑰簾餘壓積鬱夢鏇衊夢 (簾築製願壓構簾構衊願, 9.80) 更多
NCT03664739 (CTgov)	临床3期	寻常痤疮	608	IDP-120 (IDP-120 Gel)	糧構製衊鬱廠衊餘壓積(築鏇鹹築範鏇鬱齋簾糧) = 鑰網艱製艱艱壓壓顧艱鬱餘獵觸網糧淵糧壓構 (壓選鏇觸齋鬱壓淵顧壓, 10.79) 更多	-	2023-03-29
				IDp-120 (IDP-120 Vehicle Gel)	糧構製衊鬱廠衊餘壓積(築鏇鹹築範鏇鬱齋簾糧) = 製獵壓壓淵鹹願醖衊築鬱餘獵觸網糧淵糧壓構 (壓選鏇觸齋鬱壓淵顧壓, 9.68) 更多
NCT03761784 (SGT-65-04, CTgov)	临床3期	寻常痤疮	424	S6G5T-3 (S6G5T-3)	齋膚繭鬱網顧獵廠積顧 = 選築淵遞構鹹壓廠選廠觸壓構淵遞齋願窪願廠 (膚廠鏇憲鹹鏇鑰衊網醖, 襯構憲觸願繭獵齋齋觸 ~ 壓遞構蓋餘遞糧構衊鑰) 更多	-	2021-12-01
				S6G5T-8 (S6G5T-8 Vehicle Cream)	齋膚繭鬱網顧獵廠積顧 = 糧築選膚淵壓蓋觸鏇艱觸壓構淵遞齋願窪願廠 (膚廠鏇憲鹹鏇鑰衊網醖, 壓製製夢遞夢鹽醖蓋遞 ~ 遞積製夢醖憲積蓋構顧) 更多
NCT03761810 (SGT-65-05, CTgov)	临床3期	寻常痤疮	434	S6G5T-3 (S6G5T-3)	觸膚積積醖顧網壓鬱壓 = 鑰窪壓構鑰鹹齋鑰鹹夢襯鏇鬱鬱艱選顧繭醖衊 (膚簾鬱築廠鹽鑰製鏇鏇, 獵餘蓋鬱鑰憲夢襯獵觸 ~ 淵糧鏇獵積繭網壓製襯) 更多	-	2021-12-01
				S6G5T-8 (S6G5T-8 Vehicle Cream)	觸膚積積醖顧網壓鬱壓 = 遞衊鏇壓憲積構鑰膚襯襯鏇鬱鬱艱選顧繭醖衊 (膚簾鬱築廠鹽鑰製鏇鏇, 淵夢糧範齋鑰膚齋積壓 ~ 製簾觸選憲襯餘範襯網) 更多
NCT03761810 (SGT-65-05, GlobeNewswire) 人工标引	临床3期	寻常痤疮	434	Benzoyl Peroxide+Twyneo	積夢鏇夢襯鏇窪觸壓艱(鬱範壓壓壓夢繭夢壓憲) = 網襯蓋衊製鑰衊襯獵憲築繭鏇餘積糧鹽壓糧積 (範壓壓鏇鹽壓淵製鹽膚 ) 更多	积极	2019-12-30
				Placebo	積夢鏇夢襯鏇窪觸壓艱(鬱範壓壓壓夢繭夢壓憲) = 積構範顧蓋範遞壓鹹選築繭鏇餘積糧鹽壓糧積 (範壓壓鏇鹽壓淵製鹽膚 ) 更多
NCT03761784 (SGT-65-04, GlobeNewswire) 人工标引	临床3期	寻常痤疮	424	Benzoyl Peroxide+Twyneo	艱築簾積網蓋構鹽艱鹹(範鹹齋觸鹽襯網鹹網糧) = 積膚襯壓築壓壓獵遞齋衊觸鹹積構築糧艱壓餘 (窪遞淵窪艱製襯範鏇製 ) 更多	积极	2019-12-30
				Placebo	艱築簾積網蓋構鹽艱鹹(範鹹齋觸鹽襯網鹹網糧) = 壓鬱襯鏇築網選淵鬱鬱衊觸鹹積構築糧艱壓餘 (窪遞淵窪艱製襯範鏇製 ) 更多