On March 26, 2025 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported its 2024 annual results, including major business updates, financial performance and the strategy and outlook for 2025 and beyond (Press release, Innovent Biologics, MAR 26, 2025, View Source [SID1234651489]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "2024 marked a year of historic milestones—Innovent’s Non-IFRS net profit and EBITDA both turned positive for the first time, underscoring our strategic excellence and execution as a pioneer in sustainable biopharmaceutical operations. Meanwhile, we achieved record revenue, expanded our robust product portfolio to 15 approved products and delivered all late-stage development milestones to secure sustained growth momentum. We are also advancing breakthrough innovations in our early-stage pipeline for global opportunities while strengthening both global and local partnerships to accelerate innovation and growth.

With a clear strategy outlined above and a strong track record of execution, we are laying a solid foundation to enter a new phase of growth and global innovation. In the coming years, we aim to achieve RMB20bn product revenue in 2027 and advance five pipeline assets to the global MRCT Phase 3 stage by 2030. Through these efforts, we will evolve into a premier global biopharmaceutical company, delivering long-term value for patients, employees, shareholders and society."

Pioneering profitability with RMB20bn sales target in 2027

First-ever Non-IFRS Positive Profit and EBITDA*
Non-IFRS profit was RMB331.6 million and Non-IFRS EBITDA was RMB411.6 million
The gross profit margin was 84.9%, a year-over-year increase of 2.1 percentage points
The S,G&A expenses ratio was 50.9%, a year-over-year decrease of 7.1 percentage points
R&D expenses were RMB2,499.8million; Cash and short-term financial assets were RMB10,221.1 million, or approximately over USD1.4 billion, providing a solid foundation to our long-term ambitions
Revenue reached new height with solidified oncology leadership
Total revenue reached RMB9,421.9 million, growing by 51.8% year-over-year.
Product sales revenue reached RMB8,227.9 million, growing by 43.6% year-over-year.
Expansion of oncology product portfolio with new indications and broader NRDL coverage and patient access
Building CVM commercialization as another core capability
* Note: The financial numbers mentioned above, unless stated, were based on non-IFRS measure. Detailed disclosure can be found at the Company’s 2024 annual results announcement.

Six new product launches in 2025 with growth momentum anticipated
Three additional approved precision therapies to strengthen lung and hematological cancer franchises:
Dovbleron (taletrectinib) : Potentially best-in-class ROS1 inhibitor
Limertinib: Third-generation EGFR TKI
Jaypirca(pirtobrutinib) : First non-covalent BTK inhibitor launched in China
Build chronic disease as another growth engine:
SINTBILO (tafolecimab injection): First PCSK-9 inhibitor successfully included in the NRDL
SYCUME (Teprotumumab N01 injection): First approved anti-IGF-1R monoclonal antibody, ending a 70-year drought of no new treatment options for thyroid eye disease in China；new studies for front-line treatment and inactive thyroid eye disease in plan
Mazdutide (GCG/GLP-1) : Global first GCG/GLP-1 dual receptor agonist, with two NDAs under NMPA review — first NDA for weight management in obese or overweight populations and second NDA for glycemic control of T2D adults. In addition, new Phase 3 studies are in plan for adolescent obesity, obstructive sleep apnea (OSA) and obesity with metabolic dysfunction-associated fatty liver disease (MAFLD, head-to-head with semaglutide 2.4mg). New clinical studies are also in plan for metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), and higher dose of mazdutide for obesity.
Picankibart (IL-23p19): Potentially best-in-class YTE IL-23p19 monoclonal antibody, with an NDA for moderate-to-severe plaque psoriasis under NMPA review. New studies for psoriasis with prior inadequate response to IL-17, adolescent psoriasis, and psoriatic arthritis(PsA) in plan.
2027 RMB20bn sales target with clear growth trajectory
With ever-growing innovative pipeline, sustainable growth is anticipated to continue even beyond 2027
Embarking on a new era of global innovation

Innovent Academy powers core technology platforms
Robust High-potential Pipeline Targeting 5 Assets in MRCT Phase 3 by 2030
Encouraging data readouts of key pipeline in support of next-step pivotal development
IBI363 (PD-1/IL-2α-bias): Unleashing potential as a next-generation IO therapy with global first-in-class design
Promising Phase 1 results reported in NSCLC, CRC and melanoma, aiming to address some of the most challenge cancer types including IO-failed, PD-L1 low expression and cold tumors;
Two Fast-track Designations from U.S. FDA for IO-treated melanoma and IO-treated squamous NSCLC;
First pivotal clinical trial has been initiated, in head-to-head comparison with pembrolizumab in IO-naïve mucosal and acral melanoma.
IBI343 (CLDN18.2 ADC): Novel Site-specific TOPO1i CLDN18.2 ADC
First MRCT Phase 3 of GC has been initiated in China and Japan
MRCT Phase 1 of PDAC is underway in China and U.S.
NMPA CDE Breakthrough Therapy Designation (BTD) and FDA Fast-track Designation (FTD) granted.
Nearly 10 next-generation programs aiming for global development
Oncology: IBI3009 (DLL3 ADC), IBI3001 (EGFR/B7H3 ADC), and IBI3020 (CEACAM5 dual-payload ADC)
CVM: IBI3016（AGT siRNA）, IBI3032（GLP-1 oral）, IBI3012 (GGG Antibody-peptide conjugate, APC), IBI3030（GGG-PCSK9 APC）
Autoimmune: IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP)
Hybrid models to accelerate innovation
IBI3009 (DLL3 ADC): global rights granted to Roche, to benefit SCLC patients worldwide
Research innovation showcased at medical conferences, including:
AACR, ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) GI, ESMO (Free ESMO Whitepaper) plenary, ESMO (Free ESMO Whitepaper), WCLC, SITC (Free SITC Whitepaper), ESMO (Free ESMO Whitepaper) Asia for oncology pipeline innovation
ADA, APAO, ICE, CSE for general biomedicine pipeline material progress
Facilities and manufacturing capacity adhering to high-quality standards

Shanghai R&D Center (medical) is newly operational in August 2024
Building U.S. lab in San Francisco
First manufacturing site: 60,000L antibody production capacity and ADC production lines in operation
Second manufacturing site: first phase of 80,000L completed construction
Committed to responsible business practices and enhancing ESG management practices

Innovent has been graded ‘AAA’ rating in MSCI ESG rankings, positioning us at the forefront of the biotechnology industry.
We recently launched our ESG website to further strengthen commitment to sustainability, corporate responsibility and ethical business conduct.
We initiated the "Warmth Stations" program to support frontline urban workers (e.g., sanitation workers, delivery personnel), by providing rest areas and essential supplies. Additionally, we launched the third annual "Children’s Book Donation" campaign, bringing hope and support to underprivileged children through book donations.
We have supported over 200,000 patients through our dedicated patient assistance programs, with drug donations totaling RMB 3.6 billion.
Our commitment to medical philanthropy has been recognized through prestigious awards, including the "Medical Philanthropy Promoter" title and designation as a "China Philanthropic Enterprise".
We were recognized on the "2024 China’s Most Attractive Employers List," with a workforce of 7,000 employees.

On March 26, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported the publication of abstracts for an oral presentation in the New Drugs on the Horizon series, and three poster presentations on IDE275 (GSK959) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois (Press release, Ideaya Biosciences, MAR 26, 2025, View Source [SID1234651488]). IDE275 (GSK959), a potential best-in-class Werner Helicase (WRN) inhibitor, has demonstrated selective preclinical efficacy in the high microsatellite instability (MSI-H) solid tumor setting, and is advancing in a Phase 1 dose escalation trial in partnership with GSK.

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"IDE275 (GSK959) has a potential best-in-class profile and the preclinical data to be presented at AACR (Free AACR Whitepaper) 2025 with GSK highlights the molecule’s selectivity to treat MSI-H solid tumors and potential to be developed clinically as both a monotherapy agent and in combination with PD1," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "MSI-H represents a meaningful biomarker-defined population with double-digit percent prevalence observed in multiple solid tumor types, including endometrial, colorectal, and gastric cancers. By binding uniquely to the helicase domain of WRN, IDE275 (GSK959) delivers potent and selective inhibition across MSI-H models," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDE275 (GSK959) was discovered through a collaboration between IDEAYA and GSK. Preclinical studies have demonstrated IDE275’s (GSK959) potential as a best-in-class WRN inhibitor, inducing single-agent tumor regressions in MSI-H patient-derived xenograft (PDX) and cell line-derived xenograft (CDX) models for endometrial, colorectal, and gastric cancers. Notably, MSI-H prevalence in these cancers has been reported at approximately 31%, 20%, and 19%, respectively, underscoring the significant patient population that could benefit from this therapeutic approach.

As part of the collaboration, GSK is responsible for 80% of global research and development costs for IDE275 (GSK959), and IDEAYA is responsible for 20% of such costs. GSK holds a global, exclusive license to develop and commercialize IDE275 (GSK959). IDEAYA has the potential to earn a $10.0 million milestone payment upon initiation of Phase 1 clinical dose expansion. Additionally, IDEAYA is eligible to receive up to $465 million in future late-stage development and regulatory milestone payments. Upon commercialization, IDEAYA will be eligible to receive up to $475.0 million of commercial milestones, 50% of U.S. net profits and tiered royalties on global non-U.S. net sales of the IDE275 (GSK959) – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.

At AACR (Free AACR Whitepaper) 2025, IDEAYA will have 8 total presentations across 3 clinical and 2 pre-clinical programs. There will be 4 IDEAYA/GSK presentations of IDE275 (GSK959) and 4 additional presentations across the IDE397/MAT2A, IDE161/PARG, PRMT5, and KAT6/7 programs.

Details for the oral presentation are as follows:
Presenter: Dr. Yanhua Rao, GSK
Title: An innovative and reversible WRN helicase inhibitor, GSK4418959 (IDE275), emerges as a promising clinical candidate for MSI-H cancers
Session: New Drugs on the Horizon Session, Part 3 (DDT003)
Date and Time: Monday, April 28, 2025 at 10:40am CDT
Location: Room S406 (Vista Ballroom) – McCormick Place South (Level 4)

Poster presentation details are below:
Author: Rao, Y. et al.
Title: Patient selection, target engagement and pharmacodynamic markers of WRN inhibitor GSK4418959 (IDE275)
Poster Number: 6393/30
Session Title: Pharmacokinetics and Pharmacodynamics of Cancer Therapeutics
Date and Time: Tuesday, April 29, 2025 at 9:00am – 12:00pm CDT

Author: Lee, Y. et al.
Title: Preclinical Characterization of GSK4418959 (IDE275): A Potent, Selective, and Highly Efficacious WRN Inhibitor for MSI-H Tumors Across Multiple Cancer Types
Poster Number: 2913/20
Session Title: DNA Damage Response and Modulation of DNA Repair 1
Date and Time: Monday, April 28, 2025 at 2:00pm – 5:00pm CDT

Author: Taygerly, P. et al.
Title: Discovery of GSK4418959 (IDE275): A novel, non-covalent, reversible Werner Helicase inhibitor and a new potential therapeutic for the treatment of MSI-H cancers
Poster Number: 5750/50
Session Title: Drug Design, Synthesis, & Disposition
Date and Time: Tuesday, April 29, 2025 at 2:00pm CDT

Author: Gupta, M. et al.
Title: Dual KAT6/7 inhibition disrupts epigenetic programs that promote tumor evolution and adaptive drug resistance
Poster Number: 442/3
Session Title: Epigenetic Targets
Date and Time: Sunday, April 27, 2025 at 2:00pm – 5:00pm CDT

Author: Maskey, R. et al.
Title: PARG inhibition provokes a DNA damage-dependent innate immune reaction that enhances ICI-driven anti-tumor immunity
Poster Number: 2899/6
Session Title: DNA Damage Response and Modulation of DNA Repair 1
Date and Time: Monday, April 28, 2025 at 2:00pm – 5:00pm CDT

Author: Garbett, D. et al.
Title: The allosteric MAT2A inhibitor IDE397 uniquely exploits metabolic liabilities associated with MTAP deletion to perturb DNA replication and repair
Poster Number: 4268/25
Session Title: New and Emerging Cancer Drug Targets
Date and Time: Tuesday, April 29, 2025 at 9:00am – 12:00pm CDT

Author: Aubi, O. et al.
Title: The impact of metabolite kinetics on dysregulation of essential enzymes in cancers with MTAP deficiencies
Poster Number: 4504/15
Session Title: Proteomic Biomarkers and Therapeutics
Date and Time: Tuesday, April 29, 2025 at 9:00am – 12:00pm CDT

The oral presentation and posters will be available online at View Source following the presentations.

On March 26, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that management will participate in the following upcoming virtual investor conferences in April 2025 (Press release, Compugen, MAR 26, 2025, View Source [SID1234651487]):

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H.C. Wainwright 2nd Annual AI Based Drug Discovery & Development Conference
Date: Wednesday, April 2, 2025
Format: Fireside chat and 1×1 meetings
Fireside chat time: 9:30 am ET

24th Annual Needham Virtual Healthcare Conference
Date: Monday, April 7, 2025
Format: Fireside chat and 1×1 meetings
Fireside chat time: 8:00 am ET

Stifel’s 2025 Virtual Targeted Oncology Forum
Date: Wednesday, April 9, 2025
Format: Fireside chat and 1×1 meetings
Fireside chat time: 12:00 pm ET

Live webcasts of the fireside chats will be available on the events page of the Investor Relations section of Compugen’s website at www.cgen.com. Replays will be available following the live events.

On March 26, 2025 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, reported the upcoming presentation of the results of its double-blind, placebo-controlled phase 2 randomized clinical trial of lead compound, LUT014 gel (Press release, Lutris Pharma, MAR 26, 2025, View Source [SID1234651486]). The topically-applied novel B-Raf inhibitor is optimized for paradoxical MAPK activation, for patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy who develop dose-limiting acneiform rash. The new clinical data will be released in an oral presentation at the Clinical Trials Plenary Session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, being held April 25-30 in Chicago, IL.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Presentation Details:

Presentation Title: A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies
Presenting Author: Anisha B. Patel, MD, Associate Professor, Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, TX
Abstract Number: CT018
Session Title: New Frontiers in Precision Oncology
Session Date: Sunday, April 27, 2025
Session Time: 3:30 pm – 5:30 pm CT
About EGFR Inhibitor-Induced Rash
EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of the EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.

EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically to the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.

On March 26, 2025 Vaximm AG, a subsidiary of OSR Holdings, Inc. and a pioneering biotechnology company focused on developing innovative immunotherapies, reported final data from the successful conclusion of its open-label Phase 2a clinical trial assessing the safety and tolerability of VXM01, an investigational oral anti-VEGFR-2 vaccine, in combination with avelumab (PD-L1 inhibitor) in patients with recurrent glioblastoma (GBM). The trial was part of a collaboration with Merck KGaA, Darmstadt, Germany (Press release, Vaximm, MAR 26, 2025, View Source [SID1234651485]).

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Key results and observations:

The VXM01-avelumab combination therapy was generally well-tolerated, with the majority of safety events being mild to moderate in severity. These safety and tolerability data are in-line with previously reported data on avelumab alone with no additional safety signals for the combination of VXM01 and avelumab.
No serious adverse events (SAEs) were attributed to VXM01, while 9 of 11 (81.8%) were related to the target disease, underscoring the well manageable safety profile of this combination therapy in a frail patient population.
The non-resected patient cohort showed a 12.0% objective response rate (ORR). 12.0% of these patients showed a partial remission and 4.0% had stable disease. This suggests that, with further investigation, VXM01 in combination with PD-L1 inhibition (e.g. avelumab) could offer meaningful clinical benefit for this challenging patient population. In resected patients, the overall survival (OS) ranged from 2.2 to 46.5 months, highlighting the variability in response and the need for additional studies to determine optimal treatment regimens for specific subgroups of GBM patients.
Despite the small size of this open-label trial (n=25), the observed median time to progression of 2.7 months (95% CI: 2.7 – 2.7, range 0.3 – 22.1 months), and median OS of 11.1 months (95% CI: 8.5 – 16.3, range 3.8- 38.2 months), are encouraging initial results in the context of prognosis for patients with recurrent glioblastoma, reported to have a median PFS of 1.5 to 6 months and median OS of 2 to 9 months.(Birzu et al. 2020)
Decreased tumor size was observed in responding patients independent of tumor size at baseline, supporting the expectation that VXM01 vaccine treatment may be effective in patients with larger sized tumors as well as patients with early-stage cancer or very small tumors.
Exploratory biomarker investigations identified potential predictive and pharmacodynamic biomarkers of a VXM01-mediated tumor response
Moving Forward:

The reported safety and tolerability data, together with early indications for the potential relevance of a VXM01dependent, VEGFR-2 specific immune response in GBM therapy warrant further study.

"The completion of this Phase 2a study is a significant milestone for Vaximm AG, as it provides strong evidence that VXM01, in combination with avelumab is generally well-tolerated in patients with recurrent glioblastoma," said Dr. Constance Hoefer, CEO of Vaximm AG. "We are encouraged by these early results and the potential to improve outcomes for patients with this aggressive cancer. We remain committed to advancing VXM01 as a key therapeutic candidate for the treatment of glioblastoma, other cancers and other diseases where VXM01 may have positive impact on treatment outcomes"

About VXM01:

VXM01 is an oral T-cell immunotherapy that is designed to activate T-cells to attack the tumor vasculature and, in several tumor types, attack cancer cells directly. It is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to carry vascular endothelial growth factor receptor-2 (VEGFR2) as the target gene. VXM01 stimulates the patient’s immune system to activate VEGFR2-specific, cytotoxic T-cells (so-called killer cells). These immune killer cells then actively destroy cells in the tumor vasculature, leading to an increased infiltration of various immune cells into the tumor. In several tumor types, including brain cancer, VEGFR2 is highly over-expressed on the cancer cells themselves. In preclinical studies, a murine analog VXM01 vaccine showed broad anti-tumor activity in different tumor types. This activity was linked to a VEGFR2-specific T-cell response and was accompanied by the destruction of the tumor vasculature and increased immune cell infiltration. In a Phase I double-blind, randomized, placebo-controlled study in 71 patients with advanced pancreatic cancer, VXM01 appeared to be safe and well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival. Clinical activity in terms of objective responses and survival has been observed in recurrent glioblastoma.