Innovent Announces First Patient Dosed in Phase 1 Study of IBI3020, Global First-in-class Dual Payload CEACAM5 ADC, in Patients with Advanced Malignancies

On April 29, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported completion of the first patient dosing for IBI3020, its first-in-class dual-payload CEACAM5 ADC, in Phase 1 clinical trial for the treatment of patients with advanced solid tumors (Press release, Innovent Biologics, APR 29, 2025, View Source;in-patients-with-advanced-malignancies-302441146.html [SID1234652331]). IBI3020 is the first dual-payload ADC developed from Innovent’s proprietary DuetTx dual-payload ADC platform and the first dual-payload ADC globally known in the same class to complete the first-in-human dosing.

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The study is an open-label, multi-regional Phase 1 study evaluating the safety, tolerability, and preliminary efficacy of IBI3020 in participants with advanced solid tumors, as well as determining the recommended Phase 2 dose (RP2D). The study has received IND approval in the U.S. recently and will be conducted in both China and the U.S.

As a global first-in-class ADC candidate, IBI3020 is generated from Innovent’s proprietary DuetTx dual-payload ADC platform. The internationalization of the CEACAM5-dependent ADC occurs after IBI3020 selectively binds to CEACAM5-expressing tumor cells, followed by lysosomal degradation. This process releases two types of cytotoxic payloads, leading to cell killing of tumor cells.

In preclinical studies, IBI3020 has demonstrated robust antitumor activity across various tumor-bearing pharmacology models, with a notable bystander killing effect. Additionally, IBI3020 has shown favorable safety characteristics in preclinical models, with an overall manageable safety profile.

Professor Yu Jinming, Shandong Cancer Hospital, stated:" Carcinoembryonic antigen (CEA), also known as CEACAM5, is a glycosylphosphatidylinositol-anchored cell-surface glycoprotein involved in cell adhesion, invasion, and metastasis of cancer cells. There is a significant clinical need for effective therapies in advanced colorectal cancer, non-squamous lung cancer, gastric cancer, pancreatic cancer, and others. CEACAM5 is overexpressed in these solid tumors but shows limited expression in healthy tissues, making it a potentially safe and promising therapeutic target. The dual payload of IBI3020 consists of two types of payloads that have been clinically validated. This dual-payload design has demonstrated enhanced tumor-killing effects in preclinical studies. We look forward to observing the clinical profiles and potential breakthrough of IBI3020 in terms of safety, tolerability, and efficacy in clinical trials."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to announce the successful dosing of the first patient dose with IBI3020. We will continue to advance the global development of IBI3020, aiming to offer better treatment options for patients with advanced solid tumors. Innovent possesses innovative ADC technology platforms with independent intellectual property rights. Multiple ADC molecules have clinically validated their differentiated competitiveness. IBI3020, Innovent’s first dual-payload ADC, has successfully entered clinical trials and is the first dual-payload ADC globally known in the same class to complete the first-in-human dosing, marking a breakthrough in Innovent’s ADC technology. We will continue our "IO+ADC" strategy, focusing on next-generation innovations with global potential to benefit cancer patients worldwide."

About IBI3020

IBI3020 is a global first-in-class ADC candidate developed from Innovent’s proprietary DuetTx dual-payload ADC platform. The CEACAM5 dependent ADC internalization occurs after IBI3020 selectively binds to the CEACAM5-expressing tumor cells, followed by the lysosomal degradation. This process releases two types of cytotoxic payloads, leading to tumor cell killing.

The multi-regional Phase 1 study of IBI3020, initiated in China, assesses the safety, tolerability, and preliminary efficacy of IBI3020 in patients with advanced solid tumors and aims to determine the recommended Phase 2 dose (RP2D). The study has also received IND approval in the U.S. recently and will be conducted in China and the U.S.

Pfizer Reports Solid First-Quarter 2025 Results And Reaffirms 2025 Guidance

On April 29, 2025 Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2025 and reaffirmed its 2025 financial guidance (Press release, Pfizer, APR 29, 2025, View Source [SID1234652347]).

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EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and CEO of Pfizer:

"We continued to execute with focus and discipline against our strategic priorities, including strengthening our R&D organization and driving improved productivity. With the underlying strength of our business, we believe we can be agile in navigating an uncertain and volatile external environment."

David Denton, CFO and EVP of Pfizer:

"Our overall solid first-quarter performance demonstrates our continued focus on commercial execution amid U.S. Medicare Part D headwinds. Our focus on operational efficiency and financial discipline is driving strong results to our bottom line. We are currently trending towards the upper end of our 2025 Adjusted diluted EPS guidance range."

OVERALL RESULTS

First-Quarter 2025 Revenues of $13.7 Billion, Reported(2) Diluted EPS of $0.52, and Adjusted(3) Diluted EPS of $0.92
On Track to Deliver Operating Margin Expansion from Ongoing Cost Realignment Program(4) with Approximately $4.5 Billion of Net Cost Savings by End of 2025, and Announces Additional Productivity Gains Expected Through 2027 Leveraging Digital Enablement and Process Simplification
Additional Anticipated Net Cost Savings of Approximately $1.2 Billion(4) Primarily in SI&A by End of 2027
Expanded Program to Include Anticipated R&D Re-Organization Cost Savings of Approximately $500 Million by End of 2026, with Savings to be Reinvested in the Pipeline
First Phase of Manufacturing Optimization Program On Track to Deliver Approximately $1.5 Billion in Net Cost Savings by End of 2027 with Initial Savings Anticipated in the Latter Part of 2025
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(5).

Results for the first quarter of 2025 and 2024(6) are summarized below.

($ in millions, except per share amounts)

First-Quarter

2025

2024

% Change

Revenues

$

13,715

$

14,879

(8

%)

Reported(2) Net Income

2,967

3,115

(5

%)

Reported(2) Diluted EPS

0.52

0.55

(5

%)

Adjusted(3) Income

5,237

4,674

12

%

Adjusted(3) Diluted EPS

0.92

0.82

12

%

REVENUES

($ in millions)

First-Quarter

2025

2024

% Change

Total

Oper.

Global Biopharmaceuticals Business (Biopharma)

$

13,441

$

14,604

(8

%)

(6

%)

Pfizer CentreOne (PC1)

257

258

2

%

Pfizer Ignite

17

17

(3

%)

(3

%)

TOTAL REVENUES

$

13,715

$

14,879

(8

%)

(6

%)

2025 FINANCIAL GUIDANCE(1)

Reaffirms All Components of Full-Year 2025 Financial Guidance(1), including Revenues in a Range of $61.0 to $64.0 Billion and Adjusted(3) Diluted EPS in a Range of $2.80 to $3.00. The company’s reaffirmed guidance does not currently include any potential impact related to future tariffs and trade policy changes, which we are unable to predict at this time.
Pfizer’s 2025 financial guidance(1) is presented below.

Revenues

$61.0 to $64.0 billion

Adjusted(3) SI&A Expenses

$13.3 to $14.3 billion

Adjusted(3) R&D Expenses

$10.7 to $11.7 billion

Effective Tax Rate on Adjusted(3) Income

Approximately 15.0%

Adjusted(3) Diluted EPS

$2.80 to $3.00

CAPITAL ALLOCATION

During the first three months of 2025, Pfizer deployed its capital in a variety of ways, which primarily included:

Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
$2.2 billion invested in internal research and development projects, and
Approximately $90 million invested in business development transactions.
Returning capital directly to shareholders through $2.4 billion of cash dividends, or $0.43 per share of common stock.
No share repurchases have been completed to date in 2025. As of April 29, 2025, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. Pfizer has actively de-levered and as of March 30, 2025 is below our previously stated gross leverage(7) target. The company expects to continue to de-lever in a prudent manner in order to maintain a balanced capital allocation strategy. This includes maintaining the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases.

Diluted weighted-average shares outstanding of 5,710 million and 5,697 million were used to calculate Reported(2) and Adjusted(3) diluted EPS for first-quarter 2025 and 2024, respectively.

QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2025 vs. First-Quarter 2024)

First-quarter 2025 revenues totaled $13.7 billion, a decrease of $1.2 billion, or 8%, compared to the prior-year quarter, reflecting an operational decrease of $908 million, or 6%, as well as an unfavorable impact of foreign exchange of $256 million, or 2%. The operational decrease was primarily driven by a decline in Paxlovid revenues, partially offset by growth from the Vyndaqel family, Comirnaty(8), and several other products across categories despite the unfavorable impact of higher manufacturer discounts resulting from the Inflation Reduction Act (IRA) Medicare Part D Redesign.

First-quarter 2025 operational revenue reflected higher revenues primarily for:

Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 33% operationally, driven largely by strong demand with continuing uptake in patient diagnosis, primarily in the U.S. and international developed markets; partially offset by lower net price in the U.S. mostly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign;
Comirnaty(8) globally, up 62% operationally, driven primarily by higher revenues in the U.S. reflecting lower expected returns and higher market share, as well as higher contractual deliveries in certain international markets;
Padcev globally, up 25% operationally, driven primarily by increased market share in first-line metastatic urothelial cancer (mUC);
Nurtec ODT/Vydura globally, up 40% operationally, driven primarily by strong demand in the U.S. and favorable changes in channel mix and, to a much lesser extent, recent launches in certain international markets; and
Lorbrena globally, up 39% operationally, driven primarily by increased patient share in the first-line ALK-positive metastatic non-small cell lung cancer (ALK+ mNSCLC) treatment setting in the U.S., China, and certain other international markets;
more than offset primarily by lower revenues for:

Paxlovid globally, down $1.5 billion or 75% operationally, mostly driven by the U.S. market in part due to the non-recurrence of the $771 million favorable final adjustment(9) recorded in the first quarter of 2024 to the estimated non-cash revenue reversal of $3.5 billion recorded in the fourth quarter of 2023. The year-over-year decline was also attributable to both (i) lower COVID-19 infections across U.S. and international markets and (ii) lower international government purchases;
Eliquis globally, down 4% operationally, driven primarily by lower net price in the U.S. including the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign; partially offset by strong underlying demand as well as higher revenues in international markets partly due to timing of shipments;
Xeljanz globally, down 31% operationally, mostly driven by lower net price in the U.S. due to unfavorable changes in channel mix as well as the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign; and
Ibrance globally, down 6% operationally, driven primarily by generic entry and timing of shipments in certain international markets, as well as lower net price in the U.S. mostly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign.
GAAP Reported(2) Statement of Operations Highlights

SELECTED REPORTED(2) COSTS AND EXPENSES

($ in millions)

First-Quarter

2025

2024

% Change

Total

Oper.

Cost of Sales(2)

$

2,845

$

3,379

(16

%)

(9

%)

Percent of Revenues

20.7

%

22.7

%

N/A

N/A

SI&A Expenses(2)

3,031

3,495

(13

%)

(12

%)

R&D Expenses(2)

2,203

2,493

(12

%)

(11

%)

Acquired IPR&D Expenses(2)

9

*

*

Other (Income)/Deductions—net(2)

953

680

40

%

54

%

Effective Tax Rate on Reported(2) Income

(6.8

%)

8.6

%

* Indicates calculation not meaningful or results are greater than 100%.

First-quarter 2025 Cost of Sales(2) as a percentage of revenues decreased by 2.0 percentage points compared to the prior-year quarter, driven primarily by a favorable revision of our estimate of accrued royalties and the favorable impact of foreign exchange, partially offset by the unfavorable impact of changes in sales mix as well as the non-recurrence of the Paxlovid favorable final adjustment(9) recorded in the first quarter of 2024 to the estimated non-cash revenue reversal recorded in the fourth quarter of 2023.

First-quarter 2025 SI&A Expenses(2) decreased 12% operationally compared with the prior-year quarter, primarily reflecting ongoing productivity improvements that drove a decrease in marketing and promotional spend for various products and lower spending in corporate enabling functions, as well as lower spending on COVID-19 products.

First-quarter 2025 R&D Expenses(2) decreased 11% operationally compared with the prior-year quarter, driven primarily by a net decrease in spending due to pipeline focus and optimization, as well as lower compensation-related expenses.

The unfavorable period-over-period change in Other (income)/deductions—net(2) of $273 million for the first quarter of 2025, compared with the prior-year quarter, was driven primarily by (i) net losses on equity securities in the first quarter of 2025 versus net gains on equity securities in the first quarter of 2024, (ii) the non-recurrence of a gain on the partial sale of our investment in Haleon plc in the first quarter of 2024 and (iii) higher intangible asset impairment charges; partially offset by (iv) lower net interest expense.

Pfizer’s effective tax rate on Reported(2) income for the first quarter of 2025 is negative, primarily due to favorable global income tax resolutions in multiple tax jurisdictions spanning multiple tax years, as well as a favorable change in the jurisdictional mix of earnings.

Adjusted(3) Statement of Operations Highlights

SELECTED ADJUSTED(3) COSTS AND EXPENSES

($ in millions)

First-Quarter

2025

2024

% Change

Total

Oper.

Adjusted(3) Cost of Sales

$

2,593

$

3,036

(15

%)

(8

%)

Percent of Revenues

18.9

%

20.4

%

N/A

N/A

Adjusted(3) SI&A Expenses

3,010

3,454

(13

%)

(12

%)

Adjusted(3) R&D Expenses

2,173

2,477

(12

%)

(12

%)

Adjusted(3) Other (Income)/Deductions—net

246

296

(17

%)

14

%

Effective Tax Rate on Adjusted(3) Income

7.8

%

16.6

%

See the reconciliations of certain Reported(2) to non-GAAP Adjusted(3) financial measures and associated footnotes in the financial tables section of this press release located at the hyperlink below.

RECENT NOTABLE DEVELOPMENTS (Since February 4, 2025)

Product Developments

Product/Project

Milestone

Recent Development

Link

Abrysvo
(Respiratory Syncytial Virus Vaccine)

Regulatory

April 2025. Announced the European Commission (EC) amended the marketing authorization for Abrysvo to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age. The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway.

Full Release

ACIP Vote

April 2025. Announced the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of RSV vaccines approved for adults 50-59 years of age at increased risk of RSV-associated LRTD, which includes Abrysvo. The updated ACIP recommendation, which lowers the recommended age for RSV vaccination from 60 to 50 for high-risk adults, is pending final approval by the director of the CDC and the Department of Health and Human Services.

Full Release

Adcetris (brentuximab vedotin)

Regulatory

February 2025. Announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Adcetris in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma, after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.

Full Release

Padcev
(enfortumab vedotin-ejfv)

Phase 3 Results

February 2025. Pfizer and Astellas Pharma Inc. presented additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of Padcev plus Keytruda(10) (pembrolizumab, a PD-1 inhibitor) in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months), with no new safety signals identified.

Full Release

Talzenna (talazoparib)

Phase 3 Results

February 2025. Announced positive OS results from the Phase 3 TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI), demonstrating a statistically significant and clinically meaningful improvement in OS compared to placebo plus Xtandi in patients with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The safety profile of Talzenna plus Xtandi was generally consistent with the known safety profile of each medicine.

Full Release

Pipeline Developments

A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.

Product/Project

Milestone

Recent Development

Link

danuglipron

Discontinued

April 2025. Announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management. This decision followed a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators. The company remains committed to evaluating and advancing promising programs for cardiovascular and metabolic diseases, including obesity.

Full Release

sasanlimab

Phase 3 Results

April 2025. Presented results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The findings showed a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression, with the sasanlimab combination regimen as compared with SOC treatment alone. The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors. Pfizer has shared these data with global health authorities to support potential regulatory filings.

Full Release

vepdegestrant

Phase 3 Results

March 2025. Arvinas, Inc. and Pfizer announced topline results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, demonstrating a statistically significant and clinically meaningful improvement in PFS compared to fulvestrant. The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population.

Full Release

Corporate Developments

Topic

Recent Development

Link

Cost Realignment Program(4)

Announced at Q1-2025 Earnings. Pfizer announced approximately $1.2 billion of additional anticipated savings associated with its ongoing cost realignment program(4), expected to be achieved by the end of 2027, designed to further reduce costs primarily in SI&A driven in large part by enhanced digital enablement, including automation and AI, and simplification of business processes. We expect one-time costs to achieve the additional savings to be incurred through 2027 and to total approximately $1.6 billion, primarily representing cash expenditures for severance, digital enablement and implementation.

We remain on track to deliver net cost savings of approximately $4.5 billion by the end of 2025, and, with the additional targeted savings, we now expect total net cost savings of approximately $5.7 billion from this program through 2027.

N/A

Announced at Q1-2025 Earnings. In connection with our efforts to simplify the structure and sharpen the focus of our R&D organization, in the first quarter of 2025 we expanded this program after having identified additional opportunities to drive improvements in productivity and operational efficiencies through enhanced digital enablement, including automation and AI, and simplification of business processes. Savings associated with the simplification of our R&D organization are anticipated to be realized by the end of 2026 and are expected to total approximately $500 million and be reinvested in R&D programs. We expect one-time costs to implement these initiatives to be incurred through 2026 and to total approximately $600 million, primarily representing cash expenditures for severance, digital enablement and implementation.

N/A

Haleon Stock Sale

March 2025. Pfizer sold 618 million ordinary shares of its investment in Haleon to institutional investors and separately Haleon purchased 44 million ordinary shares from Pfizer for a combined total net proceeds of approximately $3.3 billion. This follows the previously announced sale of 700 million Haleon shares in January 2025 which resulted in approximately $3.0 billion in net cash proceeds. Pfizer has fully exited its position in Haleon.

N/A

R&D Leadership

March 2025. James List, M.D., Ph.D., joined Pfizer as Chief Internal Medicine Officer, overseeing the company’s Internal Medicine portfolio, from early discovery to late development, inclusive of Medical Affairs and Business Development strategies. He is responsible for advancing Pfizer’s emerging pipeline of cardiovascular, metabolic, and obesity medicines. Dr. List reports to Chris Boshoff, M.D., Ph.D., Chief Scientific Officer and President, Pfizer Research & Development.

Full Release

February 2025. Announced Jeffrey Legos, Ph.D., MBA, will join Pfizer as Chief Oncology Officer and will be responsible for leading the company’s Oncology R&D, overseeing all functions from pre-clinical to late-stage clinical development activities. Dr. Legos will report to Chris Boshoff, and will succeed Roger Dansey, M.D., Interim Chief Oncology Officer, who will transition to retirement as previously communicated.

Full Release

February 2025. Announced Patrizia Cavazzoni, M.D., rejoined Pfizer as Chief Medical Officer, Executive Vice President. In this role, Dr. Cavazzoni leads Pfizer’s regulatory, pharmacovigilance, safety, epidemiology, and medical information and evidence generation, among other medical functions, and reports to Chris Boshoff.

Full Release

IN8bio to Present Clinical and Preclinical Data from Gamma-Delta T Cell Platform at Upcoming Scientific Conferences

On April 29, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, reported that it will present new clinical and preclinical data from its pipeline of gamma-delta T cell therapies at several upcoming scientific conferences (Press release, In8bio, APR 29, 2025, View Source [SID1234652311]).

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"The breadth of data we’re presenting at upcoming medical conferences reflects the scientific rigor and clinical potential of IN8bio’s gamma-delta T cell platform," said William Ho, CEO and co-founder, IN8bio. "From our INB-200/400 program in newly glioblastoma to our novel T cell engager technologies, we are expanding the therapeutic applications of this unique class of therapies. These presentations highlight IN8bio’s capabilities, know-how in manufacturing, and the clinical potential of our programs to help patients with significant unmet needs across oncology and immune-mediated diseases."

Upcoming presentations:

American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025

Poster Title: A novel gamma-delta T cell engager platform for cancer immunotherapy
Abstract Presentation Number: 7321 (Poster Board 7)
Session Title: Immunology/T Cell Engagers and Novel Antibody-Based Therapies
Date/Time: Wednesday, April 30, 2025, 9:00 – 12:00 PM CDT
Location: McCormick Place Convention Center, Chicago, IL
More information: www.aacr.org/meeting/aacr-annual-meeting-2025/abstracts.

International Society for Cell & Gene Therapy (ISCT) 2025

Oral Presentation Title: From Donor to Therapy: How Robust Manufacturing Shapes the TCR Repertoire and Cytotoxic Power of Donor-Derived Allogeneic ex vivo Expanded and Activated γδ T Cell Products*
Date/Time: Friday, May 9, 2025, 3:00 – 4:00 PM CDT
Presenter: Mariska ter Haak, Senior Director Analytical Development, IN8bio
Session: Oral Abstract Session – Immunotherapy (CAR-T, T Reg, NK Cells etc.)
*Host Region (US East) Abstract Award

Poster Presentation Title: Selection and Implementation of the Electronic Quality Management System for High Complexity Clinical Stage Cellular Therapy Company
Date/Time: Thursday, May 8, 2025, 6:00 – 7:30 PM CDT
Presenter: Guoling Chen, Senior Director of Quality Operations, IN8bio
More information: View Source

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2025 Conference

Poster Presentation Title: INB-600: A Novel T Cell Engager Platform Specific for gamma-delta (γδ) T cells
Date/Time: Thursday, May 15, 2025, Time: 5:30 – 7:00 PM CDT
Presenter: Lawrence Lamb, Ph.D., Co-Founder and Chief Scientific Officer, IN8bio
Location: Poster Hall I2, New Orleans Ernest N. Morial Convention Center

Oral Presentation Title: Decoding the Molecular Signature of Expanded Gamma-delta T Cell Products; TCR and Immune Gene Expression from Allogeneic derived Products
Title: Molecular and Cellular Methods – Applications
Date/Time: Saturday, May 17, 2025, 10:30 – 10:45 AM CDT
Presenter: Mariska ter Haak, Senior Director Analytical Development, IN8bio
Location: NOLA Theater B, New Orleans Ernest N. Morial Convention Center
More information: View Source

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025

Oral Presentation Title: INB-200: Phase 1 study of gene-modified autologous gamma-delta (γδ) T cells in newly diagnosed glioblastoma multiforme (GBM) patients receiving maintenance temozolomide (TMZ).
Presenter: Louis "Burt" Nabors, MD
Abstract #: 2007
Session: Central Nervous System Tumors
Session Type: Oral Abstract Session
Session Date and Time: May 30, 2025, 2:45 – 5:45 PM CDT
Presentation Time/Duration: 4:57 – 5:09 PM CDT
More information: View Source

NEUVOGEN Announces Poster Presentation at the American Association of Cancer Research Annual Meeting

On April 29, 2025 NEUVOGEN, Inc. ("NEUVOGEN THERAPEUTICS" or "NEUVOGEN"), a San Diego based biotechnology company, reported that it will present data that its next generation whole tumor cell vaccine (NGEN-143) activates T cells that recognize a diverse antigen repertoire (Press release, NEUVOGEN, APR 29, 2025, View Source [SID1234652332]).

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"These findings support that NGEN-143 can deliver an unprecedented breadth of targets and activate cytotoxic T cells, as compared to other currently available cancer vaccines, making NGEN-143 a better potential option for patients" said Todd Binder, Chief Executive Officer of NEUVOGEN. "Our dedicated team is eager to bring this new cancer vaccine forward to treat patients with non-small cell lung cancer (NSCLC)."

Key Findings:

In a fully human in vitro system, NGEN-143 expands effector T cells against a broad repertoire of both tumor-associated antigens and common shared neo-antigens across a wide range of HLA types.

NGEN-143 activates polyfunctional, cytotoxic T cells; the response is dominated by CD8+ cells without any evidence of antigenic competition. CD4+ T cell responses are skewed toward CD4+ Th1 cells over CD4+ Th2 cells.

NGEN-143 activated T cells efficiently kill human tumor cells in a caspase-3 dependent manner.

In the ‘immune warm’ CT26 mouse tumor model, vaccine abrogates or slows tumor growth – durable protection against rechallenge supports efficient induction of immune memory; vaccine + αPD1 improved survival over αPD1 monotherapy.

In the ‘immune cold’ B16F10 mouse tumor model, our vaccine approach inhibits tumor growth and prolongs survival; vaccine + αPD1 improved survival.
Bernadette Ferraro, Ph.D., NEUVOGEN’s Vice President, Immuno-oncology, is scheduled to present "An optimized off-the-shelf whole tumor cell vaccine activates T cells that recognize a diverse antigen repertoire with potential to provide meaningful clinical benefit to patients with NSCLC," at AACR (Free AACR Whitepaper) on Tuesday, April 29 from 2:00 – 5:00 PM CT. A copy of the poster will be made available for download at neuvogen.com/our-science after the meeting concludes.

Incyte Reports 2025 First Quarter Financial Results and Provides Updates on Key Clinical Programs

On April 29, 2025 Incyte (Nasdaq:INCY) reported 2025 first quarter financial results, and provides a status update on the Company’s clinical development portfolio (Press release, Incyte, APR 29, 2025, View Source [SID1234652312]).

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"The double-digit revenue growth in the first quarter driven by the continued growth of Jakafi and Opzelura and the recent launch of Niktimvo, puts us on track to achieve our full year objectives," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We also continued to advance our innovative pipeline, which will be critical for driving long-term growth. The positive Phase 3 results for povorcitinib in hidradenitis suppurativa in addition to the proof-of-concept in chronic spontaneous urticaria, strengthens the potential of povorcitinib as a multibillion-dollar product addressing patient needs across the five indications currently in development."
Key Commercial Highlights
Jakafi(ruxolitinib):
Net product revenues for the first quarter 2025 of $709 million (+24% Y/Y):
▪Net product revenue growth in the first quarter of 2025 versus the same quarter in the prior year, was driven by an increase in paid demand, the positive impact of the Part D redesign under the Inflation Reduction Act, partially offset by growth in 340B, and less de-stocking compared to the first quarter of 2024. Jakafi inventory levels were within normal range at the end of the first quarter of 2025.
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Opzelura(ruxolitinib) cream:
Net product revenues for the first quarter 2025 of $119 million (+38% Y/Y):
▪U.S. net product revenue of $95 million in the first quarter of 2025 increased 20% compared to the first quarter of 2024 driven by patient demand and refills in both atopic dermatitis (AD) and vitiligo, partially offset by a reduction in channel inventory. Opzelura inventory levels were within normal range at the end of the first quarter of 2025.
▪Ex-U.S. net product revenues of $23 million in the first quarter of 2025 were primarily driven by continued growth in sales in Germany and France, as well as the recent launches in Italy and Spain.
Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
▪The Phase 1 studies evaluating mutCALR in myelofibrosis (MF) and essential thrombocythemia (ET) and JAK2V617Fi in MF are enrolling patients. Initial proof of concept data for both studies are anticipated in 2025.
▪A Phase 2 trial evaluating axatilimab (Niktimvo) in combination with ruxolitinib (Jakafi) in patients with newly diagnosed chronic GVHD is ongoing and enrolling patients.
▪A Phase 3 trial evaluating axatilimab in combination with corticosteroids in patients with newly diagnosed chronic GVHD is ongoing and enrolling patients.
MPN and GVHD Programs Indication and status
Ruxolitinib XR (QD)
(JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD
Ruxolitinib + INCB57643
(JAK1/JAK2 + BETi) Myelofibrosis: Phase 2
Ruxolitinib + axatilimab1
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 2
Steroids + axatilimab1
(Steroids + anti-CSF-1R)
Chronic GVHD: Phase 3
INCA33989
(mutCALR) Myelofibrosis, essential thrombocythemia: Phase 1
INCB160058
(JAK2V617Fi) Myelofibrosis: Phase 1

1 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
▪Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments.
▪The Phase 3 study evaluating tafasitamab as first-line treatment for DLBCL is ongoing. The Phase 3 data are anticipated in the second half of 2025.
▪The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing and enrolling patients. Initial proof of concept data for both studies are anticipated in the second half of 2025.
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Heme/Oncology Programs Indication and status
Tafasitamab (Monjuvi/Minjuvi)
(CD19)
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Relapsed or refractory follicular lymphoma (FL): Phase 3 (inMIND)
Retifanlimab (Zynyz)1
(PD-1)
Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303)
Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304)
MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)
INCB123667
(CDK2i) Solid tumors with CCNE1 amplification/Cyclin E overexpression: Phase 1
INCB161734
(KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation: Phase 1
INCA33890
(TGFßR2×PD-1)2
Advanced or metastatic solid tumors: Phase 1

1 Retifanlimab licensed from MacroGenics.
2 Development in collaboration with Merus.
Inflammation and Autoimmunity (IAI) – key highlights
Ruxolitinib Cream
▪In March 2025, results from two Phase 3 studies (TRuE-PN1 and TRuE-PN2) evaluating ruxolitinib cream in patients with prurigo nodularis (PN) were presented in a late-breaking oral session at the American Academy of Dermatology annual meeting. The TRuE-PN1 study met the primary endpoint of a > 4-point improvement from baseline in Worst-Itch Numeric Rating Scale (WI-NRS4) at Week 12 and all key secondary endpoints. The TRuE-PN2 study did not reach statistical significance for the primary endpoint, resulting in the key secondary endpoints with nominal p-values. These key secondary endpoints still demonstrate positive trends for ruxolitinib cream 1.5% versus vehicle. These data will inform planned discussions with regulatory authorities on submission.
▪A Phase 3 trial for ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) is on track to initiate in the first half of 2025 following achieving alignment on the study design with FDA.
Povorcitinib (INCB54707)
▪In April 2025, Incyte announced positive topline results from the Phase 2 study evaluating povorcitinib in patients with chronic spontaneous urticaria (CSU). The study met the primary endpoint at Week 12 of change from baseline in the Urticaria Activity Score summed over 7 days (UAS7). Povorcitinib was well tolerated with no new safety signals observed. These data will support planned discussions with regulatory agencies and will be presented at an upcoming medical conference.
▪In March 2025, positive results from the Phase 3 studies (STOP-HS1 and STOP-HS2) of povorcitinib in patients with HS were presented and demonstrated that both studies met their primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 and at both tested doses (45mg and 75mg). In addition, at Week 12, patients treated with povorcitinib achieved deep levels of clinical response with a greater proportion achieving HiSCR75, reduction in flares, >3-point decrease in the Skin Pain Numeric Rating Scale (NRS) score and Skin Pain NRS30. Furthermore, povorcitinib demonstrated rapid onset of response, including rapid skin pain reduction. Additional longer-term data demonstrate that at Week 18, HiSCR rates continue to improve over Week 12 in patients treated with povorcitinib including high levels of response in those patients previously treated on placebo and crossed over to active povorcitinib treatment. These data support the planned regulatory submission of povorcitinib for the treatment of HS worldwide.
▪Two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with PN versus placebo are ongoing and enrolling patients.
▪A Phase 2 trial evaluating povorcitinib in asthma is ongoing and enrolling. Data are anticipated in the second half of 2025.
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IAI and Dermatology Programs Indication and status
Ruxolitinib cream (Opzelura)1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3)
Hidradenitis suppurativa: Phase 2; Phase 3 expected to initiate in 2025
Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2)
Povorcitinib
(JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 3 (STOP-V1, STOP-V2)
Prurigo nodularis: Phase 3 (STOP-PN1, STOP-PN2)
Chronic spontaneous urticaria: Phase 2
Asthma: Phase 2
INCA034460
(anti-CD122) Vitiligo: Phase 1

1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.
Other – key highlights
•In February 2025, Incyte and Genesis Therapeutics, Inc. (Genesis) entered into a strategic collaboration focused on the research, discovery and development of novel small molecule medicines, with an initial focus on collaboration targets selected by Incyte. Incyte receives exclusive rights to develop and commercialize collaboration products leveraged through Genesis’ GEMS artificial intelligence (AI) platform.
Other Program Indication and Phase
Zilurgisertib
(ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2

2025 First Quarter Financial Results
The financial measures presented in this press release for the three months ended March 31, 2025 and 2024 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.
As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.
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Financial Highlights
Financial Highlights
(unaudited, in thousands, except per share amounts)
Three Months Ended
March 31,
2025 2024
Total GAAP revenues $ 1,052,898 $ 880,889
Total GAAP operating income 205,168 91,898
Total Non-GAAP operating income 283,641 161,183
GAAP net income 158,203 169,548
Non-GAAP net income 229,459 132,719
GAAP basic EPS $ 0.82 $ 0.76
Non-GAAP basic EPS $ 1.18 $ 0.59
GAAP diluted EPS $ 0.80 $ 0.75
Non-GAAP diluted EPS $ 1.16 $ 0.58

Revenue Details
Revenue Details
(unaudited, in thousands)
Three Months Ended
March 31, %
Change
(as reported)
%
Change
(constant currency)1
2025 2024
Net product revenues:
Jakafi $ 709,412 $ 571,839 24 % NA
Opzelura 118,705 85,724 38 % 39 %
Iclusig 29,544 30,343 (3 %) — %
Pemazyre 18,440 17,676 4 % 6 %
Minjuvi/ Monjuvi 29,551 23,874 24 % 25 %
Niktimvo 13,613 — NM NA
Zynyz 3,009 467 544 % NA
Total net product revenues 922,274 729,923 26 % 27 %
Royalty revenues:
Jakavi 92,145 89,595 3 % 6 %
Olumiant 30,800 30,589 1 % 6 %
Tabrecta 6,413 5,234 23 % NA
Other 1,266 548 131 % NM
Total royalty revenues 130,624 125,966 4 %
Total net product and royalty revenues 1,052,898 855,889 23 %
Milestone and contract revenues — 25,000 — % — %
Total GAAP revenues $ 1,052,898 $ 880,889 20 %

NM = not meaningful
NA = not applicable
1 Percentage change in constant currency is calculated using 2024 foreign exchange rates to recalculate 2025 results.
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Product and Royalty Revenues Total net product and royalty revenues for the quarter ended March 31, 2025 increased 23% over the prior year comparative period. Total net product revenues for the quarter ended March 31, 2025 increased 26% over the prior year comparative period primarily driven by the following:
•Jakafi net product revenue increased 24% versus the prior year comparable period, driven by an increase in paid demand of 10% reflecting continued demand growth in all indications, the positive impact of the Part D redesign under the Inflation Reduction Act, partially offset by growth in 340B, and 7% favorable impact from less de-stocking compared to the first quarter of 2024. Jakafi inventory levels were within normal range at the end of the first quarter of 2025.
•Opzelura net product revenue increased 38% due to continued growth in new patient starts and refills in the U.S. with U.S. paid demand up 24% versus the first quarter of 2024, partially offset by a reduction in channel inventory, and increased contribution from ex-U.S. driven by continued uptake in Germany and France, as well as growth from the recent launches in Italy and Spain. Opzelura inventory levels were within normal range at the end of the first quarter of 2025.
•Minjuvi/Monjuvi net product revenue increased 24% as a result of the first quarter of 2025 reflecting three months of net product revenues in the U.S., compared to two months of net product revenue in the first quarter of 2024 due to the acquisition of U.S. rights to Monjuvi, which closed in February 2024.
•Niktimvo net product revenue driven by the commercial launch of the product during the first quarter of 2025.
Operating Expenses
Operating Expense Summary
(unaudited, in thousands)
Three Months Ended
March 31, %
Change
2025 2024
GAAP cost of product revenues $ 73,188 $ 60,956 20 %
Non-GAAP cost of product revenues1
66,945 54,959 22 %
GAAP research and development 437,279 429,260 2 %
Non-GAAP research and development2
400,020 388,437 3 %
GAAP selling, general and administrative 325,691 300,256 8 %
Non-GAAP selling, general and administrative3
302,292 277,335 9 %
GAAP loss (gain) on change in fair value of acquisition-related contingent consideration 11,572 (456) NM
Non-GAAP loss (gain) on change in fair value of acquisition-related contingent consideration — — — %
GAAP (profit) and loss sharing under collaboration agreements — (1,025) — %

1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.
2 Non-GAAP research and development expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient severance payments.
3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient severance payments.
Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended March 31, 2025 increased 20% and 22% respectively, compared to the same period in 2024 primarily due to increased royalty expense.
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Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended March 31, 2025 increased 2% and 3%, respectively, compared to the same period in 2024, reflecting continued investment in our late stage development assets and timing of certain expenses.
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended March 31, 2025 increased 8% and 9%, respectively, compared to the same period in 2024 primarily due to timing of consumer marketing activities and of certain other expenses.