Lumicell Announces Promising Feasibility Trial Findings Using Pegulicianine in Gastrointestinal Cancer Patients

On April 28, 2025 Lumicell, Inc., a leader in developing innovative fluorescence-guided imaging technologies for cancer detection, reported the release of early clinical trial findings from the ex vivo feasibility study for molecular imaging in gastric cancer (Press release, Lumicell Diagnostics, APR 28, 2025, View Source [SID1234652275]).

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Today, Andrew T. Chan, MD, MPH, and David A. Drew, Ph.D. of the Clinical and Translational Epidemiology Unit and Division of Gastroenterology at Massachusetts General Hospital, presented during the session "Advances in the Detection and Treatment of Gastrointestinal Cancers" as a part of the Stand Up To Cancer (SU2C) Gastric Cancer Open Scientific Session at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Dr. Drew presented compelling new findings highlighting the potential of cathepsin activity as a biomarker for gastric cancer, confirmed through single-cell analysis in patient samples and molecular profiling in genetically engineered mouse models. These findings support the use of pegulicianine-fluorescence imaging in detecting early-stage and neoadjuvant-treated gastric tumors.

In collaboration with Lumicell, Dr. Drew and Dr. Chan led the first clinical trial of pegulicianine in gastrointestinal cancer patients (NCT02584244). In this study, patients with diffuse and intestinal-type gastric cancers received intravenous pegulicianine prior to undergoing curative-intent surgical resection. Post-surgical specimens imaged ex vivo demonstrated strong, tumor-specific fluorescence signals, correlating with pathologically confirmed cancerous tissue. Importantly, pegulicianine was well tolerated by all study participants.

"Most gastric cancers are diagnosed at a locally advanced stage, with five-year survival rates below 30%," said Dr. Chan. "Current screening approaches, such as random biopsies during upper endoscopy, lack sensitivity. These findings represent a shift toward enabling early and more accurate detection."

Dr. Drew added, "We are thrilled to share these feasibility results. This work is propelling us toward real-time, in vivo endoscopic imaging, which could improve early detection strategies of gastric and gastroesophageal cancers in the at-risk patient population."

The next stage of this research is in progress, involving an in vivo clinical trial of pegulicianine and Lumicell’s newly developed endoscopic imaging system.

Juncell Therapeutics Announces Data on Feeder-free IL-2-Independent TIL Manufacturing Process at ASGCT Annual Meeting 2025

On April 28, 2025 Shanghai Juncell Therapeutics Co., Ltd. (Juncell Therapeutics), a clinical-stage biotech specializing in developing innovative IL-2-independent Tumor-Infiltrating Lymphocyte (TIL) therapies for cancer, reported it will present preclinical data on a feeder-free manufacturing process for IL-2-independent TIL expansion at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), taking place May 13–15, 2025, in New Orleans, LA (Press release, Juncell Therapeutics, APR 28, 2025, View Source [SID1234652274]).

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The study highlights Juncell Therapeutics’ breakthroughs in TIL process development, demonstrating that its proprietary feeder-free system can generate robust, functional TILs from both "hot" and "cold" tumor tissues without relying on high-concentration interleukin-2 (IL-2). These TILs exhibited significant anti-tumor activity in syngeneic patient-derived organoid (PDO) and patient-derived xenograft (PDX) models. By eliminating IL-2 dependence and removing the need for feeder cells, the technology paves the way for safer TIL treatment regimens and reduces manufacturing costs.

Presentation Details:

Title: Development of A Feeder-Free Process for IL-2-Independent TIL Expansion
Poster Number: AMA362
Session: Thursday Poster Reception
Date and Time: May 15, 2025, 5:30 PM–7:00 PM
Location: Poster Hall Hall I2

WuXi AppTec Q1 2025 Revenue, Profit Resume Double Digit Growth, Revenue Up 21.0% YoY, Adjusted Non-IFRS Net Profit Up 40.0% YoY; Backlog for Continuing Operations Up 47.1% YoY

On April 28, 2025 WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical and life sciences industry, reported financial results for the first quarter ending March 31, 2025 ("Reporting Period") (Press release, WuXi AppTec, APR 28, 2025, View Source [SID1234652273]):

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Total revenue reached RMB9.65 billion, up 21.0% year-over-year. Revenue from Continuing Operations reached RMB9.39 billion, up 23.1% year-over-year.
Adjusted non-IFRS gross profit reached RMB4.05 billion. Adjusted non-IFRS gross profit margin was 41.9%.
Net profit attributable to the owners of the Company was RMB3.67 billion, up 89.1% year-over-year; diluted EPS was RMB1.28, up 93.9% year-over-year.
Adjusted non-IFRS net profit attributable to the owners of the Company was RMB2.68 billion, up 40.0% year-over-year; adjusted non-IFRS diluted EPS was RMB0.94, up 44.6% year-over-year.
As of March 31, 2025, backlog for Continuing Operations reached RMB52.33 billion, up 47.1% year-over-year.
Operating cash flow climbed 41.8% year-over-year to RMB3.03 billion, driven by business growth, increases in operational efficiency, and continued improvement of financial management capabilities.
The Company’s sustained and steady business growth is the result of our unique, fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) platform. WuXi Chemistry’s small molecule Development and Manufacturing (D&M) pipeline has maintained growth, with a total of 203 new molecules added in the first quarter of 2025. As of March 31, 2025, our small molecule D&M pipeline reached 3,393 molecules, with an increase of 5 projects in phase III and commercial stages during the first quarter of 2025.
The Company has been accelerating global D&M capacity expansion. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA inspections with no single observation. By the end of 2025, total reactor volume of small molecule APIs is expected to reach over 4,000kL, and the total reactor volume of Solid Phase Peptide Synthesizers is expected to increase to more than 100,000L.
[1] Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS).

[2] In 2024 Q1 and 2025 Q1, WuXi AppTec had a fully-diluted weighted average share count of 2,925,052,346 and 2,899,579,930 ordinary shares, respectively.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "Revenue and profit both resumed double-digit growth during the first quarter, and our backlog for Continuing Operations sustained rapid growth, as we maintained our laser focus on leveraging WuXi AppTec’s unique CRDMO platform to expand delivery of enabling services across research, development and manufacturing."

"The Company currently maintains its full-year guidance set at the beginning of the year. We expect revenue from Continuing Operations to grow 10-15% in 2025, and our adjusted non-IFRS net profit margin will further improve."

"WuXi AppTec is dedicated to ‘doing the right thing and doing it right’, as our services drive long-term growth, improve the health of those in need and realize our vision that ‘every drug can be made and every disease can be treated’."

Business Performance by Segments

WuXi Chemistry: CRDMO Business Model Drives Continuous Growth; Q1 2025 Revenue Up 32.9% YoY, with TIDES Revenue Up 187.6% YoY
Q1 revenue of WuXi Chemistry reached RMB7.39 billion, up 32.9% year-over-year. With continued optimization of production process and improvement in capacity efficiency driven by the growth of late-stage clinical and commercial projects, Q1 adjusted non-IFRS gross profit margin steadily improved 4.2pts year-over-year to 47.5%.
Small molecule drug discovery service ("R") continues to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 460,000 new compounds to customers, which resulted in 6% year-over-year growth. Through our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our customers globally, supporting the sustainable growth of our CRDMO business. In the first quarter, 75 molecules were converted from R to D.
Small molecule D&M service remains strong.
i. The small molecule CDMO pipeline continued to expand. Q1 revenue of small molecule D&M services was up 13.8% year-over-year to RMB3.85 billion. In the first quarter of 2025, 203 new molecules were added to the small molecule D&M pipeline. As of March 31, 2025, our small molecule D&M pipeline reached 3,393 molecules, including 75 commercial projects, 82 in phase III, 368 in phase II and 2,868 in phase I and pre-clinical stages, with an increase of 5 projects in the commercial and phase III stages during the first quarter of 2025.
ii. We continued to build small molecule capacities. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA inspections with no single observation. The total reactor volume of small molecule APIs is expected to reach over 4,000kL by the end of 2025.
TIDES business (oligo and peptides) sustains rapid growth.
i. With the ramp-up of new capacities released sequentially each quarter last year, Q1 TIDES revenue grew 187.6% year-over-year to RMB2.24 billion. As of the end of March 2025, TIDES backlog was up 105.5% year-over-year.
ii. TIDES D&M customers grew 14% year-over-year, while the number of TIDES molecules grew 25% year-over-year.
iii. We continued to build peptide capacities in Taixing. Total reactor volume of Solid Phase Peptide Synthesizers is expected to increase to over 100,000L by the end of 2025.
WuXi Testing[3]: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leading Positions
WuXi Testing reached RMB1.29 billion during Q1. Adjusted non-IFRS gross profit margin was 23.4%. Q1 revenue of lab testing services declined 4.9% year-over-year to RMB0.88 billion, due to market impact as pricing gradually reflected in revenue along with backlog conversion, accompanied by a decline in Q1 adjusted non-IFRS GPM. Of which, drug safety evaluation services revenue was down 7.8% year-over-year, while maintaining an industry-leading position in the Asia-Pacific region.
New modality business continued to develop, while the Company maintained its leading position in areas including nucleic acids, conjugates, mRNA, multispecific antibodies and peptides.
The Company is committed to actively enabling customers’ global licensing. WuXi AppTec has supported approximately 40% of successful out-licensed deals from Chinese biotech companies since 2022.
The Suzhou facility has successfully passed 4 consecutive FDA on-site inspections.
Q1 revenue for clinical CRO & SMO declined 2.2% year-over-year to RMB0.41 billion due to market pricing impact. Of which, SMO revenue grew 5.5% year-over-year and maintained the industry leading position in China. During the quarter, our clinical CRO business supported customers to obtain 10 IND approvals.
The SMO business continued steady growth, and supported 28 new drug approvals for customers in the first quarter. Over the past decade, SMO has supported 283 new drug approvals in total, maintaining significant advantages in multiple areas (endocrinology, dermatology, lung cancer and cardiovascular disease, etc.).
[3] As disclosed in the 2025 First Quarterly Report, WuXi Testing here includes only the core business of Continuing Operations (similar to the 2024 baseline).

WuXi Biology: Continues to Generate Downstream Opportunities; In Vitro & In Vivo Business Synergies and New Modality Business Drive Growth
WuXi Biology follows the science and continuously strengthens drug discovery capabilities in emerging areas. It efficiently generates downstream opportunities for CRDMO model by continuously contributing more than 20% of the Company’s new customers.
WuXi Biology’s Q1 revenue rose 8.2% year-over-year to RMB0.61 billion. Due to market pricing impact, Q1 adjusted non-IFRS gross profit margin was down 2.2pts to 36.3%.
The Company continuously leverage synergies between in vitro and in vivo platforms, and efficiently supports customer demand for one-stop drug discovery service platform. Revenue of the in vitro integrated screening platform grew 28.9% year-over-year. Revenue of the in vivo pharmacology platform grew 9.4% year-over-year, driven by accelerated advancements in focused disease areas. The constantly improved competitive edge in non-oncology business has laid a solid foundation for sustained growth throughout the year.
New modality drug discovery services continue to perform well, contributing more than 30% of WuXi Biology’s total revenue.
This release provides a summary of the results and does not intend to provide a complete statement relating to the Company, its securities, or any relevant matters herein that a recipient may need in order to evaluate the Company. For additional information, please refer to the WuXi AppTec 2025 First Quarterly Results Presentation and 2025 First Quarterly Report disclosed on the Company’s official website, as well as the Company’s disclosure documents and information on the Shanghai Stock Exchange, the Stock Exchange of Hong Kong Limited website. Investors are advised to exercise caution and be aware of the investment risks in trading Company shares.

Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS), in currency of RMB. Besides, all other financial information disclosed in this press release is prepared in accordance with the International Financial Reporting Standards Accounting Standards ("IFRSs"), in currency of RMB.

The 2025 First Quarterly Report of the Company has not been audited.

Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted
non-IFRS
Gross Profit

Change

Adjusted non-
IFRS Gross
Profit Margin

WuXi Chemistry

7,390.97

32.9 %

3,509.84

45.7 %

47.5 %

WuXi Testing

1,292.32

(4.0) %

301.90

(40.2) %

23.4 %

WuXi Biology

607.07

8.2 %

220.42

2.1 %

36.3 %

Others

99.73

(36.1) %

14.51

(17.4) %

14.6 %

Discontinued
Operations (Note 1)

264.50

(25.6) %

1.64

N/A

0.6 %

Total

9,654.60

21.0 %

4,048.32

31.0 %

41.9 %

Note 1: In accordance with the IFRSs, the Company has classified the operations for which equity sale agreements were signed during the Reporting Period or the comparison year as discontinued operations.

Note 2: Any sum of the data above that is inconsistent with the total is due to rounding.

Consolidated Statement of Profit or Loss[4] – Prepared under IFRSs

RMB Million

Quarter Ended

March 31, 2025

Quarter Ended

March 31, 2024

Revenue

9,654.6

7,981.9

Cost of sales

(5,641.5)

(4,976.2)

Gross profit

4,013.1

3,005.7

Other income

311.4

242.0

Other gains and losses

1,073.3

192.9

Impairment losses under expected credit losses ("ECL") model, net of reversal

(153.1)

(19.7)

Impairment losses of non-financial assets

(69.5)

Selling and marketing expenses

(194.1)

(179.1)

Administrative expenses

(597.8)

(610.5)

R&D expenses

(224.4)

(306.4)

Operating Profit

4,158.9

2,324.9

Share of results of associates

63.9

33.9

Share of results of joint ventures

0.1

0.2

Finance costs

(80.2)

(61.7)

Profit before tax

4,142.7

2,297.4

Income tax expense

(564.4)

(338.5)

Profit for the period

3,578.3

1,958.9

Profit for the period attributable to:

Owners of the Company

3,536.3

1,942.2

Non-controlling interests

42.0

16.6

3,578.3

1,958.9

Consolidated Statement of Profit or Loss (continued) – Prepared under IFRSs

Quarter Ended

March 31, 2025

Quarter Ended

March 31, 2024

Weighted average number of ordinary shares for calculating EPS
(expressed in shares)

– Basic

2,846,244,009

2,919,696,373

– Diluted

2,899,579,930

2,925,052,346

Earnings per share

(expressed in RMB per Share)

– Basic

1.24

0.67

– Diluted

1.24

0.66

[4] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position[5] – Prepared under IFRSs

RMB Million

March 31,

December 31,

2025

2024

Non-current Assets

Property, plant and equipment

25,260.3

25,267.8

Right-of-use assets

1,938.3

1,874.8

Goodwill

972.1

972.4

Other intangible assets

535.4

601.0

Interests in associates

2,106.9

2,322.2

Interests in joint ventures

3.4

3.4

Deferred tax assets

489.8

473.1

Financial assets at fair value through profit or
loss ("FVTPL")

8,707.8

8,943.4

Other non-current assets

144.8

114.7

Biological assets

1,045.2

1,063.0

Total Non-current Assets

41,204.0

41,635.7

Current Assets

Inventories

4,647.0

3,532.1

Contract costs

903.5

912.2

Biological assets

941.2

955.5

Amounts due from related parties

91.9

89.3

Trade and other receivables

9,269.2

9,643.7

Contract assets

876.2

988.8

Income tax recoverable

89.7

87.2

Financial assets at FVTPL

901.0

1,234.0

Derivative financial instruments

0.6

Other current assets

736.5

734.1

Pledged bank deposits

10.2

22.1

Term deposits with initial term of over three
months

4,826.1

4,865.6

Bank balances and cash

20,014.9

13,434.3

43,308.1

36,498.8

Assets classified as held for sale

2,191.3

Total Current Assets

43,308.1

38,690.2

Total Assets

84,512.1

80,325.8

[5] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position (continued)[6]– Prepared under IFRSs

RMB Million

March 31,

December 31,

2025

2024

Current Liabilities

Trade and other payables

6,863.6

7,025.5

Amounts due to related parties

7.5

15.3

Derivative financial instruments

63.1

202.0

Contract liabilities

2,349.8

2,251.0

Bank borrowings

4,829.4

1,278.6

Lease liabilities

211.5

224.2

Income tax payables

1,035.7

870.8

Convertible bonds

3,513.3

3,493.1

18,873.8

15,360.6

Liabilities associated with assets classified as
held for sale

865.5

Total Current Liabilities

18,873.8

16,226.1

Non-current Liabilities

Bank borrowings

763.3

2,959.5

Deferred tax liabilities

493.8

522.4

Deferred income

976.6

985.6

Lease liabilities

625.8

546.6

Total Non-current Liabilities

2,859.5

5,014.1

Total Liabilities

21,733.3

21,240.2

Net Assets

62,778.8

59,085.6

Capital and Reserves

Share capital

2,888.0

2,888.0

Reserves

59,444.4

55,744.7

Equity attributable to owners of the Company

62,332.4

58,632.7

Non-controlling interests

446.4

452.9

Total Equity

62,778.8

59,085.6

[6] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Adjusted Non-IFRS Net Profit Attributable to the Owners of the Company[7]

RMB Million

Quarter Ended

March 31,

Quarter Ended

March 31,

2025

2024

Net profit attributable to the owners of the Company under CAS

3,672.0

1,942.2

GAAP difference[8]

(135.7)

Net profit attributable to the owners of the Company under IFRSs

3,536.3

1,942.2

Add:

Share-based compensation expenses

34.4

87.8

Issuance expenses of convertible bonds

9.8

Foreign exchange related losses

178.0

14.4

Amortization of acquired intangible assets from merger and acquisition

7.1

13.6

Losses from impairment and disposal of non-financial assets

65.0

Gains from divestiture and restructuring initiatives

(56.4)

Non-IFRS net profit attributable to the owners of the Company

3,774.1

2,058.0

Add:

Realized and unrealized gains from venture capital investments

(1,096.3)

(144.7)

Realized and unrealized share of gains from joint ventures

(0.1)

(0.2)

Adjusted non-IFRS net profit attributable to the owners of the Company

2,677.7

1,913.1

Lutris Pharma Presents New Data from Its Completed Clinical Trial of LUT014 Gel Demonstrating Efficacy in Treating Acneiform Rash Associated with Use of Anti-EGFR Cancer Therapies at AACR Annual Meeting 2025

On April 28, 2025 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, reported data from its recently completed double-blind, placebo-controlled phase 2 randomized clinical trial of lead therapy, LUT014 gel, demonstrating statistically-significant reductions in dose-limiting acneiform rash in patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy (Press release, Lutris Pharma, APR 28, 2025, View Source [SID1234652272]). This new clinical data, showing that Lutris’ topically-applied novel B-Raf inhibitor gel is optimized for paradoxical MAPK activation, was presented yesterday in an oral presentation at the Clinical Trials Plenary Session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025.

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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
"Due to the widespread use of EGFR inhibitors for cancer treatment and the frequent occurrence of dermal toxicities, many patients do not receive optimal cancer therapy. This is often because the toxicity leads to dose reductions or complete discontinuation of treatment," stated Benjamin W. Corn, M.D., Chief Medical Officer of Lutris Pharma. "By reversing the inhibitory effect of anti-EGFR therapy on downstream signaling in skin cells, we firmly believe LUT014 has the potential to be a key therapeutic, offering significant benefits to patients with no other effective treatment options. In the trial, as we expected, LUT014 demonstrated statistically significant improvement in acneiform rash compared to placebo, with highly successful outcomes in both intention-to-treat and per-protocol patient analyses. LUT014 was also shown to be safe and well tolerated, with fewer adverse events reported than in the placebo group, with the majority of adverse events being mild."

"This was the first placebo-controlled randomized clinical trial demonstrating the benefit and safety of an agent for the treatment of the acneiform rash associated with anti-EGFR therapy. Therefore, having these overwhelmingly positive results for LUT014 selected for an oral presentation at the prestigious AACR (Free AACR Whitepaper) Annual Meeting, is a testament to the potential of our lead asset and a significant milestone for the company," added Noa Shelach, Ph.D., Chief Operating Officer of Lutris Pharma. "In addition, our successful $30 million financing, completed in January 2025, allows us to continue advancing our clinical development program as we pursue our goal of commercializing LUT014 which will align with our mission to enhance the effectiveness of anti-cancer therapies and significantly improve the quality of life for patients."

The trial enrolled 118 colorectal cancer patients from 23 clinical sites, all of whom had developed grade 2 or non-infected grade 3 acneiform rash while receiving cetuximab or panitumumab. Participants were randomized in a 1:1:1 ratio to receive either LUT014 gel 0.03%, LUT014 gel 0.1%, or a placebo gel. The gel was applied daily for 28 days.

The primary endpoint was the proportion of patients who achieved treatment success, measured by an improvement of at least one grade in Common Terminology Criteria for Adverse Events (CTCAE) scoring or an improvement of at least 5 points in the Functional Assessment of Cancer Therapy (FACT)-EGFRI-18 HRQoL skin-specific assessment. The study employed both an intention-to-treat (ITT) analysis and a Per-Protocol (PP) analysis (i.e., patients who dropped out or did not discontinue their EGFR inhibitor for reasons unrelated to the rash, such as disease progression were excluded from the analysis). Sample size calculation was based on an expected treatment success of 20% for the placebo group and 50% for one of the treatment groups. A total of 117 patients were required for a two group ꭕ2 test with a 0.05 two-sided significance and 80% power.

Efficacy is shown in the table below. In the ITT as well as the PP, the composite endpoint demonstrated statistically significant rates of success for the high dose LUT014 group, compared to placebo.

Treatment
Arm

N

Success
Rate

(ITT)

P
Value

N

Success
Rate

(PP)

P Value

LUT-014 0.1%

39

69 %

0.0015

25

76 %

0.002

LUT-014 0.03%

40

47.5 %

0.12

29

59 %

0.07

Placebo

39

33 %

29

34.5 %

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 an 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.

Actinium Highlights Mutation Agnostic Antileukemic Activity of Actimab-A Against FLT3, NPM1, KMT2A and TP53 Mutations in AML Models Demonstrating Backbone Potential for Acute Myeloid Leukemia Treatment at the American Association for Cancer Research Annual Meeting

On April 28, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supporting Actimab-A’s mutation agnostic antileukemic effect and backbone therapy potential in preclinical acute myeloid leukemia (AML) models (Press release, Actinium Pharmaceuticals, APR 28, 2025, View Source;302439223.html [SID1234652271]). The preclinical data demonstrate that the combination of Actimab-A with standard of care AML therapies including menin and FLT3 inhibitors and the hypomethylating agent (HMA) azacitidine resulted in significant antileukemic activity in AML cells lines with FLT3, NPM1, KMT2A and TP53 mutations. Additionally, in animal models, Actimab-A significantly enhanced tumor growth inhibition, prolonged the duration of response and survival when combined with the menin inhibitor revumenib (Syndax Pharmaceuticals, Inc.), and potentiated AML cell killing in combination with the FLT3 inhibitor gilteritinib (Astellas Pharma US, Inc.) and HMA azacitidine.

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Sandesh Seth, Actinium’s Chairman and CEO, said, "In multiple clinical trials, Actimab-A has demonstrated potent single agent activity, synergy with other therapeutic modalities and efficacy in patients with high-risk features such as a TP53 mutation. To our knowledge, Actimab-A is the only AML therapy to achieve all of these outcomes, which we attribute to its mutation agnostic, backbone therapy profile. The data presented at AACR (Free AACR Whitepaper) further support Actimab-A’s mutation agnostic mechanism of action across several of the most commonly expressed mutations and synergy with the targeted therapies approved for patients with these mutations. With multiple clinical trials underway and being planned across the AML treatment settings, we are focused on generating strong clinical outcomes starting in the second half of this year and committed to realizing Actimab-A’s potential for patients who have significant unmet needs."

Actimab-A is Actinium’s lead radiotherapy that delivers Actinium-225, a potent alpha-emitter radioisotope payload that can produce lethal double strand DNA breaks to kill targeted cells that express CD33. CD33 is expressed ubiquitously in AML and in other myeloid malignancies such as myeloid dysplastic syndromes (MDS), which Actinium estimates to be an addressable market of over 100,000 patients in the U.S. and EU5. Actimab-A is also being advanced into a pivotal Phase 2/3 trial in combination with the chemotherapy regimen CLAG-M in patients with relapsed or refractory AML and in newly diagnosed AML in combination with Venetoclax and ASTX-727 (Taiho Oncology, an Otsuka holdings company) an oral hypomethylating agent (HMA) under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI). Actimab-A has demonstrated a mutation agnostic profile with positive clinical results in high-risk relapsed and refractory (r/r) AML patients including those with a TP53 gene mutation, prior Venetoclax treatment and prior bone marrow transplant (BMT).

The Actimab-A AACR (Free AACR Whitepaper) presentation is available for viewing on the Presentations& Webinars page of Actinium’s website HERE.

Title: Actimab-A (Lintuzumab-Ac-225) has potent mutation agnostic antileukemic activity in preclinical models of AML
Abstract Number: 594