Lantern Pharma Completes Targeted Enrollment for Lung Cancer Phase 2 Harmonic™ Clinical Trial in Japan for LP-300

On July 31, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR AI platform, reported the successful completion of targeted enrollment for its Phase 2 HARMONIC clinical trial in Japan (Press release, Lantern Pharma, JUL 31, 2025, View Source [SID1234654696]). The company enrolled 10 patients ahead of schedule across five clinical sites in Japan, including the National Cancer Center Japan.

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The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs). The successful Japanese enrollment validates Lantern’s strategic decision to expand the trial internationally to regions with significantly higher rates of never-smoker NSCLC patients such as Japan and Taiwan.

"Completing our targeted enrollment in Japan ahead of schedule demonstrates excellent execution of our international expansion strategy and validates our decision to focus on regions where never-smoker NSCLC has the highest prevalence," said Panna Sharma, President and CEO of Lantern Pharma. "This achievement builds momentum as we continue enrollment in Taiwan and the United States, bringing us closer to generating the clinical data that could establish LP-300 as a treatment option for this underserved patient population with significant unmet medical need."

The completion of Japanese enrollment represents an important milestone in the global HARMONIC trial, which is designed to enroll approximately 90 patients across multiple regions. Japan’s notably higher rate of never-smoker NSCLC patients (33-40% of new cases) compared to Western populations (typically 15%) makes it a strategically important region for the trial. Similarly, Taiwan, where more than 50% of lung cancer cases occur in never-smokers, represents another key enrollment region.

The HARMONIC trial previously demonstrated encouraging results in its initial safety lead-in cohort, showing an 86% clinical benefit rate and 43% objective response rate among the first seven patients enrolled in the United States. Notably, recent data revealed that one patient has achieved a durable complete response in target cancer lesions with survival continuing for nearly two years, demonstrating the potential for LP-300 to deliver meaningful long-term outcomes for never-smoker NSCLC patients.

Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic characteristics1, representing a global market opportunity estimated at over $4 billion annually. Currently, there are no therapies specifically approved for never-smoker NSCLC patients, highlighting the significant unmet medical need this population faces.

Lantern is actively exploring collaboration and partnering opportunities to maximize LP-300’s commercial potential in multiple geographies. Lantern is scheduled to provide further clinical and outcome data from the HARMONIC trial later this quarter, with updates covering both Asian and U.S. patient cohorts.

About LP-300 LP-300 is a disulfide small molecule and investigational drug candidate with a multimodal mechanism of action directed toward tyrosine kinase receptors and cell redox enzymes. It modulates cellular redox in key signaling pathways in NSCLC and directly engages with TKI receptors via cysteine modification. LP-300 has been evaluated in multiple Phase 1, 2, and 3 clinical trials in over 1,000 subjects, with retrospective analysis showing significant survival benefit in never-smoker lung adenocarcinoma patients.

About the HARMONIC Trial The HARMONIC trial is a multicenter, open-label, randomized Phase 2 trial designed to evaluate the efficacy and safety of LP-300 in combination with standard-of-care chemotherapy (pemetrexed/carboplatin) versus chemotherapy alone in never-smoker NSCLC patients who have relapsed following TKI treatment. The trial is expected to enroll approximately 90 patients across sites in the United States, Japan, and Taiwan. The primary endpoints are progression-free survival (PFS) and overall survival (OS). For more information about the trial, visit www.harmonictrial.com or clinicaltrials.gov (NCT05456256).

OPM Announces Its 2025 Half-Year Financial Results and Provides an Update on Its Clinical Developments and Financial Position

On July 31 2025 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, reported its financial results for the first half of 2025, as approved by the Board of Directors on July 31, 2025 (Press release, Oncodesign Precision Medicine, JUL 31, 2025, View Source [SID1234654695]).

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Philippe GENNE, Chairman and CEO of Oncodesign Precision Medicine, comments: "To date, it remains impossible to raise funds on Euronext for a biotechnology company that needs to conduct clinical proof-of-concept trials. As a result, our hopes for revenue and therefore cash availability rest primarily on discussions with potential buyers of our assets. The various cost-cutting measures we have taken since the beginning of this year are enabling us to continue these discussions over time, and the last quarter will be crucial in this regard."

Karine LIGNEL, Managing Director and COO of Oncodesign Precision Medicine adds: "In a very difficult financial environment, we have taken management decisions that have enabled us to significantly reduce our expenses and thus extend our cash flow horizon as much as possible. We have also set up an equity financing line to deal with market uncertainties. Nevertheless, the situation remains complicated, and we are making every effort to secure a partnership for one of our assets."

Oncodesign Precision Medicine – Income Statement

in M€
Audited data

H1 2025

H1 2024

Evolution

In %

in value

Revenues

0.14

0.14

0%

+0.00

Other revenues and operating income

0.60

0.50

21%

+0.10

Total revenues and operating income

0.74

0.64

16%

+0.10

Stock variation

13.00

NS

+13.00

Purchases consumed

(2.24)

(3.33)

-33%

+1.09

Personnel costs

(1.51)

(1.35)

12%

-0.16

Other operating expenses

(0.02)

(0.03)

-19%

+0.01

Taxes and duties

(0.03)

(0.03)

19%

-0.01

Net change in depreciation and amortization

(0.15)

(0.13)

16%

-0.02

Total operating expenses

9.05

(4.86)

NS

+13.91

Operating result

9.79

(4.22)

-332%

+14.01

Financial income and expenses

(0.26)

(0.06)

342%

-0.20

Income from ordinary activities of consolidated companies

9.53

(4.28)

-323%

+13.81

Extraordinary income and expenses

0

(0.01)

NS

+0.01

Income tax

0.31

0.65

-52%

-0.34

Net result

9.85

(3.64)

NS

+13.48

Key financial data

A cost reduction program was implemented in the first half of 2025:

Negotiations were held with the banks and BPI that granted the loan, resulting in a six-month deferral of principal repayments starting in April 2025
Expenses were reduced through
The layoff of five employees in early 2025
A 50% reduction in the compensation of non-salaried corporate officers
A freeze on salaries and bonus payments for the 2024 fiscal year
A reduction in spending on non-priority programs.
In terms of cash flow, rather than from an accounting perspective, this results in a reduction in payroll costs of €242k in the first half of 2025 and a projected reduction of €440k in the second half of this year. The reduction in expenditure is particularly significant for the item "subcontracting and fees," which will fall from €2,900k in the first half of 2024 to €1,773k in the first half of 2025.

R&D expenses amounted to €1.74 million in the first half of 2025, compared with €3.61 million in the same period last year, as the company focused its efforts on the clinical development of OPM-101.

Oncodesign Precision Medicine – R&D expenditure

in M€
Analytical data

H1 2025

H1 2024

Evolution

In %

in value

Partnerships

0.46

0.68

-32%

-0.2

Licensing

1.28

2.93

-56%

-1.7

Total R&D expenses

1.74

3.61

-52%

-1.9

Reintegration, in close collaboration with Servier, of all OPM-201 data and product stocks

The most significant financial item in the first half of 2025 is the reintegration, as provided for in the partnership agreement, of the stock of OPM-201 GMP material produced by Servier. As this reintegration is being carried out without financial competing, OPM has called upon an external expert to determine fair value for these stocks. This expert carried out three different valuations to arrive at this fair value.

A summary of these valuations is shown in the table below:

in M€

Min.

Centrale

Max.

Valuation of inventories based on cost price

7.2

7.2

7.2

Valuation of inventories using the "milestone economy" method

13.0

13.0

13.0

Valuation of inventories using rNPV discounting

15.3

15.7

16.2

The expert concluded that the fair value of these inventories falls within a range of €13 million to €16.2 million. OPM used the lower end of this range.

OPM’s revenue for the first half of 2025 was €0.1 million, the same as in the first half of 2024.

Other income mainly consists of subsidies amounting to €0.3 million and €0.3 million in provision reversals.

OPM’s financial result was (€0.26) million, compared with (€0.1) million in the same period last year, mainly due to interest on outstanding loans and financial income from cash investments.

OPM recorded €0.4 million in R&D tax credits in the first half of 2025, down 52% compared to last year. The amount of R&D tax credits was reduced by the amount of public aid, the R&D expenditure base decreased, and the rules for collecting R&D tax credits changed (exclusion of technology watch patents, etc.).

OPM’s half-year net income thus stands at €9,846k, due to the integration of OPM-201 inventories at an estimated value of €13m.

Cash position of €2.5m at June 30, 2025

As of June 30, 2025, OPM had cash reserves of €2.5 million, before receiving the Research Tax Credit, compared to €9.6 million (including the Research Tax Credit) as of June 30, 2024.

The Research Tax Credit, amounting to €1.1 million, was received in July 2025.

OPM has access to a maximum €5 million equity financing facility, which it has not yet used. The Company is in discussions with financial and pharmaceutical partners with the goal of signing a partnership agreement or raising funds.

2025 perspectives

OPM has submitted its Phase 1b/2a protocol for the REVERT study evaluating OPM-101 in patients with advanced melanoma resistant to anti-PD1 and is awaiting a response from Swiss ethics institutions. The first patient is expected to be enrolled by the end of 2025.

Work on radioligands is continuing as part of the COMETE project.

Partnership prospects or transfer mainly focus on the two most advanced molecules to date (OPM-101 and OPM-201).

OPM’s goal is to license or transfer OPM-101 at the end of Phase 2a to a pharmaceutical partner who will complete its development and commercialization. While we do not anticipate licensing or sales before the end of this phase in 2027, we are considering the possibility of a pharmaceutical partner taking a licensing option with the payment of an exclusivity fee, giving them first refusal on the results.

For OPM-201, the objective is to find a partnership similar to the one we found with Servier in 2019 or a buyer.

Availability of the 2025 half-year financial report

The 2025 half-year financial report will be available on the company’s website, within the legal deadline, before October 31, 2025.

Chipscreen Biosciences’ Brain-Penetrant Aurora B Selective Inhibitor CS231295 Tablet Receives FDA IND Approval, Advancing Global Clinical Development

On July 31, 2025 Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences") reported that its wholly owned subsidiary, Chipscreen Biosciences (USA) Ltd., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative drug CS231295 tablet for the treatment of advanced solid tumors (Press release, Shenzhen Chipscreen Biosciences, JUL 31, 2025, View Source [SID1234654694]). This significant milestone marks a key step forward in the global development strategy for CS231295.

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Malignant tumors remain one of the leading causes of death worldwide. Despite continuous advancements in clinical treatments and efficacy, most cancers remain incurable. Drug resistance, recurrence, and metastasis pose significant threats to long-term patient survival. In particular, due to the presence of the blood-brain barrier, primary brain tumors and brain metastases not only pose a severe danger to life but also serve as natural barriers to effective drug therapy. Thus, developing novel brain-penetrant anti-cancer drugs has become a pressing challenge and a key research focus.

CS231295 is a next-generation brain-penetrant Aurora B selective inhibitor discovered through years of mechanism-based research by Chipscreen Biosciences. On one hand, it precisely inhibits tumor-specifically overexpressed Aurora B kinase to induce synthetic lethality, directly targeting the genetic vulnerability of hard-to-treat cancers such as those with RB1 deletion. On the other hand, due to its strong blood-brain barrier permeability, it shows significant therapeutic potential for both primary and metastatic brain tumors. Furthermore, this molecule also exhibits broad-spectrum anti-tumor activity, which improves the tumor microenvironment. It is expected to provide a novel solution for tumors with similar genetic defects and the global challenge of brain metastases. Currently, there is no similar compound with this design that has entered clinical trials globally.

With its unique mechanism and chemical structure, CS231295 demonstrates synergistic effects when combined with chemotherapy, targeted therapy, and cancer immunotherapy. In preclinical studies, CS231295 has shown remarkable pharmacodynamic activity, ideal pharmacokinetic properties, and a favorable safety profile.

Notably, CS231295 completed the first patient enrollment in its Phase I first-in-human clinical trial in China in May 2025, providing preliminary evidence to support the scientific rationale and feasibility of global multicenter clinical development. The FDA’s IND approval will further accelerate the initiation and implementation of its clinical research in the United States.

Immunophotonics Completes Treatment of Last Patient in INJECTABL-1 Phase 1b/2a Clinical Trial of IP-001 for Advanced Solid Tumors

On July 31, 2025 Immunophotonics, Inc., a clinical-stage biotech company developing novel immunostimulatory drugs to improve efficacy of routine tumor destruction techniques, reported the completion of treatment of the last patient in its INJECTABL-1 multicenter Phase 1b/2a clinical trial of IP-001 for advanced solid tumors (Press release, Immunophotonics, JUL 31, 2025, View Source [SID1234654693]). The 41-patient trial, which focused on three distinct cancer types — colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma— was conducted in France, Germany, Switzerland, the UK, and the US.

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The INJECTABL-1 trial was designed to evaluate the systemic immune-mediated anti-cancer effects of IP-001 following tumor ablation, which aims to destroy all cells in targeted tumor lesions in patients with advanced solid tumors but fails to induce robust anti-tumor immunity. Tumor ablation is an approved and well-established procedure that is readily available at most hospitals and clinics. IP-001 is a novel immunotherapy administered by injection into the ablation zone. It works by retaining tumor debris, including tumor antigens, and by activating the patient’s own immune system to allow systemic tumor surveillance. Such immune surveillance enables the patient’s own defense mechanisms to recognize and destroy tumor cells that had escaped the destroyed metastatic lesion.

Prof. Dr. Markus Jörger, Principal Investigator for the trial at the Cantonal Hospital St. Gallen Clinic for Medical Oncology and Hematology, commented: "We are proud to announce the completion of treatment of the last patient in our INJECTABL-1 Phase 1b/2a clinical trial. This significant milestone brings us closer to potentially providing a new treatment option for patients with advanced solid tumors."

"Immunophotonics is committed to leading the field of Interventional Immuno-Oncology through a therapeutic approach intended to reduce tumor recurrence after standard-of-care local ablation therapy, which remains a significant unmet medical need. With the completion of our INJECTABL-1 trial, we will evaluate data to assess IP-001’s ability to transform ablation into something more powerful as we continue to advance the clinical development of our proprietary novel asset. Early signals are positive, and the company has expanded clinical collaborations to further assess the efficacy of this novel therapy," stated Lu Alleruzzo, Immunophotonics co-founder and CEO.

About IP-001
IP-001 is a proprietary glycan polymer that generates tumor antigen depots and acts as a potent, multimodal immune stimulant intended to induce immunological responses to eradicate cancer. IP-001 is designed to (1) prolong the availability of the targeted tumor antigens, (2) facilitate the recruitment and activation of innate immune cells such as antigen-presenting cells (APCs), (3) increase the uptake of the tumor antigens into the APCs, and (4) lead to a downstream adaptive immune response against the tumor cells. Activation of a systemic, adaptive immune response allows immune effector cells to seek out and eliminate tumor cells throughout the body.

Actinium Presents Data Supporting Paradigm Changing Potential of ATNM-400 in Prostate Cancer Demonstrating Its Superior Efficacy and Improved Survival in Treatment Resistant Tumor Models versus Pluvicto and ARPI Therapy, and Also Enhanced Efficacy in Combination with ARPI Therapy at the 4th Annual Targeted Radiopharmaceuticals Summit

On July 31, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported additional preclinical data supporting its ATNM-400 radiotherapy prostate cancer candidate at the 4th Annual Targeted Radiopharmaceuticals Summit (TRP) being held July 29 – 31, 2025 in San Diego, CA (Press release, Actinium Pharmaceuticals, JUL 31, 2025, View Source [SID1234654691]). ATNM-400 is a novel, first-in-class targeted radiotherapy designed to deliver potent Actinium-225 (Ac-225), an alpha-emitter radioisotope, to prostate cancer cells by targeting a non-Prostate Specific Membrane Antigen (PSMA), disease-driving protein overexpressed in advanced and treatment-resistant disease. Unlike PSMA-targeted agents that primarily serve as imaging and targeting tools, the ATNM-400 target is directly implicated in tumor progression, survival signaling, and resistance to androgen receptor (AR) pathway inhibitor (ARPI) therapy. The presentation titled, "Building a Transformative Ac-225 Portfolio for Next-Generation Precision Oncology" on Wednesday, July 30, 2025, highlighted new PET imaging data showing tumor-specific uptake of ATNM-400, robust tumor control and improved survival outcomes in preclinical studies.

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ATNM-400 Demonstrated Sustained Tumor-Specific Uptake

PET imaging confirmed tumor-specific uptake of the ATNM-400 antibody

The ATNM-400 antibody showed sustained tumor uptake up to 216 hours with rapid clearance from normal tissues
ATNM-400 Produced Robust Tumor Control, Improved Survival and Superior Efficacy After Pluvicto Resistance

ATNM-400 is more efficacious than Pluvicto (Lu-177-PSMA-617) with potent tumor control

ATNM-400 significantly improved survival compared to Pluvicto with continued follow-up ongoing

ATNM-400 is highly effective in prostate cancer tumors with acquired Pluvicto resistance, halting tumor growth and producing potent tumor cell killing after Pluvicto stops working, highlighting its potential in advanced disease settings that are resistant to standard treatments
Enhanced Efficacy of ATNM-400 with Enzalutamide Supports Potential for Novel Combinations

ATNM-400 demonstrated significant in vitro tumor cell killing when used in combination with AR-targeting agents, such as enzalutamide (Xtandi)

The ATNM-400 enzalutamide combination produced superior anti-tumor efficacy and durable tumor control compared to enzalutamide alone with 40% of prostate cancer tumor-bearing animals having complete cures

Actinium previously highlighted that ATNM-400 inhibited tumor growth of enzalutamide resistant tumors whereas re-treatment with Pluvicto or additional enzalutamide did not

Actinium highlighted that follow-up continues to further evaluate the durability of ATNM-400’s anti-tumor efficacy in prostate cancer with additional data expected in the second half of 2025. Actinium’s TRP presentation can be accessed via the Investor Relations page of Actinium’s website HERE.

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are highly encouraged by the growing body of data supporting the therapeutic potential of ATNM-400 and the significance of its target being directly implicated in tumor progression, survival signaling, and resistance to ARPI therapy. The new data presented at TRP highlight the utility of the differentiated mechanism of action of ATNM-400 via the Ac-225 alpha-emitter payload evidenced by durable tumor control, improved survival rates compared to Pluvicto, and efficacy in enzalutamide and Pluvicto resistant models. We believe ATNM-400 has the potential to redefine the treatment paradigm in the high-value, advanced disease, and metastatic castrate-resistant prostate cancer settings, which impact tens of thousands of patients annually. We look forward to presenting additional data in the second half of this year and further highlighting ATNM-400’s differentiated potential in treatment settings with high unmet needs."

About ATNM-400

ATNM-400 is a highly innovative, first-in-class, non-PSMA targeting Actinium-225 (Ac-225) radiotherapy candidate for prostate cancer. In comparison to Pluvicto (Lu-177-PSMA-617) and the majority of radiotherapies in development for prostate cancer, which target prostate specific membrane antigen (PSMA) and are either non-differentiated or barely differentiated, ATNM-400 targets a distinct non-PSMA disease-driving protein overexpressed in advanced and treatment-resistant disease. The receptor specifically targeted by ATNM-400 is highly expressed in metastatic castration-resistant prostate cancer (mCRPC), contributes directly to disease progression, poorer survival outcomes, and continues to be expressed at a high level even after androgen receptor inhibitor (ARPI) and Pluvicto treatment. ATNM-400 leverages the alpha-particle emitter Ac-225, which can cause lethal irreversible double-stranded DNA breaks and is more potent compared to the beta-particle emitter Lutetium-177 (Lu-177) used by Pluvicto, as well as a shorter path length that could result in fewer off-target effects.

Prostate cancer is the most commonly diagnosed cancer in men, with ~1.5 million new cases globally and over 313,000 expected in the U.S. in 2025. While early-stage disease is typically managed with surgery, radiation, and ARPI therapy, up to 20% of cases progress to mCRPC – a lethal stage with limited treatment options. Targeted radiotherapy is a growing field in prostate cancer, dominated by PSMA-targeting agents like Pluvicto, which had sales of over $1.3 billion in 2024, yet many patients either lack PSMA expression or develop resistance to Pluvicto. In the U.S., 40,000–60,000 mCRPC patients annually progress after ARPIs such as Xtandi, which had sales of over $5.9 billion in 2024, highlighting a significant unmet need.