On August 25, 2025 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases, reported that financial capacity will be improved through a new fund raise of €500,000 following on the May 2025 fundraise of €1.7M (Press release, TME Pharma, AUG 25, 2025, View Source [SID1234655476]). The improved financial situation should strengthen TME Pharma’s position in discussions with financial and strategic partners. It would also enable the Company to prepare for the future investments recently communicated by TME Pharma and about which the Company will continue to inform shareholders.

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"I’m pleased to feel the renewed support from our shareholders and investors for the newly adopted strategy. While we see many companies struggling to secure financing, TME Pharma is continuing to take important steps to increase its financial strength," said Diede van den Ouden, CEO of TME Pharma. "Because we now have lower operating costs due to the shift to an outsourcing model earlier this year, we can use proceeds of financing directly to fund TME Pharma’s projects. I’m excited about this development, and with this additional financing, I’m confident that we can achieve important progress with TME Pharma."

TME Pharma is intending on increasing its financial capacity through the issuance of regular debt via private contractual agreements with European investors (Investor) in exchange for €500,000 in cash. The bonds will be issued on August 28, 2025 at 85.4% of nominal value and repaid by the Company in cash at maturity at 93.5% of nominal value. Closing date for receipt of cash by the Company is August 28, 2025, on which date the bonds and warrants will be issued. Under this bond issuance, 6,387,055 private, non-tradable warrants will be attached to the bonds, giving the holders the right to subscribe for one common share in TME Pharma for each warrant, subject to adjustment of the number of shares as described below, with an exercise price of €0.11 per warrant, which is a 2,12% premium to the volume weighted average share price (VWAP) for the 10 days preceding the initial announcement of this bond issuance made on August 25, 2025.

In recent months, TME Pharma has implemented measures to drastically reduce costs (starting on July 1, 2025), while preserving the Company’s main assets. This transaction aims to increase financial runway while limiting near-term dilution potential for existing shareholders by using debt repayable in cash. While the warrants issued in the transaction have dilutive potential, their exercise price is above the current share price. If all warrants are exercised, the warrant exercise will bring the Company an additional €702,576 in cash. The proceeds from this financing will support TME Pharma’s research and development activities and its recently announced treasury investment strategy and the search for the potential acquisitions and partnerships in profitable businesses. Along with an analysis of TME Pharma’s tax carry forward losses, the Company is continuing to work to creating a fundamentally profitable corporate structure in which revenues from non-core activities will support and strengthen the further development of its patented drug candidates, which remain the company’s flagship products, NOX A12 and NOX-E36.

TME Pharma will inform shareholders if significant developments occur.

Description of the August 28, 2025 debt issuance

Designation

Subscription Price Paid for Bonds

Amount to be Reimbursed by TME Pharma in Cash at Maturity

Nominal Amount of Bonds

% of Total Debt to be Issued

Warrants attached to bonds
No. to be Issued

Cash to be received upon full warrant exercise

% of Total Warrants to be issued

Total Transaction

500,000.00 €

547,423.90 €

585,480.10 €

100.0%

6,387,055

€702,576

100.0%

Including participation by the following TME Pharma Management Board executives and Supervisory Board members as indicated below:

Mr. Diede van den Ouden (CEO/Management Board)

22,956.00 €

25,132.89 €

26,827.87 €

4.58%

292,667

€32,193

4.59%

Dr. Maurizio PetitBon (Chairman of Supervisory Board)

50,044.00 €

54,791.00 €

58,600.00 €

10.01%

639,272

€70.320

10,01%

Details of the debt and non-tradable warrants issued via individual private agreements with Investors:

Debt:

The debt is purchased at discount to nominal value of 85.4% and repaid at maturity in cash at 93.5% of nominal value. Closing date for receipt of cash by the company is August 28, 2025, on which date the debt and warrants will be issued.
Maturity of the debt is 9 months from the issuance date, August 28, 2025.
TME Pharma has the right to reimburse in cash any outstanding loan amount early. In such cases, a lower percentage of the nominal value will be paid, determined by the number of months remaining before maturity of the debt at between 83.7% and 93.5% of the nominal value, according to table below:
Number of whole months remaining prior to maturity of debt when loan amount reimbursed in cash

(dates when this applies)

8

(Aug 28 – Sept 27 2025)

7

(Sept 28 – Oct 27 2025)

6

(Oct 28 – Nov 27 2025)

5

(Nov 28 – Dec 27 2025)

4

(Dec 28 2025 – Jan 27 2026)

3

(Jan 28 – Feb 27 2026)

2

(Feb 28 – Mar 27 2026)

1

(Mar 28 – Apr 27 2026)

0 and at Maturity

(Apr 28 2026 to Maturity)

Percentage of loan amount to be reimbursed in cash to fully extinguish debt obligation

86.3 %

87.2 %

88.1 %

89 %

89.9 %

90.8 %

91.7 %

92.6 %

93.5 %

The debt amount shall constitute direct, unconditional, unsubordinated and unsecured obligations of TME Pharma, ranking equally between the lenders and (with the exception of the mandatory provisions of Dutch law) equally with all other present or future unsubordinated and unsecured obligations (with the exception of those benefiting from a preference in accordance with the law) of the issuer.
If the Company conducts a capital increase by issuance of new shares, the debt holders will be given the opportunity to participate on equal conditions to other investors in the capital increase. The payment for shares is then settled against a percentage of the value of the debt the Company owes to the debt holder according to the following table:
Number of whole months remaining prior to maturity of debt when loan amount contributed to capital increase (dates when this applies)

8

(Aug 28 – Sept 27 2025)

7

(Sept 28 – Oct 27 2025)

6

(Oct 28 – Nov 27 2025)

5

(Nov 28 – Dec 27 2025)

4

(Dec 28 2025 – Jan 27 2026)

3

(Jan 28 – Feb 27 2026)

2

(Feb 28 – Mar 27 2026)

1

(Mar 28 – Apr 27 2026)

0 and at Maturity

(Apr 28 2026 to Maturity)

Percentage of loan amount to be settled for shares to fully extinguish debt obligation

92%

93%

94%

95%

96%

97%

98%

99%

100%

Warrants:

The amount of warrants issued is based on the nominal value of the total amount of bonds issued, multiplied by 1.20. The exercise price is €0.11, with maturity of 21 months from August 28, 2025. This transaction will thus result in the issuance of 6,387,055 warrants. This could lead to the issuance of 6,387,055 shares if all warrants are exercised, with proceeds for the Company worth €702,576.11, subject to adjustment as set forth below.
If subsequent to issuance of these warrants, the Company conducts a financing operation of >€1.5 million resulting in issuance of shares or giving rights to purchase shares at a price per share below €0.11 (the "Qualifying Financing"), this will trigger an adjustment to the number of shares issued on exercise of each warrant. This adjustment will result in additional shares being issued upon exercise of the warrant to effectively adjust the price per share paid upon exercise to a 20% premium above the price paid in the Qualifying Financing triggering the adjustment. For example, if a capital raise were to be conducted at €0.08 per share and warrants worth €10,000 were exercised, then 104,167 ordinary shares would be issued instead of 100,000 and the effective price per share once warrants are exercised would become €0.096. The number of shares to be issued upon the exercise of each warrant is calculated using the following formula:
warrant exercise price (always €0.11)
Number of warrants issued 6,387,055
Number of shares issued on warrant exercise: (a) if no Qualifying Financing has occurred, then 1 share per warrant; and (b) subsequent to the occurrence of a Qualifying Financing, the number of shares to be issued per warrant is the result of the following calculation: €0.11 divided by the price per share paid in the context of the Qualifying Financing divided by 1.2 ((a) an d (b) together the "Warrant Exercise Ratio")
For the purposes of calculating this formula,
Price per share in the context of the Qualifying Financing shall mean, in any Qualifying Financing, the consideration paid to acquire one ordinary share in the context of such Qualifying Financing.
Such adjustment shall become effective on the date of issue of such shares in a Qualifying Financing.
The Warrant Exercise Ratio shall be rounded to 4 digits after the decimal place for calculation of the number of shares per warrant.
No partial shares can be issued, any fractions shall be rounded down and ordinary shares may never be issued at below their nominal value, currently €0.01.
No adjustment shall be made if the Warrant Exercise Ratio obtained with the above calculation is lower than the Warrant Exercise Ratio in force prior to the transaction.
By way of example: if shares are issued under a Qualifying Transaction at 0.08 per share, then the calculation would be as follows:

Warrant Exercise Ratio prior to Qualifying Transaction: 1
New Warrant Exercise Ratio after Qualifying Transaction: €0.11/€0.08/1.2 = 1.14583
Exercise of 100,000 warrants would then result in the issuance of 114.583 shares for an aggregate exercise price of €11,000, or a price per share of €0.0960 per share, a 20% premium to the price per ordinary share paid in the Qualifying Transaction.
A minimum number of 100,000 warrants must be exercised at each exercise, which would result in payment of €11,000 to the company for exercise (100,000 warrants exercised * €0.11 exercise price = €11,000)

A tracking table of the outstanding debt and warrants will be available on the company’s website as of the issuance date, August 28, 2025.

Shareholder and Corporate Authorizations
The issuance of the warrants giving the right to subscribe for the same number of ordinary this transaction is carried out in accordance with Dutch law and relies upon the delegation of authority to issue shares and rights to subscribe for shares granted to the company’s board of directors by its shareholders in the annual general meeting (AGM) on June 25, 2025. The Company has completed and obtained all necessary corporate approvals for this transaction.

Dilutive Potential
The table below summarizes the dilution from the new ordinary shares that would be issued upon exercise of all of the private, non-tradable warrants to be issued under this transaction, assuming no adjustment to the number of shares issued per warrant is required.

Description

Shares to be issued

Total shares outstanding

Dilution (cumulative)

Shareholder starting with 1% on 21 August 2025, would then hold

Outstanding shares on 21 August 2025

–

94,188,981

–

–

Shares issued from exercise of 17,056,000 private, non-tradable warrants, latest on May 27, 2027

17,056,000

111,244,981

15.33%

0.85%

Shares issued from exercise of 6.387.055 private, non-tradable warrants, latest on August 27, 2027

6,387,055

117,632,036

19,93%

0.80%

Investors may familiarise themselves with the risks described in the Company’s 2024 annual financial report (LINK) available on the company website.

On August 25, 2025 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, reported that a pre-recorded presentation from the Company will be available on demand as a part of the H.C. Wainwright 27th Annual Global Investment Conference in New York (Press release, Inovio, AUG 25, 2025, View Source;Wainwright-27th-Annual-Global-Investment-Conference/default.aspx [SID1234655461]). During the conference, members of INOVIO’s management team will also be conducting in-person one-on-one meetings with investors.

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H.C. Wainwright 27th Annual Global Investment Conference
Presentation available: Beginning Friday, September 5, 2025, 7:00AM ET
Format: Pre-recorded webcast
Link: View Source

The webcast will be available for 90 days at the link above or on the INOVIO Investor Relations Events page: View Source

On August 25, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported corporate highlights and unaudited financial results for the first half of 2025 (Press release, Molecular Partners, AUG 25, 2025, View Source [SID1234655462]).

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"Molecular Partners continues to make good progress towards key development milestones, notably in our two clinical programs. Following the expansion of our strategic radiotherapy partnership with Orano Med in January, we are advancing our lead program MP0712 towards its first-in-human trial. With the data package complete, we anticipate the IND filing and Phase 1 initiation in 2025, and initial clinical data in H1 2026. Our multispecific T cell engager MP0533 is making progress in its Phase 1/2a trial for acute myeloid leukemia. Recently presented data show both increased response rates and greater depth of responses and we look forward to presenting the first data under the amended study protocol in Q4 2025. We also strengthened our leadership with the appointment of Martin Steegmaier, Ph.D., as CSO, further underlining our commitment to delivering improved treatment options for patients and significant value for our stakeholders. Our finances remain robust with funding projected into 2028," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Research & Development Highlights

MP0533 (Multispecific T Cell Engager; CD33 x CD123 x CD70 x CD3)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)/AML (ClinicalTrials.gov: NCT05673057). Molecular Partners presented updated data from the study at the 30th Annual European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June, outlining the impact of accelerated step-up dosing regimen of MP0533 on exposure and clinical responses in cohort 8, providing the rationale for further optimization to the dosing regimen implemented in the ongoing cohort 9. Initial data from cohort 8 show promising antitumor activity: 3 of 8 (>30%) evaluable patients with relapsed/refractory disease achieved a clinical response after the first cycle, with one complete response and two complete responses with partial hematologic recovery. Notably, two patients maintained their responses for over three months, including one patient still responding after more than six months at data cutoff (14 April 2025) and still on treatment today. This cohort benefited from a higher starting dose and a faster step-up dosing schedule, leading to prolonged exposure within the predicted therapeutic range and notable blast reduction in most patients, with an acceptable safety profile after dose adjustments in cohort 8.

Encouraged by these results, Molecular Partners amended the study protocol for cohorts 9 and 10 by further accelerating the step-up dosing, increasing the dosing frequency and introducing anti-CD20 premedication for greater cumulative exposure. These changes aim to enhance both the depth and duration of patient responses. Cohort 9 is exploring a lower target dose than cohort 8 to assess the safety of up to daily dosing for the first 14 days of treatment, leading to significantly denser dosing; cohort 10 aims at reaching the same target dose as cohort 8 while exposing patients to more drug over time. Initiation of cohort 10 is anticipated to start in the coming weeks, pending appropriate approvals. Cohort 9 is now fully recruited, with initial data expected to be presented in Q4 2025.
MP0533 continues to show broad activity, with initial blast reductions in a majority of patients treated. The data continue to indicate that the patients more likely to see durable responses will be those who initiate therapy with a lower level of blasts at baseline. Looking forward, Molecular Partners plans to explore future cohorts of MP0533 in combination settings, both in relapsed/refractory as well as in front-line patients, should favorable antitumor activity continue to be observed. The company is engaging with regulators such as the U.S. Food and Drug Administration (FDA) to discuss next steps.

MP0712 (212Pb x DLL3), Radio-DARPin Pipeline and Global Partnership with Orano Med

The Phase 1 Investigational New Drug (IND) application for MP0712, a 212Pb-based Radio-DARPin therapy (RDT) candidate targeting the tumor-associated protein delta-like ligand 3 (DLL3), co-developed with Orano Med for the treatment of small cell lung cancer (SCLC), is in preparation. Molecular Partners presented preclinical data in April at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, showing a high tumor uptake and a favorable safety profile for MP0712, with good efficacy in mouse models matching clinically relevant DLL3 expression levels. Dialogue with the FDA is ongoing and IND filing expected in Q3 2025. The first clinical sites in the U.S. are identified and, pending regulatory clearance, patient dosing is planned to initiate in 2025 with initial first-in-human clinical data expected in H1 2026.

In H1 2025, Molecular Partners accepted a request from Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa to provide MP0712 for imaging use under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). This approach allows for the potential to generate initial images applying MP0712 labelled with 203Pb in patients with SCLC and other DLL3-expressing neuroendocrine cancers. While the decision of where and how to share data from the image work under Section 21 remains at the discretion of NuMeRI, the Company anticipates providing an update on MP0712 in H2 2025. 203Pb and 212Pb are an element-equivalent pair of lead (Pb) isotopes, with 203Pb primarily used for imaging and 212Pb for therapeutic applications (targeted alpha therapy, TAT). As a "matched pair", pre-treatment imaging with 203Pb will provide a prediction of treatment behavior with 212Pb.

The second RDT program co-developed with Orano Med is MP0726, targeting mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. The development of therapeutics against MSLN has been hampered by high levels of shed MSLN. Leveraging the unique properties of DARPins, Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN. The Company presented preclinical data on MP0726 at AACR (Free AACR Whitepaper) 2025 in April and at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. Initial clinical data are expected in 2026.

In January 2025, Molecular Partners and Orano Med further expanded their agreement to co-develop up to ten radiotherapy programs. In addition to its world class expertise and capabilities in the development of TAT with 212Pb, Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization. Orano Med possesses virtually unlimited source material for 212Pb production and has established robust and independent supply and manufacturing capabilities required for the seamless delivery of TAT to clinical sites internationally.
Switch-DARPins (Next-Generation Immune Cell Engagers)

By employing a multi-specific Switch-DARPin, Molecular Partners aims to increase the safety and potency of T cell engagers (TCEs). Preclinical proof-of-concept in a solid tumor model for a novel CD3 Switch-DARPin TCE with CD2 costimulation was presented at AACR (Free AACR Whitepaper) in April 2025. The data show the feasibility of conditional T cell activation with potent co-stimulation in solid tumors, but not in healthy tissues. In addition, data showed that the CD3 Switch-DARPin activates T cells specifically in the presence of cells co-expressing the tumor targets MSLN and EpCAM, increasing tumor specificity. The Company will present an update on the CD3 Switch-DARPin program at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Q4 2025.

MP0317 (tumor-localized CD40 agonist)

Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 dose escalation trial of the localized CD40 agonist MP0317 in solid tumors at SITC (Free SITC Whitepaper) in November 2024. MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

Molecular Partners has committed to supporting an investigator-initiated trial of MP0317. The study is being designed for the treatment of patients with advanced cholangiocarcinoma in combination with standard-of-care. A study protocol has been submitted; pending regulatory approval, the study could be initiated in 2025.

Corporate Governance Highlights

As announced on August 21, 2025, Molecular Partners appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer (CSO) and member of its Executive Committee, effective October 1, 2025. He brings a wealth of experience in oncology drug development, having previously contributed to the advancement of several innovative cancer therapies at major biotech and pharmaceutical companies.

In H1 2025, Molecular Partners undertook a strategic review of its operations and headcount, with the objectives of increased efficiency in the organization and to sharpen the focus on advancing its clinical assets. As a result of this review, the Company informed the Amt für Wirtschaft of Kanton Zürich (Office for Economic Affairs) in June 2025 of its intention to reduce its current workforce by no more than 40 positions, representing up to ~24% of all positions. All employees affected have been informed, and based upon these headcount reductions, the Company now anticipates its cash runway to extend into 2028, beyond its prior guidance of 2027.

All motions proposed by the Board of Directors at the Annual General Meeting, held in April 2025, were approved by the shareholders of the Company by a wide majority.

Financial and Business Outlook
For the full year 2025, at constant exchange rates, the Company expects total operating expenses of CHF 55-65 million of which around CHF 7 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation.

The Company’s cash and cash equivalents and short-term time deposits were CHF 114 million as of June 30, 2025 and based on current operating assumptions, will be sufficient to fund its operating expenses and capital expenditure requirements into 2028.

On August 25, 2025 Daiichi Sankyo reported that DATROWAY (datopotamab deruxtecan) has been approved in China for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy and at least one line of chemotherapy in the advanced setting (Press release, Daiichi Sankyo, AUG 25, 2025, View Source [SID1234655446]).

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DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Breast cancer is the second most common cancer in women in China. 1 Approximately 357,000 cases of breast cancer were diagnosed in China in 2022, with nearly 75,000 deaths.1 It is estimated that 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).

The approval of DATROWAY by China’s National Medical Products Administration (NMPA) is based on results from the TROPION-Breast01 phase 3 trial. In the trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. There were two (0.5%) complete responses (CRs) and 131 partial responses (PRs) (36%) seen in the DATROWAY arm compared to zero (0%) CRs and 84 (23%) PRs in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the DATROWAY arm compared to 5.7 months (95% CI: 4.9-6.8) in the chemotherapy arm. The final overall survival (OS) results of the trial did not achieve statistical significance (HR 1.01; 95% CI: 0.83-1.22). In an exploratory sensitivity analysis, OSadjusted for subsequent ADC treatment was 19.1 months in the DATROWAY arm versus 17.5 months in the chemotherapy arm (HR 0.86; 95% CI: 0.70-1.06).

In an exploratory analysis of the 83 patients enrolled in TROPION-Breast01 in China, median PFS was 8.1 months in patients treated with DATROWAY versus 4.2 months with chemotherapy (HR 0.54; 95% CI: 0.30-0.96) and a confirmed ORR of 38.6% was observed in the DATROWAY arm compared to an ORR of 17.9% in the chemotherapy arm.

"Despite the progress we have made in managing HR positive, HER2 negative metastatic breast cancer, many patients still face limited options once their disease progresses after endocrine therapy and chemotherapy," said Professor Binghe Xu, Director of Clinical Trial Center (GCP) of National Cancer Center, Cancer Hospital Chinese Academy of Medical Sciences, and China leading PI of TROPIONBreast01. "The approval of datopotamab deruxtecan, a novel TROP2 directed antibody drug conjugate, represents a meaningful step forward in expanding therapeutic choices for patients with breast cancer."

"The approval of DATROWAY provides a new treatment option for patients with metastatic HR positive, HER2 negative breast cancer, enabling timely access to an innovative TROP2 targeted antibody drug conjugate in China," said Michio Hayashi, China President, Daiichi Sankyo. "DATROWAY is now the second DXd antibody drug conjugate approved in China following ENHERTU and expands our portfolio to meet the evolving treatment needs of patients with a range of breast cancer subtypes."

"Despite considerable advancements in the treatment of HR positive breast cancer, new medicines are still needed to tackle the frequent and complex challenge of disease progression following initial therapies," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "We are proud to bring DATROWAY to patients in China for the first time, offering those with metastatic HR positive, HER2 negative breast cancer a new and needed option."

In TROPION-Breast01, the most common (≥20%) adverse reactions, including laboratory abnormalities were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST and increased alkaline phosphatase. Grade 3 or higher adverse reactions in patients (>0.5%) receiving DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), interstitial lung disease (ILD)/pneumonitis (1.1%), acute kidney injury (0.6%), pulmonary embolism (0.6%), vomiting (0.6%), diarrhea (0.6%), hemiparesis (0.6%) and anemia (0.6%). A grade 5 adverse reaction occurred in one patient (0.3%) and was attributed to ILD/pneumonitis.

About TROPION-Breast01

TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease.

Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.

The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPIONBreast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025.

TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Hormone Receptor Positive, HER2 Negative Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.5 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.5 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or progress to metastatic disease are expected to live five years following diagnosis.2 Approximately 357,000 cases of breast cancer are diagnosed annually in China, representing the most cases diagnosed anywhere in the world, and of these about 20% are diagnosed in the advanced or metastatic setting.

Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 Endocrine therapy is widely given consecutively in the early lines of treatment for metastatic HR positive breast cancer.7 However, after initial treatment, further efficacy from endocrine therapy is often limited.

About DATROWAY

DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized antiTROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY (6 mg/kg) is approved in more than 35 countries worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

DATROWAY (6 mg/kg) is approved in Russia and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on the results from the TROPIONLung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in the confirmatory trial.

About the DATROWAY Clinical Development Program

A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other cancer medicines in various settings.

On August 25, 2025 PDS Biotechnology presented its corporate presentation (Presentation, PDS Biotechnology, AUG 25, 2025, View Source [SID1234655463]).

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