On October 7, 2025 Eradivir Inc., a clinical-stage biotechnology company that harnesses the power of the immune system to target and treat disease, reported the recent closing of a $10 million private financing round (Press release, Eradivir, OCT 7, 2025, View Source [SID1234656498]). The investment will support continued clinical development of the company’s lead antiviral therapeutic for influenza, EV25, and advancement of a second molecule, EV148, for the treatment of respiratory syncytial virus (RSV).

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A significant amount of the $10 million raised came from previous investors, reflecting their continued confidence in Eradivir’s platform and vision.

"The funding marks a pivotal moment for Eradivir as we prepare to share EV25 Phase 2a results and underscores the confidence investors have in our ability to build out our toolkit of small molecule immunotherapies," said Martin Low, Chief Executive Officer of Eradivir. "We’ve minimized dilution by raising our first $30 million in milestone-based tranches. This disciplined financing strategy has preserved shareholder value while driving meaningful progress in our lead programs."

The funds have been used to complete the EV25 Phase 2a influenza challenge study and will also support IND-enabling studies of Eradivir’s RSV development candidate, EV148. The results from the EV25 Phase 2a challenge study will be publicly released in the coming weeks.

EV25 and EV148 were built on Eradivir’s BAiT (Bispecific Antigenic immuno-Therapy) platform that combines the simplicity of small molecules with the efficacy of antibodies. The simplicity of the platform’s technology provides the opportunity to address multiple diseases, including additional viruses and cancer, by switching the targeting ligand to another that binds specifically to a pathological cell.

On October 7, 2025 Daiichi Sankyo (TSE: 4568) reported it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab for the treatment of patients with HER2 positive unresectable or recurrent breast cancer.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

HER2 targeted therapies have improved outcomes in HER2 positive metastatic breast cancer; however, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with taxane, trastuzumab and pertuzumab (THP), which has been the standard of care for more than a decade.

The sNDA is based on data from the DESTINY-Breast09 phase 3 trial presented during a special latebreaking oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting.

"In DESTINY-Breast09, ENHERTU plus pertuzumab demonstrated a median progression-free survival of more than three years, which represents an impressive improvement over the current standard of care," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "Following the recent approval of ENHERTU in Japan for the treatment of HER2 low or HER2 ultralow metastatic breast cancer, this new submission of ENHERTU plus pertuzumab for the first-line treatment of patients with HER2 positive disease underscores the commitment of Daiichi Sankyo to bring ENHERTU to as many patients as possible in this region across certain subtypes of metastatic breast cancer."

A supplemental Biologics License Application for ENHERTU plus pertuzumab based on data from DESTINY-Breast09 was granted Priority Review in the U.S. under the Real-Time Oncology Review program. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in July 2025.

About DESTINY-Breast09

DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a first-line treatment in patients with HER2 positive metastatic breast cancer.

Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is progression-free survival (PFS) as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America, and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Metastatic 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 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed and 17,600 deaths in 2022. 6 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.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.8 HER2 protein overexpression may occur as a result of HER2 gene amplification.1 Approximately one in five cases of breast cancer are considered HER2 positive.9 3 HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.10 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.1,2,3,4 Further, approximately 25% to 30% of patients do not receive any treatment following first-line therapy due to discontinuation or death.

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, OCT 7, 2025, View Source [SID1234665027])

On October 6, 2025 Nanoligent reported the completion of a €12 million Series A financing round led by Inveready (Inveready Biotech IV), with participation from CDTI (through the Innvierte program), Clave Capital (Clave Innohealth), and existing investors i&i Biotech Fund I, Italian Angels for Growth / Nanolinvest, and AVANTECA Partners (Press release, Nanoligent, OCT 6, 2025, https://www.nanoligent.com/nanoligent-closes-12-million-series-a-financing-to-advance-its-lead-oncology-nanodrug/ [SID1234656462]).

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The proceeds will support completion of the regulatory preclinical package for the company’s lead candidate, NNL1524, enable manufacturing scale-up, and fund the initiation of a Phase Ia clinical study in patients with solid tumors.

NNL1524 is a multivalent cytotoxic nanoparticle designed to selectively target the chemokine receptor CXCR4, a protein involved in tumor growth, invasion, and metastasis, and frequently overexpressed in several hematologic and solid malignancies including colorectal, lung, and breast cancers. In preclinical studies, NNL1524 demonstrated significant antitumor activity as a single agent and a favorable safety profile, supporting its advancement into clinical development.

Dr. Montserrat Cano, Chief Executive Officer of Nanoligent, commented:
"This financing represents an important milestone for Nanoligent. The support of such a strong syndicate of investors will be instrumental as the company progresses toward clinical validation of its technology and first-in-human studies."

Antonio Herce, Director of Investments at Inveready, stated:
"Nanoligent’s nanodrug platform offers a distinctive approach to targeted cytotoxic therapy, combining high selectivity, internalization efficiency, and stability. We are pleased to support the company’s efforts to bring this promising technology closer to patients."

The transaction was advised by Hoffmann Eitle and VentureTech Audit.

On October 6, 2025 Daiichi Sankyo reported positive topline results from the TROPION-Breast02 phase 3 trial showed DATROWAY (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progressionfree survival (PFS) compared to investigator’s choice of chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option.

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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).

Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including all patients whose tumors do not express PD-L1 as well as patients with PD-L1 expressing tumors who cannot receive immunotherapy due to other factors.1 Chemotherapy remains the first-line standard of care for these patients.

"DATROWAY is the first antibody drug conjugate and the only therapy to significantly improve overall survival compared to chemotherapy in patients with metastatic triple negative breast cancer for whom immunotherapy is not an option," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "These landmark results from TROPION-Breast02 strengthen our confidence in our ongoing clinical development program for DATROWAY in triple negative breast cancer and other tumor types. We look forward to 2 discussing these data with global regulatory authorities and to bringing DATROWAY to patients with triple negative breast cancer as soon as possible."

"TROPION-Breast02 is the only trial ever to show an overall survival benefit in the first-line treatment of patients with metastatic triple negative breast cancer for whom immunotherapy is not an option," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "We expect today’s results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options."

The safety profile of DATROWAY was consistent with previous clinical trials of DATROWAY in breast cancer. These data from TROPION-Breast02 will be presented at an upcoming medical meeting and shared with regulatory authorities.

Daiichi Sankyo and AstraZeneca are evaluating DATROWAY across stages and treatment settings of TNBC in three additional phase 3 trials. TROPION-Breast03 is evaluating DATROWAY as adjuvant therapy with or without AstraZeneca’s anti-PD-L1 therapy durvalumab versus investigator’s choice of therapy in patients with stage I-III TNBC with residual invasive disease after neoadjuvant systemic therapy. TROPIONBreast04 is evaluating neoadjuvant DATROWAY plus durvalumab versus neoadjuvant pembrolizumab plus chemotherapy in patients with stage II-III triple negative or hormone receptor (HR) low, HER2 low or negative breast cancer. TROPION-Breast05 is evaluating first-line DATROWAY with or without durvalumab versus investigator’s choice of therapy in patients with metastatic TNBC whose tumors express PD-L1.

About TROPION-Breast02

TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of DATROWAY versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as brain metastases.

The dual primary endpoints of TROPION-Breast02 are PFS assessed by blinded independent central review and OS. Key secondary endpoints include PFS as assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov

About Triple Negative Breast Cancer

TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.5,6,7 Metastatic TNBC is the most aggressive type of breast cancer and has the worst prognosis, with median overall survival of just 12 to 18 months and only about 14% of patients living five years following diagnosis.

While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.5 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.5 For patients with metastatic disease with PDL1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the firstline setting.10,11 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the first-line standard of care.

TROP2 is a protein broadly expressed in several solid tumors, including TNBC. TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer.

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 anti-TROP2 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/regions 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 EGFRdirected therapy and platinum-based chemotherapy, based on the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a 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, TNBC and urothelial 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 treatments in various settings.

(Press release, Daiichi Sankyo, OCT 6, 2025, View Source [SID1234665028])

On October 6, 2025 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking approval for Orca-T, its lead investigational allogeneic T-cell immunotherapy, for the treatment of hematological malignancies including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS) (Press release, Orca Bio, OCT 6, 2025, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-fda-acceptance-and-priority-review-of-the-biologics-license-application-bla-for-orca-t-to-treat-hematological-malignancies [SID1234656463]).

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The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

"A stem cell transplant has been the only potentially curative option for many people with AML, ALL or MDS, however treatment-related toxicities too often hinder patient recovery. Acceptance of the Orca-T BLA marks a pivotal moment in our ability to deliver a first-in-class therapy designed to improve survival free from complications like graft versus host disease," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "Supported by positive Phase 3 clinical data, today’s regulatory milestone reflects important recognition of the transformative potential of Orca-T. We look forward to working collaboratively with the FDA on the review of our application with the goal of advancing Orca-T and making it available to patients in need."

The BLA submission for Orca-T is supported by positive results from the pivotal Phase 3 study, Precision-T (NCT04013685), a randomized, open-label multi-center study that evaluated the safety, efficacy and tolerability of Orca-T compared to conventional allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with AML, ALL and MDS. The study met its primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD) with Orca-T versus alloHSCT.

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated for the treatment of multiple hematological malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration.