Entry into a Material Definitive Agreement

On April 12, 2026, ImageneBio, Inc., a Delaware corporation (the "Company") reported to have entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain institutional and accredited investors (the "Investors"), pursuant to which the Company agreed to sell and issue pre-funded warrants to purchase shares of the Company’s voting common stock, par value $0.001 ("Common Stock" and the shares subject to the pre-funded warrants, the "Warrant Shares"), in a private placement transaction (the "Private Placement").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The closing of the Private Placement is anticipated to occur on or about April 14, 2026 (the "Closing"), subject to customary closing conditions. At the Closing, the Company has agreed to issue and sell pre-funded warrants to purchase up to 5,770,335 Warrant Shares at a purchase price of $5.199 per Warrant Share to the Investors for gross proceeds to the Company of approximately $30 million pursuant to the Purchase Agreement.

The pre-funded warrant will have an exercise price of $0.001 per Warrant Share, subject to customary adjustments, and will be exercisable at any time after original issuance and will not expire until exercised in full. The pre-funded warrant will also be exercisable on a net exercise "cashless" basis. The pre-funded warrant may not be exercised if the aggregate number of shares of Common Stock beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation, not to exceed 19.99%.

The Purchase Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the Purchase Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the Purchase Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Purchase Agreement is included with this filing only to provide investors with information regarding the terms of the transaction and not to provide investors with any other factual information regarding the Company. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Purchase Agreement, which subsequent information may or may not be fully reflected in public disclosures.

Registration Rights Agreement

In connection with the Private Placement, the Company has agreed to enter into a Registration Rights Agreement (the "Registration Rights Agreement") with the Investors at the Closing, pursuant to which the Company will agree to prepare and file, within three business days following August 1, 2026, subject to certain allowable delays, a registration statement with the U.S. Securities and Exchange Commission (the "SEC") to register for resale the Warrant Shares issuable upon the exercise of the pre-funded warrants that were issued and sold under the Purchase Agreement, and generally to cause the applicable registration statement to promptly become effective. Certain cash penalties will apply to the Company in the event of registration failures, as described in the Registration Rights Agreement.

The foregoing summaries of the Purchase Agreement, the pre-funded warrant and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the complete text of the Purchase Agreement, the form of pre-funded warrant and the Registration Rights Agreement, which are filed with this report as Exhibits 10.1, 4.1 and 4.2, respectively.

(Filing, ImaGene, APR 12, 2026, View Source [SID1234664319])

AbbVie Showcases Late‑Breaking Phase 2 Data for Mirvetuximab Soravtansine-gynx (ELAHERE®) in Platinum‑Sensitive Ovarian Cancer (PSOC) at SGO 2026

On April 12, 2026 AbbVie (NYSE: ABBV) reported that late-breaking results from the Phase 2 IMGN853-0420 trial will be presented in an oral session at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting (San Juan, Puerto Rico; April 10-13, 2026). The study evaluated the potential efficacy and safety of mirvetuximab soravtansine-gynx, a first-in-class antibody-drug conjugate (ADC), in combination with carboplatin followed by maintenance of mirvetuximab soravtansine-gynx monotherapy, in patients with folate receptor alpha (FRα)-expressing, recurrent platinum‑sensitive ovarian cancer (PSOC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The multicenter, open-label study enrolled 125 patients with FRα‑positive, measurable disease who had received one prior platinum‑based chemotherapy regimen. Participants received mirvetuximab soravtansine-gynx plus carboplatin every three weeks for six to eight cycles, followed by single-agent mirvetuximab soravtansine-gynx as a continuation therapy. Nearly half of patients had prior exposure to a polymerase inhibitor (PARPi), a patient population who may experience reduced responses to subsequent platinum-based chemotherapy.1

The primary endpoint of the study was a confirmed objective response rate (ORR) in the ≥50% FRα subgroup after six cycles of combination therapy.2 Key secondary endpoint was ORR after six cycles in the overall population (FRα ≥25%) and additional secondary endpoints included duration of response (DoR), progression-free survival (PFS) and overall survival (OS).

"Despite being considered chemotherapy-responsive, platinum-sensitive ovarian cancer (PSOC) remains challenging to treat. With each recurrence, responses to standard platinum-based chemotherapy often diminish and patients may experience cumulative toxicities,"3 said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These results are encouraging and further support the potential of mirvetuximab soravtansine-gynx in PSOC as a novel treatment regimen."

Key highlights from the late-breaking oral presentation include:

Response rates across combination regimen: By the end of the induction phase, confirmed ORR was 62.7% (95% CI, 52.6–72.1) in the FRα ≥50% subgroup and 62.4% (95% CI, 53.3–70.9) in the overall population. 81% of patients (101/125) showed no disease progression and continued treatment with single-agent mirvetuximab soravtansine.2 Median DoR was 11.2 months across the overall population.2
Additional responses with continuation monotherapy: Among patients who were on the combination and transitioned to mirvetuximab soravtansine-gynx monotherapy, ORR was 68% (59.1–76.1) across the overall population.2
Responses in patients with prior exposure to polymerase inhibitor (PARPi): In nearly half of patients (49%) in the overall population (FRα ≥25%) who had prior PARPi exposure, ORR was 63.9% (50.6–75.8).2
Safety data: The safety profile of mirvetuximab soravtansine-gynx was consistent with findings from previous studies. The most common treatment-related adverse events (TRAEs) with mirvetuximab soravtansine-gynx plus carboplatin followed by a continuation of mirvetuximab-soravtansine-gynx alone were low‑grade ocular events, including corneal changes that were reversible in over 90% of patients.2 The most common grade ≥3 TRAEs (>5%) were neutropenia (15%), blurred vision (10%), thrombocytopenia (10%), cataract (6%), dry eye (5%), diarrhea (5%) and peripheral sensory neuropathy (5%).2
"The combination of mirvetuximab soravtansine-gynx and carboplatin delivered strong responses in this Phase 2 study and many patients continued to experience responses during the monotherapy treatment phase," said Gottfried E. Konecny, M.D., Professor of Medicine, David Geffen School of Medicine at UCLA, and primary investigator. "These findings support further investigation of a novel treatment approach that integrates antibody drug conjugates with standard chemotherapy in patients with folate receptor alpha (FRα)-expressing recurrent platinum‑sensitive ovarian cancer and in patients previously treated with PARP inhibitors who often face resistance and remain in need of additional options."

The data is being presented during the Rapid-Fire Oral III: Translational and ADC session on Sunday, April 12 at 12:32 PM ET. More information about the 2026 SGO Annual Meeting and abstracts being presented are available here.

Further information on AbbVie clinical trials is also available at View Source

Use of mirvetuximab soravtansine-gynx plus carboplatin followed by mirvetuximab soravtansine-gynx continuation in FRα-expressing recurrent PSOC is not approved in the U.S. or in the E.U. or in any other territory. The safety and efficacy of mirvetuximab soravtansine-gynx for use as a combination therapy in PSOC have not been established.

About the IMGN853-0420 Trial
IMGN853‑0420 (NCT05456685) is a multicenter, open‑label, single-arm Phase 2 study evaluating the efficacy and safety of carboplatin plus mirvetuximab soravtansine-gynx followed by mirvetuximab soravtansine-gynx continuation in folate receptor‑alpha (FRα) positive (≥25% tumor cells with ≥2+ membrane intensity), recurrent platinum-sensitive high‑grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following one prior line of platinum‑based chemotherapy. After completing six cycles of mirvetuximab soravtansine-gynx plus carboplatin, participants without progressive disease continue on single‑agent mirvetuximab soravtansine-gynx. Eligibility requires confirmed FRα positivity using the Ventana FOLR1 Assay, ensuring enrollment of participants most likely to benefit from this FRα‑targeted ADC approach.

About ELAHERE
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE is currently indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. It is being investigated in patients with platinum-sensitive ovarian cancer.

ELAHERE U.S. USE and IMPORTANT SAFETY INFORMATION

What is ELAHERE?

ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:

have not responded to or are no longer responding to treatment with platinum-based chemotherapy and
have received 1 to 3 prior types of chemotherapy.
Your healthcare provider will perform a test to make sure that ELAHERE is right for you.
It is not known if ELAHERE is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ELAHERE?

ELAHERE can cause serious side effects, including:

Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.

Your healthcare provider will send you to see an eye care professional to check your eyes before you start treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and symptoms of eye problems.
Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider.
Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your healthcare provider.
What should I tell my healthcare provider before receiving ELAHERE?

Tell your healthcare provider about all of your medical conditions, including if you:

have vision or eye problems.
have numbness or tingling in your hands or feet.
have liver problems.
are pregnant or plan to become pregnant. ELAHERE can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ELAHERE.
Patients who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE.
You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of ELAHERE.
are breastfeeding or plan to breastfeed. It is not known if ELAHERE passes into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of ELAHERE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may cause side effects.

What are the possible side effects of ELAHERE?

ELAHERE can cause serious side effects, including:

Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.
Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, cough, or chest pain.
Peripheral neuropathy. Nerve problems called peripheral neuropathy are common during treatment with ELAHERE and can also be severe. Your healthcare provider will monitor you for signs and symptoms of nerve problems. Tell your healthcare provider if you get new or worsening numbness, tingling, burning sensation or pain in your hands or feet or muscle weakness.
The most common side effects and abnormal labs of ELAHERE include:

increased liver enzymes in the blood
feeling tired
blurred vision
nausea
diarrhea
stomach-area (abdominal) pain
changes in the cornea (part of the eye)
peripheral neuropathy
muscle, bone, or joint pain
decreased red or white blood cell counts

decreased platelets
decreased magnesium level in the blood
dry eye
constipation
vomiting
decreased albumin level in the blood
decreased appetite
Your healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have certain side effects.

These are not all of the possible side effects of ELAHERE. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

(Press release, AbbVie, APR 12, 2026, View Source [SID1234664309])

GSK presents positive data for B7-H4-targeted ADC in gynaecological cancers

On April 12, 2026 GSK plc (LSE/NYSE: GSK) reported positive findings from its global phase I BEHOLD-1 clinical trial for mocertatug rezetecan (or Mo-Rez for short), a novel antibody-drug conjugate (ADC) targeting the B7-H4 antigen. At the highest doses evaluated, Mo-Rez monotherapy achieved confirmed objective response rates (cORR) of 62% (5.8 mg/kg n=21/34; 95% CI: 44, 78) in platinum-resistant ovarian cancer (PROC) and 67% (4.8 mg/kg n=8/12; 95% CI: 35, 90) in recurrent or advanced endometrial cancer (EC).1 These data will be presented for the first time in a late-breaking oral session at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in San Juan, Puerto Rico.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Currently, there are limited treatment options with modest response rates for patients with PROC and advanced EC. B7-H4 is an immune checkpoint that is widely expressed in ovarian and endometrial cancers and is low in normal tissues, providing potential for a differentiated precision-therapy. The response to Mo-Rez observed across a range of B7-H4 expression levels reinforces its broad potential in gynaecologic cancers and further validates the relevance of targeting B7-H4.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Treatment of gynaecological cancers remains a major challenge, with a pressing need for new therapies that offer improved response rates. With Mo-Rez, we now have compelling evidence of a promising clinical profile, with response rates that support accelerating development into five pivotal global phase III trials later this year across ovarian and endometrial cancers, including earlier line settings."

Ana Oaknin, Study Investigator for BEHOLD-1, Medical Oncology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain said: "In the early phase BEHOLD-1 study, we saw meaningful antitumour activity for this patient dataset, with response rates higher than typically seen in ADCs in development, and a manageable safety profile. For patients with platinum-resistant ovarian cancer and recurrent endometrial cancer, these findings are particularly encouraging."

At the highest doses evaluated in BEHOLD-1, few patients needed to stop treatment because of a treatment-related adverse events (TRAE) (0% in PROC and 4% in EC). The most common TRAE was nausea (82% in PROC; 75% in EC). Grade ≥3 TRAEs occurred in 64% and 54% patients in PROC and EC, respectively, and were predominantly haematologic, as expected for treatments in this class. Overall rates of interstitial lung disease or pneumonitis were low (3%; 5 out of 178 patients) and all cases were mild to moderate (grade 1-2). The interim analysis showed the median duration of response had not yet been reached. Based on the findings from this study, the recommended dose for the first of the phase III trials, BEHOLD-Ovarian01 and BEHOLD-Endometrial01, is 5.8 mg/kg.

About the BEHOLD clinical trial programme
The BEHOLD clinical programme is GSK’s global development plan that includes the BEHOLD-1 (NCT06431594) monotherapy study and the ongoing BEHOLD-2 (NCT06796907) combination study. Mo-Rez will advance to five pivotal global phase III trials in 2026, starting with PROC (BEHOLD-Ovarian01 / NCT07286266) and 2L EC (BEHOLD-Endometrial01 / NCT07286331). Additional phase III studies will evaluate Mo‑Rez in platinum‑sensitive ovarian cancer (BEHOLD-Ovarian02) and in first‑line maintenance settings for ovarian cancer without homologous recombination deficiency (BEHOLD-Ovarian03) and mismatch‑repair–proficient endometrial cancer (BEHOLD-Endometrial02).

About BEHOLD-1
The BEHOLD-1 clinical trial is a two-part, open-label, phase I study evaluating the safety, tolerability and efficacy of Mo-Rez injection in patients with PROC or advanced/recurrent EC. Phase Ia assessed up to four Mo-Rez dose levels in patients with advanced solid tumours, with intravenous administration every three weeks until progression or toxicity. In the phase Ib dose expansion, patients with PROC or EC (1–3 prior lines of therapy) were randomised to three or two Mo-Rez dose levels, respectively.

At data cut-off, a total of 224 patients were enrolled in BEHOLD-1; n=44 in phase 1a (n=21 PROC, n=23 mix of other solid tumours) and n=180 in phase Ib (n=131 PROC, n=49 EC). Primary endpoints included: incidence of dose-limiting toxicity in phase Ia and confirmed ORR (cORR) by investigator per RECIST 1.1 in phase Ib. At the highest dose evaluated in phase Ib, the most common adverse events in PROC were nausea (86%), neutropenia/neutrophil count decreased (73%), anaemia (52%), fatigue (52%) and alopecia (52%). In EC, the most common adverse events were nausea (79%), neutropenia/neutrophil count decreased (58%), anaemia (54%), vomiting (46%) and fatigue (42%). Treatment related adverse events led to dose interruptions in 39% of patients with PROC and 21% of those with EC, and to dose reductions in 39% in PROC and 17% in EC, at the highest dose. The trial is ongoing and currently in the dose expansion phase.

About mocertatug rezetecan
Mo-Rez is a novel investigational B7-H4-targeted antibody-drug conjugate designed to optimise efficacy and tolerability. It is composed of a fully human anti-B7-H4 monoclonal antibody covalently linked to a topoisomerase inhibitor payload and has a drug-to-antibody ratio (DAR) of 6. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Mo-Rez globally.

About ovarian cancer and endometrial cancer
Endometrial cancer affects 1.6 million people globally, with 417,000 new cases each year and 15% to 20% of patients presenting in later stages of the disease.2,3 Ovarian cancer affects 843,000 people with 240,000 new cases annually.4 70% of these patients present with advanced disease.5 Recurrence is common in advanced cases of disease, up to 67% in endometrial cancer and 70% in ovarian cancer, and survival usually declines after recurrence.

(Press release, GlaxoSmithKline, APR 12, 2026, View Source [SID1234664307])

BioNTech and DualityBio’s Antibody-Drug Conjugate Trastuzumab Pamirtecan Demonstrated Clinically Meaningful Efficacy in Patients with HER2-Expressing, Recurrent Endometrial Cancer

On April 11, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported positive results from the primary analysis of a Phase 2 cohort evaluating trastuzumab pamirtecan (BNT323/DB-1303) in patients with HER2-expressing, advanced endometrial cancer whose disease progressed on or after first-line chemotherapy with or without prior checkpoint inhibitor treatment. This cohort is part of a global Phase 1/2a clinical trial (NCT05150691) investigating the HER2-targeted antibody-drug conjugate ("ADC") candidate trastuzumab pamirtecan in multiple solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The data demonstrated clinically meaningful efficacy and a manageable safety profile for trastuzumab pamirtecan monotherapy across all HER2 immunohistochemistry ("IHC") expression levels (IHC1+, IHC2+, IHC3+)ii. Outcomes were consistent among patients regardless of prior checkpoint inhibitor treatment. The data will be presented today in an oral session at the 2026 Society of Gynecologic Oncology ("SGO") Annual Meeting on Women’s Cancers in San Juan, Puerto Rico.

"Endometrial cancer is one of the few cancers with an increasing mortality rate,1 and there is an urgent need for new treatment options, especially for patients with recurrent disease with lower HER2 expression levels where current standard-of-care chemotherapy offers only a 15 % response rate2," said Bhavana Pothuri, M.D., Medical Director of the Clinical Trials Office (CTO) and Director of Gynecologic Oncology Research at the NYU Langone Perlmutter Cancer Center. "We are encouraged by these results for trastuzumab pamirtecan, which showed clinically meaningful responses across all HER2 levels. Importantly, these results were seen in a broad patient population that reflects real-world clinical practice, including patients who have received prior immune checkpoint inhibitor treatment and those with visceral metastases."

The analysis of the Phase 2 cohort included 145 patients with advanced or metastatic HER2-expressing endometrial cancer whose disease had progressed following first- or later lines of therapy. This cohort met its primary efficacy endpoint of objective response rate ("ORR") evaluated in 73 patients previously treated with checkpoint inhibitor therapy and confirmed HER2 status by central testing, showing a confirmed ORR of 49.3% (95% CI: 37.4, 61.3). In all centrally tested patients (n=96) the confirmed ORR was 47.9% (95% CI: 37.6, 58.4) with a median progression-free survival ("mPFS") of 8.1 months (95% CI: 5.5, 11.8).

Among the 143 efficacy-evaluable patients by locali HER2 status testing, the confirmed ORR was 44.1% (95% CI: 35.8, 52.6). Trastuzumab pamirtecan consistently demonstrated encouraging antitumor activity across all HER2 expression levels, with comparable results whether HER2 testing was conducted locally or centrally. Among patients with local HER2 testing, the confirmed ORR was 33.9% (IHC1+) and 40.4% (IHC2+) in patients with lower levels of HER2 expression, and 73.1% (IHC3+) in patients with higher HER2 expression levels. The median duration of response ("mDoR") was 10.3 months. mPFS for all evaluable patients (n=145), whether they had received prior checkpoint inhibitor treatment or not, was 8.0 months (95% CI: 5.6, 8.3).

The safety profile was manageable and as expected for HER2-targeted ADCs. The most common treatment-related adverse events (TRAEs) were low-grade nausea, anemia, platelet count decrease, and low-grade fatigue. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 68 of 145 (46.9%) patients. Adjudicated cases of interstitial lung disease ("ILD") or pneumonitis of grade ≥3 occurred in 4.8% of patients and were consistent with the known safety profile of HER2-targeted ADC therapies. The majority of events grade 3 or higher were efficiently manageable with appropriate medical interventions.

"These positive results in patients with endometrial cancer including those with lower HER2 expression levels support the potential of trastuzumab pamirtecan," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "HER2 remains an important therapeutic target, particularly in gynecologic cancers and breast cancer. We are continuing to advance trastuzumab pamirtecan, both as a monotherapy and in novel-novel treatment combination approaches, with the aim to address the significant unmet medical needs in the treatment of patients with HER2-driven tumors."

Trastuzumab pamirtecan received Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration ("FDA") for the treatment of endometrial cancer in 2023. A global confirmatory Phase 3 clinical trial Fern-EC-01 (NCT06340568) evaluating trastuzumab pamirtecan monotherapy compared to chemotherapy in previously treated patients with HER2-expressing, recurrent endometrial cancer is ongoing. BioNTech and DualityBio plan to file a biologics license application ("BLA") in 2026, subject to regulatory feedback from the FDA.

About trastuzumab pamirtecan
Trastuzumab pamirtecan (BNT323/DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2 and is being developed by BioNTech and Duality Biologics. Trastuzumab pamirtecan was built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates ("DITAC") platform. HER2 is a surface-expressed protein on solid tumors and has been linked to the aggressive growth and spread of cancer cells. Preclinical data and preliminary clinical data for trastuzumab pamirtecan indicate its potential to target HER2 receptors on solid tumors irrespective of expression level with a manageable safety profile and a potentially expanded therapeutic window.

Trastuzumab pamirtecan is being evaluated in an ongoing Phase 1/2 trial (NCT05150691) in patients with advanced/metastatic solid tumors, and in two global Phase 3 clinical trials. Fern-EC-01, a randomized Phase 3 clinical trial (NCT06340568) evaluating trastuzumab pamirtecan compared with investigator’s choice of single agent chemotherapy in previously treated patients with HER2-expressing advanced recurrent endometrial cancer, is currently enrolling patients. DYNASTY-Breast02, a Phase 3 clinical trial (NCT06018337) evaluating trastuzumab pamirtecan in patients with Hormone Receptor-positive ("HR+") and Human Epidermal Growth Factor Receptor 2 ("HER2")-low, metastatic breast cancer that have progressed on hormone and/or cyclin-dependent kinase 4/6 ("CDK4/6") therapy, is fully enrolled and expected to read out this year.

About the Phase 1/2a trial
The global, multi-cohort Phase 1/2a clinical trial (NCT05150691) evaluated the safety and tolerability of trastuzumab pamirtecan in patients with advanced solid tumors that express HER2. Cohort 2b is a Phase 2 expansion cohort which enrolled 145 patients with advanced/metastatic HER2-expressing endometrial cancer whose disease had progressed after first- and later lines of therapy. The HER2 status was determined for all patients through local testing and, where possible, confirmed via central testing. The primary endpoints were objective response rate in patients with prior checkpoint inhibitor treatment with HER2 expression, confirmed by retrospective central testing, and safety. Secondary endpoints included ORR, DoR, DCR, PFS and OS.

(Press release, BioNTech, APR 11, 2026, View Source [SID1234664306])

Vivatides Therapeutics Announces Oversubscribed $54 Million Series A Financing to Accelerate Extrahepatic RNA Therapeutics Development

On April 10, 2026 Vivatides Therapeutics, a global biotechnology company focused on developing extrahepatic RNA-targeting therapeutics, reported the successful closing of an oversubscribed $54 million Series A financing. The round was co-led by Qiming Venture Partners and a leading industry fund, with participation from Highlight Capital, a leading venture fund, and TF Capital. Existing investor Apricot Capital also continued to support the company with additional investment. Proceeds from the financing will be used to further advance Vivatides’ extrahepatic delivery platform, accelerate multiple pipeline programs into clinical development, and expand its global team and R&D network. As an emerging player in the RNA therapeutics field, Vivatides has completed both its seed and Series A financings within less than one year of founding, underscoring strong investor confidence in the company’s technological innovation and execution capabilities in extrahepatic RNA delivery.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

RNA therapeutics, with their broad target space, high specificity, and durable efficacy, are poised to become the third major therapeutic modality following small molecules and antibodies. However, traditional RNA therapeutics have largely been limited to liver-targeted applications due to delivery challenges. Diseases involving extrahepatic tissues remain significantly underserved and represent the next major frontier for innovation.

With advances in extrahepatic delivery technologies, RNA therapeutics are rapidly expanding beyond rare diseases into large, chronic disease areas such as hyperlipidemia, hypertension, and oncology, unlocking substantial market potential.

Founded in 2025, Vivatides has been dedicated to the innovation and translation of proprietary extrahepatic RNA delivery technologies. The company’s globally experienced leadership team includes experts from leading RNA therapeutics companies. The team has previously led or played key roles in multiple extrahepatic RNA programs, several of which have progressed into clinical development. Leveraging this deep expertise, Vivatides has built a differentiated extrahepatic delivery platform with capabilities spanning both siRNA and antisense oligonucleotides (ASO). The company has achieved key advances in ligand conjugation, delivery efficiency, tissue targeting specificity, and safety, with encouraging in vivo results already demonstrated. Combined with strong capabilities in sequence design and target discovery, the platform enables rapid parallel advancement and expansion of a diversified pipeline.

"Extrahepatic delivery is the key that will unlock RNA therapeutics from niche rare diseases to broad chronic indications," said Keming Zhou, Founder of Vivatides Therapeutics. "We are honored to have the support and recognition of leading investors. This financing will accelerate the evolution of our platform and pipeline, advancing innovative RNA therapeutics into extrahepatic disease areas. We believe that overcoming delivery barriers will enable RNA therapeutics to transform treatment paradigms across a wide range of diseases. We also look forward to engaging with more long-term, value-driven partners to bring transformative therapies to patients worldwide."

Dr. Kan Chen, Partner at Qiming Venture Partners and Co-leads Qiming’s investments in the healthcare sector, commented: " We have long been optimistic about the application potential of small nucleic acid drugs across a broader range of disease areas. Continuous advances in extrahepatic targeting technologies are steadily expanding their clinical frontiers. Vivatides Therapeutics has demonstrated solid technological expertise and efficient execution capabilities in this field, with encouraging progress achieved on its platform. We look forward to the company driving further technological breakthroughs, accelerating the clinical translation of its pipeline, and delivering safer and more effective innovative therapies to patients worldwide."

Dr. Wei Ding, Partner at Apricot Capital, commented: "As an early investor in Vivatides’ seed round, we are delighted to see the company successfully complete its Series A financing and welcome new investors. Since its founding, Dr. Zhou and his team have consistently exceeded expectations with exceptional execution in platform development and pipeline advancement. We look forward to Vivatides translating its differentiated platform into breakthrough therapies that benefit patients worldwide and leading the next wave of extrahepatic RNA therapeutics."

Following the financing, Vivatides will further accelerate preclinical optimization and IND-enabling studies, expand its R&D and management teams, and continue to strengthen its extrahepatic delivery platform. Looking ahead, the company will remain focused on addressing unmet medical needs in high-prevalence extrahepatic diseases, becoming a leader in RNA therapeutics and delivering more effective and safer treatment options to patients worldwide.

(Press release, Vivatides Therapeutics, APR 10, 2026, View Source [SID1234664305])