On February 5, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) (TransCode), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancers, in collaboration with Quantum Leap Healthcare Collaborative (Quantum Leap), reported the submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application amendment for a planned Phase 2a clinical trial with TransCode’s lead therapeutic candidate, TTX-MC138. The study will be conducted by Quantum Leap within their PRE-I-SPY program, a leading platform for innovative oncology clinical trials, and represents the program’s first expansion into colorectal cancer.

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As part of the PRE-I-SPY platform, the TTX-MC138 Phase 2a dose-expansion portion of the trial will enroll up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and have positive markers for circulating tumor DNA (ctDNA). Recent studies have demonstrated that ctDNA is a prognostic marker of cancer recurrence and may be indicative of the presence of minimal residual disease (MRD) that could be amenable to early interventions. The Phase 2a trial is planned to begin in the first half of 2026 and will be led by Principal Investigator Dr. Paula Pohlmann of MD Anderson Cancer Center. This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the MRD setting, where we believe the therapeutic intervention may have the greatest opportunity to improve long-term outcomes.

"This IND submission marks a pivotal step in TransCode’s clinical development program, positioning TTX-MC138 where its mechanism of action has the potential to deliver meaningful benefit to patients," said Sue Duggan, TransCode’s Senior VP, Operations. "We are pleased to partner with Quantum Leap’s PRE-I-SPY program to evaluate TTX-MC138 and to support the expansion of this platform into new indications such as colorectal cancer," added Duggan.

The clinical trial will be performed at several clinical sites of the PRE-I-SPY Platform Network, many of which are members of the National Cancer Center Network. Additionally, the program is focused on partnering with the Colorectal Cancer Alliance, a leading advocacy organization. Information on the PRE-I-SPY program and the Phase 2a trial can be found at clinicaltrials.gov (NCT05868226).

(Press release, TransCode Therapeutics, FEB 5, 2026, View Source [SID1234662512])

On February 4, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to pelareorep in combination with bevacizumab (Avastin) and leucovorin, fluorouracil, irinotecan ("FOLFIRI") for the treatment of patients with KRAS ("Kirsten rat sarcoma")-mutant, microsatellite-stable ("MSS") metastatic colorectal cancer ("mCRC") in the second-line ("2L") setting. As part of the Company’s increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall, the Company applied for and has now received Fast Track Designation.

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The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate ("ORR") for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care ("SOC") in this patient population.1-2 In addition, pelareorep combination therapy was associated with a median progression-free survival ("PFS") of 16.6 months, compared to 5.7 months with SOC, and a median overall survival ("OS") of 27 months, compared to 11.2 months with SOC.1

KRAS-mutant MSS metastatic colorectal cancer represents one of the most challenging diseases in gastrointestinal oncology, as few effective treatment options exist following first-line progression, and available immune-based therapies provide little benefit. There are an estimated 2 million new colorectal cancer cases each year globally, with an annual total addressable market of approximately $3-5 billion for the 2L KRAS-mutant MSS mCRC subgroup.3-7

"This designation is an important validation of our focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics. "Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate in a market that is estimated to be worth several billion dollars. Pelareorep offers the potential to help a meaningful number of patients, and I look forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible."

Oncolytics expects to initiate a controlled clinical study in second-line KRAS-mutant MSS mCRC comparing standard-of-care therapy alone versus standard-of-care plus pelareorep. The first clinical site is expected to be activated in March, with up to 10 additional sites anticipated to open shortly thereafter. Interim data from the study are expected by year-end. Further details regarding the study design and milestones are forthcoming.

The Fast Track Designation enables more frequent meetings and communication with the FDA to ensure alignment on development plans and the collection of clinical data needed to support approval. Furthermore, clinical programs with Fast Track Designation may be eligible for Accelerated Approval and Priority Review if relevant criteria are met. For conditions where an available treatment exists, a candidate therapy regimen must show some advantage over the available treatment, such as superior effectiveness, to be granted Fast Track Designation.

(Press release, Oncolytics Biotech, FEB 4, 2026, View Source [SID1234662474])

On February 4, 2026 enGene Holdings Inc. (Nasdaq: ENGN or "enGene"), a clinical-stage, non-viral genetic medicines company, reported that Ron Cooper, President and Chief Executive Officer, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11, 2026, at 2:30 p.m. ET.

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A live webcast of the fireside chat can be accessed on the "Events and Presentations" page under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

(Press release, enGene, FEB 4, 2026, View Source [SID1234662490])

On February 4, 2026 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the fourth quarter and full-year 2025.

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Net sales for Q4 2025 rose 4% to $540 million, with sales at constant exchange rates (CER) up 1% and exceeding the outlook for steady CER results compared to the year-ago period while overcoming macroeconomic challenges and the impact of the 2025 U.S. government shutdown. Solid ongoing trends among the growth pillars, which rose 7% CER, led the performance. Net sales results included headwinds of approximately $10 million from discontinued products (NeuMoDx and Dialunox) and the first-time contributions from the Parse acquisition that was completed in December 2025. Adjusted diluted EPS CER of $0.62 CER was above the outlook for about $0.60 CER.

For full-year 2025, QIAGEN achieved its increased sales outlook for 5% CER growth, which was at the high end of the outlook for about +4-5% CER growth. Net sales included headwinds of about $20 million from discontinued products (NeuMoDx and Dialunox) as well as contributions from the Parse acquisition. Adjusted diluted EPS was $2.38, with adjusted diluted EPS of $2.40 CER ahead of the outlook for about $2.38 CER and $0.12 ahead of the initial outlook for 2025. Diluted EPS was $1.94.

For 2026, QIAGEN expects net sales growth of at least 5% CER from 2025 driven by the growth pillars contributing about 9% CER growth and combined sales of about $1.64 billion CER. Adjusted diluted EPS is expected to be at least $2.50 CER compared with $2.38 in 2025.

"QIAGEN finished 2025 with disciplined execution, exceeding our outlook for sales and adjusted EPS in Q4 2025," said Thierry Bernard, CEO of QIAGEN. "Our performance underscores the strength of our portfolio and positions us well to demonstrate our commitment to delivering solid profitable growth in a challenging environment. Our growth pillars delivered 8% growth to reach $1.49 billion CER in combined sales in 2025 and keeping us on track toward our 2028 targets. We continue to drive efficiency and digitization across the organization to fund growth investments and expand profitability."

"We also made good progress in capital allocation," said Roland Sackers, CFO of QIAGEN. "We returned more than $1.1 billion to shareholders to date ahead of schedule and closed two bolt-on acquisitions with Genoox strengthening our QDI business and Parse expanding our Sample technologies portfolio with our entry into single-cell analysis. At the same time, we maintain significant flexibility to continue investing in growth and shareholder returns."

Please find the full press release incl. tables as a PDF for download at the top of this page.

Investor presentation and conference call

A conference call is scheduled for Thursday, February 5, 2026, at 15:30 Frankfurt Time / 14:30 London Time / 9:30 New York Time. A live audio webcast will be available in the Investor Relations section of the QIAGEN website (www.qiagen.com), with a recording accessible after the event. The accompanying presentation will be published in advance under "Events and Presentations" in the same section.

Use of adjusted results

QIAGEN reports adjusted results and constant exchange rate (CER) measures, along with other non-GAAP financial metrics, to provide deeper insight into business performance. These include adjusted gross margin and profit, adjusted operating income and expenses, adjusted operating income margin, adjusted net income, adjusted income before taxes, adjusted diluted EPS, adjusted EBITDA, adjusted tax rate and free cash flow. Free cash flow is calculated as cash flow from operating activities less capital expenditures for property, plant and equipment. Adjusted results are non-GAAP measures that QIAGEN views as complementary to GAAP-reported results. They exclude items considered outside of ongoing core operations, subject to significant period-to-period fluctuation, or that reduce comparability with competitors and historical performance. QIAGEN also uses these non-GAAP and constant currency measures internally for planning, forecasting, reporting and employee compensation purposes. These metrics enable consistent comparison of current and past performance, which QIAGEN has historically presented on an adjusted basis.

(Press release, Qiagen, FEB 4, 2026, View Source [SID1234662475])

On February 4, 2026 Daiichi Sankyo reported that the first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

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DS3790 is a specifically engineered, potential first-in-class CD37 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568).

CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed on malignant B-cells, making it a promising therapeutic target.1 Currently, there are no CD37 directed therapies approved for any type of cancer.

"The initiation of this trial of DS3790 with its novel CD37 target marks a significant milestone as our first DXd antibody drug conjugate in hematology," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "DS3790 expands our portfolio to seven DXd antibody drug conjugates, all developed using our in-house technology, underscoring our dedication to scientific innovation to create new medicines for patients with cancer."

About the Phase 1/2 Trial
The multicenter, open-label, multi-cohort, first-in-human phase 1/2 trial will assess the safety and efficacy of DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

The first part of the trial (dose escalation) is evaluating DS3790 as a monotherapy to determine the recommended dose for expansion. The second part of the trial (dose expansion) will consist of multiple expansion cohorts to further evaluate DS3790 as a monotherapy.

Following the assessment of preliminary safety and efficacy in the monotherapy part of the trial, subsequent cohorts will evaluate DS3790 in combination with other targeted therapies in both dose escalation and dose expansion phases.

The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events, as well as efficacy endpoints including overall response, disease control rate, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetics and biomarker endpoints also will be assessed.

The trial is expected to enroll approximately 420 patients across multiple sites globally, including Asia, Europe and North America. For more information, please visit ClinicalTrials.gov.

About CD37
CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed in various B-cell hematological malignancies.1 B-cells, which are a type of white blood cell (B-lymphocyte) that help the body fight infection, can uncontrollably multiply and fail to function properly.2 Because of its high prevalence on B-cells, CD37 is considered a promising therapeutic target for the treatment of B-cell cancers.3 Currently, there are no CD37 directed therapies approved for any type of cancer.

About B-cell Non-Hodgkin Lymphoma
More than 604,000 cases of non-Hodgkin lymphoma were diagnosed in 2021, with approximately 267,000 deaths globally.4 B-cell non-Hodgkin lymphoma accounts for more than 85% of all non-Hodgkin lymphoma cases with a five-year survival rate of 74%.5

While advances in targeted therapies have improved outcomes in B-cell non-Hodgkin lymphoma, many patients with relapsed or refractory disease continue to face limited treatment durability and poor long-term survival.6

About DS3790
DS3790 is an investigational, potential first-in-class CD37 directed ADC. Designed using the proprietary DXd ADC technology of Daiichi Sankyo, DS3790 is comprised of a humanized anti-CD37 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

(Press release, Daiichi Sankyo, FEB 4, 2026, https://www.businesswire.com/news/home/20260204176261/en/DS3790-Enters-Clinical-Development-as-First-DXd-ADC-in-Hematology-from-Industry-Leading-ADC-Portfolio-of-Daiichi-Sankyo [SID1234662491])