On April 8, 2026 Sidewinder Therapeutics, a biopharmaceutical company pioneering the development of next-generation bispecific ADCs (antibody-drug conjugates) for the treatment of cancer, reported the closing of an oversubscribed $137 million Series B financing. The round was co-led by Frazier Life Sciences and Novartis Venture Fund, with participation from the sole Series A investor OrbiMed as well as new investors including Life Sciences at Goldman Sachs Alternatives, DCVC Bio, Samsara BioCapital, Longwood Fund, Astellas Venture Management and Alexandria Venture Investments. Concurrent with the financing, Daniel Estes, Ph.D., from Frazier Life Sciences, Michal Silverberg from Novartis Venture Fund, Josh Richardson, M.D., from Life Sciences at Goldman Sachs Alternatives and John Hamer, Ph.D., from DCVC Bio were named to the Board of Directors.

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"We are pleased to receive the support of this exceptional group of investors and their shared enthusiasm in advancing Sidewinder’s mission to develop next-generation bispecific ADCs for difficult to treat cancers," said Eric Murphy, Ph.D., Co-Founder and CEO of Sidewinder Therapeutics. "The ADC field is at an inflection point driven by technological breakthroughs enabling next-generation bispecific ADCs, and Sidewinder is eager to lead this wave of innovation and advance promising therapies for patients with cancer."

Sidewinder’s mission focuses on developing bispecific ADCs designed to target receptor co-complexes that are highly expressed on certain solid tumors. The pipeline features bispecific antibodies engineered from internally discovered antibody sequences and finely tuned to target tumor-specific co-complexes consisting of an oncogenic driver receptor and an internalizing receptor. Precise targeting of these co-complexes enhances both tumor cell specificity and internalization, thereby improving the delivery of drugs to cancer cells while avoiding normal cells. Sidewinder’s programs are designed to address oncology indications that have limited treatment options and affect substantial patient populations such as squamous cell carcinomas in lung and head and neck cancers as well as gastrointestinal cancers including colorectal cancer. The company expects to advance its lead program into clinical development in 2027.

"Founded on compelling science and a differentiated approach, Sidewinder’s novel bispecific ADC pipeline has the potential to address key hurdles limiting safety and efficacy for this class of therapeutics," said Daniel Estes, Ph.D., General Partner at Frazier Life Sciences. "We believe that Sidewinder Therapeutics will significantly advance the ADC space and is well positioned to transform the treatment paradigm for cancer patients."

(Press release, Sidewinder Therapeutics, APR 8, 2026, View Source [SID1234664253])

On April 7, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, reported broad alignment with the U.S. Food and Drug Administration (FDA) on the registration path for CRB-701, the Company’s next-generation, highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma (HNSCC) and cervical cancer. Corbus also announced that Dr. Dominic Smethurst, MA, MRCP is stepping down from his role as Chief Medical Officer; his last day with the company will be June 30, 2026.

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The agreed upon second-line registrational study designs for CRB-701 include:

HNSCC: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice chemotherapy with potential accelerated approval using objective response rate (ORR) as the primary endpoint and potential full approval granted on overall survival (OS) benefit.
Cervical cancer: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice of chemotherapy or Tivdak with potential accelerated approval using ORR as the primary endpoint and potential full approval granted on OS benefit.
Continued interactions with the FDA planned to finalize the protocols and statistical analysis plans for the registrational studies.

Updated clinical data from the Phase 1/2 study of CRB-701 in both HNSCC and cervical cancer will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held May 29 – June 2 in Chicago. Data will include clinical response durability as well as HNSCC patient subgroup analysis. Corbus previously presented dose optimization data from the study, including encouraging efficacy and safety findings, at the 2025 European Society for Medical Oncology Congress (ESMO 2025). The company also anticipates reporting data with CRB-701 in combination with Keytruda in first-line HNSCC patients in Q4 2026 to support potential further registration-enabling trials.

"We’re pleased to share this important regulatory update as we continue to progress CRB-701 as a novel oncology therapeutic to address unmet medical needs for patients. We look forward to sharing updated monotherapy data on CRB-701 at ASCO (Free ASCO Whitepaper) and expect to initiate a registrational study for CRB-701 in second-line HNSCC in mid-2026," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.

Dr. Cohen continued, "This milestone marks an important transition from clinical proof of concept to pending late-stage registrational development and the potential for regulatory submission of CRB-701. This year we will be adding several key new senior leaders to best prepare us for this critical next phase. We are very grateful for Dr. Smethurst’s contributions to advance our pipeline programs through early development, well positioning Corbus for continued success."

About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.

(Press release, Corbus Pharmaceuticals, APR 7, 2026, View Source [SID1234664201])

On April 7, 2026 Singlomics Biopharmaceuticals, an innovative clinical-stage biopharmaceutical company focused on the discovery and development of antibody therapeutics for oncology, inflammation, and autoimmune diseases, reported that the first patient has been dosed in its Phase I clinical trial of DXP-106, a potential best-in-class IL-1RAP monoclonal antibody, in China.

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DXP-106 has previously received Investigational New Drug (IND) approvals from both the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). The ongoing first-in-human Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of DXP-106 in patients with advanced solid tumors.

"Dosing of the first patient in our Phase I trial represents a key milestone as we advance DXP-106 into clinical development globally," said Dr. Qian Shi, Chief Executive Officer of Singlomics. "IL-1RAP is a compelling target in oncology and immune-related diseases. DXP-106 is designed to function through both directly killing tumor cells by ADCC, and inhibit MDSCs in tumor microenvironment via inhibition of multiple IL-1 superfamily signaling pathways. It has demonstrated strong anti-tumor activity in preclinical studies. We look forward to generating initial clinical data and exploring potential global partnering opportunities to accelerate development."

DXP-106 is a humanized monoclonal antibody that specifically binds to a differentiated epitope on IL-1RAP domain 2, enabling simultaneous blockade of IL-1, IL-33, and IL-36 signaling pathways. This multi-pathway inhibition approach may provide broader anti-tumor activity and improved therapeutic benefit.

IL-1RAP is broadly expressed across tumor cells, stromal cells, and immune cells within the tumor microenvironment, and plays a central role in tumor progression, immune evasion, and chronic inflammation. Elevated IL-1 pathway signaling has been associated with poor clinical outcomes across multiple cancer types, supporting IL-1RAP as a promising therapeutic target.

Singlomics is advancing a differentiated pipeline of antibody therapeutics leveraging its proprietary single-cell sequencing and AI-enabled antibody engineering platform. The Company is actively seeking global partnerships for selected programs.

About DXP-106: IL-1RAP mAb

DXP-106 is a humanized IL-1RAP monoclonal antibody targeting a unique epitope on domain 2 of IL-1RAP, enabling inhibition of three key IL-1 superfamily signaling pathways. In preclinical in vitro and in vivo tumor models, DXP-106 demonstrated robust anti-tumor activity and favorable developability, supporting its potential as a best-in-class therapeutic.

(Press release, Singlomics Biopharmaceuticals, APR 7, 2026, View Source [SID1234664217])

On April 7, 2026 CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that senior management will be participating in a fireside chat and investor meetings at the upcoming 25th Annual Needham Virtual Healthcare Conference taking place April 13 – 16, 2026.

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25th Annual Needham Virtual Healthcare Conference
Date: April 14, 2026
Time: 3:00pm Eastern
Format: Fireside Chat
Webcast: Link to webcast

(Press release, CorMedix, APR 7, 2026, View Source [SID1234664202])

On April 7, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the submission to the U.S. Food and Drug Administration (FDA) of the Company’s NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC.

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"The advancement of neladalkib from first clinical trial initiation to NDA submission in less than four years represents a remarkable pace in oncology drug development, underscoring the vigor and urgency our team brought to this program and our deep commitment to the ALK-positive NSCLC community," said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. "We would like to extend our sincere gratitude to the patients, families and investigators who have made this progress possible, and are committed to working closely with the FDA throughout the NDA review process toward our goal of bringing neladalkib to patients as quickly as possible."

The application is based on data in TKI pre-treated patients with advanced ALK-positive NSCLC treated with neladalkib in the global, registration-directed ALKOVE-1 Phase 1/2 clinical trial. In this population, neladalkib demonstrated encouraging overall activity, including intracranial responses, the ability to address key drivers of disease progression, and a generally well-tolerated safety profile consistent with its ALK-selective, TRK-sparing design. The company plans to share detailed results at a future medical meeting.

Neladalkib has received breakthrough therapy designation from the FDA for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About Neladalkib

Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About the ALKOVE-1 Phase 1/2 Clinical Trial

The ALKOVE-1 trial (NCT05384626) is a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ALK-positive NSCLC patients who previously received at least one ALK TKI, or patients with other ALK-positive solid tumors who had been previously treated or for whom no satisfactory standard of care exists. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of neladalkib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The global, single arm, open label Phase 2 portion is designed with registrational intent for TKI pre-treated patients with advanced ALK-positive NSCLC. Global enrollment in ALKOVE-1 remains ongoing for adult and adolescent patients with ALK-positive solid tumors outside of NSCLC, and adolescent patients with ALK-positive NSCLC.

(Press release, Nuvalent, APR 7, 2026, View Source [SID1234664218])