Clinical Trials

In Brief: BriaCell’s Breast Cancer Cell Therapy Boosts Survival In Phase II

 

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

Disappointing Asthma Phase II Results Take Wind Out Of Sanofi’s Amlitelimab

 

Sanofi’s OX40L candidate missed a Phase II primary endpoint, but the company believes it can still work in a sub-group of ‘heterogeneous inflammatory asthma’ patients.


Stock Watch: Disappointing ACC Share Price Reactions For AstraZeneca And Lilly

 
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The end of the American College of Cardiology conference was a prelude to a volatile trading week for most stocks. Even before Liberation Day, reactions to the conference announcements were not encouraging.

Pfizer’s Danuglipron Is Done, Sparking M&A Speculation

 

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.

Amgen’s Imdelltra Sets The Pace In Small-Cell Lung Cancer

 

The bispecific is the first in its class to record a Phase III survival win in small-cell lung cancer, although antibody-drug conjugates and other rivals could challenge in the coming years.

Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.


Scancell Signs UK Match-Making Pact For Melanoma Vaccine

 
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The Oxford group has linked up with the NHS Cancer Vaccine Launch Pad.

New Data Strengthen Case For RemeGen’s Telitacicept In gMG

 

Results from a China Phase III trial show the potential of RemeGen's fusion protein telitacicept in generalized myasthenia gravis. But study design differences make direct comparisons with argenx's FcRn inhibitor Vyvgart challenging.

UK Promises To ‘Turbo-Charge’ Clinical Trials As Tariff Threat Remains

 

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.

PureTech Weighs Up Pros And Cons Of Going Private

 
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The biotech has rejected a takeover bid from Nordic Capital but a sale to private equity could be a solution to the public market's continued reluctance to adequately value PureTech’s hub-and-spoke business model.


Epsilogen Hits Antibody Acquisition Trail With TigaTx Takeover

 
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Following the near-total dominance of IgG antibodies, the UK group is backing the potential of IgA and IgE-based therapies to transform cancer treatment with the purchase of US-headquartered TigaTx.

Aldeyra Expects Mid-2025 Refiling Of Reproxalap After Second CRL

 
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Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.

Pipeline Watch: 13 Approvals And 13 Phase III Trial Updates

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Roche’s Brain Shuttle Delivers In Alzheimer’s, Moves Ahead To Phase III

 

By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.


Compass’ Bispecific BTC Contender Meets Phase II/III Endpoint

 
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Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.

BeiGene Ends Anti-TIGIT Development In Lung Cancer

 
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BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.

Edgewise’s HCM Candidate May Provide Advantages Over BMS’s Camzyos

 
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With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.

AbbVie On A STEAP Learning Curve In ADCs

 

Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.