Category: Uncategorized

Dr Rosanne Dunn, Co-Founder and Chief Scientific Officer at HaemaLogiX, authored an article for Drug Discovery World that explored how the discovery of a new class of tumour‑specific antigens is transforming how we treat plasma cell dyscrasias.

"Proteasome inhibitors, immunomodulatory drugs, anti‑CD38 antibodies, and, more recently BCMA‑directed CAR‑T cells and bispecifics, have each extended survival and transformed expectations. But the malignant plasma cell clone adapts, escapes, and ultimately progresses through every line of therapy. The central limitation is not the ingenuity of modalities but the biology of the targets themselves" she said.

Read the full article here. 

In June, Cereno Scientific CMO and Head of R&D Rahul Agrawal spoke with Clinical Leader Executive Editor Abby Proch about the scientific and strategic rationale behind extending the company’s Phase IIb study duration. He also shares how patient input, regulatory guidance, and earlier-phase data shaped a design intended to generate more meaningful and durable insights in a complex, heterogeneous disease.

Read the full article here. 

Cereno Scientific and Racura Oncology spoke to DDN Assistant editor Allison Whitten about drug repurposing, in light of the recent FDA announcement that it had launched an initiative seeking to target unmet needs across many conditions. 

“This initiative is long overdue, but like all new FDA initiatives it will be the details that matter,” Daniel Tillett, CEO of Racura Oncology, told DDN. “The FDA recognizes that there is little or no commercial incentive to pursue labeling changes for drug repurposing if a drug is off patent. Until there is a viable mechanism to recoup the costs involved in running repurposing studies, commercial interest in drug repurposing will remain muted.”

While Sten Sorensen, CEO of Cereno Scientific, commented that the new FDA initiative could help their clinical program move forward in two main ways. “A more structured and supportive regulatory framework for repurposed drugs has the potential to streamline interactions with the FDA, reduce perceived development risk, and accelerate the path toward approval,” he said. “From a partnering perspective, the initiative also matters. Big pharma, when evaluating transactions, views repurposed drugs as a risk, and a clear regulatory signal of support from FDA for repurposed drug development improves the attractiveness of assets like ours in those conversations.”

However, Sorensen added that “demonstrating disease-modification in a complex disease like PAH requires robust, long-duration clinical data, and that takes time and resources regardless of the regulatory environment. Generating the kind of evidence that satisfies both regulators and potential partners remains the central challenge, and one we are addressing head-on through the design of our global Phase 2b study.”

Read the full article here. 

Fierce Biotech spoke with Affibody about the plans for its Phase III IL-17A inhibitor izokibep. 

Senior editor James Waldron wrote: "Affibody brought Week 52 data along to EULAR 2026 to remind people of what the drug can do when compared to PsA mainstays like Novartis’ Cosentyx and UCB’s Bimzelx. Affibody’s slides show izokibep holding its own on measurements like a 50% improvement in rheumatology symptoms (ACR50), as well as a 70% improvement and the proportion of patients who saw a 100% improvement in psoriasis area and severity (PASI100)."

Read the full article here. 

In a recent article featured in In Vivo, the CEO of Albus Health, Mikesh Udani, explores why nighttime physiology is still under‑represented in clinical evidence, and how that is beginning to change.

Overnight symptoms across respiratory, neurological, paediatric and cardiometabolic disease remain largely invisible to tools like diaries, morning recall and sleep‑lab assessments. Yet these signals often reflect treatment response, risk and disease biology.

The op‑ed highlights three shifts now reshaping evidence generation:
● Improvements in sleep and nighttime symptoms are emerging as a meaningful dimension of treatment response.
● Objective nighttime data is now achievable at scale. Entire nights of physiology no longer need to be compressed into a single morning entry.
● Passive, contactless remote monitoring is moving upstream into core study design.

The piece also points to the growing value of early‑warning signals such as passive detection of respiratory deterioration days before symptoms appear. This has implications far beyond respiratory disease, from oncology safety monitoring to neurological progression.

Read the full commentary here.

In a recent feature for Biospace, journalist Tristan Manalac spoke with Racura chairman Pete Smith about the difficulties in targeting the notoriously undruggable myc gene. Along with RIPK1, STING and alpha-synuclein, myc has left a trail of failed clinical trials, cancelled partnerships and sunk investments in their wake, said Manalac.

Read the full article here.

Clinical trials have advanced dramatically in precision, yet a large portion of chronic disease activity still occurs outside the clinic and outside traditional measurement windows. Nighttime symptoms, sleep‑related biomarkers and overnight deterioration are central to many conditions, but remain challenging to capture with diaries, morning recall or short‑duration assessments.

In this International Clinical Trials article, Albus Health CEO Mikesh Udani examines how continuous, passive monitoring is beginning to change that. He describes the longstanding gap between when disease manifests and when trials typically measure it — and how contactless technologies are now making it possible to capture objective nighttime physiology at scale, without adding burden to patients or sites.

The piece explores the evidence behind these approaches, including validation against clinical reference standards, long‑term usability data, and applications across asthma, COPD, heart failure, neurological conditions and safety monitoring. It also outlines the implications for trial design, from more sensitive endpoints to earlier detection of deterioration.

As continuous monitoring moves from exploratory pilots into protocol planning, it is reshaping how the industry understands treatment response, risk and disease biology, particularly in the domains that matter most to patients.

Read the full article here.

The CEO of One-carbon Tx, Dr Ana Slipicevic, spoke with Yilmaz Biter at BioPitch about her path from oncology research to leading a first‑in‑class clinical program at One‑carbon Therapeutics.

The conversation offers a clear look at the decisions, data, and translational focus shaping the work of this pioneering biotech.

Read the full interview here. 

Following Dr Giedrius Gasiunas’ presentation on the compact Cas12l CRISPR-Cas editor at the ASGCT Annual Meeting in Boston, a new GEN article highlights Caszyme’s development work on this promising genome editing platform.

Thanks to its compact size and C-rich PAM recognition, Cas12l opens exciting opportunities: expanding the CRISPR toolbox and positioning itself as a compelling alternative to Cas9.

Read the full GEN article here.

Australian biotech HaemaLogiX spoke to Scrip about its approach to the multiple myeloma space, and how it differentiates itself with new drug targets.

“There are a lot of drugs for multiple myeloma. It’s, in some ways, a very crowded space,” said CEO Chris Baldwin. “But we’re the only ones who are targeting KMA/LMA. Part of that is due to the extensive patent portfolio that we’ve established and developed over the course of the last 20 years. It means that when we come into the market, we have a very strong differentiator compared to anything out there,” Baldwin continued.

Read the full story here.