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Patient-Centered Endpoints for Biotech Startups: Choosing Outcomes That Matter in the Real World

CURE. – By making endpoints patient-centered from the outset, founders ensure the focus remains on how patients feel, function, and survive, said Amin Zargar, PhD, CEO of ResVita Bio, a company using synthetic biology and metabolic engineering to develop therapies for skin diseases such as Netherton Syndrome. These endpoints reflect the aspects of treatment and disease management that matter most to patients themselves. When defining them, Zargar said, founders should prioritize factors like symptom burden, quality of life, functional status, and treatment tolerability.

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Marco Lobba

Marco Lobba Wins 2025 Biocom Catalyst Award: Precision Therapeutics at the Molecular Level

Marco Lobba co-founded CatenaBio to advance targeted therapeutics at the intersection of chemistry and molecular biology. He co-invented the CysTyr platform, enabling precise conjugation of multiple payloads to antibodies for oncology, gene therapy and cell-based therapies. “I truly believe that the biggest challenge in making new therapeutics is how to direct them in the body,” he says. Dr. Lobba earned his Ph.D. at UC Berkeley, training with Nobel Laureate Jennifer Doudna, and holds numerous patents. Beyond CatenaBio, he mentors scientists, supports food equity programs and advocates for investment in basic research to drive future breakthroughs. Read post
Decorative image with Bakar Bio Labs logo and photo of skylight

AI Development at UC Berkeley’s Top Biotech Incubator, Bakar Bio Labs

AI has taken the world by storm. On the scientific front, the ability to mine huge datasets and make informed, actionable predictions has accelerated the pace of innovation. So it makes sense that startups at UC Berkeley’s Bakar Bio Labs, the university’s leading biotech incubator, would embed AI into their work to discover new medicines, redesign how they are delivered, and even create entirely new biological tools. Bakar Bio Labs’ tenant companies are redefining the world of biotech, and they’re doing it with out-of-the-box solutions. For three of the tenants — Insamo, Aikium, and Profluent — AI is core to their technology and strategy. Read post
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ResVita Bio Announces Positive FDA Pre-IND Meeting, Advancing RVB-003 Toward IND Filing for Netherton Syndrome in Early 2026

ResVita Bio, a biotechnology company pioneering continuous protein therapy for skin diseases, today announced the successful completion of a face-to-face Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for RVB-003, its lead investigational therapy for Netherton Syndrome, a chronic and life-threatening genetic skin disorder. Read post
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Profluent’s AI-Designed Gene Editor Glimpses into Generalizable Platform

Ali Madani, PhD, CEO of Profluent, says there’s an urgent need to move away from the time-consuming slog of random therapeutic discovery and into artificial intelligence (AI)-based bespoke design. “There are real people with lives at stake and patients waiting,” he emphasized in an interview with GEN. Madani’s Bay Area-based company is currently building foundation models to steer functional protein design for generalizable applications across agriculture, biotechnology, and human health. The team has recently taken one step toward this goal for CRISPR-based therapeutics. Read post
Three people standing in front of a Cyclarity banner

New data supports Cyclarity’s approach to atherosclerosis reversal

The central role of 7-ketocholesterol (7KC) in the pathogenesis of atherosclerosis is well documented: as a toxic oxidized derivative of cholesterol, 7KC accumulates in arterial walls and contributes to the transformation of macrophages into dysfunctional, lipid-laden foam cells. These cells drive inflammation, destabilise plaque and ultimately fuel cardiovascular disease – the leading cause of mortality worldwide. Many therapeutic strategies have focused on lipid lowering or anti-inflammatory approaches; few have attempted to directly remove 7KC from cells, and fewer still have demonstrated the ability to reverse foam cell formation. Now, Cyclarity Therapeutics has published preclinical data suggesting its cyclodextrin-based compound UDP-003 can do just that – and with a favorable safety and pharmacokinetic profile that supports IND-readiness for first-in-human trials. Read post
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Renasant Bio Launches With $54.5 Million Seed Funding To Develop Kidney Disease Treatments

Renasant Bio has officially launched with $54.5 million in seed funding to develop next-generation disease-modifying treatments for autosomal dominant polycystic kidney disease (ADPKD). ADPKD is the leading genetic cause of end-stage renal failure. The funding round was co-led by founding investor 5AM Ventures, with significant participation from Atlas Venture, OrbiMed, and Qiming Ventures. This capital will advance Renasant’s lead corrector program and fuel discovery efforts for its first-in-class potentiator program. Read post
The Renasant team

Kidney health biotech emerges with $54M to follow in Vertex’s footsteps

A Berkeley, CA-based biotech that wants to replicate Vertex’s success with corrector and potentiator medicines has raised a $54.5 million seed round. The funding, disclosed Thursday morning, will help Renasant Bio get closer to the clinic with small molecule treatment candidates for a leading cause of end-stage renal failure. Renasant is focused on hitting the disease-causing biology of autosomal dominant polycystic kidney disease, or ADPKD. The condition is marked by cysts that form in the kidneys and can lead patients to use dialysis or resort to a kidney transplant. Renasant said 12 million people worldwide have ADPKD. Read post
Emily Conley

East Bay startup led by former 23andMe exec snags $54.5 million to target deadly kidney disease

Patients with a life-threatening genetic kidney condition often feel knocked out with an organ that can balloon to 30 pounds. Now a Berkeley biotech startup led by a former 23andMe executive plans to deliver a one-two punch of its own against the disease. Renasant Bio said Thursday it raised a $54.5 million seed round to create oral drugs targeting ADPKD, or autosomal dominant polycystic kidney disease. The condition, which fills the kidneys with cysts, is the leading genetic cause of end-stage kidney failure. Read post
The Renasant team

Renasant Bio launches to develop kidney disease treatment

Renasant Bio has launched with $54.5 million in seed financing to develop treatments for autosomal dominant polycystic kidney disease (ADPKD), which causes severe kidney damage. The financing was led by venture capital firm 5AM VentureManagement, with additional funding from Atlas Venture, OrbiMed, and Qiming Venture Partners USA. Read post
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Synthetic proteins are being built with the help of AI models

Others are taking a slightly different tack. Profluent, in Emeryville, California and EvolutionaryScale, in New York, are building protein-design AI models that resemble not image-generating software, but large language models (LLMs) of the sort that power the world’s chatbots. These firms’ models treat the amino-acid sequences in protein chains like the words in a piece of text—analysing relationships found in zillions of exemplars to design novel useful structures. According to Ali Madani, Profluent’s chief executive, the firm is particularly focused on creating new CRISPR-Cas gene-editing tools. Here, its USP is a curated database of around 5m CRISPR-Cas protein complexes on which its AI model has been trained in order to design new versions. Read post
Aikium receives the Nebius award onstage in the Netherlands

Aikium Wins Nebius AI Drug Discovery Award

Aikium targets “undruggable” proteins comprising half the human proteome using its Yotta-ML² platform. The company has secured partnerships with four organizations, including three top cancer hospitals, based on successful GPCR proof-of-concept work. Read post

Sampling Human Named as One of Top Five Emerging Startups Harnessing Single Cell Sequencing

Sampling Human genetically engineers yeasts to detect and classify specific cells such as cancer cells hidden within millions of other cells. They also allow users to measure RNA and protein levels in the target cells. This has the potential to supercharge liquid biopsies—the ability to detect cancer cells in the blood—by making them faster and more precise. Unlike traditional approaches, it does not require expensive equipment and specialist staff to use. Sampling Human raised $2 million in 2022 in a round led by i&i Biotech Fund to fuel its research and hire new staff. Read post

Cancer-fighting immune cells could soon be engineered inside our bodies

CAR T cells are among the most powerful therapies oncologists have to treat many types of blood cancer. And studies suggest that they might hold promise for brain cancer and other solid tumours, as well as autoimmune and other diseases. One research firm estimates that the value of the CAR-T-therapy market, expected to hit US$11 billion this year, will grow to nearly $190 billion by 2034. But CAR-T therapies come with a serious downside — they are laborious to make and difficult to administer. Some biotechnology companies have an answer: alter T cells inside the body instead...CRISPR–Cas9 pioneer and Nobel prizewinner Jennifer Doudna has co-founded a separate company, Azalea Therapeutics in Berkeley, California, that is developing in vivo CAR T. Read post
Abstract graphic with colored dots in shape of retina

Valitor Presents Multiple Preclinical Datasets on the Potential of its Innovative Anti-VEGF Therapy

“VLTR-559 was developed using our pioneering MVP technology platform and was designed to be an anti-VEGF therapy with increased potency and extended therapeutic duration compared to the current standard-of-care anti-VEGF biologics,” said Wesley Jackson, Ph.D., president and chief scientific officer of Valitor. “Based on our clinical modeling from preclinical results, we anticipate VLTR-559 could enable a twice-yearly dosing regimen for patients with wet AMD, thereby improving long-term outcomes while also reducing the clinical costs required to treat this disease. We are making great progress through IND-enabling activities with the goal of initiating a Phase 1 clinical study next year. Additionally, we are excited by the broader potential of our MVP platform, which is based on our proprietary methods of combining large molecular weight hyaluronic acid biopolymers with diverse active pharmaceutical ingredients to create potent and long-acting drugs.” Read post
Keylika founders, Buddha Chaudhuri, CEO (left) and Frederik Ceyssens, CTO (right)

Keylika Develops World’s First Buccal Patch for Iron Deficiency Anemia

“Most people have no idea how debilitating iron deficiency anemia can be. As a critical micronutrient, iron has a foundational role to play in multiple biological processes in the body down to the cellular level, its uncorrected deficiency has far-reaching consequences,” says Buddha Chaudhuri, Ph.D., CEO of Biotech company, Keylika. After years working on drug delivery and medical devices, Keylika’s team has pioneered what could be a breakthrough solution: the world’s first buccal (oral) patch for treating iron deficiency. Read post

Bootstrapped Indian Startup Innovating Treatment for Eczema, Itch & Beyond

When personal health challenges inspire innovation, remarkable solutions can emerge. Such is the story behind NistuHeal, a breakthrough dermocosmetic product addressing eczema and chronic itch. After suffering from relentless eczema for a decade, Buddhadev "Buddha" Chaudhuri, Ph.D. and CEO of Keylika, turned his scientific expertise toward creating a better treatment. What began as a kitchen experiment has evolved into a successful family-run enterprise delivering relief to thousands across India. Read post