The Bio Report

There’s been a stunning lack of innovation around male contraceptives when it comes to the area of male contraceptives. Men have the choice between a vasectomy, a procedure innovated in the 19th century, or condoms, which date back to at least King Minos in Crete in 3000 BCE. Next Life Sciences is hoping to change that with its Plan A, an experimental hydrogel that is injected into the vas deferens and provides a barrier that prevents sperm from passing. Plan A, which is regulated as a medical device, is expected to be easily reversible. We spoke to Darlene Walley, CEO of Next Life Sciences, about Plan A, the need it is addressing, and why she expects men and women to see it as a welcome alternative to current choices.

There have been great advances in the treatment of hepatitis C with the advent of curative therapies, but hepatitis B has proven far more elusive. That’s due to differences in the way the virus replicates and how it creates a reservoir of viral DNA in the cells in the liver. nChroma Bio, the result of a merger between Chroma Medicine and Nvelop Therapeutics, thinks it has an answer. It’s developing a one-and-done epigenetic editing therapy that silences hepatitis B viral transcription. We spoke to nChroma Bio chief development officer Jenny Marlowe and chief scientific officer Melissa Bonner, about its experimental epigenetic editor for hepatitis B, the merger that brought together the two companies, and how it plans to leverage Chroma’s epigenetic editing platform with Nvelop’s programmable non-viral delivery technologies in future therapies.

While AI has been seductive in its promise for revolutionizing drug development, one of the constraints remains the quality of the data that is used by any given platform. BPG Bio, an early innovator in the application of AI to drug development as Berg, is taking what it calls a “biology-first” approach. It capitalizes on its proprietary biobank to conduct multi-omics analysis to understand the biological mechanisms of diseases. We spoke to Niven Narain, CEO of BPGbio, about how the company’s platform technology uncovers novel targets, its evolution from its start as Berg, and how the platform continues to provide insight into experimental therapies after they advance to the clinic.

Despite the market success of GLP-1 agonists to treat obesity, many patients suffer side effects such as nausea, diarrhea, and vomiting. These medicines also cause significant loss of muscle mass. And when someone discontinues use, they often regain the weight they lost. Skye Bioscience is developing nimacimab, an experimental therapy that has the potential to induce weight loss by inhibiting the CB1 receptor. Because of its different target, it may be able to be used in conjunction with GLP-1 agonists and lower the dose of those drugs to make them more tolerable, or combined with other therapeutic approaches. We spoke to Punit Dhillon, president and CEO of Skye Bioscience, about CB1 as a target for treating obesity, its experimental therapy nimacimab, and the potential to combine it with GLP-1 agonists and other therapeutic approaches.

Many companies are seeking to develop non-opioid treatments for pain, but Persica Pharmaceuticals may be taking a surprising approach for chronic low-back pain. The company’s lead experimental therapy for the condition is an antibiotic. That may sound odd, but it turns out that about half of chronic low back pain cases are due to bacterial infections that occur after herniation of the spinal disc or injury. We spoke to Steve Ruston, CEO of Persica Pharmaceuticals, about the need for new approaches to chronic low back pain, the company’s experimental targeted intradiscal antibiotic injections, and the need to educate physicians about the role infection can play in the condition.

Though there are plenty of therapeutic alternatives for asthma and chronic obstructive pulmonary disease, or COPD, there are no approved biologics for treating acute exacerbations of these conditions. Connect Biopharma believes that’s an opportunity. It's experimental therapy rademikibart has shown promise treating exacerbations and providing sustained improvements. We spoke to Barry Quart, CEO of Connect Biopharma, about the unmet need the company is seeking to address, how rademikibart works, and Connect’s repositioning as a U.S.-centric company.

When Vanderbilt University Medical Center began to consider how big data and precision medicine were going to impact both research and development and clinical care, it struck on the idea of building a large-scale biobank and tying it to its store of millions of electronic health records. That ultimately led to the founding of Nashville Bioscience, a for-profit subsidiary of the medical center. We spoke to Leeland Ekstrom, co-founder and CEO of NashBio, about the company’s data collection methods, the significance of the alliance it's developed with leading biopharmaceutical companies, and how it's enabling a transformation of drug development with data.

Spirulina, also known as blue-green algae, is edible. It can be engineered to cost-effectively produce biologics that can be taken orally. Though people have long sought to do this, Lumen Bioscience has developed platform technology that solved the various challenges is engineering spirulina to produce medicines. We spoke to Brian Finrow, co-founder and CEO of Lumen, about the company’s platform technology, why it makes possible the pursuit of biologics for indications that were previously not practical, and the potential to make these advanced therapies affordable and accessible in parts of the world where people may not have widely enjoyed their benefits.

Cancer is a global disease, and BeOne Medicines believes it should develop its cancer therapies for global markets. To do so, it’s taking innovative approaches to clinical trials, pricing, and manufacturing to enable it to support patients not only in high-income countries but also in low- and middle-income countries. We spoke to Matt Shaulis, general manager of North America for BeOne Medicines, about the significant global disparities in cancer care, the mission of BeOne Medicines to improve access and affordability to therapies, and the opportunities and challenges of taking a global approach to marketing innovative medicines.

The advent of immunotherapies is transforming cancer care. While early efforts have focused on enabling T cells to attack cancers, Myeloid Therapeutics is developing next-generation immunotherapies that use mRNA to train myeloid cells to attack cancer. We spoke to Daniel Getts, founder and CEO of Myeloid Therapeutics, about the limitations of existing immunotherapies, the role myeloid cells play in the immune system, and the benefits of the company’s therapeutic approach.