Kiwi company’s stock climbs after US cancer triage rule change. 👨‍🔬 Dunedin-based cancer diagnostics company Pacific Edge (PEB, PEB.AX) shared news on Friday that boosted their stock 130.2% by last night. The boost came from the American Urological Association (AUA), which has set new standard of care guidelines for US patients who present with blood in their urine (microhematuria). Instead of needing an invasive cystoscopy, they’ll now receive a simple urine test produced by Pacific Edge (Cxbladder Triage) that’s able to rule out bladder cancer. 

The diagnostic change could reduce Americans’ need for cystoscopies by up to 59%. Pacific Edge is optimistic the rule change will increase US and global demand for their products.

CAR T-cell therapy Kiwi breakthroughs

A world-class cancer treatment being developed in Aotearoa. 🔬 CAR T-cell therapy is midway through Phase 2 clinical trials. BioOra, the Malaghan Institute of Medical Research and Wellington Zhaotai Therapies are co-developing New Zealand’s first CAR T-cell manufacturing facility for treatment of some cancers for Kiwi patients. CAR T-cell therapy essentially teaches the body’s own immune cells to recognise and attack cancer cells. 

Cancer survivor David Downs, and now Malaghan advocate — who’d been given ‘just months to live’ — paid NZ$1 million to receive CART T-cell therapy in the US. His hope is that Kiwis will be able to get access to the same potentially lifesaving cancer treatment at a fraction of the cost here in Aotearoa.

‘T-cell therapy is basically a type of immune therapy. So immunotherapy is basically using the immune system to fight cancer. I would not be alive today if it wasn't for this treatment,’ — David Downs, Kiwi Yarns podcast, via Stuff

Before investing in biotech, know this. 🧬 To get FDA (Food and Drug Administration) approval, new drug clinical trials in the US are conducted in four phases, which can take up to a decade (a timeline that AI may help to reduce). And for FDA-approved drugs, it can take a further 12-18 months for our own agency, Medsafe, to approve them in New Zealand:

• Phase 1: 20-100 people (both healthy and with the disease/condition), over several months — looks at how the drug interacts with the human body and identifies any side effects; approximately 70% of drugs move to phase 2
• Phase 2: up to 300 people with the disease/condition, several months to 2 years — assesses drug effectiveness and safety; approximately 33% of drugs move to phase 3
• Phase 3: around 1-4 years, up to 3,000 volunteers with the disease/condition — a deeper look at the drug's possible benefits, risks and side effects compared to commonly used treatments; around 25-30% move to the final phase

Phase 4: occurs after the drug has been approved — monitors long-term effectiveness and safety in the general population, and identify any rare or long-term side effects

Cancer treatments are needed, and soon

Around 40% of Americans could be diagnosed with cancer in their lifetime. 🧪 Based on previous years’ data, around 2 million Americans could receive a cancer diagnoses in 2025. Just as it is in New Zealand, breast and prostate cancers are the most diagnosed in the US, with lung cancer being the most deadly. 

Immunotherapy drug Keytruda (also known as Pembrolizumab) can treat specific cancers, including triple negative breast cancer. In New Zealand, Pharmac only recently approved Keytruda funding for a handful of cancers, and only for people with advanced or metastatic cancers. It otherwise costs Kiwis up to NZ$130,000 out of pocket for treatment — and even more in the US.

Is Merck's dominance coming to an end?

Keytruda is a blockbuster drug for Merck. 💰 In 2023, Keytruda sales accounted for approximately 41.6% of Keytruda producer Merck’s (MRK) total revenue — generating around US$25 billion in sales in 2023. This continued into the fourth quarter of 2024, where Keytruda contributed to 45% of Merck's sales — that's US$29.5 billion.

Merck’s Keytruda patent expires in 2028. 🌡️ When Merck’s Keytruda patent expires, it opens the door for competitors to create biosimilar products. Several pharmaceutical companies could be well placed to develop Keytruda biosimilars. But this means they’ll also need to follow the possibly up to decade-long clinical trial phases above, meaning it will likely to be several years before any new drug starts treating cancer patients. And because of Medsafe’s own safeguards and Pharmac's approval process, it might be into the late 2030s before Kiwis could access any successful drugs.

Big Pharma companies that could seek to produce biosimilars may include:

• Pfizer (PFE) — has successfully launched several biosimilars in the market
• Amgen (AMGN) — has a significant presence in the biosimilars market
• Viatris (VTRS) — Mylan is a division in Viatris and has been actively involved in the development and commercialisation of biosimilars
• Novartis (NVS - ADR) — Sandoz is a division of the Swiss company that ‘s one of the pioneers in the biosimilars industry and that has developed a strong pipeline of biosimilar products
• Teva Pharmaceutical Industries (TEVA) — has a growing biosimilars portfolio and is focused on expanding

Small pharma Summit to the rescue?

Could Summit Therapeutics give hope to lung cancer patients? 🩻 Biopharmaceutical company Summit Therapeutics (SMMT) is in phase 3 of clinical trials for a potential treatment, called ivonescimab for cancers that includes non-small cell lung cancer (NSCLC). 

In late November 2022, Summit announced a clinical trial collaboration with China’s Akeso Biopharma (which first developed ivonescimab) to evaluate the efficacy of combining the drug with Akeso's PD-1/VEGF (a bispecific antibody). Lung cancer is the world’s most common and deadliest, and in China, around 1 million people are diagnosed with it each year. In China’s clinical trials, ivonescimab has shown success in preventing tumours from growing for ‘nearly twice as long’ as Ketruda.

Since the partnership announcement, Summit’s stock has surged despite having never released a single drug. Although, the collaboration may face some barriers. Compared to the FDA’s rigorous requirements, China has ‘low cost, high speed trials’, and drugs produced there still face skepticism from the country’s own population.

Other biotech companies are making progress with potential cancer treatments:

• Pfizer (PFE) — has also partnered with Summit Therapeutics to assess the efficacy of ‘Keytruda-challenging ivonescimab’ in combination with Pfizer's antibody-drug conjugates (ADCs). 
• Eli Lilly (LLY) — has partnered with Magnet in a deal potentially worth US$1.25 billion to develop new molecular glues for oncology applications
• Kazia Therapeutics (KZIA - ADR) — has announced a phase 1b clinical trial that combines Paxalisib with Keytruda or Lynparza (which is jointly developed and commercialised by the UK’s AstraZeneca (AZN - ADR) and Merck) for treatment of advanced triple negative breast cancer 

Could DOGE federal cuts impact cancer treatment?

Scientists have raised concerns about cuts to federal grants. ✂️ Trump’s administration has put a funding freeze on the National Institutes of Health (NIH) from reviewing new research grant applications, estimated to be worth US$1.5 billion — the news sending ‘a wave of panic through the scientific community’. The NIH has been an important funding resource for some of America’s most prominent universities, particularly those engaged in cancer-fighting T cell research.

‘This is a huge cut. Johns Hopkins Medical School would lose $200 million a year. It’s not a viable enterprise to do science.’ — Rick Huganir, neuroscientist at Johns Hopkins University, NBC News

Zoomin’ in on Iowa. 🐖 Red state Iowa is America’s largest pig producer; it also has the second-highest cancer rates. Now health cuts may be impacting cancer prevention and treatment access in rural areas — impacting the  roughly 2.7 million people living rurally or in small towns in Iowa (just half a million Iowans live in the state’s five largest cities. 

Job cuts have also eaten into the CDC (Centers for Disease Control and Prevention), and in Iowa this has impacted roles including its Public Health Associate Program for graduates, who do work like giving cervical cancer vaccines in rural Iowa.

‘It's not just the funding, it's the talent they're bleeding, because you can't get anything done without the talent.’ — Mark Burkhard, director of the Holden Comprehensive Cancer Center at the University of Iowa, NPR

Advancements in CAR T-cell therapy, and the potential future of Keytruda immunotherapy biosimilars shows cancer treatment and diagnostics is advancing as quickly as regulations allow, offering hope for accessible treatments for people with cancer worldwide.

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