Biotech, in brief

The FDA, the US drug regulator, has widened the use of Tukysa, a pill for HER2-positive breast cancer, to the first round of treatment for cancer that has spread. [1]

HER2-positive means the cancer cells carry too much of a protein called HER2, which pushes them to grow. Drugs that block HER2 have made it a highly treatable cancer. [3]

Tukysa will be taken with two antibody drugs, Herceptin and Perjeta, as a follow-on treatment with no chemotherapy in it. [1]

That follow-on comes after a first stretch of treatment that includes chemotherapy. Until now, the follow-on was usually Herceptin and Perjeta alone. [2]

In a final-stage trial, adding Tukysa cut the risk of the cancer growing, or of death, by 36% compared with Herceptin and Perjeta alone. [1]

The extra pill had a cost: more diarrhoea and more signs of liver strain in blood tests. Whether it helps people live longer is not yet known. [2]

Tukysa first reached patients in 2020, for cancer that kept growing after other HER2 drugs. It was developed by Seagen and is now sold by Pfizer. [1]

In that first trial, the time before the cancer grew went from 4.9 to 7.6 months, and average survival from 19.2 to 24.7 months. [2]

The cancer spreads to the brain in 30% to 50% of people whose HER2-positive cancer has spread. Pills of Tukysa's kind can reach the brain. [2]

In its first trial, almost half the patients had cancer in the brain. In them, Tukysa slowed new brain tumours and lengthened life. [2]

Doctors now choose between two ways to start: chemotherapy then a follow-on, or a newer drug, Enhertu, given without stopping. The best order is still unsettled. [2][3]

Why it matters. The next test is whether women given Tukysa in the follow-on live longer, which the trial has not yet shown. [2]

Shares of Revolution Medicines fell 6% on Thursday after the FDA published its review of Rasonque, the company's pancreatic cancer pill. [1] The FDA approved Rasonque in August because it nearly doubled survival against chemotherapy, in patients whose cancer had grown despite earlier chemotherapy. [1] The review showed tumours shrank far more often in patients with one change in the KRAS gene, called G12V. [1] The gain was smaller with the G12D change, which is the commonest in pancreatic cancer, and worse with G12R. [1]

Why it matters. G12D patients are the largest group with pancreatic cancer, so the overall result says less about what they can expect. [1] One analyst said rivals building drugs aimed only at G12D now have an opening, while others called the share fall an overreaction. [1]

Africa CDC, the African Union's health agency, has traced the six-week journey of Kenya's first Ebola patient, a 40-year-old businessman. [5] He was treated in Congo for a skin infection and given antibiotics, but never tested for Ebola. [5] He then crossed into Uganda and passed airport temperature checks in Uganda and Kenya. [5] He died in Nairobi on 5 October, and Kenya has found 66 people he may have met there. [5]

Why it matters. More than 4,000 people have died of Ebola in Congo this year, the second deadliest outbreak known. [5] A temperature check misses a patient whose fever is down, and investigators are asking whether his medicines lowered it. [5]

Endeavor BioMedicines, a US company, said its pill taladegib met its main goal in a mid-stage trial of 213 people with idiopathic pulmonary fibrosis. [4] In that disease, the lungs scar and stiffen for no known cause. [4] After 24 weeks, people on taladegib could breathe out more air than those on a dummy pill. [4] The two drugs sold now, Boehringer's Ofev and Roche's Esbriet, only slow the decline. [4] Serious side effects were similar in both groups. [4]

Why it matters. Endeavor says it could be the first drug to reduce the scarring, not just slow it. [4] The company has not released the numbers, which it is keeping for a future medical meeting, and next must agree a final-stage trial with the FDA. [4]

Just over 71,000 people in South Africa had received lenacapavir by 5 October, health department figures show. [6] Lenacapavir is an injection given every six months that almost completely protects HIV-negative people from catching the virus. [6] It has been offered free at 360 government clinics since June, and cheaper copies arrive next year. [6] Researchers at Wits University estimate that one to two million people taking it each year would end AIDS as a public health threat. [6]

Why it matters. The daily HIV prevention pill, equally effective, reached only 2.3 million of about 40 million people who could benefit. [6] A 2022 survey found only a third of sexually active South Africans had heard of it. [6]

Cochrane, a group that pools medical trials, updated its review of ways to quit smoking. [19] It now covers 80 trials and 29,861 people, nine trials more than before. [19] Nicotine vapes helped about 4 more people in every 100 quit than nicotine patches or gum. [19] The reviewers called that evidence high-certainty, and found no sign that vaping to quit raised the risk of serious harm. [19]

Why it matters. Smoking kills more than seven million people a year, the WHO estimates. [19] The finding covers regulated nicotine vapes only, and longer-term research on vaping is still needed. [19]

The share of US adults with obesity fell from 39.9% in 2022 to 36.4% this year, Gallup figures cited in a Fortune commentary show. [22] About one in nine US adults now takes a weight-loss drug such as Wegovy or Zepbound. [22] Prices that topped $1,000 a month last year now start at $149. [22] In India, copies sold for under $14 a month after patents there ran out this year. [22]

Why it matters. The commentary credits the drugs for most of the fall, but the survey alone cannot show what caused it. [22] Patents on Wegovy in the US run into the early 2030s. [22]

Researchers studied more than 2,246 healthy schoolchildren in Mfou, Cameroon, and the malaria parasites inside them. [16] Children carrying one copy of the sickle cell gene, called sickle cell trait, caught malaria as often as others. [16] But they carried a different variety of the parasite, and were about a tenth as likely to fall ill. [16] Two copies of the gene cause sickle cell disease; one copy protects against malaria. [16]

Why it matters. It suggests the trait protects partly by deciding which parasites can survive in a person. [16] The lead researcher, Sandrine Nsango, said humans shape the parasite's evolution in return. [16]

A team at Washington University in St Louis and King's College London studied 12.4 million immune cells from over 2,600 adults aged 20 to 90. [17] They found that the balance between two kinds of immune cell shifts with age, and shifts differently in different people. [17] In 50,000 UK Biobank volunteers, a lean toward one kind went with more deaths, and more diabetes and kidney failure, ten years later. [17]

Why it matters. It may explain why two people born the same year age so differently. [17] The team is now turning the finding into a simple blood test. [17]

GSK, a British drugmaker, will use Chai Discovery's computer models to design antibodies, proteins that latch onto a chosen target. [7] GSK signed after its own laboratory tested Chai's designs and found ones that stuck to every target tried. [7] Chai, based in San Francisco, already works with Bristol Myers Squibb, Eli Lilly, Novartis and Pfizer, and raised $400 million this year. [7]

Why it matters. Five big drugmakers now use Chai's models. [7] Chai's designs have not yet been proven in patients, because drug development takes years. [7]

A study of health records from 67 US health groups linked weight-loss drugs like Wegovy to a higher risk of hair loss. [20] A smaller study presented in Austria found 66% of users reported at least one nail problem, but nail problems were common in non-users too. [20] About 11% of Americans now take one of these drugs for weight loss, up from 3% in 2024, a Gallup poll found. [20]

Why it matters. These studies show a link, not proof that the drugs cause the problem. [20] Prescriptions for US children aged 8 to 11 rose 310-fold between 2019 and 2026, and data on side effects in children is thin. [20]

An Australian patient group asked Australia's government to pay for weight-loss drugs for people with PMOS, a lifelong hormone condition. [21] PMOS, formerly called polycystic ovary syndrome, affects one in eight women and raises the risk of type 2 diabetes. [21] Doctors already prescribe the drugs for it without approval for that use, and patients pay several hundred dollars a month. [21]

Why it matters. Australia does not pay for these drugs in PMOS, and a doctors' spokesperson said that may never happen. [21] Another patient group said more research is needed on long-term safety in PMOS. [21]

Eli Lilly released new results from a trial giving people with obesity and psoriasis, an immune disease of the skin, both its skin drug Taltz and its weight-loss drug Zepbound. [8] The pair cleared skin and cut weight more than Taltz alone by week 36. [8] The new analysis found the pair changed 482 blood proteins against 140 with Taltz alone. [8]

Why it matters. Lilly says it points to links between body fat and skin inflammation. [8] The analysis was exploratory, and patients in the trial knew which drugs they were given. [8]

A first trial in people of roginolisib, an experimental pill, was published in Nature Communications. [13] It gave the drug to 44 patients, 20 of them with a cancer that starts in the eye and spreads. [13] Severe side effects hit 3 of the 44. [13] Patients with the eye cancer lived a median 18.4 months. [13] A second paper showed the drug locks its target enzyme in an off position. [14]

Why it matters. The trial had no comparison group, so it shows the drug is safe enough to test further, not that it works. [13] The second paper explains how it hits only one of several closely related enzymes. [14]

Researchers published a method in Nature Chemical Biology for finding why some experimental prostate cancer drugs harm the liver. [15] The drugs belong to a new kind, called degraders, that make the cell destroy a chosen protein. [15] A computer model trained on protein readings from cells traced the harm to the cell's power supply. [15] A small change to one part of the molecule made it gentler on the liver and still active against prostate tumours in mice. [15]

Why it matters. Degraders can remove proteins that ordinary drugs cannot block, but their two-headed shape brings harms of its own. [15] The work so far is in cells and mice. [15]

A team led by the University of Oxford filmed the enzyme that builds the ring at the heart of penicillin as it works. [18] They used powerful X-ray lasers to follow the reaction as it happened, instead of studying still pictures. [18] They caught short-lived steps never seen before, including the moment the first ring forms. [18]

Why it matters. Knowing exactly how the enzyme works could help chemists design new antibiotics. [18] Professor Christopher Schofield said this matters as resistance to existing antibiotics keeps rising. [18]

Ultragenyx, a US rare-disease company, sold a priority review voucher for $210 million on Wednesday. [1] The FDA awards such a voucher with some approvals, and a buyer can use it to get a faster review of another drug. [1] Ultragenyx earned this one with Glenglycos, a gene therapy for a rare disease in which the body cannot use stored sugar, and holds a second. [1]

Why it matters. The money comes a month after Ultragenyx said it would consider cuts, when its Angelman syndrome drug failed. [1] The buyer was not named, so whose drug gets the faster review is unknown. [1]

TRex Bio raised $116.7 million selling shares on the Nasdaq exchange, at $14, the bottom of its range. [10] TRex makes drugs to calm an overactive immune system by switching on regulatory T cells, the body's own brakes. [9] Its first results in eczema are due in mid-2027. [10] Retension, which is testing a blood pressure pill, raised $45 million, more than planned. [10]

Why it matters. Eli Lilly owned about 24% of TRex before the sale. [9] They are among 23 drug developers to list on the stock market this year. [9]

A closely watched index of biotech shares more than doubled in the year to August, then went sideways. [11] Analysts blamed weak trial results, rising interest rates and worry about the US midterm elections. [11] Meanwhile big companies bought 26 private biotechs this year, against 21 listed ones. [11] The median price for a startup rose from $496 million in 2023 to $1 billion. [11]

Why it matters. Startups that waited out the slump now have trial data to sell. [11] One analyst said buyouts usually pick up after a slow summer. [11]

Matchpoint Therapeutics, a startup near Boston backed by Sanofi, raised $150 million. [12] It is building pills that bind to their target permanently, aimed at immune diseases. [12] Its lead drug, MPT-062, should start human trials next year. [12] Novartis paid it $60 million earlier for an option on another drug idea. [12]

Why it matters. Its lead drug has not yet been tested in people, so the money pays for its first human trials. [12]

TCGX, a US biotech investor, closed a $600 million fund for biotech companies in Asia on Wednesday. [1] It is opening offices in Shanghai and Hong Kong. [1] The fund will run alongside two TCGX funds that back biotechs in the US and Europe. [1]

Why it matters. It is more money aimed at Asian drug companies. [1] The firm said only that a mix of international institutions put up the money, without naming them. [1]

Russia's public health agency, Rospotrebnadzor, said on Thursday that reports of a second person falling ill after contact with a dead lab worker were fake. [23] The 28-year-old worked at a plague research institute in Irkutsk, Siberia, and died on 2 October. [23][24] The agency says testing found none of the germs she worked with, and a safety check found no accidents at the institute. [23] It says nearly 5,000 tests found no dangerous germs among her contacts. [24]

Why it matters. The WHO said on Wednesday that it still does not know what killed her, and asked Russia for more information. [23] Plague that reaches the lungs can spread from person to person, which is why one death drew this much concern. [24]

Researchers analysed 1,543 samples of breast milk from three groups of mothers, two of them in randomised trials, in a study published in Science. [25] They measured the milk's proteins, fats, sugars, vitamins and other small molecules. [25] In the trials, giving mothers extra nutrition helped babies who had fallen behind in growth to catch up. [25] A computer model picked out seven markers in milk that show how well the breast is making it. [25]

Why it matters. High levels of one molecule, valerylcarnitine, and low levels of vitamin B5 were linked to how the babies grew. [25] The authors say the effect of a mother's own diet on her milk has often been played down in rich countries. [25]