Aleth

Open access research

ALETH / LIFESCI-BRIEF / 2026-10-30 / FORMATION BIO LAUNCHES $600M AI DRUG FUND

Formation Bio launches $600m AI drug fund

Also this week: Anthropic’s IPO filing reveals its own drug-discovery lab, Amgen’s Imdelltra cuts lung cancer death risk by 58%, Lilly’s retatrutide beats Ozempic & the FDA drafts rules for bespoke gene editing.

The Aleth Briefs link to the sources behind the stories and show how the week unfolded.

The week in five lines:

Browse by day:

Weekend catch-up

Bristol Myers Squibb disclosed a patient death in its phase 1 trial of the CAR-T therapy zola-cel in multiple sclerosis.

The patient developed neurological symptoms after infusion and died of septic pneumonia 44 days later, the day after receiving high-dose cyclophosphamide. No other deaths have been reported among 190 patients treated in zola-cel’s autoimmune trials. BMS said the event was unrelated to its earlier decision to pause enrolment over a separate safety signal, which it says it has now identified. It is working with regulators to restart trials.

Tempus AI signed $192.5m in data agreements with Bristol Myers Squibb and Pathos AI, alongside a $237m financing for Pathos led by BMS.

BMS will pay Tempus $137.5m for wider access to oncology data, while Pathos will pay up to $55m for records of 500,000 patients with Alzheimer’s disease and other neurological conditions. Pathos will use the data with its AI drug-development platform, which BMS has also licensed. The agreements run for approximately five years. Pathos’s financing valued the company at about $3bn.

Hengrui’s trastuzumab rezetecan more than doubled progression-free survival against chemotherapy in HER2-low breast cancer.

In the 551-patient phase 3 HORIZON-Breast06 trial in China, published in JAMA and presented at ESMO, median progression-free survival was 16.4 months against 6.8 (HR 0.27), with benefit in both hormone receptor-positive and -negative disease. Severe treatment-related side effects, mostly low blood counts, hit 84.1% of patients against 67.9% on chemotherapy, and half needed a dose cut.

Further phase 3 data on Moderna and Merck’s melanoma vaccine showed overall survival remains immature.

In INTerpath-001, intismeran autogene plus Keytruda reduced recurrence or death by 42% and distant metastasis or death by 38%. The overall survival hazard ratio was 0.77 (p=0.33), not yet statistically significant, and follow-up continues. The vaccine was manufactured for more than 99% of patients assigned to receive it, with no deaths attributed to the vaccine.

Amgen’s Imdelltra cut the risk of death by 58% as first-line maintenance in small cell lung cancer.

In the phase 3 DeLLphi-305 trial in extensive-stage disease, presented at ESMO on Saturday and published in NEJM, adding Imdelltra (tarlatamab) to AstraZeneca’s Imfinzi (durvalumab) extended median overall survival to 21.1 months from 12.7 on Imfinzi alone. Nearly 80% of patients on the combination were alive at one year, against 53%. Amgen is sharing the results with regulators worldwide.

Roche’s divarasib cut the risk of death by 44% against a pooled control of the two approved KRAS G12C drugs.

In the phase 3 Krascendo 1 trial in previously treated KRAS G12C-mutated non-small cell lung cancer, presented at ESMO on Sunday and published in NEJM, median overall survival was 17.7 months on divarasib against 12.0 in the control arm, where 156 patients took Amgen’s Lumakras (sotorasib) and 15 took Bristol Myers Squibb’s Krazati (adagrasib). Median progression-free survival was 9.8 months against 5.7. Fewer patients stopped divarasib because of side effects: 4.8% against 11.7%.

AstraZeneca reported significant survival benefits in two phase 3 lung and gastric cancer trials at ESMO.

In SAFFRON, Tagrisso plus Hutchmed’s Orpathys (savolitinib) cut the risk of death by 32% against chemotherapy in EGFR-mutated non-small cell lung cancer that had become MET-driven on Tagrisso (median 17.8 against 12.9 months), and the risk of progression or death by 45%. Hutchmed said a US application has been filed.

In CLARITY-Gastric01, the antibody-drug conjugate sonesitatug vedotin cut the risk of death by 53% in third-line and later Claudin 18.2-positive gastric cancer (10.0 versus 5.0 months). The reduction was 42% across all patients treated in second line or later, although the other primary endpoint, progression-free survival, missed significance.

Monday 26 October

BioNTech/DualityBio’s HER2 ADC gave only a modest benefit over chemotherapy in a phase 3 trial in hormone receptor-positive, HER2-low breast cancer.

DYNASTY-Breast02 met its progression-free survival endpoint, but interstitial lung disease was more common than in earlier trials, with some severe and fatal cases. The partners said the benefit to patients is limited and that they will decide next steps.

Abbott launched a whole-genome version of its Oncodetect molecular residual disease (MRD) test for solid tumours.

The tumour-informed blood test tracks up to 5,000 patient-specific variants, against 200 previously, and uses MAESTRO technology to achieve a 30-fold improvement in its analytical detection limit. In colorectal cancer data presented at ESMO, sensitivity for recurrence within two years improved to 72.2% from 42.2%, using a single post-surgical blood sample. Oncodetect came with Abbott’s $21bn acquisition of Exact Sciences in March, giving it an established position in the rapidly growing cancer diagnostics market.

The FDA approved Pfizer’s Talzenna plus Xtandi for HRR gene-mutated metastatic hormone-sensitive prostate cancer.

In the phase 3 TALAPRO-3 trial, the combination cut the risk of radiographic progression or death by 52% against Xtandi plus placebo. Overall survival data remain immature, and severe anaemia occurred in 51% versus 3% of patients. The combination was approved in castration-resistant disease in 2023.

Keytruda alone beat carboplatin-paclitaxel chemotherapy as first-line treatment for mismatch repair-deficient endometrial cancer in a phase 3 trial.

In KEYNOTE-C93, presented at ESMO and published in The Lancet, median progression-free survival was 38.2 months on Keytruda against 8.4 on chemotherapy. Overall survival favoured Keytruda numerically but not significantly, with 85.2% of patients progressing on chemotherapy subsequently receiving immunotherapy. Severe treatment-related adverse events were less frequent (18% versus 51%). The trial did not compare Keytruda alone with the current standard of chemotherapy plus immunotherapy.

Anthropic’s IPO filing revealed an expanding drug-discovery operation, including its own molecular biology lab.

In the S-1 it filed with the SEC on Monday, Anthropic says it has acquired Coefficient Bio, hired industry experts, built a molecular biology lab and developed AI agents to support drug development. In a separate update on Tuesday, Anthropic reported early results from six collaborations with pharmaceutical and biotechnology partners, including experimental antibody engineering and an 89% reduction in manufacturing-document review time at Enveda. It is also pursuing its own drug-discovery programmes for rare childhood muscular dystrophies. Most work remains preclinical.

Tuesday 27 October

Novartis took a $1.9bn impairment on del-desiran after it missed its primary endpoint in phase 3.

Del-desiran came with Novartis’s $12bn acquisition of Avidity in February. The drug missed its primary endpoint of video hand opening time in the phase 3 HARBOR trial in myotonic dystrophy type 1, despite activity on secondary measures. The impairment helped cut reported Q3 operating income 61% to $1.8bn, while core operating income rose 10%, sales grew 4% to $14.5bn, and full-year guidance was raised. CEO Vas Narasimhan said Novartis may launch new drugs in Europe’s private or self-pay markets because of US most-favoured-nation pricing, Endpoints reported.

The European Commission approved Enhertu after surgery for HER2-positive early breast cancer with residual disease.

It is Enhertu’s first EU approval in early breast cancer. In the phase 3 DESTINY-Breast05 trial, Enhertu cut the risk of invasive recurrence or death by 53% against Kadcyla. At three years, invasive disease-free survival was 92.4% versus 83.7%.

Artiva abandoned its NK cell therapy after two trial deaths and disappointing response durability, and will cut 94% of its staff.

Artiva stopped developing AlloNK, an allogeneic natural killer cell therapy given with Rituxan in rheumatoid arthritis and other autoimmune diseases. One trial participant died of leukoencephalopathy assessed as likely fludarabine toxicity, and a second death was judged unrelated. Longer-term durability also fell short of Artiva’s threshold. The company reported cash equivalents of ~$319m at 30 September, and is weighing liquidation options. Its board approved the wind-down on 22 October.

Ferring Pharmaceuticals agreed to buy fertility start-up Gameto in a deal worth up to $1.4bn.

Gameto’s Fertilo uses stem cell-derived ovarian support cells to mature eggs outside the body, potentially shortening IVF cycles and reducing the need for hormone injections. It is available in Australia and parts of Latin America and is in phase 3 in the US. The acquisition value depends on development, regulatory and commercial milestones, with no upfront payment disclosed. The deal has yet to close.

The FDA issued draft guidance on how individualised gene-editing products can be approved.

Sponsors could submit multiple patient-specific variants in one biologics licence application (BLA) and add new variants after approval, potentially without further clinical trials. The proposed framework could make treatments for ultra-rare genetic diseases more commercially viable by allowing regulatory evidence to be shared across variants of a therapy.

Wednesday 28 October

Eli Lilly’s retatrutide beat Novo Nordisk’s Ozempic (semaglutide) on blood sugar and weight loss in a phase 3 trial in type 2 diabetes.

In the 1,298-patient TRANSCEND-T2D-2 trial, retatrutide reduced HbA1c by 2.2 percentage points against 1.8 on Ozempic 2 mg at 80 weeks. Weight loss was 19.5–20.9% versus 9.4%. Discontinuations due to side effects were higher at 4.8–7.9% versus 2.7%. Retatrutide remains unapproved, and detailed results have yet to be published.

Formation Bio launched a $600m fund to license stalled drug programmes and develop them with AI.

The Formation Bio Drug Development Accelerator Fund will license phase 1 and 2 drug programmes into separate companies, each supported by Formation’s clinical development teams and AI systems. Partners may receive upfront payments and retain a share of future milestones and royalties. Chief executive Ben Liu told Forbes the fund aims to advance 10 to 15 programmes over three to five years.

Investors include research foundations, endowments and hospitals. The structure gives Formation access to development capital without diluting shareholders in the parent company. Formation has separately raised $615m at a reported $1.8bn valuation. Whether its AI-enabled development model can improve clinical productivity at scale remains to be demonstrated.

The US Department of Homeland Security added BGI Group, BGI Genomics and MGI Tech to its Uyghur Forced Labor Prevention Act entity list.

DHS alleges that the Chinese genomics companies’ genetic-testing activities supported forced-labour programmes in Xinjiang. Goods produced by listed entities are presumed to involve forced labour and are barred from US import unless that presumption is rebutted. BGI Genomics denies the allegations. The restrictions could further constrain MGI’s ability to compete with Illumina in the US sequencing market.

Thursday 29 October

Dren Bio raised $350m to fund late-stage development, regulatory submission and a planned launch of its lead antibody dibotatug.

Juvia Group and Lightspeed Venture Partners co-led the round. Dibotatug targets CD94 to selectively deplete pathogenic cytotoxic cells and is being developed for cytotoxic T-cell lymphoma and large granular lymphocytic leukaemia, two rare blood cancers with no specifically approved therapies. Dren previously received $600m upfront from Sanofi for a separate B-cell depletion programme.

Eli Lilly’s Q3 revenue rose 39% to $24.4bn, and it raised 2026 guidance to $91bn-$92bn.

Mounjaro (tirzepatide) revenue rose 65% to $10.7bn, while US sales of Zepbound, its obesity brand, rose 48% to $5.3bn. Together, the two brands accounted for approximately two-thirds of Lilly’s revenue. The new guidance range lifts the midpoint by $5.5bn (6%), although quarterly revenue benefited from approximately $900m in milestone payments and favourable rebate adjustments.

Friday 30 October

Bambusa Therapeutics and Aspen Neuroscience priced Nasdaq IPOs expected to raise $168.9m and $140.6m.

Bambusa, which develops long-acting bispecific antibodies for inflammatory diseases, upsized its offering to 10.6m shares at $16, the midpoint of its range. Aspen, which is developing induced pluripotent stem cell-derived therapies for Parkinson’s disease, priced 9.4m shares at $15, the bottom of its range. Both are scheduled to begin trading on 30 October, with the offerings expected to close on 2 November.

Born on Substack · read and comment there