The month ahead: January’s upcoming events

The JP Morgan healthcare conference in January is usually accompanied by a flurry of biotech deals, and investors will be hoping for some big-bucks M&A after a relatively quiet 2024. But, if the trend towards buying inexpensive Chinese assets continues, the markets might be disappointed.

Meanwhile, several FDA approval decisions are expected, including calls on Amgen’s Lumakras in colorectal cancer, and AstraZeneca/Daiichi’s datopotamab deruxtecan in breast cancer. One event no longer expected is an EU verdict on dato-dxd's filing for lung cancer, which Astra and Daiichi have just withdrawn, mirroring the action they took with the FDA in November.

Readouts could also come from Kura/Kyowa Kirin’s menin inhibitor ziftomenib, and MacroGenics’ troubled ADC vobramitamab duocarmazine (vobra-duo).

JPM flurry?

The run-up to JP Morgan 2024 saw several transaction: AstraZeneca bought Gracell for $1bn, Johnson & Johnson spent $2bn on Ambrx, and Merck & Co speared Harpoon for $680m. But nothing came close to Bristol Myers Squibb’s $74bn swoop for Celgene, or even Lilly’s $8bn purchase of Loxo, both in January 2019.

The rest of 2024 has followed a similar pattern, with no $10bn-plus cancer deals, according to OncologyPipeline. Indeed, the biggest up-front fee was the €2.7bn that Novartis paid for MorphoSys in February – a purchase that has since gone south.

Investors will hope for more in 2025, but the current trend is for US players to pick up Chinese assets at relative bargain prices; see, for example, Merck’s $588m move for LaNova’s anti-VEGF x PD-1 MAb.

Readouts

A company that was once talked about as an acquisition target is Kura, which disappointed the markets by licensing its menin inhibitor ziftomenib to Kyowa Kirin in November. 

That project is due data in early 2025 from the Komet-001 trial in NPM1-mutant relapsed/refractory AML. If ziftomenib can continue to avoid the side effect of QTc prolongation it could have an edge over Syndax’s similarly acting Revuforj, which recently disappointed in NPM1m disease.

And Allogene could report initial results with its allogeneic CD19 Car-T in chronic lymphoblastic leukaemia – an indication that’s seen a recent renaissance.

MacroGenics, meanwhile, still has hopes for its B7-H3-targeting ADC vobra-duo, despite having to stop dosing in the phase 2 Tamarack trial in metastatic castration-resistant prostate cancer. The last update saw eight treatment-related deaths.

Mature median radiographic PFS data, due “no later than early 2025”, could be key to determining whether the project has a future against all the odds. In the meantime MacroGenics, whose chief executive, Scott Koenig, is stepping down next year, has halted efforts in other tumour types.

Also facing a make-or-break readout is MaaT Pharma, which in January will finally report topline data from the uncontrolled phase 3 Ares trial of MaaT013, an enema-delivered product containing faecal microbiota from healthy donors. 

The study is in late-line acute graft-versus-host disease, and MaaT hopes to see a gastrointestinal ORR of at least 40%. However, the company only has enough cash to last until the second quarter of 2025, so a fund-raising could be on the cards.

FDA rulings

Meanwhile, January should see an approval decision on Amgen’s KRAS G12C inhibitor Lumakras plus Vectibix in relapsed colorectal cancer – this had originally been expected in October, but was extended by three months so the FDA could review supplemental data. Amgen is behind Bristol Myers Squibb, whose Krazati (plus Erbitux) got an accelerated nod in second-line CRC in June.

And it could be a nervous Christmas for Astra and Daiichi, as they await an FDA ruling on their TROP2-targeting ADC datopotamab deruxtecan in second-line breast cancer. The project failed to show an overall survival benefit in breast and lung cancers, and in NSCLC the companies recently switched focus, to EGFR-mutant disease.

A narrowed focus on non-squamous NSCLC couldn't rescue dato-dxd's US filing, which was pulled last month, and now the same has happened to the corresponding EU application. However, during its third-quarter earnings call Astra said the timeline in breast cancer remained unchanged, and this also remains the case in the EU. 

January’s upcoming events

Source: OncologyPipeline.