Biopharma Week in Review
We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A. Morphic Holding, Inc. (MORF) agreed to be acquired by Eli Lilly and Co. (LLY) for $3.2 billion or $57/share in cash, with value primarily driven by lead drug MORF-057, an oral a4ß7 integrin inhibitor, in Phase 2s for inflammatory bowel disease (IBD). MORF-057 looks to compete against injectable biologics in the large UC and Crohn’s markets, aiming for similar efficacy, better safety, and oral convenience. Morphic’s novel drug shares the same target as Takeda’s Entyvio, a successful anti-a4ß7 antibody. MORF was up 75% last Monday. IDEAYA Biosciences, Inc. (IDYA) reported robust IDE397 (MAT2A inhibitor) Phase 2 expansion dose data in MTAP-del 2L+ urothelial cancer and NSCLC (n=18). IDE397 showed 39% ORR (1 CR and 6 PRs), 94% DCR, and 78% with tumor shrinkage. Efficacy easily exceeded the single arm monotherapy hurdle of 15% ORR for clinical activity, with a CR providing further support of antitumor benefit. Safety was highly benign for a cancer drug, with 1 drug-related Gr3 AE (5.6%) of asthenia, no drug-related SAEs, and no drug-related discontinuations. Three cases of low-grade peripheral neuropathy are worth watching. Results suggest an accelerated regulatory path is possible with monotherapy. IDYA was up 15% last Monday. uniQure N.V. (QURE) provided updated AMT-130 Phase 1/2 data in Huntington’s with 21 patients (12 low and 9 high dose) at 24-month follow-up. Using a propensity-weighted external control, post-hoc analysis showed high-dose AMT-130, an mHTT gene therapy, had a significant 80% reduction in cUHDRS decline (-0.2 versus -1.0 control), with a nominal p=0.007. While prior data updates had sham control and natural history as comparators, AMT-130 was granted FDA RMAT designation with the external control analyses. Investor enthusiasm was driven by a possible FDA buy-in of an external control for pivotal data and potential accelerated pathway using NfL, a disease biomarker. QURE was up 76% on Tuesday. HilleVax, Inc. (HLVX) reported norovirus vaccine HIL-214 Phase 2b NEST-IN1 study in infants failed, showing a 5% vaccine efficacy against moderate or severe acute gastroenteritis due to GI.1 or GII.4 genotypes. Although HIL-214 had significant efficacy in a prior study in adults, emerging GII.4 strains may have negatively affected the infant study. HLVX was down 88% last Monday. ARQT, LGVN, PFE, NVO and IMMP news on page 2.
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