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Immutep enters into a New Collaboration with Merck for LAG-3 Therapy, Efti
“Through INSIGHT-005, we plan to explore the effect of releasing the brakes and pushing the accelerator of the body’s immune system in three different positions of the cancer immunity cycle. The new trial builds on our knowledge and the encouraging data from the INSIGHT trial of efti, also in solid tumours. We are excited about this new clinical collaboration which allows us to extend and strengthen our relationship with an existing partner in a new and exciting setting, particularly at a time when there is growing awareness and validation of the LAG-3 MHC class II interaction,” said Immutep CEO Marc Voigt.
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Genmab and Bolt Biotherapeutics Announce Oncology Research and Development Collaboration
“This exciting collaboration will provide a unique opportunity to combine Genmab’s innovative bispecific antibody technologies with Bolt’s powerful, advanced ISAC technology to develop targeted antibody products with the potential to transform cancer treatment,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Genmab’s partnership approach is part of our DNA and we are pleased to be collaborating with Bolt to develop and deliver potential next-generation cancer therapeutics to patients in need of novel treatment options.”
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 Business Review
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FDA approves Biogen’s Aducanumab as treatment for all forms of Alzheimer’s disease
What does this mean for Biogen’s business?
Biogen Inc. (Biogen, Massachusetts, CA) was founded in 1978 by a group of scientists that included nobel laureate Walter Gilbert and Philip Sharp and went IPO in 1983. It merged with IDEC Pharmaceuticals (San Francisco, CA) in 2003 to become the world’s third largest Big Pharma and to enter the multiple sclerosis (MS) market with Avonex (interferon beta-1a), and the cancer drug market with Rituxan (rituximab). Biogen has focussed its R&D on neurological and haematological diseases with unmet needs and has the MS drugs Plegridy, Tysabri, Tecfidera, and Vumerity; the haemophilia drugs Eloctate and Alprolix, and the spinal muscular atrophy drug Spinraza in its portfolio. The Alzheimer’s drug, aducanumab, the latest and most important addition to its portfolio is set to generate billions in revenue for Biogen.
Aducanumab has made controversial news since March 2019 when Biogen pulled out of its identical phase 3 trials EMERGE and ENGAGE on account of not meeting the primary endpoint for reduced cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score (over placebo). By October 2019, Biogen announced a post-hoc analysis showing statistically significant reduction in CDR-SB for EMERGE (P=0.01) and for a subset of ENGAGE patients, relative to placebo. The reversal of Aducanumab’s efficacy status was attributed to the cumulative effects of higher dosing and exposure time. There were no unmanageable side effects reported. This back and forth over efficacy showed the stock market speculations fluctuating as well, with Biogen stocks falling by 29% when the clinical trials were canned.
On 8th June 2021, FDA made a surprising announcement of clearing Aducanumab for use against all categories of Alzheimer’s patients, and not just the patient subset with early onset and mild cognitive impairment, as initially filed by Biogen. The reasons for this could be two-fold:
- There is no effective drug for Alzheimer’s, not even beta-amyloid inhibitors that completely clear plaques
- For a disease that has been confounding to understand, the FDA may have looked upon aducanumab, a drug with manageable side effects, as a Hail-Mary pass for Alzheimer’s treatment (which is currently an unmet condition)
Since the FDA announcement, Biogen’s stocks have risen by 38.4%. Whether this positive speculation will sustain is being debated as divided opinion covers skepticism over ENGAGE subset data analysis and interpretation, while more positive opinions consider the fact that aducanumab is the first anti-amyloid to elicit complete reversal of amyloid plaques, which is unprecedented among anti-amyloids. Further competitors in the space are few. Eli Lily’s donanemab, has shown promising plaque clearance activity but is still a long way off towards FDA approval. Further, a certain population of the physician community has voiced their reluctance to prescribe aducanumab across all Alzheimer’s groups.
But we should take into account that physicians many times relent to patients’ insistence on treatment options. With the FDA approval, aducanumab now has a bonafide label. With controllable side effects in the context of a life consuming disease, the prescription rates may well rise over the years. Further, with no direct competition at hand and a 9-year window granted to Biogen to provide confirmatory results from clinical trials, we may well be looking at the only therapeutic option to Alzheimer’s in aducanumab. In terms of stock investments, the positive speculation over aducanumab may last over the next half decade, and now is a good time to invest in Biogen stocks (BIIB.O).
In terms of Biogen’s business, which has relied on the blockbuster model, aducanumab is now the blockbuster that can replace the MS drug Tecfidera, whose patent no longer holds and consequently faces market dilution from generics. Aducanumab is estimated to earn Biogen between $10 billion to $15 billion per year according to Wall Street estimates. Aducanumab will be sold as Aduhelm at $56,000 annually and owns the market covering 1.5 million Alzheimer’s patients in America alone. For Biogen, going after diseases with unmet needs and orphan drugs (Spinraza), has worked in their favour so far.
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