The New Year began with two mid-size deals centered around the use
of artificial intelligence (AI) in drug development. Sanofi and AI-powered
biotech Earendil Labs struck a collaboration deal worth up to US$ 2.56 billion
to discover and develop bispecific antibodies for autoimmune diseases. Eli
Lilly partnered with Nimbus Therapeutics in an up to US$ 1.3 billion AI-driven
obesity research program. Additionally, Lilly acquired clinical-stage biopharma
Ventyx Biosciences for US$ 1.2 billion in cash for its experimental oral drugs
for autoimmune diseases.In oncology, AbbVie licensed a late-stage cancer drug from China’s Suzhou Zelgen for up to US$ 1.2 billion. And British pre-clinical gene therapy company Ikarovec entered into a deal with Chicago-based VectorBuilder to use the latter’s novel AAV capsid technology along with its gene therapy candidate to explore a treatment for intermediate age-related macular degeneration (AMD). In the US, the Centers for Disease Control and Prevention (CDC) has revised the immunization guidelines for children. The Trump administration froze federal childcare and welfare funds worth over US$ 10 billion for five states. And India is planning to tackle the menace of contamination by proposing a ‘prescription-only’ model for the sale of cough syrups.In clinical trials, Jazz Pharmaceuticals reported positive phase 3 results for its drug to treat HER2-positive gastroesophageal cancer. Incyte said it plans to seek an expanded US Food and Drug Administration (FDA) approval for Monjuvi (tafasitamab) as a first-line therapy for diffuse large B-cell lymphoma (DLBCL) following positive results from a phase 3 trial. And AstraZeneca’s subcutaneous drug showed promising results in a phase 3 trial on lupus patients.Sanofi, Earendil ink AI-powered autoimmune drug deal worth up to
US$ 2.56 bnArtificial intelligence-powered biotech Earendil Labs has signed a strategic collaboration with Sanofi to apply its discovery platform to multiple autoimmune and inflammatory disease programs. Sanofi will lead the development and worldwide
commercialization of bispecific candidates arising from the collaboration.
Under the agreement, Earendil will receive up to US$ 160 million in upfront and near-term payments linked to early program milestones. The deal’s total potential value is up to US$ 2.56 billion, including milestone payments. This collaboration builds on an earlier agreement signed between the two
companies in April.Lilly, Nimbus sign up to US$ 1.3 bn AI-driven obesity drug
research, licensing dealNimbus Therapeutics has entered into a multi-year research and licensing agreement with
Eli Lilly to develop new oral treatments for obesity and other
metabolic diseases using AI. Under the deal, Boston-based Nimbus will
receive US$ 55 million in upfront and near-term
milestone payments. Nimbus will be eligible to receive up to US$ 1.3 billion in
total, which will include development, commercial and sales milestone payments.
Nimbus will use its AI capabilities to identify potential drug candidates,
while Lilly will contribute its expertise in metabolic diseases to help develop
oral medicines. Lilly acquires Ventyx Biosciences for US$ 1.2 bn: Eli Lilly is acquiring San Diego-based clinical-stage biopharma Ventyx Biosciences for US$ 1.2 billion in cash. Ventyx is working on multiple oral drugs for
inflammatory-mediated diseases, including treatments for autoimmune diseases,
cardiovascular and neurological conditions.AbbVie inks up to US$ 1.2 bn deal with China’s Zelgen for its late-stage cancer drugAbbVie has signed a deal worth up to US$ 1.2 billion with China’s Suzhou Zelgen Biopharmaceuticals to strengthen its
immuno-oncology pipeline. AbbVie has licensed Zelgen’s ZG006 (alveltamig), a trispecific T‑cell engager engineered to target small cell lung cancer and other tumors. AbbVie will receive exclusive rights to develop and commercialize
the drug outside Greater China, while Zelgen keeps full rights in mainland
China, Hong Kong, and Macau.Ikarovec, VectorBuilder ink deal: Ikarovec has entered into an
exclusive worldwide option agreement with VectorBuilder to use its novel AAV capsid
technology along with its gene therapy candidate IKAR-003 for intermediate
AMD. The deal is expected to be worth over US$ 1 billion.CDC revises childhood vaccine guidelines; US freezes childcare,
welfare funds to 5 statesThe CDC has overhauled America’s childhood immunization guidelines, reducing the number of diseases children should
be vaccinated against from 17 to 11. The decision comes after the US President
Donald Trump issued a memorandum to the CDC to review
the childhood vaccine schedule. The updated schedule no longer recommends routine flu and Covid-19 vaccination for children. Shots for Covid and hepatitis A and B are recommended based on risk and “shared clinical decision-making” between doctors and parents. The CDC has also limited immunization against respiratory syncytial virus (RSV) to high-risk children and infants whose mothers were not vaccinated.US freezes funds to five states: The Trump administration is freezing more
than US$ 10 billion in federal childcare and family assistance funding to California, Colorado, Illinois, Minnesota, and New York, citing concerns over fraud and misuse, the US Department of Health and Human Services (HHS) has said. The states’ access to these funds will remain restricted while the department conducts further review.India plans ‘prescription-only’ rule for cough syrups after contamination reportsIndia’s drug regulator, the Central Drugs Standard
Control Organization has proposed removing cough syrups from
the list of medicines that can be sold without a
prescription. The proposal follows discussions at a drugs consultative
committee meeting in November, where members were briefed on incidents linked
to contaminated cough syrups.Incyte’s Monjuvi scores phase 3 win as first-line treatment for DLBCLIncyte plans to seek an expanded FDA approval for Monjuvi (tafasitamab) as a first-line treatment for DLBCL following positive results from a phase 3 trial. The
study tested Monjuvi plus lenalidomide added to standard R-CHOP
therapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) in newly diagnosed
patients. Tafasitamab was approved in combination with lenalidomide by the FDA
in 2020 for adult patients with relapsed or refractory DLBCL not otherwise
specified including DLBCL arising from low-grade lymphoma, and who are not eligible
for autologous stem cell transplant.Jazz’s gastroesophageal cancer med posts phase 3 win: Jazz Pharmaceuticals announced positive results
from the phase 3 trial testing Ziihera
(zanidatamab) in combination with chemotherapy, with or
without the PD-1 inhibitor Tevimbra (tislelizumab), as first-line treatment for adults with HER2-positive locally
advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers
of the stomach, gastroesophageal junction and esophagus.Astra reports positive phase 3 results for its lupus med: AstraZeneca has reported positive
results from a phase 3 trial evaluating a subcutaneous
version of Saphnelo (anifrolumab) in patients with systemic lupus erythematosus
(SLE). The subcutaneous version is already approved in the EU.
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