Genmab A/S is shelling out $1.8 billion in cash to acquire Profoundbio Inc., picking up a phase II-stage FRα-targeted antibody-drug conjugate (ADC) and next-generation ADC technology. The deal, the biggest by far for the Copenhagen, Denmark-based biopharma, marks a “very significant step to really build the next phase of growth and development for the company,” said Jan van de Winkel, president and CEO. It also marks the latest deal in the red hot ADC space.

Phase III wins for Lenz with aceclidine in presbyopia

Lenz Therapeutics Inc. unveiled positive top-line data from its pair of phase III Clarity studies testing two formulations of the muscarinic acetylcholine receptor agonist aceclidine, LNZ-100 and LNZ-101, for presbyopia. In Clarity 1 and 2, LNZ-100 (1.75% aceclidine) – which has been chosen as lead candidate – achieved the primary endpoints and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity in near vision, without losing one line or more in distance vision. An NDA will be submitted to the U.S. FDA around the middle of this year. Shares of the San Diego-based firm (NASDAQ:LENZ) were trading at $21.22, up 22 cents, after rising as high as $24.59, a 52-week record.

US NIH under fresh scrutiny for questionable research funding

Does the NIH have the ability to screen for U.S. security issues in its award of research grants? That question is at the heart of an April 2 letter the leadership of the House Energy and Commerce Committee sent to the Government Accountability Office asking the government watchdog to examine the extent to which the NIH “adequately safeguards research funds from national security concerns related to the Chinese military or over the unethical use of human beings in research studies, especially from entities of concern in China.” The letter cited recent reports that raised concerns about the agency’s decisions to fund certain research over the past decade that other federal departments had flagged for security reasons.

Diagonal launches with $128M series A to develop agonist antibodies

With a $128 million series A financing, Diagonal Therapeutics Inc. launched to develop its lead program using agonist antibodies for treating, among other indications, the rare disease hereditary hemorrhagic telangiectasia. The antibodies are designed to activate a receptor complex in the TGF-β superfamily genetically impaired in patients with the bleeding disorder. Diagonal also is developing a treatment for the orphan disease pulmonary arterial hypertension. The round was co-led by BVF Partners and Atlas Venture, with participation from Lightspeed Venture Partners, RA Capital Management, Frazier Life Sciences, Viking Global Investors, Velosity Capital and Checkpoint Capital.

Aging, and aging well, gives clues for dementia drug discovery

Ironically, the first person to be diagnosed with what is now Alzheimer’s disease (AD) was missing its major risk factor. When she first began showing symptoms of dementia in 1901, Auguste Deter was not particularly old. Deter became symptomatic at the age of 50 and died in 1906 at the age of 55. Her autopsy revealed the amyloid plaques that would become AD’s anatomical calling card, and the target of a drug discovery effort that would consume decades and untold billions of dollars before delivering its first, moderate, success in 2021. Despite Deter’s case, aging is the largest risk factor for developing Alzheimer’s, by a large margin. But “geroscience has not been translated into drugs for Alzheimer’s disease,” Howard Fillit, Alzheimer’s Drug Discovery Foundation co-founder and chief scientific officer, told BioWorld. “We’re just starting to see that cross-fertilization now.”

Newco Neurosterix takes Addex’s preclinical assets private

Addex Therapeutics has offloaded its portfolio of preclinical allosteric modulation drugs into Neurosterix, a new company that arrives on the scene with a $63 million series A round. The funding, from New York-based Perceptive Advisors, will be used to accelerate development of the lead asset, a muscarinic acetylcholine receptor subtype 4 positive allosteric modulator (M4 PAM), in the treatment of schizophrenia. The transferred assets also include an mGlu7 negative allosteric modulator with potential for development in anxiety, post-traumatic stress disorder, depression, drug abuse, and schizophrenia.

FDA accepts Daiichi/Astrazeneca’s BLA for Trop2 breast cancer drug

The U.S. FDA accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan (dato-dxd) to treat adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease. The PDUFA data is set for Jan. 29, 2025. Last month, the FDA accepted the duo’s BLA for dato-dxd to treat adults with locally advanced or metastatic nonsquamous non-small-cell lung cancer who have received prior systemic therapy. That PDUFA date is set for Dec. 20, 2024. Discovered by Daiichi Sankyo and jointly developed by Daiichi Sankyo and Astrazeneca, dato-dxd could be the first trophoblast cell surface antigen 2-directed antibody-drug conjugate for lung cancer.

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