APEIRON Biologics GmbH

QARZIBA is indicated to treat high-risk neuroblastoma in patients aged 12 months and above. Credit: Kateryna Kon/Shutterstock. Ligand Pharmaceuticals has announced a definitive agreement for the acquisition of the complete outstanding shares of Austria-based biopharmaceutical company APEIRON Biologics in a $100m cash deal. The deal also includes future payments based on commercial and regulatory milestones. The strategic move will grant Ligand royalty rights to QARZIBA (dinutuximab beta), a treatment for high-risk neuroblastoma in patients aged 12 months and above. It is indicated for those who have responded to induction chemotherapy, undergone myeloablative therapy and stem cell transplantation, and with a history of relapsed or refractory neuroblastoma with or without residual disease. APEIRON co-developed QARZIBA, which received the European Medicines Agency approval in 2017. This therapy is currently available in more than 35 countries. See Also: How will a Labour government support the UK clinical trials industry? TLC-2716 by OrsoBio for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia): Likelihood of Approval The company receives royalties on the product’s net sales outside mainland China from Recordati and within mainland China from BeiGene. Ligand will make further payments based on commercial and regulatory milestones, with potential payments up to $28m by either 2030 or 2034 on QARZIBA royalties exceeding preset thresholds. The agreement received unanimous approval from the board of directors of Ligand and the supervisory board of APEIRON. The acquisition will conclude in July 2024. Ligand is also investing $4m in invIOs Holding, an APEIRON spin-off, under a stock purchase agreement. This funding will support the research and development of three early-stage immuno-oncology assets. Ligand CEO Todd Davis stated: “The addition of QARZIBA to our commercial royalty portfolio further supports our growth strategy to invest in high-value medicines that deliver significant clinical value and generate predictable and long-term revenue streams for our investors. “QARZIBA is the only immunotherapy for high-risk neuroblastoma marketed across Europe and in other parts of the world. We believe this drug will be a meaningful contributor to our royalty revenue, which is now driven by a diversified portfolio of 12 key commercial-stage products.”

Ligand Pharmaceuticals snapped up Apeiron Biologics for $100 million on Monday, gaining royalty rights to cancer drug Qarziba (dinutuximab beta). The royalty asset aggregator expects the purchase to pad its yearly profits and is now targeting revenues of $140 million to $157 million for 2024, up from its previous guidance of $130 million to $142 million.Under the deal, which is expected to close this month, Apeiron is eligible to receive an additional payment of up to $28 million if royalties for Qarziba exceed an undisclosed threshold in the next decade.Apeiron out-licensed exclusive global rights for Qarziba to EUSA Pharma in 2016, shortly after which the European Medicines Agency approved the anti-GD2 antibody for high-risk neuroblastoma. Then in 2022, Recordati acquired EUSA for €750 million ($812 million), gaining commercial control of the drug.Ligand will also invest via a stock purchase up to $4 million in invIOs, which Apeiron spun out in 2022 to house its preclinical and clinical programmes. The firm has three early-stage immuno-oncology assets, to which Apeiron is entitled to royalties and milestones, further expanding Ligand’s portfolio. According to Ligand, Qarziba is the sixth commercial asset it has gained since the beginning of 2023, including Novan and its berdazimer gel, which won FDA approval in January under the name Zelsuvmi.

Exscientia founder and CEO Andrew Hopkins is out of a job after an investigation found the CEO engaged in relationships with two employees, the artificial intelligence drug discovery company announced Tuesday. The termination is for cause and effective immediately. In a regulatory filing, Oxford, U.K.-based Exscientia said this decision follows an investigation that found the relationships were “inappropriate and inconsistent with the Company’s standards and values.” No other details were provided about the employees or the relationships, but the filing does not indicate any financial impropriety. “Dr. Hopkins’ conduct did not impact the Company’s consolidated financial statements or its internal controls over financial reporting, and his termination is unrelated to the Company’s operational or financial performance,” Exscientia said in the filing. “The Company remains committed to advancing its internal oncology pipeline and broad partnership portfolio through AI-based drug design and laboratory technologies.” Exscientia said the board of directors is searching for a successor to Hopkins. In the meantime, Chief Science Officer Dave Hallet has been appointed interim CEO and interim principal executive officer, effective immediately. Hallet will also serve as an executive director on the Exscientia board. According to Hopkins’ employment agreement signed when Exscientia went public in 2021, he must disclose to the board “full details of any wrongdoing by the Executive or any other employee of any Group Company where that wrongdoing is material to that employee’s employment by the relevant company or to the interests or reputation of any Group Company.” The agreement goes on to state that grounds for termination include being “guilty of any gross misconduct or behavior which tends to bring himself or the Company or any Group Company into disrepute.” If the company terminates employment for cause, Hopkins is not entitled to any payment, nor can he make any claim against the company for damages stemming from the termination, the document states. The fallout extends beyond Hopkins. A special committee of the board engaged outside counsel to investigate the executive’s alleged conduct. The inquiry found that David Nicholson, board chairman, had prior knowledge of the existence of the earlier of Hopkins’ relationships and addressed the matter—but with outside counsel rather than in consultation with the board. The filing states that after discussions with other board members, Nicholson resigned from his board positions on Monday. A search for Nicholson’s replacement is underway. In the meantime, Elizabeth Crain, a non-executive director, was appointed Nicholson’s interim replacement. Exscientia was founded in 2012 by Hopkins, who had previously spent nearly a decade at Pfizer and five years in academia. The company initially struck up partnerships in which it used its AI technology platform to discover drugs for pharmaceutical companies. Partners include Apeiron and Bristol Myers Squibb. The IPO was part of a strategy to expand the application of the AI platform to the R&D of Exscientia’s own drugs. The company had reached early-stage clinical development with an internally discovered cancer therapy, but stopped work on that program last fall after peer data and internal research indicated challenges for safely and effectively drugging the intended target. With the discontinuation of this cancer drug, Exscientia’s most advanced wholly owned program is a molecule in preclinical development.