AC Immune SA, of Lausanne, Switzerland, disclosed a research partnership with scientists in the Perelman School of Medicine at the University of Pennsylvania focused on studying the pathological mechanisms of TDP-43 misfolding and aggregation. TDP-43, the transactive response DNA binding protein, is a transcription factor found in most human tissues. It is a recently identified target of growing interest for neuro-orphan indications such as frontotemporal lobar degeneration (FTLD) and amyotrophic lateral sclerosis. It also plays an important role in other significant neurodegenerative indications such as Alzheimer's disease. The collaboration is aimed at deciphering the governing principles of how pathological forms of TDP-43 spread from neuron to neuron, leading to a better understanding of the TDP-43 pathologies in order to support the company's effort to develop therapeutic and diagnostic approaches against FTLD and other neurodegenerative diseases.
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and The University of Texas MD Anderson Cancer Center disclosed a multiyear partnership to conduct collaborative research to advance therapies for various types of cancers, including gastrointestinal and lung. The establishment of a joint virtual research and development center will enable effective data sharing and analysis between the organizations, the entities said. The partnership is built on a flexible framework, allowing for projects to enter at different stages (research, development and/or clinical stage) over several years.
Biotime Inc., of Carlsbad, Calif., said it rebranded as Lineage Cell Therapeutics Inc. to better reflect its cell therapy platform. The company's NYSE American ticker changed to LCTX effective at Monday's market opening, with shares dropping 2 cents to close at 90 cents.
Calliditas Therapeutics AB, of Stockholm, in-licensed Budenofalk 3-mg oral capsule for the U.S. market from Dr. Falk Pharma GmbH, of Freiburg, Germany. The agreement covers all indications excluding orphan indications outside of liver targets. Initially, Calliditas will leverage Dr. Falk's clinical trial data and expertise in liver indications, such as autoimmune hepatitis, with a view to accelerating approval and market access. The deal involves an initial up-front payment of €1.5 million (US$1.6 million) and more if the drug is approved. The total deal value amounts to €40 million.
Eidos Therapeutics Inc., of San Francisco, confirmed that it received a nonbinding proposal from Bridgebio Pharma Inc., of Palo Alto, Calif., parent company of Eidos' majority stockholder, for wholly owned subsidiary Bridgebio Pharma LLC to purchase the remaining 33.4% of Eidos outstanding common shares not already owned by Bridgebio. Terms of the proposal call for Bridgebio to acquire the shares for a fixed exchange ratio of 1.30 Bridgebio shares for each Eidos share. Eidos said its board formed a special committee consisting of its disinterested and independent directors to consider the proposal, and the special committee retained Centerview Partners LLC as its independent financial advisor and Cravath, Swaine & Moore LLP as its independent legal advisor. Eidos declined additional comment on the proposal except to advise shareholders to take no action at present. On Monday, shares of Eidos (NASDAQ:EIDX) gained $2.15 to close at $37.32, while Bridgebio, which priced its IPO in June, saw its shares (NASDAQ:BBIO) fall 69 cents to close at $26.19. (See BioWorld, June 28, 2019.)
Oncologie Inc., of Waltham, Mass., said it agreed to a clinical collaboration with Merck & Co. Inc., of Kenilworth, N.J., to evaluate the combination of Oncologie's vascular targeting agent, bavituximab, a beta 2 glycoprotein 1 inhibitor, with the anti-PD-1 therapy Keytruda (pembrolizumab) in advanced gastric or gastroesophageal cancer. Oncologie plans to conduct a single-arm, open-label phase II study to assess efficacy and safety in approximately 80 participants enrolled across sites in the U.S., U.K., Korea and Taiwan. Recruitment is expected to begin by year-end.
Onconova Therapeutics Inc., of Newtown, Pa., and Mission Bio Inc., of South San Francisco, said they formed a collaboration to use Mission Bio's Tapestri platform, which allows researchers to detect rare cancer subclones and co-occurring cancer mutations at the single-cell level, for targeted DNA analysis of Onconova's cancer therapy, rigosertib, as it advances through clinical trials. Onconova is running the phase III INSPIRE trial of rigosertib, a small-molecule RAS mimetic, in individuals with higher-risk myelodysplastic syndrome who failed current standard of care and is seeking to complete enrollment by year-end. (See BioWorld, Jan. 18, 2018.)
Propanc Biopharma Inc., of Melbourne, Australia, said company scientists, in collaboration with research partners at the Universities of Jaén and Granada, published data in Scientific Reports confirming the mechanism of proenzymes and their effects against cancer stem cells (CSCs). Data showed the company's lead candidate, PRP, a formulation of two proenzymes designed to act synergistically against solid tumors, destroyed CSCs in significant numbers. The researchers observed that more than a dozen genes that induce cancer were down-regulated by PRP. Additionally, genes implicated in metastasis were down-regulated, and seven genes related to normal cell adhesion were up-regulated. PRP also impaired engrafting of human-derived pancreatic CSC tumors in immune compromised mice while displaying an anti-growth effect toward initiated xenografts, resulting in a decreased amount of tumor surrounding fibrotic tissue of treated mice. Propanc is seeking to advance PRP into a first-in-human trial in advanced cancer patients, with enrollment expected to begin next year.
Relief Therapeutics Holding SA, of Geneva, said it executed a binding share exchange agreement with privately held Sonnet Biotherapeutics Inc., of Princeton, N.J., covering acquisition of the outstanding shares of its subsidiary, Relief Therapeutics SA, in exchange for issuance of approximately 7.1 million of Sonnet's common shares. The agreement, subject to normal conditions, is expected to close at the time that Sonnet becomes a publicly traded corporation. Relief said the agreement was designed to ensure continued development of atexakin alfa, a low-dosage formulation of interleukin-6 (IL-6). In 2015, Relief executed a license agreement with Ares Trading SA, a wholly owned subsidiary of Merck KGaA, of Darmstadt, Germany, for the exclusive global right to study, develop, use and commercialize atexakin alfa, and phase I/II studies were conducted in individuals with thrombocytopenic cancer by Merck's Serono arm. Preclinical results generated by Serono in animal models also suggested the ability of atexakin to regrow nerves and reinstate their normal functions, suggesting its potential to treat neuropathies. Upon closing of the agreement, Sonnet will assume development of atexakin (SON-080), along with Relief's other candidates. Sonnet, which is developing targeted biologics based on its fully human albumin binding, or FHAB, platform, said it plans initially to pursue development of atexakin in chemotherapy-induced peripheral neuropathy, with the potential to extend the asset into related diseases, such diabetic neuropathy.
Theratechnologies Inc., of Montreal, said it applied to list its common shares on Nasdaq and intends to file a 40-F registration statement to that effect with the SEC. The company said it expects its shares to be listed on Nasdaq within 60 days. Theratechnologies plans to maintain its listing on the Toronto Stock Exchange under the ticker TH, where shares closed Monday at CA$5.35 (US$4.04), down CA24 cents.
Xoma Corp., of Emeryville, Calif., said its portfolio of potential royalty and milestone payments increased with the addition of drug candidates for Janssen Biotech Inc., a unit of Johnson & Johnson, of New Brunswick, N.J. For each Janssen program, Xoma said it is entitled to development and approval milestone payments plus a 0.75% royalty on net sales. Xoma also said that Janssen elected to accelerate its base annual license fee obligation and make a one-time $2.5 million payment to the company.