Advanced Proteome Therapeutics Corp., of Toronto, which is focused on producing technologies to perfect the use of antibody-drug conjugates for the treatment of various cancers, said it is progressing collaborations with partners to translate its site-selective chemistries into high-value antibody conjugate products. The company's research efforts, following recently signed collaborations, are centered on antibody candidates that will be linked to drugs or toxins for treating advanced solid tumors such as ovarian cancer, breast cancer and non-small-cell lung cancer.

Aileron Therapeutics Inc., of Cambridge, Mass., said the FDA granted orphan drug designation for ALRN-6924 for the treatment of acute myeloid leukemia (AML). The compound is currently being tested in clinical trials for AML.

Amgen Inc., of Thousand Oaks, Calif., said it submitted a biologics license application to the FDA for erenumab to prevent migraine. Erenumab is designed to prevent migraine by blocking the calcitonin gene-related peptide receptor. The application includes data from pivotal studies in patients with episodic and chronic migraine. More than 2,600 patients experiencing four or more migraine days per month have been enrolled in the clinical trial program. (See BioWorld Today, Nov. 18, 2016.)

Bavarian Nordic A/S, of Copenhagen, disclosed a new share buy-back program, under which the company intends to buy back 12,156 of its own shares. The purpose of the share buy-back is to meet the company's obligations arising from the share-based incentive programs for the board and executive management, in accordance with the company's remuneration policy and the general guidelines for incentive remuneration. The share buy-back program is being done pursuant to the authorization granted at the annual general meeting on April 25, according to which the company may purchase up to 10 percent of the share capital for the time being.

Immunomic Therapeutics Inc., of Rockville, Md., and Trianni Inc., of San Francisco, have entered a license agreement for the Trianni Mouse model for use in the discovery of therapeutic antibodies in cancer. Terms were not disclosed.

Oncoceutics Inc., of Philadelphia, said Cell Cycle published a manuscript detailing the anticancer efficacy of members of the imipridone family. The publication describes the synthesis and efficacy of a series of imipridone compounds, derived from the core chemical structure of Oncoceutics' lead clinical-stage molecule, ONC-201, and concludes that the therapeutic utility of the imipridone class extends beyond ONC-201. The imipridone family represents a class of chemical compounds that possess a three-ring heterocycle, the company said.

Organovo Holdings Inc., of San Diego, presented new preclinical data showing extended survival and sustained functionality of its 3-D bioprinted human liver tissue when implanted into diseased animal models. Those data were presented at the World Advanced Therapies and Regenerative Medicine Congress in London. Organovo previously implanted its 3-D bioprinted human liver tissue patches onto the livers of healthy NOD/SCID mice, and is now presenting data from early studies in an established model for alpha-one-antitrypsin deficiency. The tissue was composed of human hepatocytes and select nonparenchymal cells.

Sage Therapeutics Inc., of Cambridge, Mass., said the FDA granted fast track designation to SAGE-217 for development as a potential treatment for major depressive disorder. The compound is an orally active neuroactive steroid that is a positive allosteric modulator of synaptic and extrasynaptic GABAA receptors.

Siwa Therapeutics Inc., of Chicago, said it has humanized its SIWA-318 monoclonal antibody and, following a recently completed new funding round, is planning to submit an investigational new drug application to the FDA, with the goal of conducting phase I trials for senescent cell removal. Based on initial results, the primary focus likely will be pancreatic cancer metastasis, the company said.

Sosei Group Corp., of Tokyo, said its subsidiary, Heptares Therapeutics, has been notified by partner Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel, that a preclinical candidate calcitonin gene-related peptide antagonist has been nominated for advancement into further preclinical studies as an investigational treatment for migraine. Nomination of the small-molecule candidate, discovered by Heptares using its structure-based design approach in partnership with Teva, has triggered a $5 million payment from Teva to Heptares under the terms of their licensing and drug-discovery agreement signed in 2015. It's the first milestone in a partnership to generate candidates for the treatment of episodic and chronic migraine. (See BioWorld Today, Nov. 30, 2015.)

Swedish Orphan Biovitrum AB, of Stockholm, announced that the Saudi Food & Drug Authority has approved Elocta (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of hemophilia A. It's the first therapy of its type to be approved for the treatment of hemophilia A in Saudi Arabia, according to the company. The approval was based on data from the pivotal phase III A-LONG study, which demonstrated the efficacy, safety and pharmacokinetics of the therapy in previously treated males 12 years and older with severe hemophilia A, and from the phase III Kids A-LONG study.

Thermo Fisher Scientific Inc., of Carlsbad, Calif., said it entered an agreement with Agios Pharmaceuticals Inc., of Cambridge, Mass., to develop and commercialize a next-generation sequencing (NGS) oncology companion diagnostic (CDx) for ivosidenib (AG-120) to identify isocitrate dehydrogenase 1 (IDH1) mutations in cholangiocarcinoma patients. Ivosidenib is an IDH1 inhibitor currently in a phase III trial for the treatment of patients with advanced IDH1m-positive cholangiocarcinoma, a rare form of cancer that affects the human bile duct system. Upon validation of the CDx, Thermo Fisher plans to submit a supplemental premarket approval application to expand clinical claims for its multitherapy NGS test that is currently awaiting approval by the FDA. It will retain the rights to commercialize the test globally and will lead all necessary filings to seek clearance from regional regulatory agencies. The NGS-based test is designed to simultaneously screen patient tumor samples for multiple gene variants, minimizing the need to perform numerous sequential analyses in an effort to generate a relevant tumor profile.

Xoma Corp., of Berkeley, Calif., earned a $10 million milestone payment from Novartis AG, of Basel, Switzerland, which licensed its anti-transforming growth factor beta antibody program in September 2015. Under the license agreement, Xoma received a $37 million up-front fee and became eligible to receive up to a total of $480 million in development, regulatory and commercial milestones. CEO Jim Neal said that the $10 million milestone payment is the first of a potential $40 million the company could receive from its portfolio of partnerships over the next 36 months. (See BioWorld Today, Oct. 2, 2015.)