Just weeks after two unexpected cases of blood cancer landed trials of its investigational gene therapies for sickle cell disease (SCD) and beta-thalassemia on FDA-issued clinical holds, Bluebird Bio. Inc. said it is now talking to regulators about their resumption. Analyses demonstrate the lentiviral vector common to both medicines is unlikely to be the cause of acute myeloid leukemia in an SCD study, Bluebird said. It's still investigating a case of myelodysplastic syndrome in another SCD trial participant. Company shares (NASDAQ:BLUE) rose 8.3% by midday.

Affimed moves ahead with its T-cell lymphoma study

Following an interim futility analysis, Affimed NV has decided to continue enrollment in its phase II, registration-directed study of AFM-13, a tetravalent, bispecific innate cell engager, as a monotherapy for treating relapsed or refractory CD30-positive peripheral T-cell lymphoma. The analysis found antitumor complete and partial responses in both cohorts. The analysis also noted the response in both cohorts was enough to merge them. The study’s primary outcome measure is the antitumor activity of AFM-13 and an independent review committee-confirmed objective response rate. The Heidelberg, Germany-based company stock (NASDAQ:AFMD) jumped on the study continuation, rising 15% at midday.

Arctic Vision closes $100M+ series B worth to move UME drug to phase III in China

Chinese eye disease specialist Arctic Vision (Shanghai) Biotechnology Co. Ltd. raised more than $100 million in a series B financing round. The clinical-stage company will use the funds to initiate a phase III trial for its core asset, ARVN-001 (triamcinolone acetonide suprachoroidal injectable suspension), for uveitic macular edema in China this year. The series B round was led by Loyal Valley Capital and drew a list of prominent investors, including Tencent, Octagon Capital, Adrian Cheng from New World Development Group, as well as existing investors Nan Fung Life Sciences, Pivotal Bioventure Partners China and Morningside Ventures. It follows the company’s $32 million series A round led by Morningside Ventures last July.

Redmile leads Agomab’s $74M series B round

DUBLIN – Agomab Therapeutics NV raised $74 million in a series B round that attracted two heavyweight U.S. crossover investors, Redmile Group, which led the financing, and Cormorant Asset Management. The scale of the transaction and the nature of the participants involved both signal the company’s intent to become a significant player in the development of antibody therapies in regenerative medicine.

Using AI/ML to reduce the costs and risks of CNS diseases research

With the prevalence of central nervous system disorders such as Alzheimer’s disease, multiple sclerosis, epilepsy, Parkinson’s disease and stroke increasing annually, the need for novel therapeutics to treat neurologic and psychiatric disorders has never been greater. Unfortunately, even though there is a significant unmet medical need, because of the high risk and low approval rates of drugs targeting those devastating diseases, in the past decade big pharma companies have been dramatically reducing their R&D spending on CNS disorders, noted Naheed Kurji, president and CEO of Toronto-based Cyclica Inc. who was leading a panel discussion that was part of a webinar on the role of AI and its potential in treating neurological conditions organized by the Alliance for Artificial Intelligence in Healthcare.

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