Magnet Biomedicine Inc. made its public debut with a $50 million series A round co-led by founding investor Newpath Partners and Arch Venture Partners. The firm is advancing molecular glue discovery by way of rational selection and design, looking past known protein-protein interactions and what Magnet calls “tangential” degradation approaches. The Cambridge, Mass.-based firm’s Trueglue platform combines screening methods that deploy proprietary and diverse chemical libraries and human biology-driven target selection to identify therapeutic prospects – small molecules designed to offer a range of benefits.

Adcom a make-it-or-break-it hearing for combo diabetes product

A U.S. FDA advisory committee meeting Sept. 21 will either be a “Hail, Mary” or a last gasp of life for ICTA-650, an exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes. In response to the FDA’s proposed order last year to deny approval to the subcutaneously implantable product due to safety concerns with the device, Intarcia Therapeutics Inc. requested a public hearing before the Endocrinologic and Metabolic Drugs Advisory Committee in lieu of a formal evidentiary hearing. Following the meeting, FDA Chief Scientist Namandjé Bumpus will make the final decision on whether ICTA-650 should be approved, according to the agency’s briefing document for the meeting. Previous FDA reviews of the product have led to two complete response letters, denials of three formal dispute resolution requests and repeated recommendations for Intarcia to redesign the device so it provides reliable and clinically appropriate release of exenatide. I2o Therapeutics Inc. acquired the combo product last month.

Starpharma’s dendrimer platform delivers impressive results in bowel, ovarian cancer

Starpharma Holdings Ltd.’s nanoscale drug delivery technology shows enhanced safety and durable responses in phase II trials compared to standard of care therapies in patients with advanced colorectal and ovarian cancer. Starpharma’s dendrimer enhanced product (DEP) uses nanoscale polymers called dendrimers to improve the effectiveness and safety of cancer drugs. Because the dendrimer is larger than the small-molecule drug, by attaching to the dendrimer, the drug accumulates in the tumor for a more targeted effect. A phase II trial of DEP-irinotecan, a DEP version of the widely used drug irinotecan – marketed as Camptosar by Pfizer Inc., demonstrated durable antitumor responses in heavily pre-treated advanced colorectal cancer patients and platinum-resistant/refractory ovarian cancer patients and was well-tolerated.

Airna launches to develop RNA therapeutics

Airna Corp. Inc. has launched through a $30 million financing to develop a pipeline of RNA editing therapeutics for treating rare diseases and prevalent diseases. The company’s first candidate is designed to treat the genetic disease alpha-1 antitrypsin deficiency, a hereditary condition that severely affects lung function. It also is developing a pipeline of candidates for treating other prevalent diseases that have a high, unmet need. The financing was led by Arch Venture Partners, along with ND Capital, Fast Track Initiative, Novalis and Codon Capital. Airna is headquartered in Cambridge, Mass., and does its research in Tübingen, Germany.

Kinnate cuts back, Histogen shuts down as industry squeeze continues

Shares of Kinnate Biopharma Inc. (NASDAQ:KNTE) were trading midday at $1.42, down 28 cents, or 16.5%, on word that the San Francisco-based firm is cutting 70% of its workforce, including all employees at the Shanghai-based subsidiary Kinnjiu Biopharma Inc. The news came as part of a pipeline update and plan to reprioritize assets. Hard times have befallen another West Coast biotech: Histogen Inc., of San Diego, which said its board has adopted a dissolution plan after exploring other alternatives. The stock (NASDAQ:HSTO) was selling for 44 cents, down 21 cents, or 33%.

Machine learning tool Alphamissense analyzes human mutations to predict diseases

Proteome analysis with artificial intelligence has made it possible to create a catalog of all possible missense mutations in the human genome to predict diseases. The new Alphamissense tool from the technology company Google Deepmind, available online, will allow scientists to refine diagnoses and design more tailored treatment strategies for patients suffering from pathologies associated with these variants.

Bipartisan momentum gathering for reforms of US Medicare program

The U.S. Centers for Medicare & Medicaid Services is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation. Many of these bills enjoy bipartisan support in the House Energy and Commerce Committee, enhancing the odds that novel medical devices will receive more timely Medicare coverage even as CMS considers an administrative overhaul of its related coverage mechanisms.

FDA eyes overhaul of IT system with an emphasis on agency-wide integration

Developers of combination products face an unusual dilemma in their interactions with the U.S. FDA, given that the data for the constituent products resides in multiple product centers. Some of the related clunkiness may soon be a thing of the past thanks to a new four-year proposal to overhaul the FDA’s information technology infrastructure, which among other things will emphasize a more seamless sharing of data across centers, precisely the kind of initiative that would facilitate reviews of combination products.

Also in the news

Accord, Acepodia, Aclaris, Aitia, Anaptysbio, Anthos, Apnimed, Astrazeneca, Atamyo, Beigene, Bioloomics, Biora, Cantargia, Cantex, Cassava, Clearmind, Compass Pathways, Contrafect, Daiichi Sanyko, Dyadic, Eloxx, Essa, Evaxion, Everimmune, Galera, GSK, Gustave Roussy, Hyku, Immunos, Kayo, Kiora, Kite, Kymera, Lantern, Lapix, Linkinvax, Lobe Sciences, Medigene, Moleculin, Omeicos, Orchard, Osmol, Primrose, Rani, Recode, Redhill, Rentschler, Sandoz, Sisaf, Tempest, Therapeutic Solutions, Thermosome, Tikomed, Tonix, Tracon