Aer Therapeutics, Inc.

There are many ways to drug cancer. Biotech startups are coming up with new twists on drugging the disease or taking existing approaches to new cancer targets. Cancer continues to represent the biggest area of investment. Other indications that are drawing investor interest include inflammation and respiratory disorders. Here’s a roundup of recent biotech financings: —Radiopharmaceuticals developer Abdera Therapeutics emerged from stealth, revealing $142 million in combined Series A and B financings. The startup, with operations in Vancouver, British Columbia, and Menlo Park, California, engineers antibodies that target the delivery of a radioactive particle to cancer cells while clearing out of healthy tissues to avoid causing toxic effects. Abdera’s lead program, a potential treatment for small cell lung cancer, is on track for an investigational new drug application next year. The startup’s $32.5 million Series A round closed in 2021. The fresh capital from the $110 million Series B financing was led by venBio partners. —Complement Therapeutics, a preclinical biotech focused on therapies addressing diseases of the complement system, raised €72 million (about $79 million). London-based Complement will use the cash to advance to human testing with a gene therapy for the vision-loss disorder geographic atrophy. The startup is a spinout from the University of Manchester. Its Series A financing was led by Belgian investment firm Gimv. —Enveda Biosciences raised $51 million, an extension of the Series B financing announced at the end of 2022. This Series B1 financing brings the Boulder, Colorado-based company’s latest round to a total of $119 million. Enveda uses artificial intelligence to discover new drugs. The startup said it will use the new capital to advance multiple drugs to the clinic in inflammation, fibrosis, and neurosensory indications. —Function Oncology emerged from stealth, revealing $28 million in Series A financing and technology that matches a patient’s cancer sample to the appropriate targeted cancer therapy. During the annual meeting of the American Association for Cancer Research (AACR), the San Diego-based startup presented data that validated its technology using human samples from acute myeloid leukemia patients. —ThirtyFiveBio also chose AACR to reveal its science: small molecule inhibitors of GPR35, a receptor associated with gastrointestinal cancers. The preclinical company has four compounds in lead optimization. The company is backed by $20 million in seed financing from M:M Bio and Canaan Partners. —Clinical-stage cancer drug developer TORL BioTherapeutics raised $158 million. The Los Angeles-based company’s antibody drug conjugates (ADC) and monoclonal antibodies are based on research from UCLA. TORL’s lead program, TORL-1-23, is an ADC in development for treating multiple cancer types that express a protein called CLDN6. Goldman Sachs Asset Management led the biotech’s Series B financing. —Alentis Therapeutics raised $105 million for clinical development of two antibody drugs. ALE.F02 is set to advance to a Phase 2 test evaluating it as treatment for fibrosis in the kidney, lung, and liver. ALE.C04 is heading into a Phase 1 study in cancer. The Basel, Switzerland-based company’s Series C round was led by Jeito Capital, Novo Holdings, and RA Capital Management. —VintaBio, a contract development manufacturing organization specializing in making viral vectors used in cell and gene therapies, launched with $64 million and a new Philadelphia manufacturing facility. The company’s financing was led by Decheng Capital. —Aer Therapeutics closed $36 million in financing to support development of a drug with potential applications in chronic obstructive pulmonary disease and other lung disorders. Drug candidate AER-01 is a small molecule designed to be inhaled into the lungs where it liquefies mucus plugs. Raleigh, North Carolina-based Aer spun out of the lab John Fahy, a University of California, San Francisco, professor of medicine. Canaan, OrbiMed, and Hatteras Venture Partners participated in Aer’s Series A financing. —Cell therapy developer CTRL Therapeutics emerged with $10 million. The Chicago-based company develops its therapies from circulating tumor-reactive lymphocytes (cTRLs) with the goal of treating solid tumors—an elusive target for the cell therapy field so far. Compared to another type of experimental cell therapy made from tumor infiltrating lymphocytes (TILs), the company says cTRLs could offer advantages that include a simpler manufacturing process. Details about the company’s approach were published in Nature Biomedical Engineering. General Catalyst led CTRL’s seed financing.

Pictured: A doctor holds a chest x-ray/courtesy of iStock A small Raleigh-based startup hopes to shake up the chronic obstructive pulmonary disease (COPD) market with a treatment for an underserved target—airway mucus plugs. Aer Therapeutics closed a $36 million Series A Thursday to take its inhaled mucolytic to the clinic. The new company is a spin-out from John Fahy’s lab at UCSF. Human airways have three areas of pathological problems, Fahy told BioSpace. There are already treatments available for two of them. The smooth muscle tightening that causes bronchospasm (wheezing) is treated with a bronchodilator, and airway inflammation is treated with anti-inflammatory drugs. The third issue occurs when the natural mucus in the airways becomes completely occlusive, forming mucus plugs that obstruct airways. Very few drugs have specifically and effectively targeted the mucus component, Fahy said. Approximately 5 million COPD patients and 2 million asthma patients in the U.S. are estimated to have a mucus plug-high disease subtype. AER-01 is designed to liquefy these mucus plugs. “This is currently a ‘hot’ area and certainly important to patients,” Bruce Miller, chief scientific officer of the COPD Foundation, told BioSpace. He called Aer’s approach sensible and said the test will be whether it brings positive clinical outcomes for patients. Lack of Effective Treatments There is currently no cure for COPD. Common treatments involve dual and triple therapies that combine a corticosteroid to reduce inflammation with one or two types of bronchodilators, in addition to rescue inhalers. But these treatments do not address the airway obstruction caused by mucus plugs. Fahy’s lab, in collaboration with academic partners in Dublin, discovered they could put thiol chemistry on a sugar scaffold to create an effective mucolytic. The result turned a normally inert sugar into a tool that can cleave mucus plugs. Delivering this agent via the airway is the key with AER-01, Fahy explained. Current drugs marketed to break up mucus have limited efficacy because when taken orally, sufficient concentrations will not reach the obstructed areas through the bloodstream to break up the plugs. Fahy said the principle of using an oral medication to treat airway mucus plugs is “doomed at the door.” Cash for the Clinic Jim Shaffer The first-in-human study will launch this year, most likely in June, Aer President and CEO Jim Shaffer told BioSpace. This Series A round, which included Canaan, OrbiMed and Hatteras Venture Partners, will give the startup a cash runway of about 2.5 years—enough to complete the Phase I study and a Phase IIa proof-of-concept trial, Shaffer said. Phase I will enroll healthy volunteers in Australia with a single ascending dose, then multiple ascending dose arms, before shifting to COPD patients. The drug will first be administered via nebulizer, with plans to develop a dry powder inhaler formulation for convenience. Phase IIa will follow, with plans to dose moderate-to-severe COPD patients with mucus plugs over four weeks in mid-2024. Shaffer has expanded his one-man team to hire consultants as full-time staffers, with a target headcount of eight for now. Aer will lean on contract manufacturers to accomplish its mission in a cost-effective way, he said. The World Health Organization ranks COPD as the third leading cause of death worldwide. If successful in this first indication, Shaffer said Aer has the potential to expand into other lung diseases like asthma, bronchiectasis and cystic fibrosis. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.