The American Federation for Aging Research (AFAR) is involved in supporting research designed to unravel the biology of aging and expanding the field, and this week it held a webinar on the Business of Longevity: Moving Biomedical Advances into Biotech Opportunities. The Population Reference Bureau in its Population Bulletin projects the number of Americans ages 65 and older to almost double from the more than 52 million today to 95 million by 2060, and the 65-and-older age groups share of the total population will rise from 16% to 23%. The baby boomer generation (between ages 55 and 73) have raised challenges because aging is a strong risk factor for many chronic diseases that have become a major burden on the health care system. To respond to that situation, advancements in drugs, medical devices, diagnostics and digital health for the treatment of age-related conditions will be crucial. In addition, researchers are beginning to contemplate whether it will be possible to not only slow the aging process but also develop specific therapies to allow people to live healthier longer lives.

The panelists reviewed the latest research and looked at what it will take to attract more investment and biotech companies into what remains a nascent area but one that offers tremendous commercial opportunities.

One of the participants, Mehmood Khan, CEO of Boston-based Life Biosciences, said longevity research has been accelerating over the last decade. However, new talent and companies still need to be attracted into the sector.

Jim Mellon, chairman of Juvenescence Ltd., noted aging research is still at the dial-up stage of the internet in terms of progress. To kickstart the field, product successes are needed. Unfortunately, some commercial forays have hit roadblocks.

Most recently in August, Unity Biotechnology Inc. reported UBX-0101, a senolytic p53/MDM2 interaction inhibitor, intended to act by eliminating senescent cells and inducing cartilage regrowth for the potential intra-articular treatment of inflammatory joint disease, failed to best a placebo on an established measure of osteoarthritis (OA) pain in a phase II study.

The San Francisco-based company has now shifted its focus, announcing a restructuring last month to align its resources on cellular senescence programs in ophthalmology and neurology. It said it will advance UBX-1325 to phase I development in patients with diabetic macular edema and expects to dose the first patient later this year.

The compound targets Bcl-xL, a novel mechanism to eliminate senescent cells in age-related diseases of the eye. The UBX-1325 study in diabetic macular edema is expected to begin before the end of the year. In an announcement, Unity said it will also focus on senolytic therapies for neurological diseases as well as exploring novel mechanisms for cognitive benefit. The company said it will extend its cash resources by making a 30% cut in its workforce.

Unitys disappointing trial results followed the failure of Restorbio Inc.'s PROTECTOR 1 phase III study designed to evaluate RTB-101 in preventing clinically symptomatic respiratory illness (CSRI) in adults ages 65 and older. RTB-101 is an oral, selective target of rapamycin complex 1 inhibitor.

The failure led the companys board to examine its strategic alternatives that eventually culminated in a merger with Adicet Bio Inc., with the combined company focusing on Adicets off-the-shelf allogeneic gamma-delta T-cell therapies for oncology, with its lead candidate, ADI-001, a gamma-delta CAR T-cell therapy targeting CD20 being developed for non-Hodgkins lymphoma.

New long-term trial

Interest will also focus on the long-term study of FDA-approved drug metformin that has been used to treat diabetes for more than 60 years. The compound has also been implicated in slowing aging in model organisms and reducing the incidence of aging-related diseases. According to AFAR scientific director Nir Barzilai, metformin is being tested in the Targeting Aging with Metformin (TAME) trial that will involve 3,000 individuals between the ages of 65 and 79. The NIH-funded Geroscience Network recommended metformin because of its safety and low cost. Several studies will test whether those taking metformin experience delayed development or progression of age-related chronic diseases such as heart disease, cancer and dementia.

Barzilai noted that several other good candidates for age-related diseases have emerged from the National Institute of Agings ongoing Intervention Testing Program, a multi-institutional study investigating treatments with the potential to extend lifespan and delay disease and dysfunction in mice.

Other recent developments

Douglas, Isle of Man -based Juvenescence said it established Juvenomics Ltd., a joint venture with G3 Therapeutics Inc., of Midlothian, Va., that will focus on developing validated nutraceuticals and medicines to combat aging and aging-related diseases such as those of the musculoskeletal system. Juvenomics is built on the combination of G3s multi-omic biological dataset, consisting of trillions of datapoints collected in the global clinical study of more than 7,500 patients, and the machine learning platforms assembled by Juvenescence.

Agex Therapeutics Inc., of Alameda, Calif., a biotechnology company developing therapeutics for human aging and regeneration, and Pluristyx Inc., of Seattle, have signed a manufacturing, marketing and distribution agreement through which Pluristyx will undertake those activities on behalf of Agex with respect to Agexs research and clinical-grade ESI brand human embryonic stem cells. The agreement builds on Pluristyxs strategy with standardized Ready-to-Use brand and Ready-to-Differentiate pluripotent stem cells to industry and academic scientists working on developing therapeutic products to treat human disease, the company said.

Grifols SA, of Barcelona, Spain, said it will acquire Alkahest Inc., of San Carlos, Calif., to enhance discovery and R&D to identify therapies for age-related diseases based upon an understanding of the human plasma proteome for $146 million. The transaction is expected to close early next year. In addition to the clinical development of specific plasma fractions and protein inhibitors, Alkahest said it is focused on developing a complete understanding of the human plasma proteome.

Foster City, Calif.-based Geron Corp., which is developing a first-in-class telomerase inhibitor targeting hematologic myeloid malignancies, established a loan facility this month for up to $75 million with Hercules Capital Inc. and Silicon Valley Bank. The companys imetelstat development program includes two registration-enabling studies, IMerge, an ongoing phase II/III trial in lower-risk myelodysplastic syndromes (MDS), and a planned phase III trial in refractory myelofibrosis expected to be open for patient screening and enrollment in the first quarter of next year.

Cohbar Inc., of Menlo Park, Calif., which is developing mitochondria-based therapeutics to treat chronic diseases and extend healthy lifespan, closed its underwritten public offering of 12.3 million units, consisting of one share and one warrant to purchase 0.75 of a share of common stock at an exercise price of $1.44, priced at $1.22 each. The underwriters partially exercised the overallotment option for warrants to purchase an additional 1.38 million shares. The gross proceeds were approximately $15 million. In August, the company reported that the first subjects had been dosed with CB-4211 in the phase Ib stage of its phase Ia/Ib trial for NASH and obesity. The study is designed to assess the potential effects of CB-4211 on liver fat, body weight and various biomarkers that are relevant to NASH and obesity.

San Diego-based Deep Longevity Inc., a company focused on artificial intelligence for aging and longevity research, is being acquired by Regent Pacific Group Ltd., of Hong Kong, for HK$29.56 million (US$3.8 million). The company came out of stealth from Insilico Medicine, of Rockville, Md., in July. It also reported the launch of the first AI system on the market for aging-related biomarker development and a collaboration with San Diego-based Human Longevity Inc. The company said it has developed a new AI system that can predict an individuals biological age more accurately vs. conventional methods, paving the road to discover what biological culprits drive aging-related diseases.

Immetas Therapeutics Inc., of East Hanover, N.J., has raised $11 million from a series A financing to advance research on inflammation pathways in aging and the development of immune-modulating treatments for cancer and inflammatory disease. The companys lead program is aimed at designing a series of bispecific antibodies to regulate inflammation in the tumor microenvironment and overcome resistance to conventional immune checkpoint therapies.

More:
Investment opportunities being created as longevity research ramps up - BioWorld Online