About MAX BioPharma

Who We Are

MAX BioPharma is a California-based biotechnology firm developing novel small molecule lipids, referred to as oxysterols, as candidates for therapeutic drugs for debilitating and fatal human diseases. These oxysterol molecules belong to the family of sterols that have the ability to stimulate bone growth, block the growth of cancer cells, and inhibit their ability to metastasize. The company is a pioneer in this new field of Oxysterol Therapeutics® and focused on translating our key science into use for two large unmet medical needs: bone formation (in fracture repair, bone tissue engineering, and osteoporosis) and cancer.

  • Localized Bone Formation

    MAX BioPharma has developed proprietary Oxysterol Therapeutics® that potently stimulate bone formation. This action of oxysterols is mediated by targeting certain cells in the body called mesenchymal stem cells that can turn themselves into other types of cells such as bone, fat and cartilage cells. Our Oxysterol Therapeutics® induce these mesenchymal stem cells to turn into bone forming cells, and prevent them from converting into fat cells, something that happens at the expense of bone formation.

    The company has successfully demonstrated robust bone formation in rat and rabbit spine fusion and cranial and maxillofacial defect models, and is excited to have launched a development program which will allow translation into human use. This program is progressing at an expedited rate. We initially explored the use of these Oxysterol Therapeutics® in humans to stimulate the growth of new bone during back surgery to fuse together vertebrae in the spine. This is a common surgery for back pain and other conditions associated with an unstable spine, and there remains a large unmet need to maximize success and minimize pain and length of recovery. Depending on the type of surgical technique used, the surgeon may be required to add new bone to the site where the naturally occurring bone decayed. Currently, there are few options to accomplish this, and each comes with challenges. One option is to use the patient’s own bone harvested from his or her hip. This complicates the surgery, is accompanied by significant pain, and requires a longer recovery. The goal of using Oxysterol Therapeutics® in this setting is to allow the surgeon to operate only on the spine, removing the need to harvest bone from the hip, and encourage the patient’s naturally occurring cells to grow new bone to strengthen the spine where the old bone had decayed and was lost.

    Another application of MAX BioPharma’s Oxysterol Therapeutics® is in the area of broken bones. Often, broken bones do not knit back together naturally because the fracture is severe, the patient is diabetic, has osteoporosis, or is a smoker. A surgeon repairing the fracture may have to graft bone from elsewhere in the body or use bone from a cadaver to stimulate bone formation and healing of the fracture. Our Oxysterol Therapeutics® may induce bone growth around the fracture to knit the bones back together naturally.

    Another application of Oxysterol Therapeutics® is in the area of healing from trauma to the facial or head bones. Natural healing from these injuries can result in a gap where bone does not heal completely. There are limited options to regenerate the lost bone, and Oxysterol Therapeutics® work with cells in a scaffold to regenerate bone that is needed to repair the defect. For dental patients in need of implants, the use of Oxysterol Therapeutics® may have a significant positive impact. Often, a patient has lost too much bone in their jaw to allow for an implant to be secured. MAX BioPharma’s proprietary compounds may stimulate bone formation and strengthen the areas where implants can be placed.

    Why Our Work is Important

    Millions of orthopedic procedures are performed annually in the United States. Many involve bone grafting to stimulate bone formation and increase the likelihood of a successful procedure. Despite the prevalence of such procedures and their value to patients, they are not perfect. Using one’s own bone as graft material is accompanied by additional pain, recovery time, cost, complications and risk. An alternative is using bone other than one’s own, for example cadaver bone. This adds the risk of rejection of the foreign matter by the body, or introduction of a disease carried by that bone.

    Our Oxysterol Therapeutics®, once developed, will enter the market as an alternative to currently used bone graft substitutes. There are a number of substitutes available today, and we are developing our compounds to be more effective, safer, simpler to produce in large quantities and easier to use. Our goal is to develop Oxysterol Therapeutics® to be free of the toxicities and complexities associated with current bone graft substitutes, such as the propensity to make bone where it is not desired (ectopic bone formation), and even the potential to cause inflammation, cancer, and death.

  • Systemic Bone Formation

    We also plan to develop oxysterols as bone-building agents for the treatment of osteoporosis.

    Why Our Work is Important

    More than 44 million Americans have low bone mass, meaning that within the bone, there is more space between solid portions. Natural bone resembles a honeycomb. Osteoporotic patients are losing the walls between each space in that honeycomb. As the spaces become larger, the bones become weaker and less dense. Bone density is often measured by a “T-score”. Bone density above minus 1 is considered healthy, between minus 1 and minus 2.5 is “low” (osteopenia), and below minus 2.5 indicates severe loss of bone density or osteoporosis.

    Once one has osteoporosis, the bones become fragile and there is a very significant increase in risk of fracture. This can be especially serious in the hip and spine regions. One in two women and one in four men will break a bone due to osteoporosis. An estimated 12 million Americans have osteoporosis today. There are very few bone building therapies currently available with only modest benefits and significant complications. Our bone building oxysterols will help replace the bone lost in osteoporosis.

  • Cancer

    Many cancers are fatal and once detected, the chance of survival may be very low given available therapies. One such example is pancreatic cancer. It is the fourth leading cause of cancer death in the US, and is expected to become the second leading cause by 2020. The American Cancer Society has estimated that in 2016 in the US, 53,070 people (27,670 men and 25,400 women) will be diagnosed with pancreatic cancer, and that 41,780 people (79% of those diagnosed) will die of pancreatic cancer. As US population demographics change, the number of new cases of pancreatic cancer is expected to increase more than 2-fold and the number of deaths will increase 2.4-fold by the year 2030. Because the pancreas is located deep in the abdomen, early detection of this cancer is difficult. By the time it is detected, surgical removal of the tumor is possible in only about 15% of patients with the most common type of pancreatic cancer. Chemotherapy or chemotherapy with radiation and drug therapies are available, but survival rates remain extremely low at less than 5 percent.

    Why Our Work is Important

    Scientists at MAX BioPharma have developed a number of promising oxysterol compounds that block the growth of pancreatic cancer cells and inhibit the Hedgehog pathway in tumor cells. The company has also found effective inhibition of multiple myeloma, leukemia and osteosarcoma cells when anti-cancer oxysterols are administered to them. Together with colleagues at John Hopkins Institute, the company is pursuing the therapeutic development of oxysterols for treating deadly human cancers.