HiFiBio raises USD 67 M; FDA drafts new guidelines for Breast cancer trials; Harbour BioMed teams up with Pharmaceutical Product Development

FDA urges Pharma giants to increase their inclusion of men in new Breast Cancer trials

The recent FDA recommendations have urged the Pharma companies for the inclusion of men in the clinical trials to test new breast cancer drugs. Men rarely develop Breast cancer. Less than 1% of men develop Breast cancer. And 1 in 1000 Men gets diagnosed with it.

Because of the rarity of the disease in men, they are often excluded or their number is limited in the clinical trials. However, the FDA released new guidelines to urge Healthcare companies to increase the number of males in clinical trials. This is important since the metabolism of men and women vary and the success of any therapy in treating Breast cancer in women cannot be taken as a deciding factor for the men.

Men Breast cancer is usually hormone-dependent. In 90% of the cases, Tamoxifen is used to treat male breast cancer due to its estrogen-blocking treatments. And, in case, if a male patients stop or does not respond to Tamoxifen, there is no standard Breast cancer treatment option left for them. So the issuance of new guidelines will help the neglected fraction of patients to improve their treatment standard.

HiFiBiO Therapeutics nets USD 67 Million to advance its Cancer pipeline

HiFiBiO Therapeutics, with deep expertise in discovering and advancing a pipeline of antibody drugs to treat cancer, has raised USD 67 Million in Series C round. The funding was led by new investor IDG Capital, Delian Capital, Hanne Capital, and Kite, a Gilead Company along with the existing shareholders Sequoia Capital China, VI Ventures, Legend Star Capital, and LYFE Capital continued to invest.

The company plans to use the proceeds to accelerate its pipeline of oncology and autoimmune disorders. The company from the past many years has been working to fuel its pipeline for the same. HiFiBiO Therapeutics had also entered into a collaboration with Takeda to develop antibody therapies for various gastrointestinal diseases, cancers and other disorders. Not long ago, HiFiBio therapeutics entered into a research agreement with Kite, a Gilead company, to develop technology supporting the discovery of neoantigen-reactive T cell receptors (TCRs) for the potential solid tumour treatment.

Harbour BioMed, Pharmaceutical Product Development to develop cancer and immunology drugs

Harbour BioMed (HBM), a global, clinical-stage Biopharmaceutical Company developing innovative therapeutics in the fields of immuno-oncology and inflammatory diseases, has collaborated with Pharmaceutical Product Development (PPD).

The agreement enables HBM to expand its operations globally. Recently, the collaboration has submitted its HBM4003, anti-cancer immunotherapy to target solid tumors, for the recommendations by the Australian Ethics committee.

HBM’s drug profile contains five clinical-stage, in-licensed candidates which are undertrials to develop ground-breaking therapies and to support the patients’ lives at its best.