Ashley Roberts

Unum Therapeutics, a cellular immunotherapy company designed to treat cancer, announced it raised $12 million in Series A funding. Fidelity Biosciences and Atlas Venture led the funding initiative, with participation from Sanofi-Genzyme BioVentures. Unum was built to develop cancer treatments based upon antibody-coupled T cell receptors (ACTRs).

“We’ve created Unum to rapidly develop this universal cell therapy platform and to explore its potential in a number of different cancer types. With our Series A funding from Fidelity Biosciences, Atlas Venture, and Sanofi-Genzyme BioVentures, we will drive our lead program into Phase I testing and aim to quickly validate the ACTR approach in the clinic,” said Charles Wilson, PhD, president and CEO of Unum, in a press release.

The University of Pennsylvania and The Children’s Hospital of Philadelphia recently 

 successful clinical trial results when using genetically modified T cells from cancer patients to treat specific blood cancers with chimeric antigen receptors (CARs). The difference between CARs and ACTRs is that Unum Therapeutics’ approach uses modified T cells to attack various types of tumor cells using targeted antibodies, whereas CAR T cells are engineered to attach to a specific target by way of an antibody domain.

“In ACTR, we have effectively replaced the scFv domain with the extracellular domain of CD16. This protein acts as an Fc receptor and is able to bind a wide range of antibodies … By fusing CD16 to the components required for T-cell signaling, ACTR is essentially able to impart T cells with ADCC [

] activity. By co-administering ACTR T cells plus a tumor-targeting antibody, T cells are targeted to attack and kill a tumor based on the specificity of the targeting antibody,” said Dr. Wilson in an email to 

Articles

Unum Therapeutics raised $12 million in Series A funding for its development of antibody-coupled T cell receptors (ACTRs) for the treatment of nonspecific tumor cells.

Unum Raises $12 million in Funding for ACTR-Based Cancer Treatment

Steris offered to acquire Synergy Health for $1.9 billion in cash and stocks. 

, a company specializing in infection prevention, contamination control, surgical, and critical care technology, will benefit from the UK-based Synergy Health, specializing in outsourced sterilization services. In fiscal 2014, Synergy generated approximately $604 million in revenue and approximately $161 million in adjusted earnings before EBITDA.

Upon closing, expected in March 2015 according to a press release, the combined business will have approximately $2.6 billion in annual revenue. The acquisition will save the new company approximately $30 million annually in pre-tax cost savings due to a lowered tax rate. Similar to many mergers and acquisitions in the past year that have been dependent upon 

, Steris will see a lowered tax rate of 25%, as opposed to the US corporate income tax rate of 

Steris acquires Synergy Health, a UK-based outsourcing company focused on sterilization, for &1.9 billion USD.

Steris Acquires Synergy for $1.9 Billion

Boehringer Ingelheim announced on Oct. 16, 2014 that it received FDA approval for its idiopathic pulmonary fibrosis (IPF) treatment, OFEV. According to the 

 (NIH), IPF is a disease that causes tissue in the lungs to become scarred over time, limiting oxygen into the bloodstream. There is no cure, causing many patients to live only three to five years after diagnoses, experiencing respiratory failure, pulmonary hypertension, heart failure, pulmonary embolism, pneumonia, or lung cancer.

OFEV, or nintedanib, is the first and only tyrosine kinase inhibitor (TKI) that is FDA-approved to treat IPF. The TKI targets growth factor receptors that inhibit pulmonary fibrosis, the platelet-derived growth factor receptor, fibroblast growth factor receptor, and the vascular endothelial growth factor receptor. In clinical trials, nintedanib reduced the annual decline in lung function by approximately 50%. It also reduced the risk of acute respiratory worsening, or acute IPF exacerbation, an event in which about half of patients die while hospitalized.

“While the cause of IPF is unknown and there is no known curative treatment, the unfortunate patients confronted with the disease and physicians caring for patients in the US have been anxiously awaiting FDA-approved treatments. In three clinical trials, nintedanib slowed lung function decline compared to placebo. This approval is a welcome development for patients and caregivers and it provides hope for those who are living with this devastating disease,” said Ganesh Raghu, MD, Professor of Medicine, in the Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases at University of Washington Medical Center, Seattle, WA, in a press release.

Also approved for the treatment of IPF is Genetech’s 

Boehringer Ingelheim's OFEV was approved by FDA as the first treatment for idiopathic pulmonary fibrosis, a fatal lung disease.

FDA Approves OFEV for the Treatment of Idiopathic Pulmonary Fibrosis

Genetech announced on Oct. 15, 2014 that it received FDA approval for Esbriet, or pirfenidone, as a treatment for the fatal lung disease Idiopathic Pulmonary Fibrosis (IPF). Esbriet was developed by InterMune, a subsidiary of Roche. According to the 

The approval of Esbriet is based on a large, placebo-controlled Phase III study, ASCEND, as well as two other Phase III trials, CAPACITY 1 and 2. The ASCEND study resulted in more patients experiencing a delay in the decline of lung function compared to those receiving a placebo. Esbriet is an oral medication that is believed to interfere with the production of transforming growth factor-beta, which is a protein involved in how cells grow, and tumor necrosis factor-alpha, which is a protein involved in inflammation. Esbriet will be available to patients within two weeks.

Also approved for the treatment of IPF is Boehringer Ingelheim’s tyrosine kinase inhibitor, 

Genentech announced FDA-approved Esbriet for the treatment of Idiopathic Pulmonary Fibrosis.

Genentech Announces FDA Approval of Idiopathic Pulmonary Fibrosis Treatment

Pfizer announced on Oct. 13, 2014 that it received FDA Priority Review for its new drug application for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. The treatment, which is a combination of palbociclib and letrozole, is designed for women who have not received any prior systemic treatment for their advanced breast cancer.

Palbociclib is an oral-targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4/6 to regain cell cycle control and block tumor cell proliferation. 

 is a tablet used to treat the early stages of breast cancer in women who have experienced menopause and who have had treatments to remove the tumor; women who have had menopause and have taken tamoxifen for five years; or women who have had menopause and whose breast cancer has worsened while taking tamoxifen. Letrozole reduces the amount of estrogen produced by the body.

“If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the US who are living with metastatic breast cancer,” said Garry Nicholson, president, Pfizer Oncology, in a press release.

Pfizer announced that it has received FDA Priority Review for palbociclib, in combination with letrozole, as a treatment for HER2- advanced breast cancer.

FDA Grants Priority Review for Pfizer's HER2- Advanced Breast Cancer Treatment

Genentech announced on Oct. 8, 2014 that it received Priority Review from FDA for the diabetic retinopathy, Lucentis. Priority Review is granted by FDA to “medicines that, if approved, would have the potential to provide improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.”

Genentech submitted a supplemental biologics license application (sBLA) on Aug. 7, 2014. The submission is based on the results of two Phase III trials, which resulted in improvements in the disease.

 consisted of 759 patients with diabetic retinopathy and Diabetic Macular Edema at baseline, divided into two groups: the RISE trial with 377 patients, and the RIDE trial with 382 patients. The trials were identical, parallel, double-masked, sham treatment-controlled with each trial divided into three random groups with different monthly treatments: 0.3mg Lucentis, 0.5 mg Lucentis, or sham injection.

The trials, conducted over a three-year period, resulted in an increased proportion of patients treated with Lucentis to improve by three or more steps, compared to the sham at month 24. By month 36, the benefits of Lucentis were maintained.

FDA granted Genentech priority review for its diabetic retinopathy treatment, Lucentis.