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Human Longevity (May-11-2017)
In May 2017, Human Longevity initiated a pilot program, Health Nucleus X (HNX) as part of its Health Nucleus clinical research program, that offers individuals and their physicians proactive access to genomics and advanced MRI that provides rapid insights into individuals' health. HNX focuses on core testing areas of whole genome sequencing and advanced whole body, 3T, and non-contrast MRI and takes about 3 hours to complete. The pilot is being offered in the Health Nucleus facility in La Jolla, CA, from May 1 through June 30, 2017 for an introductory price of $7,500. The company expects to open free standing HNX facilities in other cities. Human Longevity also offers a more comprehensive Health Nucleus Platinum program, which is a full 8-hour day of health testing that includes the two modalities from HNX along with others such as CT scans, echocardiogram, EKG, and a more complete battery of metabolic and lab testing. To date 570 people have participated in the HN Platinum experience with nearly 40% having had significant findings detected at an early stage.
In May 2017, ProLung, closed a private placement that was expected to raise $5.2 million but was oversubscribed by $3.0 million to a total of $8.2 million. ProLung's Electro Pulmonary Nodule (EPN) Scan uses an established bio-conductance technology similar to an EEG or EKG, to risk stratify patients who are likely to have lung lesions suspicious for cancer. The patented computerized Scan can be used in conjunction with Low-Dose CT screening to evaluate masses identified by these scans for high or low risk of malignancy. The EPN Scan is performed on patients with a lung lesion/mass identified by a CT scan as suspicious for lung cancer.
Castle Biosciences (May-9-2017)
In May 2017, Oxford Finance and Silicon Valley Bank provided a $20 million credit facility to Castle Biosciences comprised of a $15 million senior secured term loan and a $5 million line of credit.
Immune Pharmaceuticals (May-04-2017)
In May 2017, Immune Pharmaceuticals entered into definitive agreements with several institutional investors for a private placement of up to $3.4 million of convertible debentures that are convertible at any time into up to 1,245,675 shares of the company's common stock at a conversion price of $2.89 per share, subject to adjustment. In addition, the investors will receive up to 680,000 shares of the company's common stock. The sale of the debentures will be implemented in multiple closings. The company will sell $1.5 million of convertible debentures to the investors at the initial closing of the transaction and the remaining $1.9 million in subsequent closings linked to the achievement of certain milestones.
In May 2017, Celyad signed a non-exclusive license agreement with Novartis for its USPTO-issued patents for the production of allogeneic CAR-T cells. This license agreement is related to two targets currently under development by Novartis. The agreement includes Celyad’s IP rights under the USPTO issued patent # 9,181,527 related to allogeneic human primary T cells that are engineered to be T-cell receptor (TCr) deficient and express a chimeric antigen receptor (CAr). The granted claims are not limited to specific CAr or specific methods of generating allogeneic CAr T cells, such as genome editing or genetic engineering. Under the terms of the agreement Celyad is eligible for an upfront payment and success based clinical, regulatory and commercial milestone payments. If all success based milestones are achieved, including the upfront payment, Celyad is eligible to receive payments, totaling $96 million. In addition, Celyad will receive single digit royalties based on net sales of the licensed target-associated products. Novartis has the option to extend the agreement to additional targets and/or to convert its license into an exclusive license. Celyad retains all rights to grant further licenses to third parties for the use of allogeneic CAr-T cells. Celyad will not be involved in the development of Novartis’ CAr-T cells. Celyad will continue to focus on the development of its CAr-T pipeline, including its allogeneic NKR-2 T-cell immunotherapy in the EU and USA territories and in collaboration with Ono Pharmaceuticals, its partner in Japan, Taiwan and Korea.
In May 2017, Biotheragostics presented at the 18th American Society of Breast Surgeons Annual Meeting in Las Vegas, NV, data from its newly developed Breast Cancer Index (BCI) Clinical Database for Correlative Studies for the prediction of endocrine benefit in early stage, estrogen receptor (Er)-positive breast cancer. The assay was mostly ordered at 4 to 6 years post-diagnosis (~46%), but was also common in the first year (~18%) and >6 years (~16%) post diagnosis. BCI Prognostic and BCI Predictive, components of the BCI assay, provided additional information beyond traditional clinical and pathologic ffeatures. Specifically, BCI identified 27% of patients with smaller tumors (T1a or T1b) as having a high risk of metastatic recurrence after year 5 and a high likelihood of benefit from extended endocrine therapy (EET). Conversely, among patients with larger tumors (T2 or T3), BCI identified 29.5% of patients as having a low risk of late metastatic recurrence and a low likelihood of benefit from EET.
Wuxi NextCODE (May-1-2017)
In May 2017, WuXi NextCODE closed a $75 million Series B financing from its existing investors and partners.
Agios Pharmaceuticals (Apr-28-2017)
In April 2017, Agios Pharmaceuticals issued an additional 757,575 shares of common stock at $49.50 per share, for total gross proceeds of ~ $37 million, pursuant to the exercise in full of the underwriters’ over-allotment option in connection with the company’s public offering of common stock. After giving effect to the full exercise of the over-allotment option, the total number of shares sold by Agios in the public offering was 5,808,080 shares and gross proceeds were ~ $287 million. J.P. Morgan Securities and Goldman, Sachs & Co. acted as joint book-running managers for the offering. Cowen and Company served as lead manager.
In April 2017, Agios Pharmaceuticals and Aurigene Discovery Technologies signed a global license agreement to research, develop and commercialize small molecule inhibitors of an undisclosed cancer metabolism target. Under the terms of the agreement, Aurigene will provide Agios exclusive rights to its portfolio of novel small molecules for the undisclosed target. Financial terms of the agreement include a $3 million upfront payment and potential future milestone payments of up to $17 million per licensed product if certain development and regulatory milestones are achieved by Agios. Aurigene is also eligible to receive low single digit royalties on product sales. Agios will conduct preclinical studies and, if successful, fund further global R&D, as well as regulatory and commercial activities.
In April 2017, enGene reported data from preclinical studies demonstrating successful expression of programmed death-ligand 1 (PD-L1) protein in the gut showing therapeutic efficacies in mouse models of inflammatory bowel disease (IBD) and graft versus host disease (GvHD).
Investigators at Zhongshan Hospital, Fudan University (Shanghai, China) using expression profile analysis discovered that SEMA3A was significantly overexpressed in patients with hepatocellular carcinoma (HCC) and positively correlated with the metastatic potential of HCC cells. In HCC cells, SEMA3A promoted the proliferation and migration of these cells in vitro. Overexpression of SEMA3A in HCC cells induced a significant increase in the expression levels of gelsolin-like capping protein (CapG), galectin-3, enolase 2 and epithelial cell adhesion molecule (EpCAM). Furthermore, the upregulation of SEMA3A in HCC cells promoted tumor growth and progression in an HCC mouse model. Therefore, SEMA3A enhances CapG, galectin-3, enolase 2 and EpCAM expression to promote HCC progression and is a potential therapeutic target for HCC (Li X, etal, Oncol Rep, 2 May 2017; epub ahead of print; https://www.ncbi.nlm.nih.gov/pubmed/28498470 ).
Investigators at Florida Institute of Technology (Melbourne, FL) identified SF3B1, a core component of the U2 snRNP subunit of the spliceosome, as a regulator of the heat shock response (HSR) in Caenorhabditis elegans and report that this regulatory connection is conserved in cultured human cells. There are at least two distinct pathways by which SF3B1 can regulate the HSR, a well conserved, cytoprotective stress response that activates the HSF1, the transcription factor that mediates the HSR. During severe stress, cells inhibit mRNA splicing which also serves a cytoprotective function inhibiting gene expression. Despite this functional interconnectedness, there were no previous reports of crosstalk between these two pathways. Investigators have identified at least two distinct pathways by which SF3B1 can regulate the HSR. First, inhibition of SF3B1 with moderate levels of Pladienolide B, a previously established small molecule inhibitor of SF3B1, affects the transcriptional activation of HSF1. However, both higher levels of Pladienolide B and SF3B1 siRNA knockdown also change the concentration of HSF1 revealing a form of HSR regulation that has not been previously documented during normal physiology but is observed in some forms of cancer. Also, mutations in SF3B1 have also been associated with several distinct types of cancer. Finally, regulation of alternative splicing by SF3B1 is sensitive to temperature, providing a new mechanism by which temperature stress can remodel the transcriptome (Kim Guisbert KS and Guisbert E, PLoS One, 26 Apr 2017;12(4):e0176382; https://www.ncbi.nlm.nih.gov/pubmed/28445500 ).
Investigators at the University of Colorado Anschutz Medical Campus ( CU; Aurora, CO) report that whole-exome sequencing identified recurrent SF3B1 R625 mutation in mucosal melanoma. Mucosal melanoma is a rare subtype of melanoma, arising in mucosal tissues. It is associated with a very poor prognosis because of the lack of effective targeted therapies. For instance, mutations in the BRAF gene present in half of the cases of advanced melanoma were absent in mucosal melanoma, Investigators used the computational tool IMPACT developed in the laboratory of Aik Choon Tan, PhD, at CU to distinguish functional from missense mutations and to cross-reference candidate mutations with those previously reported in other cancer types. Whole-exome sequencing was performed on samples of mucosal melanoma from 19 patients and 135 sun-exposed cutaneous melanoma. Comparisons of molecular profiles identified 161 genes enriched in mucosal melanoma (p<0.05). KIT and NF1 were frequently co-mutated (32%) in the mucosal subgroup, with a significantly higher incidence than that in cutaneous group (4%). Recurrent SF3B1 R625H/S/C mutations were identified and validated in 7 of 19 (37%) cases of mucosal melanoma. Mutated SF3B1 may improperly assemble genes for expression, allowing bits of introns to be expressed along with exons, resulting in mucosal melanoma. This study identified potential new therapeutic targets for mucosal melanoma, including co-mutation of NF1 and KIT, and recurrent R625 mutations in SF3B1. This is the first report of SF3B1 R625 mutations in vulvovaginal mucosal melanoma, with the largest whole exome sequencing project of mucosal melanoma to date. Results also indicated that the mutations in SF3B1 lead to alternative splicing in multiple genes (Hintzsche JD, etal, Melanoma Res, 14 Mar 2017; epub ahead of print; https://www.ncbi.nlm.nih.gov/pubmed/28296713 ).