On April 27, 2018 Sterias Biotherapeutics, Inc. (NYSE MKT:AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported that Nate Manley, Asterias’ Associate Director of Neurobiology, will present an AST-OPC1 program update at the American Society for Neural Therapy and Repair INTR-15 Conference, which is being held during April 25-28, 2018 in Clearwater Beach, Florida (Press release, Asterias Biotherapeutics, APR 27, 2018, View Source;date=April+27%2C+2018&title=Asterias+Biotherapeutics+to+Present+AST-OPC1+Program+Update+at+the+Upcoming+American+Society+for+Neural+Therapy+and+Repair+Conference [SID1234525789]).

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The details of the presentation are as follows:

Title: ESC-Derived Oligodendrocyte Progenitor Cells (AST-OPC1): Clinical Update and Preclinical Progress in Spinal Cord Injury
Date: Saturday, April 28, 2018
Time: 10:00 am – 11:15 am Eastern Time

On April 27, 2018 Bolder BioTechnology, Inc. reported that it has completed a Phase 1 clinical trial of BBT-015, a proprietary long-acting granulocyte colony-stimulating factor (G-CSF) analog, in healthy human volunteers (Press release, Bolder BioTechnology, APR 27, 2018, View Source [SID1234525790]). BBT-015 is being developed as a treatment for chemotherapy-related neutropenia in cancer patients and for Acute Radiation Syndrome. Demonstration that the drug is safe in healthy volunteers is one of the requirements for Food and Drug Administration approval of the drug to treat Acute Radiation Syndrome.

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Joe Cox, Ph.D., Bolder BioTechnology’s President said, "We are very pleased with the results of this trial, which appear to confirm the increased potency of BBT-015 compared to other approved G-CSF products. The trial studied the pharmacokinetics, pharmacodynamics, safety and tolerability of single subcutaneous administrations of three different dose levels of BBT-015 (0.01, 0.04, and 0.1 mg/kg), and a single dose level (0.1 mg/kg) of a comparator drug, pegfilgrastim (Neulastaâ, Amgen, Inc.). There were 5 male subjects per treatment group. The clinical trial was conducted by Celerion, Inc. (Lincoln, NE), and we are grateful for their rapid patient recruitment and excellent study performance."

"BBT-015 plasma levels were dose-dependent, being highest in subjects receiving the 0.1 mg/kg dose; at this dose, mean peak BBT-015 plasma levels were about two-fold higher than mean peak pegfilgrastim plasma levels. All BBT-015 doses stimulated long-lasting increases in circulating neutrophils. Mean peak neutrophil levels reached a maximum in subjects treated with 0.04 mg/kg and 0.1 mg/kg BBT-015, and were higher in these subjects than in subjects treated with 0.1 mg/kg pegfilgrastim."

"BBT-015 also stimulated dose-dependent increases in circulating peripheral blood progenitor cells (CD34+ cells), which are used in hematopoietic stem cell transplants. Mean peak CD34+ cell numbers were about 50% higher in subjects treated with 0.1 mg/kg BBT-015 compared to subjects treated with the 0.1 mg/kg pegfilgrastim."

"All BBT-015 doses were well tolerated and all subjects completed the trial. All adverse events attributed to BBT-015 were rated as mild, while adverse events attributed to pegfilgrastim were rated as mostly mild, with a couple moderate. Musculoskeletal pain and headaches were the most frequent adverse events for both drugs. Subjects treated with the 0.01 and 0.04 mg/kg BBT-015 experienced fewer than half as many adverse events as subjects treated with 0.1 mg/kg BBT-015 or 0.1 mg/kg pegfilgrastim. None of the 15 subjects treated with BBT-015 reported feeling nauseous or vomiting, which are common side effects of other G-CSF drugs. None of the subjects developed antibodies to BBT-015 or pegfilgrastim."

"Although subject numbers in this trial are small, the data are very promising and warrant further study of BBT-015 in additional clinical trials."

About BBT-015

BBT-015 is a long-acting G-CSF analog that stimulates production of neutrophils, a type of white blood cell important for fighting infections. G-CSF has a short half-life in humans and typically is administered to patients by daily injection. BBT-015 has been selectively modified with the polymer polyethylene glycol at a unique site in the protein, which allows the protein to last longer in patients, reducing the need for frequent administration and increasing the protein’s ability to stimulate long-lasting production of neutrophils.

On April 27, 2018 Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, reported that it has completed the sale of BioServe Biotechnologies (India) Private Limited, a wholly-owned subsidiary of Cancer Genetics to biomedical research company, REPROCELL Incorporated, for $1.9 million (Press release, Cancer Genetics, APR 27, 2018, View Source [SID1234525791]).

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Under the terms of the definitive agreement, Cancer Genetics received an upfront payment of $1.6 million in cash from REPROCELL. The remaining balance will be payable approximately 6 months from closing and is subject to BioServe’s revenues for a four month period post-closing being equivalent to the same four month period in 2017.

"The sale of BioServe to REPROCELL is consistent with our 2018 transformation and strategic plan to focus our business and execute against a path to profitability. We expect this transaction will be beneficial to the Company and our shareholders," said Jay Roberts, Interim Chief Executive Officer and COO of Cancer Genetics. "For CGI, this divestiture is one of several deliberate actions to focus our business, simplify our operating structure and generate monetary value to help fund new programs and assist in reducing overall operating expenses. Additionally, as part of our forward looking strategy, we intend to explore licensing opportunities with REPROCELL, among other business partners internationally, to bring our vast test and services menu to other regions with high demand and volume expectations. Overall, we remain focused on developing and bringing to market unique and innovative diagnostic assets from our industry leading pipeline and collaborating with biopharma companies to augment their therapeutics development capabilities."

The Company announced on April 2, 2018 that it has engaged Raymond James & Associates, Inc. as a financial advisor to assist with evaluating options for the Company’s strategic direction. These options may include raising additional capital, the acquisition of another company and / or complementary assets, the sale of the Company, or another type of strategic partnership. The Company’s Board of Directors is committed to evaluating all potential strategic opportunities and to pursuing the path most likely to create both near- and longer-term value for Cancer Genetics’ shareholders.

On April 27, 2018 Compugen Ltd. (Nasdaq: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) requested that the Company provide additional CMC information in support of its IND application for COM701, initially submitted in late March 2018 (Press release, Compugen, APR 27, 2018, View Source [SID1234525792]). COM701 is a first-in-class immuno-oncology therapeutic antibody targeting PVRIG. FDA recommended a lower starting dose of COM701 for the trial, which now requires a more sensitive COM701 assay detection method for this dose. The FDA informed the Company that the IND application review can be completed and the application can be taken off clinical hold once the requested information is provided by Compugen. The IND is intended to support initiation of a planned Phase 1 clinical trial of COM701 in patients with advanced solid tumors. This trial is not yet active at any investigational sites and has not recruited any patients.

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"We are working closely with the FDA to provide the additional information requested as quickly as possible. In anticipation for FDA clearance, site selection activities in multiple centers in the United States are currently ongoing to allow future patient enrollment, and we look forward to evaluating COM701 in a clinical setting," stated Anat Cohen-Dayag, PhD, President and CEO of Compugen. "We continue to be encouraged by the preclinical data for COM701, which suggest that targeting PVRIG may be a primary means of stimulating an anti-tumor immune response in certain cancers that may be unresponsive to available treatments."

The Company will continue to provide updates on this matter as appropriate.

On April 27, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence (Press release, Hoffmann-La Roche, APR 27, 2018, View Source [SID1234525793]). A final decision regarding the approval of the Perjeta-based regimen, along with the full details of the approved indication, is expected from the European Commission in the near future.

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"The goal of treating early breast cancer is to provide the best chance for a cure. This is why we believe that building on the existing therapies is so vital," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Today’s announcement brings hope that patients in Europe with HER2-positive early breast cancer, who are at a high risk of recurrence, will soon have a new treatment option to reduce the chance of their disease returning and potentially progressing to an incurable stage."

The CHMP recommendation is based on results from a large phase III study (APHINITY) involving over 4,800 people with HER2-positive eBC.1 At the time of the primary analysis, with a median follow-up of 45.4 months, the Perjeta-based regimen significantly reduced the risk of invasive breast cancer recurrence or death by 19% compared to Herceptin and chemotherapy alone in the overall study population (HR=0.81, 95% CI 0.66-1.00, p=0.045).1

The Perjeta-based regimen showed the greatest benefit in patients who are at high risk of recurrence:1

For patients with lymph node-positive disease, the risk of recurrence or death was reduced by 23% with the Perjeta-based regimen (HR=0.77; 95% CI 0.62-0.96, p=0.019).
Among patients with hormone receptor-negative disease, the Perjeta-based regimen reduced the risk of recurrence or death by 24% (HR=0.76; 95% CI 0.56-1.04, p=0.085).
The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies, with a low incidence of cardiac events and no new safety signals.1

Every year, almost 100,000 people in Europe are diagnosed with HER2-positive breast cancer, an aggressive type of the disease if left untreated.2,3,4 The majority of breast cancer cases are diagnosed at an early stage where the goal of treatment is to cure.5,6 In the eBC setting, treatment may be given before surgery to shrink tumours and after surgery to help prevent the cancer from returning.7,8 Despite advances in the treatment of HER2-positive eBC, one in four people treated with Herceptin and chemotherapy will eventually see their cancer return in the long-term.9 There is currently no cure for breast cancer that recurs and reaches an advanced stage and treatment for advanced disease is given to prolong life for as long as possible.10

For people diagnosed with HER2-positive eBC, the Perjeta-based regimen has already been approved for use before surgery in the EU, the US and many other countries.11,12 In December 2017, the US Food and Drug Administration (FDA) also approved the Perjeta-based regimen as a post-surgery treatment of HER2-positive eBC at high risk of recurrence.11 Patients in the US with HER2-positive eBC, eligible for the Perjeta-based regimen, should therefore receive Perjeta and Herceptin for 18 cycles, irrespective of the time of surgery, to complete one year of treatment.11

The combination has also been previously approved for the treatment of people with advanced HER2-positive breast cancer, where it has been shown to significantly extend survival compared to Herceptin and chemotherapy alone.11, 12 ,13

Perjeta works in combination with Herceptin to provide a more comprehensive, dual blockade of the HER2 receptor, thus preventing tumour cell growth and survival.14

For more information about HER2-positive breast cancer and the goals of treatment, visit our Breast Cancer Hub on roche.com.

About APHINITY 1
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy, compared to Herceptin and chemotherapy, as adjuvant therapy in 4,805 people with operable HER2-positive eBC. The primary efficacy endpoint of the APHINITY study is invasive disease-free survival (iDFS), which in this study is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival and health-related quality of life. The study will continue to follow participants for ten years.

About Perjeta
Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers.15,16 Perjeta is designed specifically to prevent the HER2 receptor from pairing (or ‘dimerising’) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival. Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signalling pathways, thus preventing tumour cell growth and survival.14,17

About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.2 Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla (trastuzumab emtansine).

Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.