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 26, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported that it is enrolling patients in a multicenter Phase 1/1b clinical trial of CPI-006, a humanized monoclonal antibody directed against CD73 (Press release, Corvus Pharmaceuticals, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344945 [SID1234525734]). The three-arm study in patients with a variety of solid tumors is evaluating CPI-006 administered as a single agent, in combination with Corvus’ CPI-444, a selective and potent inhibitor of the adenosine A2A receptor, and in combination with pembrolizumab, an anti-PD-1 antibody.

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"CPI-006 is an antibody engineered to completely inhibit the CD73 enzyme by binding to its active site. We look forward to evaluating this anti-CD73 antibody in our comprehensive Phase 1/1b trial, which we believe is the first human clinical trial in oncology to evaluate the effect of dual-blockade of the adenosine pathway by inhibiting both CD73 and the A2A receptor," said Richard A. Miller, M.D., an oncologist and co-founder, president and chief executive officer of Corvus. "This trial is designed to answer multiple important questions regarding the role of CD73 blockade and the adenosine pathway in patients with advanced cancer. With the initiation of this new trial and our ongoing Phase 1/1b clinical trial of CPI-444, we continue to reinforce our leadership position in this new therapeutic area."

ABOUT THE PHASE 1/1B TRIAL DESIGN
The Phase 1/1b trial is designed to select the dose and evaluate the safety, pharmacokinetics, immune biomarkers and efficacy of CPI-006 as a single agent, in combination with CPI-444 and in combination with pembrolizumab. Patients with non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and other cancers who have failed standard therapies are eligible. The efficacy endpoints are complete response (CR), partial response (PR), disease control rate, duration of response, progression-free survival and overall survival.

In the dose-selection part of the trial, doses of CPI-006 will be escalated in the single-agent arm and in the two combination arms to determine the maximally tolerated dose or the dose that saturates the CD73 enzyme. Fixed doses of CPI-444 and pembrolizumab will be used. Once an optimum dose of CPI-006 is determined, the second part of the trial will enroll patients in nine cohorts: three will receive CPI-006 alone, three will receive CPI-006 in combination with CPI-444, and three will receive CPI-006 with pembrolizumab. Patients with NSCLC, RCC and the group of other cancers will be enrolled into each of the three disease-specific arms. Each of the nine cohorts may initially enroll up to 11 patients. However, if there is one or more objective responses (CR or PR) in the 11 patients, the cohort may be expanded to 28 patients. The trial may enroll up to 350 patients in total.

ABOUT CD73 AND ADENOSINE
CD73 is a cell surface enzyme whose function is to convert adenosine monophosphate (AMP) to adenosine by removing phosphate from AMP. CD73 is expressed on cells of the immune system, including T-cells and B-cells. CD73 is also present on many tumors, including lung, renal, melanoma, colon, prostate, breast and others. In the tumor microenvironment, CD73 produces adenosine, which binds to the adenosine A2A receptor on immune cells and inhibits various immune responses including those directed against the tumor. Tumors utilize this immunosuppressive mechanism to escape attack by the immune system.

ABOUT CPI-006
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to adenosine. In vitro studies of CPI-006 have shown it is capable of substantially inhibiting the production of adenosine by blocking the CD73 enzyme.

ABOUT CPI-444
CPI-444 is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic

On April 26, 2018 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported its business update for the quarter ending March 31, 2018 (Press release, Transgene, APR 26, 2018, View Source [SID1234525754]).

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During the first quarter of 2018, revenue from collaborative and licensing agreements was mainly composed of research services and royalties.

As of March 31, 2018, government financing for research expenditures mainly consisted of 25% of the research tax credit expected for 2018 (€1.6 million in the first quarter of 2018, comparable with the same period in 2017).

Cash, cash equivalents, available-for-sale financial assets and other financial assets:

Cash, cash equivalents, available-for-sale financial assets and other financial assets stood at €35.6 million as of March 31, 2018, compared to €41.4 million as of December 31, 2017. In the first quarter of 2018, Transgene’s cash burn was €5.8 million, compared to €5.5 million for the same period in 2017.

Key achievements:

TG4010:
First patient treated in Phase 2 trial combining TG4010, nivolumab (ICI) and chemotherapy in 1st line treatment of advanced non-small cell lung cancer patients. The trial being conducted in a clinical collaboration with Bristol-Myers Squibb (press release distributed on January 16, 2018).
TG1050/T101:
First patient treated in China in Phase 1 trial of T101 (based on TG1050 technology) in chronic hepatitis B. This trial is conducted through a joint-venture (50/50) based in China between Transgene and Tasly Pharmaceuticals Group (press release distributed on January 17, 2018).
Research:
Presentation of a poster with promising preclinical data on a novel viral vector (pseudocowpox, PCPV) at the AACR (Free AACR Whitepaper) (American Association for Cancer Research) Annual Meeting 2018, Chicago, IL, USA, April 14 – 18 (press release distributed on April 18, 2018).
Outlook:

Transgene expects its cash burn for 2018 to be comparable to 2017, based on its current development plan.

Transgene confirms that it expects readouts in 2018 for each of its 5 products in clinical development.

– End –

Notes to editors:
Transgene (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a therapeutic vaccine against HPV-positive head and neck cancers. The Company has several other programs in clinical development, including TG1050 (chronic hepatitis B) and TG6002 (solid tumors).
With its proprietary Invir.IOTM, Transgene builds on its world-leading expertise in viral vector engineering to design and generate a new generation of multifunctional oncolytic viruses.
Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as a joint venture in China.
Additional information about Transgene is available at www.transgene.fr.
Follow us on Twitter: @TransgeneSA

Disclaimer:
This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. There can be no guarantee that (i) the results of pre-clinical work and prior clinical trials will be predictive of the results of the clinical trials currently underway, (ii) regulatory authorities will agree with the Company’s further development plans for its therapies, or (iii) the Company will find development and commercialization partners for its therapies in a timely manner and on satisfactory terms and conditions, if at all. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results and development.
For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risques") section of the Document de Référence, available on the AMF website (View Source) or on Transgene’s website (www.transgene.fr). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future

On April 26, 2018 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management plans to report its first quarter 2018 financial results on Thursday, May 3, 2018, after the close of the U.S. financial markets (Press release, CTI BioPharma, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2345109 [SID1234525735]). Following the announcement, members of the management team will host a webcast conference call to discuss the results and provide a general corporate update at 4:30 p.m. ET (1:30 p.m. PT). Access to the event can be obtained as follows:

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Thursday, May 3, 2018
1:30 p.m. PT/4:30 p.m. ET
1-866-548-4713 (domestic)
+1 323-794-2093 (international)

To access the live audio webcast or the subsequent archived recording, visit CTI BioPharma’s website, www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available at approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 9956153. The telephone replay will be available until Thursday, May 10, 2018.