On October 18, 2018 Aclaris Therapeutics, Inc. (Nasdaq:ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet patient needs in aesthetic and medical dermatology and immunology, reported the pricing of its underwritten public offering of 8,645,000 shares of its common stock at a price to the public of $10.75 per share (Press release, Aclaris Therapeutics, OCT 18, 2018, View Source [SID1234530333]). In addition, Aclaris has granted to the underwriters a 30-day option to purchase up to 1,296,750 additional shares of common stock at the public offering price, less the underwriting discount. The gross proceeds from the offering to Aclaris are expected to be approximately $92.9 million, before deducting underwriting discounts and commissions and offering expenses, but excluding any exercise of the underwriters’ option. The offering is expected to close on or about October 22, 2018, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Leerink Partners and Evercore ISI are acting as joint book-running managers for the offering. Cantor is acting as lead manager for the offering. Guggenheim Securities is acting as co-manager for the offering.

A shelf registration statement relating to this offering was filed with the Securities and Exchange Commission (SEC) on November 2, 2016 and declared effective by the SEC on November 14, 2016. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6132, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at 888-474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On October 18, 2018 During the congress of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), that will be held from the 19th to the 23rd of October in Munich, Germany, PharmaMar’s (MSE:PHM) Zepsyre (lurbinectedin) abstract #9320 entitled "Phase III trial of Lurbinectedin versus PLD or Topotecan in platinum-resistant ovarian cancer patients: Results of CORAIL trial" will be presented orally on the 19th of October (Press release, PharmaMar, OCT 18, 2018, View Source [SID1234529959]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Ali Zeaiter, Director of Clinical Development of the Oncology Business Unit at PharmaMar explains: "While we are disappointed that the CORAIL trial didn´t meet its primary endpoint of PFS, the data obtained support that lurbinectedin has activity in platinum-resistant Ovarian Cancer."

Data obtained from other PharmaMar compounds of marine origin, lurbinectedin and Yondelis (trabectedin) will also be presented. These include four other posters with the latest advances in the clinical development of trabectedin, including the results of the randomized phase III (TSAR) study evaluating the quality of life of patients with Advanced Soft Tissue Sarcoma (ASTS).

The studies that will be presented during the ESMO (Free ESMO Whitepaper) 2018 Congress are available at: View Source

Lurbinectedin

Phase III trial of Lurbinectedin versus PLD or Topotecan in platinum-resistant ovarian cancer patients: Results of CORAIL trial (#932O)
Oral presentation – 19.10.2018, 14:00 – 15:15, in Hall A1 – Room 15.
Principal Author: S. Gaillard, Baltimore, US.

SAKK 17/16 – Lurbinectedin monotherapy in patients with progressive malignant pleural mesothelioma: A multicenter, single-arm phase II trial (#1817TiP)
Poster – 20.10.2018, 13:30 Hall A3 – Poster Area – Networking Hub
Principal Author: Y. Metaxas. Chur, Switzerland.

Yondelis (trabectedin)

Health-related quality of life in patients with advanced soft tissue sarcoma (ASTS): Results from the TSAR randomized phase III trial of the French Sarcoma Group (#1604PD)
Poster Discussion – Sarcoma. 22.10.2018, 11:00 – 12:15, in Hall B3 – Room 23
Principal Author: Axel Le Cesne, Villejuif, France.

Quality of Life in patients with soft tissue sarcoma undergoing palliative treatment – A multicenter, cluster-randomized trial within the German Interdisciplinary Sarcoma Group, GISG-12 (#1606PD)
Poster Discussion – Sarcoma. 22.10.2018, 11:00 – 12:15, in Hall B3 – Room 23
Principal Author: Leopold Hentschel, Dresden, Germany.

Trabectedin and radiotherapy in advanced sarcoma: experience of a Reference Center (#1626P)
Poster – 22.10.2018, 12:45 – 13:45, in Hall A3 – Poster Area Networking Hub
Principal Author: Javier Martín-Broto, Seville, Spain.

Trabectedin plus pegylated liposomal doxorubicin (PLD) in patients with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of prior use of antiangiogenics: First results of an observational, prospective study (#987P)
Poster – 20.10.2018, 12:30 – 13:30, in Hall A3 – Poster Area Networking Hub
Principal Author: Sandro Pignata, Naples, Italy.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical enterprise, Zelnova Zeltia. To learn more about PharmaMar, please visit us at www.pharmamar.com.

About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close to 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

About lurbinectedin
Lurbinectedin (PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

On October 18, 2018 THERADIAG (ISIN: FR0004197747, Ticker: ALTER) a company specializing in in vitro diagnostics and theranostics, reported its consolidated revenue for the nine-month period to September 30, 2018

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sales for the third quarter of 2018 are up sharply at +9% compared to the third quarter of 2017. This performance is mainly due to the very strong growth in sales of Tracker kits for routine use, which rose by 34% over the period.

Theradiag’s revenue in the nine-months period to September 30, 2018 totaled €6.5 million, down 5% on its nine-months 2017 level, compared to a 9% contraction in the first half of 2018.

Nine-months sales of Tracker kits for routine use moved up 18% from their nine-months 2017 level. Growth in Tracker sales for routine use accelerated from 8% in the first, to 15% in the second and 34% in the third quarter.

As in the previous quarter, total theranostics revenue declined by 9% because no non-recurring theranostics revenue was recorded in the first nine months of the year. In contrast, substantial revenue was received in the same period of 2017 under agreements with pharmaceutical groups.

IVD revenue remained stable at September 30,2018

On October 18, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that it will release its third quarter 2018 financial results on Thursday, November 1, 2018 (Press release, NewLink Genetics, OCT 18, 2018, View Source [SID1234530683]). The company has scheduled a conference call for 4:30 PM ET the same day to discuss the results and to give an update on its clinical development activities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

NewLink Genetics’ senior management team will host the conference call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.

Access to the live conference call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link can be accessed through the NewLink Genetics website at View Source A replay of the call will be available for two weeks from the date of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 1753698.

On October 18, 2018 Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (the "Company" or "Biocure") reported the successful results of the Pre-Clinical Trial of safety and toxicity of CAR-T cells based treatment for Acute Lymphocytic Leukemia (Press release, Biocure Technology, OCT 18, 2018, View Source [SID1234628760]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This is the first breakthrough milestone achieved in Korea and serves as a pre-requisite by Korea FDA (KFDA) for proceeding to an IND (Investigation of a New Drug) application.

The trial results demonstrated a complete remission of the cancerous cells within 7 and 28 days from the injection of reengineered CAR-T cells into a mouse. The study further showed encouraging results as no toxicity symptoms have risen from the high-volume injection. Company believes these to be strong indicators for the next phase clinical trials.

CAR-T cells are a novel form of potential treatment for cancer by "enlisting" and strengthening the power of a patient’s own immune system to attack cancerous tumors. T-Cells are the fundamental protection agent of the human immune system and plays a critical role in orchestrating the immune response and killing cells infected by pathogens.

CAR-T cells immunotherapy essentially "trains" or "engineers" T-Cells to recognize specific cancer related proteins or antigens (CD19 in this case) and thus attach themselves to that cancer cell and destroy it specifically without harming healthy cells. The T-Cells are taken from the patient’s own blood, being reengineered (or "trained") and reintroduced back into the body with their new abilities to fight specific cancerous cells. The "training" entails a production of new receptors on the T-Cell surface that now will enhance the T-Cell with the ability to recognize/attach itself to the cancerous cell’s surface proteins/antigens. These new T-Cell receptors are called "Chimeric Antigen Receptors" or CARs in short which coined the industry name of this novel treatment to "CAR-T".

The trial, first of its kind in the history of Korea, is a result of a wide Korean scientific collaboration. BioCure has performed the trial via its wholly owned subsidiary BiocurePharm in collaboration with Pharos Vaccine with the assistance of Osong Medical Innovation Foundations as the trial CRO (Contract Research Organization) and Croen Corp. who led the toxicity tests under GLP (Good Laboratory Practice) standards.

Biocure has successfully completed the safety test of a Biodistribution analysis study and toxicity study for single dose intravenous injection as per the Korea FDA guidelines. This milestone allows BioCure to advance into the actual production of anti-CD19 CAR-T Cell for a clinical trial.

The Company has already contracted CdmoGen Co. Ltd. and Master Cell Bank to produce a Lentiviral Vector under GMP standards necessary for advancing to the next stage of CAR-T Cell based clinical trials.