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]).

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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.

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.

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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 The National Center for Tumor Diseases (NCT) Heidelberg and Protagen AG reported a collaboration to utilize Protagen’s Cancer Immunotherapy Array to identify biomarkers that predict therapeutic response and the incidence of immune-related adverse events (irAEs) in urothelial carcinoma patients treated with checkpoint inhibitors (Press release, Protagen, OCT 18, 2018, View Source [SID1234530339]).

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In recent years, checkpoint inhibitors have changed treatment paradigms in cancer. They offer an enormous potential in many indications, including melanoma, lung, and urothelial carcinoma. Yet, two challenges remain: only a subset of patients respond to treatment, and checkpoint inhibitors trigger (often severe) immune-related Adverse Events (irAEs). Through this collaboration, Protagen and the NCT Heidelberg will utilize Protagen‘s Cancer Immunotherapy Array to address these challenges.

Prof. Carsten Grüllich from the NCT Heidelberg, stated: "Checkpoint inhibitors offer the chance to significantly improve overall survival for cancer patients, and can potentially even cure cancer in some cases. In urothelial carcinoma especially, they can be very successful in a subset of patients, however certain subsets suffer from drug-related toxicities. This makes it vital that we understand better which patients are likely to respond and/or suffer from irAEs. Utilizing Protagen’s Cancer Immunotherapy Array will enable us to establish an immune-profile for each patient, meaning we can assess their immuno-competence to help fight their cancer."

Dr. Peter Schulz-Knappe, Protagen’s Chief Scientific Officer, commented: "Our unique Cancer Immunotherapy Array has already demonstrated its potential in malignant melanoma and prostate cancer patients. The extension into urothelial carcinoma is our next step into an indication where cancer immunotherapies have been successful, but also face significant response and toxicity challenges. We believe that applying our technology will result in improved patient selection for novel immunotherapies and better management of risks associated with therapy. We feel privileged that Prof. Grüllich and the NCT Heidelberg share this vision, and are excited about the collaboration."

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

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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 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.

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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.