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Clarity Pharmaceuticals Closes $10 million Capital Raising

On May 8, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported that it has completed its anticipated capital raising of $10,000,005.50 (Press release, Clarity Pharmaceuticals, MAY 8, 2019, View Source [SID1234535879]). This includes the previously announced strategic investment of $5,000,002.75 from GenesisCare, the largest private provider of cancer treatment in Australia and Europe, an additional $3,965,957.00 from the undertaking of a Rights Issue to Clarity’s existing shareholders, and now the remaining amount of $1,034,045.75 from new shareholders.

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The funds will enable Clarity to progress the development of its pipeline of radiopharmaceuticals, including Cu-64 SARTATE and Cu-67 SARTATE, which are next generation, highly targeted, theranostic (diagnostic and therapy) pharmaceuticals with increased specificity and in vivo stability. Clarity’s first theranostic trial of SARTATE in a serious brain cancer called meningioma commenced in July 2018 with the study halfway complete. Clarity will also progress clinical trials with SARTATE in neuroendocrine tumours (NETs) and neuroblastoma in collaboration with leading institutions in the US and Australia. In addition to the development of SARTATE, the capital raising will also enable the clinical development of two other products in Clarity’s pipeline, a prostate specific membrane antigen (PSMA) targeting product for the diagnosis and treatment of prostate cancer; and a bombesin product that targets the gastrin-releasing peptide receptor, which is present in a number of serious cancers including lung, ovarian, prostate, and breast.

Dr Alan Taylor, Executive Chairman of Clarity Pharmaceuticals, commented, "We are very pleased to have completed our capital raising which included a strategic investment from our partner GenesisCare, strong support from our current shareholder base as well as great demand from new investors. This capital raising also coincides with recent additions and changes to the team, including ex-Algeta CEO and CMO, Dr Thomas Ramdahl and Dr Gillies O’Bryan-Tear respectively, joining our Board, as well as former Algeta executive, Dr Colin Biggin, moving to acting CEO. Our growing team is dedicated to continuing our important work of developing safer and more effective treatments for children and adults with cancer together with a number of our collaborators and world leading experts in the field."

Targovax Announces Completed Enrollment of ONCOS-102 Trial in Mesothelioma

On May 8, 2019 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported that it has completed patient enrollment in the phase Ib/II trial of ONCOS-102 in combination with chemotherapy in unresectable malignant pleural mesothelioma (MPM) (Press release, Targovax, MAY 8, 2019, View Source [SID1234535856]).

The trial consists of a phase Ib safety lead-in part followed by a randomized, open label phase II part, assessing the combination of ONCOS-102 and standard of care (SoC) chemotherapy (pemetrexed and cisplatin) vs SoC chemotherapy alone in first or second/third line patients with unresectable MPM. In May 2018, Targovax reported no safety issues, strong innate and adaptive immune activation and 50% disease control rate (DCR) for the six patients in the phase Ib safety lead-in cohort – see link to press release here.

The enrollment of 25 patients into the randomized phase II part of the trial has now been completed, with a total of 31 patients on the trial who will be evaluated for safety, immune response and efficacy. There are 20 patients in the experimental arm combining ONCOS-102 with chemotherapy and eleven patients in the chemotherapy only control group. The patients in the part I safety cohort form part of the experimental arm.

The aim of the trial is to assess safety and tolerability, immunological activation and 6-month overall response rate (ORR) of the combination of ONCOS-102 and SoC chemotherapy compared to SoC chemotherapy alone. Data read out is expected around New Year.

Magnus Jäderberg, CMO of Targovax, said: "We are very pleased to have completed enrollment of our mesothelioma trial. ONCOS-102 is currently the most clinically advanced oncolytic virus in this difficult to treat cancer, and therefore a high priority for us. The randomized ORR and immune data from this study will indicate whether the ONCOS-102 and chemotherapy combination gives patients a benefit over chemotherapy. The clinical and immune data will guide the further development of ONCOS-102 in mesothelioma."

Evotec SE to report first quarter 2019 results on 14 May 2019

On May 8, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first quarter of 2019 on Tuesday, 14 May 2019 (Press release, Evotec, MAY 8, 2019, View Source;announcements/press-releases/p/evotec-se-to-report-first-quarter-2019-results-on-14-may-2019-5803 [SID1234535825]).

The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for fiscal year 2019. The conference call will be held in English.

Conference call details

Date: Tuesday, 14 May 2019

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

From Germany: +49 69 201 744 220

From France: +33 170 709 502

From Italy: +39 02 3600 6663

From the UK: +44 20 3009 2470

From the USA: +1 877 423 0830

Access Code: 35899832#

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 20 17 44 222 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 844 307 9362. The access code is 315534322#. The on-demand version of the webcast will be available on our website: View Source

Oncoceutics Invited to Present ONC201 at Public Advisory Committee Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee on June 20, 2019

On May 7, 2019 Oncoceutics reported that the US Food and Drug Administration invited the company to present information regarding its lead compound ONC201 at the public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee on June 20, 2019 (Press release, Oncoceutics, MAY 7, 2019, View Source [SID1234558355]).

The meeting will provide Oncoceutics with the opportunity to present its clinical data for patients treated with ONC201, including studies for both adult and pediatric patients with gliomas containing the H3 K27M mutation, a disease that has been recognized to be an area of high unmet medical need. Additionally, the meeting will enable Oncoceutics to receive feedback from the subcommittee on issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of ONC201 for pediatric use.

"We are honored and grateful for the opportunity to present to the Pediatric Oncology Subcommittee of the ODAC," said Wolfgang Oster, MD, PhD, Chief Executive Officer and Chairman of Oncoceutics. "ONC201 has shown biological activity that we hope will translate into the clinic and eventually make a difference in patients’ lives. We look forward to furthering the clinical development of ONC201 with the support and guidance of the FDA."

The Public Advisory Committee Meeting will take place in the Great Room of the FDA’s White Oak campus from 8am to 4:30pm. Oncoceutics will present at 12:30pm. Background materials will be available at least 2 business days before the meeting at View Source, and interested persons from the public may present data, information, or views, orally or in writing, on issues pending before the subcommittee.

GeneQuantum Healthcare completed nearly RMB 100 million in Pre-B financing

On May 7, 2019 GeneQuantum Healthcare reported that it has closed nearly RMB 100 million Pre-B round of financing (Press release, GeneQuantum Healthcare, MAY 7, 2019, View Source [SID1234553994]). This financing was led by Huagai Capital, joined by Hofon Capital and Changjinboya. GeneQuantum Healthcare’s A-round investor Oriza Seed and TF Capital continued for additional investments. The funds raised in this round are mainly used to promote the global clinical development of next generation of ADCs, as well as the rapid development and layout of a series of differentiated innovative technologies and products.

GeneQuantum Healthcare focuses on the research and development of various innovative bioconjugate drugs via its innovative LDC technology and the international first-class iLDC platform. The company’s iLDC platform utilizes an enzyme-catalyzed intelligent continuous conjugation process, which has successfully achieved pilot production for next generation of highly homogeneous ADCs with significantly improved quality and reduced costs. The platform process revolutionizes the existing chemical conjugation based production mode and can be widely applied to the automated manufacturing of various bioconjugate drugs represented by ADC drugs. Taking advantage of this platform, GeneQuantum Healthcare has established cooperation with pharmaceutical companies regarding innovative bioconjugate drug research and development.

Dr. Gang Qin, Chairman and President of GeneQuantum Healthcare, said: "GeneQuantum’s innovative ADC is about to initiate clinical trial and the pipeline is rapidly expanding. We are thrilled to be recognized and supported by the leading investors such as Huagai Capital and others at this time point. We look forward to working with investors to expedite our business growth in highly differentiated innovative products, to further expand the application of iLDC platform, and to enhance our unique advantages in precision diagnosis and treatment of tumors, so as to provide innovative treatment plan for cancer patients worldwide. With our advantages in intelligent continuous conjugation platform, we will cooperate with international and domestic pharmaceutical companies to rapidly promote more and better bioconjugate drug development and industrialization."

Mr. Zhiqiang Zeng, the managing partner of Huagai Capital, said: "GeneQuantum is a first class enzymatic-conjugation ADC company in the world. It has independently developed its unique iLDC platform and is capable of growing into an internationally competitive biopharmaceutical leader. The next generation of ADCs developed by GeneQuantum Healthcare will help more patients in the future."

Mr. Qun Zhao, partner of Oriza Seed, said: "We are very optimistic about the potential of enzymatic conjugation technology in the field of ADCs. GeneQuantum Healthcare comprises vast technical accumulation and innovative reserves. We’ll expect the release of GeneQuantum Healthcare’s products to benefit patients as soon as possible."