On September 3, 2019 Achilles Therapeutics ("Achilles"), a biopharmaceutical company developing personalised cancer immunotherapies, reported that it has closed a £100 million Series B financing led by incoming U.S. investor RA Capital Management, corner-stoned by founding investor Syncona and joined by important new investors including Forbion, Invus, Perceptive Advisors and Redmile Group (Press release, Achilles Therapeutics, SEP 3, 2019, View Source [SID1234539180]).

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Proceeds from this financing will deliver two human proof-of-concept studies using a unique personalised T cell therapy approach targeting clonal neoantigens in non-small cell lung cancer and melanoma. These programmes are expected to enter the clinic this year. In addition, the financing will enable the Company to continue building out its manufacturing capabilities as well as broadening its growing solid tumour pre-clinical product pipeline.

"Achilles is leading the next wave of immuno-oncology drug development. We have moved from concept to clinic-ready in less than three years. We are extremely pleased to welcome this excellent group of new investors to Achilles and I would like to personally thank our existing founding investors for their continued support," said Dr Iraj Ali, CEO of Achilles Therapeutics. "With this fundraising we have made a clear statement about the scale and nature of our ambitions to bring novel cancer therapies rapidly to patients with a high unmet medical need."

"In 2016, we saw an opportunity to work with world-leading experts to found a company harnessing unique insight into the understanding of cancer evolution, bioinformatics and the development of cell-based immunotherapies to target the treatment of solid tumours. We are delighted with the outcome of this funding round, which is a testament to the Company’s globally differentiated proposition and best-in-class team. We look forward to continuing to support Achilles as it works toward its goal to bring treatments to patients," added Martin Murphy, CEO of Syncona Investment Management Limited.

"The Achilles approach integrates years of multi-disciplinary scientific and clinical knowledge from immuno-oncology, cell therapy, and genomics with the goal of creating a TIL-based therapeutic enriched with T cells reactive against clonal neoantigens. We believe this approach may represent the optimal way to expand the utility of polyclonal TIL therapy to multiple solid tumour types and has the potential to provide profound clinical benefit for patients living with cancer. RA Capital is impressed by the scientific co-founders, management team, board of directors, and vision of the Company, and we are excited to support Achilles as they progress into the clinic this year," added Dr Derek DiRocco, Principal of RA Capital Management.

In association with the financing, Achilles has added two leading life science executives to the Board: Dr Derek DiRocco, Principal of RA Capital Management and Dr Rogier Rooswinkel, Partner at Forbion.

Achilles is developing personalised T cell therapies for solid tumours targeting clonal neoantigens: protein markers unique to each patient that are present on the surface of all cancer cells. Using its PELEUS bioinformatics platform, Achilles can identify clonal neoantigens from each patient’s unique tumour profile which are present on every cancer cell. Achilles uses its proprietary process to manufacture T cells which seek to exquisitely target a specific set of clonal neoantigens in each patient. Targeting multiple clonal neoantigens that are present on all cancer cells, but not on healthy cells, reduces the risk that new mutations can induce immune evasion and therapeutic resistance, and allows individualised treatments to potentially target and destroy tumours without harming healthy tissue.

– Ends –

Further information:

Achilles Therapeutics
Dr Iraj Ali – Chief Executive Officer
+44 (0)1438 906 906
[email protected]

Julia Wilson – Head of Communications
+44 (0)7818 430877
[email protected]

Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner
Tel: +44 (0) 203 709 5000
Email: [email protected]

On August 27, 2019 Vaccitech, a clinical-stage T cell immunotherapy company developing products to treat and prevent cancer and infectious diseases (ID), reported that it has appointed Bill Enright as its new Chief Executive Officer (CEO) (Press release, Vaccitech, AUG 27, 2019, View Source [SID1234539000]). Mr. Enright succeeds Tom Evans, MD who will make a planned transition to the role of Vaccitech’s Chief Scientific Officer.

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Bill joins Vaccitech after an accomplished 11 years as CEO at Gaithersburg-based Altimmune Inc, a company developing novel immunotherapies and vaccines. He led Altimmune through a significant period of growth including a Series B financing, the acquisition of Immune Targeting Systems – a UK T-cell vaccine company – and taking the company public on NASDAQ through the acquisition of PharmAthene. Bill’s prior experience includes executive and management roles at GenVec (now Intrexon), Biotech Venture Management and Life Technologies Corporation (now ThermoFisher).

Dr. Andrew Mclean, Vaccitech Board Member, Oxford Science Innovation, said, "we’re incredibly excited to welcome Bill Enright to lead Vaccitech to build a world-leading T-cell induction immunotherapy company."

"I am delighted to join Vaccitech during this exciting growth phase, ahead of pivotal Phase II data from its lead influenza program and several other key pipeline inflection points. I have been very impressed by the Company’s management team as well as its innovative T cell induction platform. I am looking forward to working with the team to drive the company through the next phase of its development." said Bill Enright.

Having successfully built Vaccitech to a late clinical stage biopharmaceutical company, in his new role as CSO, Tom Evans MD, will focus more specifically on the science, research and development that underpin Vaccitech’s next generation T-cell induction products.

"We believe that Bill’s background and leadership skills are well suited to the Company’s next phase of development and are looking forward to welcoming him to the role. We are extremely grateful to Tom Evans under whose leadership the company has grown rapidly, with over 2000 participants currently in clinical trials. We look forward to Tom’s continuing involvement and excellent scientific leadership as Vaccitech’s CSO.’ added Robin Wright, Vaccitech Chairman.

On September 2, 2019 Benelux’ largest biotech investor Aat van Herk commits a €20 million investment in diagnostics company SkylineDx after reaching major milestones in 2018, financing SkylineDx’ market potential of over $1 billion annually based on their current progress in the melanoma (skin cancer) field (Press release, SkylineDx, SEP 2, 2019, View Source [SID1234539178]). This melanoma test is discovered by a renowned US hospital and further optimized and developed by SkylineDx. Based on the unique combination of genetic information from the primary melanoma cells and other patient and tumor characteristics, the test is able to accurately predict the risk of having metastases present in the lymph nodes without having to undergo a surgery to remove (part of the) lymph nodes. Expert physicians estimate that up to 80% of these biopsies could be safely avoided as they turn out to have no sign of cancerous cells.

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"This capital commitment is a very significant call of confidence," says Dharminder Chahal, CEO SkylineDx. "With the financial requirements secured and Professor Alexander Eggermont on board as our medical advisor, we can initiate the necessary clinical studies in collaboration with expert physicians, patient associations and other stakeholders, in order to get this test from bench to bedside and reimbursed."

Professor Alexander Eggermont is the general director of cancer center Gustave Roussy in Paris and a highly respected expert physician in the melanoma space.

"It is a great feeling that our efforts are lining up, getting our dream – to improve a patient’s quality of life by enabling them to benefit from personal insights at the genetic level of their disease – within reach," concludes Dharminder Chahal.

On September 2, 2019 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and DuChemBio Co, Ltd. (DCB), a leading Korean radiopharmaceutical company, reported the conclusion of an exclusive licensing and development agreement for Solucin Targeted Radionuclide Therapy (TRT) in South Korea (Press release, ITM Isotopen Technologien Munchen, SEP 2, 2019, View Source [SID1234539177]). The agreement sets out terms concerning the local development, registration and subsequent commercialization by DCB of ITM’s proprietary brand Solucin for Targeted Radionuclide Therapy (TRT) in South Korea. Solucin patient doses will be manufactured and exclusively supplied to DCB by ITM.

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Within the framework of this collaboration, DCB and ITM plan to initiate a local clinical study for ITM’s Solucin TRT which is expected to begin recruiting patients in 2020. The study concept is based on ITM’s Phase III clinical trial COMPETE, which has recently seen a considerable increase in patients as a result of strong recruitment in the United States in particular. COMPETE involves 42 leading cancer centers in 12 countries, predominantly in Europe, North America, South Africa and Australia.

The COMPETE clinical trial is an international multi-center phase III clinical study evaluating the efficacy and safety of Targeted Radionuclide Therapy with no-carrier-added Lutetium-177-Edotreotide (Solucin). Its aim is to compare Solucin to Everolimus in patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The study’s primary endpoint is progression-free survival (PFS).

"We are very excited about our partnership with DuChemBio," said Steffen Schuster, CEO of ITM. "The strong growth in patients recruited for our phase III clinical trial COMPETE in the recent months emphasizes the demand for effective treatment options for GEP-NET patients worldwide. In DCB we have found a reliable partner that is as committed as we are, to improving the outcome and quality of life for cancer patients. Together we want to establish Targeted Radionuclide Therapy as an alternative for cancer patients in South Korea."

"Duchembio is delighted to enter this partnership with ITM as a next step to expand our product portfolio into the Theranostics domain" said Jong-Woo Kim, President and CEO of DCB. "Whilst Duchembio – via its Nuc. Med. customers across the country – already supports the diagnosis of GEP-NET patients by means of PET imaging, the inclusion of an innovative radioligand therapy like Solucin TRT in DCB’s portfolio now provides a comprehensive solution for Korea’s leading cancer centers to manage GEP-NET patients."

Solucin is a TRT agent, which consists of the targeting molecule Edotreotide, an octreotide-derived somatostatin analogue and ITM´s EndolucinBeta (n.c.a. 177Lu). The radiopharmaceutical is administered as an intravenous infusion, specifically targeting and destroying the tumor cells in-situ with ionizing radiation.

In South Korea some 400-450 patients are diagnosed with GEP-NET every year. Treatment options are limited and Solucin PRRT will offer an alternative to patients with inoperable and progressive disease. DCB also intends to initiate a Compassionate Use Program (CUP) during the phase II local clinical trial to make Solucin TRT patient doses available to additional Korean patients suffering from GEP-NET.

On September 2, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", stock ticker: XYNO), a clinical stage US-China oncology drug development company, reported encouraging interim data from an ongoing Phase 1b study of its lead candidate abexinostat, an orally dosed, hydroxamic acid-based small molecule histone deacetylase ("HDAC") inhibitor , in combination with Keytruda, for the treatment of multiple solid tumors (Press release, Xynomic Pharmaceuticals, SEP 2, 2019, http://xynomicpharma.com/en/xynomic-pharma-reports-encouraging-interim-data-from-phase-1b-study-of-abexinostat-combined-with-keytruda-in-multiple-solid-tumors/ [SID1234539176]). The trial is being conducted at University of California, San Francisco. The interim data will also be presented at the 3rd World-China Immunotherapy & Gene Therapy Congress 2019 to be held in Beijing from August 30th to 31st, 2019.

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This Phase 1b trial explores abexinostat in combination with pembrolizumab (trade name Keytruda) to treat patients with prior progression on Keytruda or other immune checkpoint inhibitor treatments. A total of 7 patients with prior progression on anti-PD1/PD-L1 treatment were enrolled in the Dose Escalation portion of the study. Tumor types included melanoma (N = 3), urothelial carcinoma (N = 2), neuroendocrine carcinoma (N = 1), and esophageal squamous cell carcinoma (N = 1). The median number of lines of prior systemic therapy was 3. Median age of patient population was 61. In the two dose levels tested (abexinostat 30 mg/m2 and 45 mg/m2 on days 1-4, 8-11 in combination with pembrolizumab 200 mg IV on day 1), there were no dose-limiting toxicities. The maximally tolerated dose was not reached, and the recommended Phase 2 dose is abexinostat 45 mg/m2 BID on days 1-4, 8-11 of a 21 day cycle in conjunction with pembrolizumab 200 mg IV on day 1. There were no treatment-related grade ≥ 3 or serious adverse events. The most common Grade 1-2 adverse events were diarrhea (N = 3), rash (n = 2), thrombocytopenia (n = 1), and dysgeusia (n = 1). 2 out of 7 patients (29%) experienced stable disease for > 6 months. 1 of these 2 patients has pembrolizumab-refractory urothelial carcinoma and remains on treatment for 6+ months with ongoing 20% reduction in tumor size from baseline.

Enrollment in Dose Expansion portion of this trial is ongoing to ascertain the response rate and disease control rate across tumor types. The trial is targeting to enroll a total of approximately 42 patients in the U.S.

"Abexinostat is known mechanistically to have potential synergy with immune checkpoint inhibitors. We are very pleased with the interim data reported today by UCSF, a world leader in solid tumor clinical research. The data reported today indicate the combination of abexinostat with Keytruda could be safe and well tolerated and there is preliminary evidence demonstrating efficacy and the potential to reverse resistance to immune checkpoint blockade. We expect to report additional data at a scientific conference early next year." Mr. Y. Mark Xu, Chairman and CEO of Xynomic commented.