Akari Therapeutics to Participate in Citi and H.C. Wainwright Conferences in Early September

On September 3, 2019 Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement (C5) and/or leukotriene (LTB4) systems are implicated, reported that Clive Richardson, Chief Executive Officer, will participate and host investor meetings at the following September Conferences (Press release, Akari Therapeutics, SEP 3, 2019, https://www.akaritx.com/2019/09/03/akari-therapeutics-to-participate-in-citi-and-h-c-wainwright-conferences-in-early-september/ [SID1234539183]):

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Citi’s 14th Annual Biotech Conference

Date: Wednesday, September 4, 2019

Place: Four Seasons, Boston, Mass.

H.C. Wainwright 21st Annual Global Investment Conference

Date: Tuesday, September 10, 2019

Place: Lotte New York Palace, New York City

Presentation Time: 12:30 p.m. ET

A live audio webcast of the H.C. Wainwright Conference presentation can be accessed by visiting ‘Events’ in the Investor Relations section on the Company’s website at www.akaritx.com. An archived replay of the webcast will be available for 60 days on the Company’s website after the conference.
Investors interested in arranging a meeting with the Company’s management during these two conferences should contact the respective conference coordinators.

Bristol-Myers Squibb to Take Part at the Morgan Stanley Conference

On September 3, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will take part in a fireside chat at the Morgan Stanley Conference on Monday, September 9, 2019, in New York (Press release, Bristol-Myers Squibb, SEP 3, 2019, View Source [SID1234539182]). Giovanni Caforio, M.D., chairman and chief executive officer will answer questions at 4:15 p.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.

Orphan Drug Designation granted for temozolomide in the treatment of neuroblastoma

On September 3, 2019 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, reported that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion for the Orphan Drug Designation of temozolomide in the treatment of neuroblastoma (Press release, ORPHELIA Pharma, SEP 3, 2019, View Source [SID1234539181]).

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« We are particularly pleased with this decision which comes after continuous efforts of ORPHELIA Pharma together with its partners », comments Jérémy Bastid, Chief Development Officer. « We are developing Kimozo, the first paediatric formulation of temozolomide, to provide patients and the medical community with a pharmaceutical form adapted to young children. This positive opinion is one step closer to this goal ».

Kimozo is the first presentation of the anticancer drug temozolomide developed for the treatment of relapsed or refractory neuroblastoma, a paediatric disease with dismal prognosis. As a taste-masked oral suspension, it will also be the first paediatric formulation of temozolomide.

« Temozolomide has been used for years in the treatment of refractory or relapsed neuroblastoma. It is now considered to be an essential drug in this indication », highlights Dominique Valteau-Couanet, President of the Société Internationale d’Oncologie Pédiatrique, Europe Neuroblastoma (SIOPEN), « The liquid formulation of Kimozo, which will be the only temozolomide-containing drug approved for the treatment of neuroblastoma, is particularly well adapted to the intended paediatric population since 90% of the patients are less than 5 years at diagnosis ».

« The COMP has acknowledged the benefit of temozolomide in the treatment of children with high-risk neuroblastoma. The paediatric formulation that we are developing addresses significant unmet medical needs for young children with neuroblastoma », comments Hugues Bienaymé, Founder and General Manager of ORPHELIA Pharma. « In Europe, we expect to submit Kimozo Marketing Authorisation application file by 2021 ».

About temozolomide in neuroblastoma

Neuroblastoma is the most frequent extra-cranial solid tumour in children. It is a rare disease with an incidence of 1.3/100,000. Prognosis is extremely variable, from spontaneously regressing tumours in low-risk neuroblastomas to highly aggressive disease with dismal prognosis in high-risk patients. Half of neuroblastomas are classified as high-risk, among which half being refractory to treatment or relapsing thereafter. Temozolomide has become the mainstay of rescue treatment of relapsed or refractory neuroblastoma, without being authorized in this condition.

ACHILLES THERAPEUTICS RAISES £100 MILLION IN OVERSUBSCRIBED SERIES B FINANCING

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]

Vaccitech Appoints Bill Enright as New Chief Executive Officer

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.