On October 19, 2020 ONK Therapeutics reported for the second time this year alongside American biotech investor Acorn Bioventures and other shareholders in an $8 million (about €6.8 million) fundraising (Press release, ONK Therapeutics, OCT 19, 2020, View Source [SID1234570585]).

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ONK, which is developing enhanced natural killer cells in the immune system to target cancers, has now raised $14.6 million over the past six months. In May, Mr Mulligan led an investment that saw his cell engineering business, Avectas, take a 20 per cent stake in ONK.

ONK, an NUI Galway spinout founded by Prof Michael O’Dwyer in 2015, has also appointed industry veteran Chris Nowers as chief executive. Mr Nowers is a cell therapy expert who has worked in management roles with both Amgen and Bristol Myers Squibb over a 25-year career.

Prof O’Dwyer will continue in his role as chief scientific officer of the group. The latest funding will allow the company expand its team and its preclinical R&D and manufacturing capabilities.

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ONK has developed a process that genetically engineers natural killer (NK) cells – which are part of the body’s immune system – to allow them to better pursue cancer cells that have made themselves invisible to normal NK cells.

It licensed one of its prospective therapies – targeting blood cell cancers such as non-Hodgkin’s lymphoma and certain forms of leukaemia – to Avectas, whose Solupure process allows the gene editing to be done rapidly and safely, without upsetting the cells and in a way that also keeps the costs of the process down.

ONK’s second programme is hoping to help certain multiple myeloma patients.

Different patients
Unlike personalised medicine, where a patient’s own cells are engineered and reintroduced to the body to fight disease, ONK and Avectas are looking to engineer cells that can be used in many different patients suffering from these cancers.

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"This exciting off-the-shelf platform has the potential to produce a next generation of cell therapies, which could improve performance and overcome some of the shortcomings seen with earlier approaches," Mr Nowers said.

Acorn Bioventures partner Isaac Manke, who will join the board of ONK, said it was "a highly innovative next-generation NK cell therapy company with an exciting portfolio of research stage assets". He said the new funding should help bring the company’s pipeline drugs towards clinical trial stage.

This is understood to be Acorn’s first investment in an Irish business. The group, founded in 2017, specialises in investing in small-capitalisation public and private biotechnology companies.

On October 19, 2020 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) ("Diffusion" or "the Company"), reported the appointment of Christopher D. Galloway, M.D. to Chief Medical Officer, effective immediately (Press release, Diffusion Pharmaceuticals, OCT 19, 2020, View Source [SID1234568923]). Dr. Galloway will report to Robert Cobuzzi, Ph.D., Diffusion’s Chief Executive Officer.

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Dr. Galloway is board certified in Emergency Medicine and will assume responsibility of leading the Company’s product development efforts, including clinical trials with Trans Sodium Crocetinate ("TSC"), which is being evaluated in an ongoing Phase 1b clinical study in Romania in patients with COVID-19. In addition, Dr. Galloway will lead the expansion of the Company’s work with TSC into other hypoxia-related conditions. Dr. Galloway brings to Diffusion more than 20 years of experience both in industry leadership roles in clinical development and medical affairs across multiple therapeutic areas and stages of development, as well as the perspective of a practicing physician.

"We are delighted to welcome Chris as a member of the Diffusion team. He brings a breadth of therapeutic area experiences both as a practicing physician and from his time in the biopharmaceutical industry. His leadership will be of significant benefit for Diffusion as we continue and expand the development of TSC for conditions and diseases where low oxygen levels are an issue, including respiratory diseases, such as COVID-19, oncology, and other hypoxia-related conditions," said Dr. Cobuzzi.

Dr. Galloway joins Diffusion from La Jolla Pharmaceuticals, where he has served as Senior Medical Director in critical care since August 2018. Among his duties at La Jolla, he chaired and oversaw the investigator-initiated and collaborative research programs, as well as supported the commercial and medical teams for the launch of GIAPREZA (angiotensin II). Prior to La Jolla, he was Medical Director for global clinical development at the immuno-oncology company, Rakuten Medical. At Rakuten, he was involved in clinical development, operations, and trial execution from Phase 1 through Phase 3 in multiple indications. Previously he has served as Medical Affairs Director within Merck’s immunotherapy division, and also led the team at DaVita Clinical Research as Medical Director and Principal Investigator specializing in early phase studies.

"I am thrilled to be joining the talented team at Diffusion and overseeing the development of our lead product, TSC," said Dr. Galloway. " Hypoxia-related pathology is prevalent across a multitude of medical conditions and therapeutic disciplines, and I believe TSC has the potential for meaningful improvement in patient care and outcomes."

Dr. Galloway received his M.D. degree from the University of Texas Medical Branch at Galveston, and completed his residency in Emergency Medicine at Carolinas Medical Center in Charlotte, N.C. He received a BA in biology from the University of Texas at Austin, and is licensed to practice medicine in Colorado. Dr. Galloway is a Diplomate of the American Board of Emergency Medicine.

Inducement Grant Under NASDAQ Listing Rule 5635(c)(4

In connection with Dr. Galloway’s new employment, the Compensation Committee of Diffusion’s Board of Directors has approved the grant of non-qualified stock options to Dr. Galloway, who will receive options to purchase 200,000 shares of Diffusion’s common stock. The grant date for the options will be October 19, 2020, and the exercise price per share for such stock options will be the closing price of Diffusion’s common stock on such date, as reported by NASDAQ. The grant was approved and will be made as an inducement material to Dr. Galloway’s acceptance of employment with Diffusion, in accordance with NASDAQ Listing Rule 5635(c)(4).

The options will have a 10-year term and will vest on a monthly basis over the 36 months after the date of grant, subject to Dr. Galloway’s continuous employment with Diffusion through each applicable vesting date. In addition, the options will be subject to acceleration or forfeiture upon the occurrence of certain events as set forth in Dr. Galloway’s option and employment agreements.

On October 19, 2020 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its third-quarter 2020 financial results on Thursday, October 29, 2020 after the financial markets close (Press release, Vertex Pharmaceuticals, OCT 19, 2020, View Source [SID1234568691]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On October 19, 2020 Orion Corporation reported that upgrades the full-year outlook for 2020, provided on 8 July 2020, both for the part regarding net sales and operating profit (Press release, Orion , OCT 19, 2020, View Source,net%20sales%20and%20operating%20profit.&text=Due%20to%20these%20reasons%2C%20among,slightly%20higher%20than%20in%202019. [SID1234568690]). In 2020, the net sales are estimated to be at a similar level as in 2019 or slightly higher than in 2019. Operating profit is estimated to be higher or clearly higher than in 2019.

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In January–September 2020 Orion’s preliminary net sales were EUR 823 million and preliminary operating profit was EUR 246 million.

Due to the COVID-19 pandemic the whole year international sales of Dexdor will be clearly higher than expected at the start of the year. The demand spike of generic prescription drugs and self-care products in March has levelled off during the year as expected but the full-year sales of some products, however, will be higher than expected at the start of the year. Additionally, the risk of COVID-19-induced lower product availability in 2020 has reduced significantly. Due to these reasons, among others, Orion estimates the full-year 2020 net sales to be at a similar level as in 2019 or slightly higher than in 2019.

Mainly due to the COVID-19 pandemic the full-year operating expenses of Orion will be lower than estimated earlier. Due to the net sales that will be higher than estimated at the start of the year, favourable sales margin structure of the sold products and lower than estimated earlier operating expenses Orion estimates the full-year 2020 operatig profit to be higher or clearly higher than in 2019.

The new outlook is based on the assumption that Orion‘s own production can continue normal operations despite the COVID-19 pandemic also during the remainder of the year. This requires that Orion continues to succeed in protecting its employees and employee absence rates do not significantly increase, that personal protective equipment, starting materials, intermediate products and materials are available and that the logistics chains are sufficiently functional.

New full-year outlook, provided on 19 October 2020

Orion estimates that in 2020 net sales will be at a similar level as in 2019 or slightly higher than in 2019 (net sales in 2019 were EUR 1,051 million).

Operating profit is estimated to be higher or clearly higher than in 2019 (in 2019 operating profit was EUR 253 million).

Previous full-year outlook, provided on 8 July 2020

Orion estimates that in 2020 net sales will be at a similar level as in 2019 (net sales in 2019 were EUR 1,051 million).

Operating profit is estimated to be slightly higher or higher than in 2019 (in 2019 operating profit was EUR 253 million).

Orion publishes Interim Report for January–September 2020 on Wednesday 21 October 2020.

On October 10, 2020 3D Medicines, a Beijing clinical-stage biopharma, reported that it completed a $225 million funding (Press release, 3D Medicines, OCT 19, 2020, View Source [SID1234568664]). Two years ago, 3DMed spun off its diagnostics business into 3D Diagnostics and now concentrates on development of immunotherapy drugs. In 2017, 3DMed agreed to conduct the clinical trials and commercialization of Alphamab’s envafolimab (KN035), a subcutaneous injection PD-L1 checkpoint inhibitor. The candidate has started clinical trials in China, the US and Japan. The company’s funding was co-led by China Capital Management and Efung Capital, a biomedical venture capital firm.

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