On September 1, 2020 Race Oncology Limited (ASX: RAC) reported that it has expanded its executive team with the appointment of Mr Phil Lynch as Chief Executive Officer and Managing Director (Press release, Race Oncology, SEP 1, 2020, View Source [SID1234564241]). Effective immediately, Mr Lynch will share the executive leadership responsibilities with Dr Daniel Tillett, who will continue in his role of Chief Scientific Officer and Executive Director and will step down from the interim Chief Operating Officer position. In line with these changes, Dr John Cullity will return to his former role of Non-Executive Chairman.

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The appointments follow the Board’s review of the organisational skills matrix required for Race to deliver on its commercial and clinical objectives. As CEO & MD, Mr Lynch will lead Race’s commercial agenda. Dr Tillett will focus on the scientific aspects of the Company’s 5-path strategy. In partnership, Mr Lynch and Dr Tillett will implement Race’s strategic agenda.

Mr Lynch and Dr Tillett will share executive leadership responsibilities, while leveraging Race’s experienced network of global partners and advisors. Dr Cullity will return his focus to governance, future partnerships and transactions.

Dr John Cullity commented, "Following his June appointment as Non-Executive Director, Phil has clearly demonstrated the leadership skills we value commercially. We are ultimately focused on delivering best value to shareholders through partnering or acquisitive transactions. The shared leadership arrangement will enable effective delivery of this strategic agenda, while leveraging the collective skillset of Race’s executive, Board and advisor network."

Dr Daniel Tillett, said, "I am pleased to see Phil stepping into the CEO role and I look forward to us working closely together to drive the company forward. We have an amazing opportunity with Bisantrene and we intend to bring it back to the market as quickly as we can for the benefit of both patients and our shareholders."

Mr Lynch joined the Race Board on 1 June 2020 following over 15 years in commercial leadership with J&J companies, bringing M&A experience and strong relationships in Asia-Pacific.

He commented, "I’m excited to be joining Race as CEO, having first-hand belief in the strategy, the capability of the team and the significant opportunity ahead of us to execute our strategies and realise additional value for our shareholders.

I would like to extend my appreciation to John and Daniel who have managed the business on an interim basis with great success."

Key elements of Mr Lynch and Dr Tillett’s employment contracts are included in the attached Appendices, together with further biographical information.

On September 1, 2020 Sun BioPharma, Inc. (Nasdaq:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported the closing of its previously announced underwritten public offering of 2,545,454 shares of common stock and the same number of warrants to purchase shares of common stock for a price to the public of $4.125 per share and warrant (Press release, Sun BioPharma, SEP 1, 2020, View Source [SID1234564239]). Gross proceeds to the company were approximately $10.5 million. Each warrant entitles the holder to purchase one share of common stock at an exercise price of $4.54 per share.

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Craig-Hallum Capital Group acted as sole book-running manager for the offering. A registration statement relating to the securities being sold in this offering was filed with the Securities and Exchange Commission (SEC) on July 2, 2020 and was declared effective on August 27, 2020. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The final prospectus has been filed with the Securities and Exchange Commission and electronic copies of the final prospectus may be obtained by contacting Craig-Hallum Capital Group at 222 South Ninth Street, Suite 350, Minneapolis, Minnesota 55402, Attention: Equity Capital Markets, by telephone at 612-334-6300, by email to [email protected], or by accessing the SEC’s website, www.sec.gov.

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial.

On September 1, 2020 LabCorp (NYSE: LH) reported that members of the executive management team will participate in a virtual fireside chat at the Baird’s 2020 Global Healthcare Conference on Wednesday, Sept. 9 at 11:25 a.m. ET (Press release, LabCorp, SEP 1, 2020, View Source [SID1234564238]).

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On September 1, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that senior management will present at an upcoming investor conference (Press release, Ligand, SEP 1, 2020, View Source [SID1234564236]).

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Management will deliver a company presentation for the H.C. Wainwright 22nd annual global investment virtual conference on Monday, September 14th at 1:00 p.m. ET.
The slides and the audio portion of the presentations will be available on the Investors page of the Ligand Pharmaceuticals website at View Source

On September 1, 2020 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that the Company has acquired Flaskworks, a company that has developed a breakthrough system to close and automate the manufacturing of cell therapy products such as DCVax (Press release, Northwest Biotherapeutics, SEP 1, 2020, View Source [SID1234564235]).

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Flaskworks was previously owned by its technical founders and Corning Incorporated. The technical team from Flaskworks has joined NW Bio as part of the acquisition.

It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs.

To date, the manufacture of immune cell therapies (including T cell therapies and others) has involved two major challenges. First, the manufacturing processes involve "open" steps in which the product is open to the air in the manufacturing suite. This necessitates extremely expensive "clean room" facilities with specialized infrastructure and specialized operating systems for sterile air and water, and personnel working in sterile lab suits ("space suits"). Second, the manufacturing processes are mostly manual processes – in essence, hand crafted artisan processes by highly skilled technicians working under sterile conditions.

These factors have made the manufacturing of immune cell therapies (such as T cells) very costly, and greatly limited the number of such therapies that can be produced. There simply are not enough of the specialized clean room facilities, not enough highly skilled artisan technicians, and each technician can only produce limited amounts of products.

The Flaskworks system is designed to fundamentally change the manufacturing process from artisan hand work to assembly line-like automation. As such, the Flaskworks system is designed to enable the scale-up to far greater production volumes. Technicians will oversee the automated systems (potentially multiple systems per technician) rather than making the products themselves.

The Flaskworks system is also expected to significantly reduce production costs: turning "open" steps in the manufacturing process into "closed" steps, in which the product is not open to the air in the manufacturing suite, removing the need to build and operate the extremely costly clean room suites for those processes, and removing the need for personnel to work in sterile lab suits. This will greatly reduce the DCVax-L production costs.

The buildout of the Sawston, UK facility has purposely been designed to proceed in phases, as modules, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage. Implementation of the Flaskworks system will enable certain phases of the buildout to be simplified and streamlined.

The existing manufacturing process for DCVax-L products already takes a practical and economical approach by using a batch manufacturing process combined with special cryopreservation technology. The full set of doses for a patient, for as much as 3 years of treatments, are all produced in a single 8-day manufacturing batch, and then are stored frozen in single doses. The freezing technology has been validated and was used throughout the Company’s Phase 3 trial. This makes DCVax-L an off-the-shelf product for the whole treatment period after the one-time manufacturing batch, while also being a fully personalized product.

The Flaskworks system will follow the same batch-manufacturing process – doing so in a "closed" and automated manner.

Certain optimization work will be required so that the Flaskworks system will produce DCVax-L products with characteristics equivalent to the products made by the current DCVax-L manufacturing processes. This will then need to be confirmed by comparability studies. The Flaskworks technical team will work with NW Bio’s contract manufacturers to accomplish this. In the meantime, the Company’s DCVax products will continue to be made through the existing processes.

The acquisition of Flaskworks was executed and closed on August 28, 2020. The total purchase price was approximately $4.33 million, of which $1.65 million was paid in cash at closing, up to $2.01 million will be paid in stock subject to milestone-based vesting, and $0.67 million will be paid in either cash or stock, or a combination thereof, within 120 days after the closing.

The acquisition includes both intellectual property owned by Flaskworks and a license of additional intellectual property from Northeastern University.

Although a number of companies have developed and are continuing to develop automated machines for certain cell therapy production processes, those machines have certain drawbacks. For example, they typically try to handle a variety of cell types and have not been optimized for a particular cell type, such as dendritic cells. In contrast, the Flaskworks system has been developed and tailored specifically for immune cells such as dendritic cells.

Linda Powers, NW Bio’s CEO commented, "We believe that our DCVax platform technologies are potentially applicable to all types of solid tumor cancers, which comprise the vast majority of all cancers. We are working to build the infrastructure and systems that can enable the scale-up of production to such volumes – and can do so at a price level that will be affordable for widespread use of DCVax treatments."

"The phased buildout of our Sawston, UK facility and now our acquisition of Flaskworks are major building blocks towards achieving these goals. These steps, along with others in process, have been years in the making to reach fruition at the same time as we are reaching the results of our Phase 3 clinical trial of DCVax-L for Glioblastoma.