On March 28, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T therapies, reported the appointment of Filippo Petti as Chief Executive Officer (CEO) of Celyad effective April 1, 2019 (Press release, Celyad, MAR 28, 2019, View Source [SID1234534758]). Mr. Petti is currently Celyad’s Chief Financial Officer (CFO), and will serve as interim CFO until the Company appoints a permanent successor for the role. Dr. Homsy will continue to serve as a member of Celyad’s Board of Directors and chair the Strategy Committee of the Board of Directors. Dr. Homsy will support Mr. Petti in his new function on an as needed basis.

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Michel Lussier, Celyad’s Chairman commented:"The Board is delighted to appoint Filippo to the role given his intimate knowledge and appreciation for Celyad’s pipeline, team and shareholders as the Company advances its CAR-T therapies to the next stage of development. Since he joined the Company, Filippo has demonstrated that his experience combined with the vision of the Company should maximize value for all of our stakeholders including patients and shareholders."

"I am honored to succeed Christian as Celyad’s next CEO and together with the Board, the senior leadership team, and all of our employees, look forward to advancing our promising CAR-T programs to deliver novel therapies to cancer patients," said Mr. Petti."The momentum we are building across our pipeline is truly exciting and should provide the Company with a tremendous opportunity as we enter our next phase of growth."

Mr Lussier added: "Christian’s vision and drive, combined with his commitment to serving the long-term interests of the Company, has helped Celyad develop a growing pipeline of CAR-T candidates. Christian will continue to support an agile organization well-positioned for success. I’d like to thank him personally, and on behalf of the Board, for his tireless contribution to Celyad as CEO."

Dr. Homsy added: "I congratulate Filippo on his appointment and look forward to working with him in my new role. It has been an honor to lead the organization over the past 12 years making it a leader in cell therapy development and manufacturing. I am humbled by the talented people I have had the pleasure of working with since the inception of the Company. Today Celyad is an incredibly talented organization with exceptional vision and operational excellence. Together with the portfolio of groundbreaking technologies, this will undoubtedly make Celyad a forefront player of the CAR-T field. I am very grateful to Celyad employees and to all the other stakeholders for making this journey possible."

Mr. Petti has nearly 20 years of work experience related to the biopharmaceutical industry. Prior to joining Celyad as CFO, Mr. Petti served as a healthcare investment banker at Wells Fargo Securities and William Blair & Company. Prior to his roles in investment banking, he worked in equity research, with a focus in oncology, both at William Blair & Company and Wedbush Securities. Mr. Petti began his career as a research scientist at OSI Pharmaceuticals, Inc., where he was involved in translational research studies focused on the EGFR inhibitor Tarceva (erlotinib) before transitioning into corporate development with the company. Mr. Petti holds a Master of Business Administration from Cornell University, a Master of Science from St. John’s University and a Bachelor of Science from Syracuse University.

On March 28, 2019 InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported financial results for the year ended December 31, 2018 (Press release, InflaRx, MAR 28, 2019, View Source [SID1234534756]).

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"2018 was marked by significant progress for InflaRx in both our business and clinical operations," said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. "Importantly, we completed enrollment of our Phase IIb trial with IFX-1 in Hidradenitis Suppurativa, from which we will report top-line results in the second quarter of 2019, and also initiated a Phase II trial in ANCA-associated vasculitis. We are continuing to execute our clinical development plans in 2019 as well, as evidenced by the recent initiation of our Phase IIa study in Pyoderma Gangraenosum."

Prof. Riedemann continued, "In addition to our pipeline progress, the Company experienced significant corporate growth in the past year by recruiting highly qualified directors to our board, opening our new R&D facility in the U.S. to support future innovation, and recruiting experienced executives to help us take InflaRx forward through 2019 and beyond. I am quite pleased with our team’s ability to execute on our core milestones of the past year and look forward to reporting on this continued progress in the months to come."

Corporate and drug development highlights – 2018 through early 2019

Corporate

Closed a primary and secondary offering in May 2018 for total gross proceeds of $117.3 million ($62.9 million to InflaRx and $54.4 million to selling shareholders), including the full exercise of the underwriters’ option to purchase additional shares.

Appointed highly experienced executives to the Board of Directors: Tony Gibney, CBO of Achillion Pharmaceuticals, Inc. and Jens Holstein, CFO of MorphoSys AG. Richard Brudnick, CBO of Codiak BioSciences, appointed as Non-Executive Director, subject to shareholder approval at our annual general meeting (currently serving as a Non-Voting Observer).

Expanded U.S. operations with opening of two U.S. sites – R&D facility in Ann Arbor, Michigan and corporate offices in New York City.

Hired senior executives for key positions – Jason Marks (formerly of Bausch Health) as Chief Legal Officer/General Counsel and Jordan Silverstein (formerly of Advanced Accelerator Applications) as Head of Corporate Strategy/Development.

Expanding research and development activities supported by growth in number of employees to 38 as of December 31, 2018 (2017: 21).

Lead product candidate, IFX-1, first-in-class anti-human complement factor C5a antibody

Hidradenitis Suppurativa (HS)

First patient enrolled in March 2018 in Phase IIb SHINE trial in moderate or severe HS and enrollment completed in November 2018. The randomized, double-blind, placebo-controlled, multicenter study is being conducted at 38 sites in North America and Europe. Topline results are expected in the second quarter of 2019.

New long-term retrospective data from completed Phase IIa trial presented in February 2019 at the 8th Conference of the European Hidradenitis Suppurativa Foundation. The data showed sustained remissions and median time to first flare of almost seven months, after only eight weeks of treatment.

ANCA-associated vasculitis (AAV).

Received FDA clearance of an IND application for U.S. Phase II study in patients with AAV in June 2018 and dosed the first patient in October 2018. The randomized, double-blind, placebo-controlled Phase II study is planned to enroll approximately 36 patients at approximately 20 sites in the U.S.

Investigational Medicinal Product Dossier (IMPD) approved in December 2018 by European regulatory authorities, to initiate a Phase II study in Europe in patients with AAV. The randomized, double-blind, placebo-controlled study is planned to enroll approximately 80 patients at about 60 sites in Europe.

2018 financial highlights

Cash and cash equivalents plus securities and other investments. As of December 31, 2018, InflaRx had cash and cash equivalents and securities and other investments of €156.6 million, compared to €123.3 million at the end of 2017. This increase in funds of approximately €33.3 million was primarily attributable to the completion of InflaRx’s follow-on offering of common shares in May 2018. Cash and cash equivalents totaled €55.4 million as of December 31, 2018 (December 31, 2017: €123.3 million). Additionally, current financial assets totaled €101.2 million compared to €0 as of December 31, 2017.

Net cash used in operating activities increased to €23.7 million in 2018, from €12.2 million in 2017, mainly due to higher cash expenses for research and development, such as third-party expenses for manufacturing and clinical trials attributable to InflaRx’ lead program IFX-1 and personnel expenses.

Research and development expenses increased by €10.6 million to €25.0 million in 2018, compared to €14.4 million in 2017. This increase is primarily attributable to a €7.1 million increase in CRO and CMO expenses for IFX-1 in connection with preparation to commence the clinical trial Phase IIb in patients with HS and the Phase II clinical program in patients with AAV, as well as with the ongoing manufacturing activities for clinical trial material for these clinical trials with IFRX-1 and to a €3.4 million increase in employee-related costs associated with salaries, bonus, benefits and non-cash share-based compensation.

General and administrative expenses amounted to €12.8 million in 2018, an increase of €7.7 million from €5.1 million in 2017. This was primarily attributable to a €6.2 million increase in employee-related costs associated with salaries, bonus, benefits and non-cash share-based compensation. Legal, consulting and audit fees and other expenses increased by €0.5 million, which is mainly attributable to expenses incurred in connection with the follow on offering of common shares in May 2018.

Net financial result was €7.7 million, up by €12.5 million compared to a net financial loss of €4.8 million in 2017, mainly due to net foreign exchange gains. Large portions of InflaRx’ funds are held in U.S. dollars and the dollar improved compared to the euro during 2018.

Loss for the period 2018 was €29.8 million or €1.2 per common share (basic and diluted), compared to €24.2 million or €2.6 per common share (basic and diluted) for 2017.

Additional information regarding these results is included in the notes to the consolidated financial statements as of and for the year ended December 31, 2018 and "ITEM 18. Financial statements", which will be included in InflaRx’ Annual Report on Form 20-F as filed with the SEC.

About IFX-1:

IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response in pre-clinical studies. IFX-1 is believed to be the first monoclonal anti-C5a antibody introduced into clinical development and has, to date, successfully completed three clinical Phase II studies. More than 150 people have been treated with IFX-1 in these completed clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various inflammatory indications, including Hidradenitis Suppurativa and ANCA-associated vasculitis.

On March 28, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it will share further data on the savolitinib development programs in lung cancer at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Georgia, USA, March 31 to April 3, 2019 (Press release, Hutchison China MediTech, MAR 28, 2019, http://www.chi-med.com/pres-on-savo-at-aacr19/ [SID1234534753]).

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Preliminary efficacy and safety results will be presented from the China Phase II study of savolitinib monotherapy in non-small cell lung cancer ("NSCLC") patients with MET Exon 14 skipping mutations who have failed prior systemic therapy, or are unable to receive chemotherapy (abstract #CT031, clinicaltrials.gov identifier NCT02897479).

In addition, several abstracts will be presented from the TATTON Phase Ib/II trial of savolitinib in combination with Tagrisso (osimertinib) in patients with epidermal growth factor receptor ("EGFR") mutation-positive NSCLC and MET-amplification who have progressed following treatment with an EGFR tyrosine kinase inhibitor ("EGFR-TKI") (clinicaltrials.gov identifier NCT02143466). One presentation will focus on patients who had progressed on a first- or second-generation EGFR-TKI and had not previously received a third-generation EGFR-TKI (abstract #CT032). Another presentation will focus on patients whose disease further progressed despite prior treatment with a third-generation EGFR-TKI (abstract #CT033). These presentations are complemented by a poster presentation on detection methods for identifying MET-driven EGFR-TKI resistance in the TATTON trial (abstract #4897/20).

TATTON preliminary results were presented at the World Conference on Lung Cancer (WCLC) in Yokohama, Japan, in October 2017.[1] The TATTON trial supports SAVANNAH, an ongoing Phase II clinical trial exploring the combination of savolitinib and Tagrisso to overcome MET-driven EGFR-TKI resistance following treatment with Tagrisso (clinicaltrials.gov identifier NCT03778229).

Further details of the presentations are as follows:

Session: Can the Challenge of NSCLC Resistance Be MET or Will We Not MEK It?
Session Type: Clinical Trials Plenary Session
Session # & Link: CTPL02
Date & Time: Sunday, March 31: 3:00 PM-5:15 PM
Location: Marcus Auditorium, Building A, Georgia World Congress Center
1st Presentation Title: Preliminary efficacy and safety results of savolitinib treating patients with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations
Lead Author: Shun Lu, Professor at Shanghai Chest Hospital, Jiao Tong University
Abstract # & Link: CT031 – abstract available after 3:00 PM EST on Friday, March 29, 2019
Time: 3:05 PM-3:30 PM
2nd Presentation Title: TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior first/second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Lead Author: Helena A. Yu, Medical Oncologist at Memorial Sloan Kettering Cancer Center
Abstract # & Link: CT032 – abstract only available at time of presentation
Time: 3:40 PM-3:55 PM
3rd Presentation Title: TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Lead Author: Lecia V. Sequist, Associate Professor of Medicine at Harvard Medical School and the Director of the Center for Innovation in Early Cancer Detection at Massachusetts General Hospital
Abstract # & Link: CT033 – abstract only available at time of presentation
Time: 3:55 PM-4:15 PM

Session: Novel Strategies for Biomarker Identification and Use in Cancer 3
Poster Title: Detection of MET-mediated EGFR tyrosine kinase inhibitor (TKI) resistance in advanced non-small cell lung cancer (NSCLC): biomarker analysis of the TATTON study
Lead Author: Ryan J. Hartmaier, AstraZeneca
Abstract # & Link: 4897 / 20 – abstract now available
Date & Time: April 3, 2019, 8:00 AM – 12:00 PM
Location: Section 19, Building B, Georgia World Congress Center

About Savolitinib
Savolitinib is a potential first-in-class inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective c-MET inhibitors. In clinical studies to date, involving over 900 patients, savolitinib has shown promising signs of clinical efficacy in patients with c-MET gene alterations in multiple tumor types with an acceptable safety profile. Chi-Med is currently testing savolitinib in partnership with AstraZeneca in Phase Ib/II studies, in multiple solid tumor indications, both as a monotherapy and in combinations.

On March 28, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer based on its novel T cell technology platforms, reported financial results and provided a corporate update for the full year ended December 31, 2018, and recent activities (Press release, Unum Therapeutics, MAR 28, 2019, View Sourcenews-releases/news-release-details/unum-therapeutics-reports-fourth-quarter-and-full-year-2018" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-reports-fourth-quarter-and-full-year-2018" rel="nofollow">View Source [SID1234534736]).

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"2018 was an important year for Unum as we brought the company public and continued to innovate in cell therapy with the advancement of our ACTR platform and the development of our new BOXR platform," said Chuck Wilson, President and CEO of Unum. "We have demonstrated proof of concept with the ACTR approach and see a clear path to further evaluating differentiated, potentially best-in-class product candidates designed to address continued patient needs. We are building out our solid tumor pipeline and have initiated our first solid tumor clinical trial, ATTCK-34-01, and selected BOXR1030 as our first product candidate from the BOXR platform. In 2019, we look forward to reporting data from all of our ongoing trials that will help determine next steps for our efforts in non-Hodgkin lymphoma, multiple myeloma, and solid tumors."

Recent Highlights

Continuing Dose Escalation in ATTCK-20-03 Phase I Trial: At the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, Unum presented preliminary results from the first two dose levels of its ongoing Phase 1 study of ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL). These data demonstrated that three of the six patients treated at Dose Level 1 (25 MM ACTR+ T cells) and one of three patients treated at Dose Level 2 (40 MM ACTR+ T cells) achieved a complete response. Enrollment and dose-limiting toxicity (DLT) assessments at Dose Level 3 (55 MM ACTR+ T cells) have since been completed, and enrollment at Dose Level 4 (80 MM ACTR+ T cells) has initiated. Through the first three cohorts, no DLTs and no severe adverse events of cytokine release syndrome (CRS) or neurologic events have been observed. Following completion of the dose escalation phase of the trial, Unum plans to initiate a cohort expansion at the preliminary recommended Phase 2 dose of ACTR707 in the second half of 2019.

Completed Enrollment of ATTCK-20-2 Phase I Trial: Following the decision in 2018 to prioritize ACTR707 for future development in r/r NHL, Unum has completed enrollment in the ATTCK-20-2 study, a Phase I clinical trial evaluating safety and anti-lymphoma activity of ACTR087 in combination with rituximab in patients with r/r NHL. Unum plans to report data on all enrolled patients from ATTCK-20-2 at the end of 2019. These data will inform other ACTR programs, specifically ATTCK-17-01, a Phase I trial of ACTR087 in combination with SEA-BCMA.

Continuing Dose Escalation with ATTCK-17-01 Phase I Trial: At the 2018 ASH (Free ASH Whitepaper) Annual Meeting in December, Unum presented data from the initial cohorts of the ongoing Phase 1 ATTCK-17-01 study, testing ACTR087 in combination with SEA-BCMA (an investigational monoclonal antibody targeting B cell maturation antigen, or BCMA) in patients with relapsed/refractory multiple myeloma (r/r MM). In the first three cohorts, no DLTs and no severe adverse events of CRS or neurologic events were observed. Having cleared cohorts with very low levels of SEA-BCMA antibody administered, dose escalation is continuing now at doses of SEA-BCMA that may be expected to have pharmacological activity based upon preclinical studies. Enrollment at Dose Level 4 (30 MM ACTR+ T cells and 2.0 mg/kg SEA-BCMA) is ongoing. In subsequent dose cohorts, the dose of both ACTR087 and SEA-BCMA will be explored. Unum expects to continue to enroll and dose patients through the dose escalation phase of the trial and to report data from multiple dose cohorts in the second half of 2019.

Initiated ATTCK-34-01 Phase I Trial in Solid Tumors: Unum announced that it has initiated ATTCK-34-01, a Phase 1, multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers. This is Unum’s first ACTR T cell study in solid tumors. The primary study objectives are to assess the safety and tolerability of the combination, and to define dose recommendations for further development. Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence, and trastuzumab pharmacokinetics. Unum plans to report initial clinical data from the ongoing dose escalation at the end of 2019.

Initiated Preclinical Development of the First Product Candidate from the BOXR Platform: In November 2018, Unum announced its new Bolt-On Chimeric Receptor technology platform (BOXR), which improves T cell functionality by countering immunosuppression in solid tumor cancers. Unum presented preclinical data at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting demonstrating the ability to significantly improve the activity of both ACTR- and CAR-targeted engineered T cells in immunosuppressive solid tumors. Unum has subsequently nominated BOXR1030 as the first product candidate from this platform and has initiated IND-enabling preclinical studies and plans to present additional information regarding BOXR1030 in the second half of 2019. BOXR1030 consists of a T cell co-expressing a glypican-3 (GPC3)-directed CAR and an undisclosed metabolism-enhancing bolt-on transgene. GPC3 is a well-known oncofetal antigen selectively expressed in a variety of tumor types including certain liver and lung cancers.
Fourth Quarter 2018 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the fourth quarter ended December 31, 2018 was $3.8 million, compared to $2.1 million in the same period of 2017. The increase reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Genetics under Unum’s collaboration agreement as well as reimbursements of research and development costs attributed to the ATTCK-17-01 study.

R&D Expenses: Research and development expenses were $10.8 million for the fourth quarter ended December 31, 2018, compared to $7.6 million for the same period of 2017. The increase reflects higher clinical trial costs for the active Phase I clinical trials, as well as increased personnel-related costs, materials and facility-related costs related to scaling manufacturing processes, and increased consultant costs to support these activities.

G&A Expenses: General and administrative expenses for the fourth quarter ended December 31, 2018, were $2.0 million, compared to $1.4 million for the same period of 2017. The increase is primarily due to expenses around operating as a public company and higher personnel related costs.

Net Loss: Net loss attributable to common stockholders was $8.6 million, or $0.29 per share, for the fourth quarter ended December 31, 2018, and $6.7 million, or $0.66 per share, for the same period of 2017.

Cash, Cash Equivalents and Marketable Securities: As of December 31, 2018, Unum had cash, cash equivalents, and marketable securities of $78.6 million. Total cash burn for 2018, net of IPO related costs, was $36.3 million. Today, Unum updated its cash runway and now anticipates that its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditure requirements into early 2021.
Investor Call and Webcast Information

Unum will host a live conference call and webcast today, March 28, 2019, at 8:00 a.m. ET, to discuss these financial results and company updates. To access the call, please dial 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 8169027. A webcast will be available at View Source at least 10 minutes before the event begins. The archived webcast will be available at the same location approximately two hours after the event and will be archived for 90 days.

On March 28, 2019 ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, reported that it has entered into a research collaboration with the University College London (UCL) and the Francis Crick Institute to use ArcherDX’s proprietary Anchored Multiplex PCR (AMP) technology to detect evidence of disease recurrence in lung cancer patients from cell-free circulating tumor DNA (ctDNA) as part of the Cancer Research UK funded UCL-sponsored TRACERx study (TRAcking lung CancEr evolution through treatment (Rx))[1] (Press release, ArcherDX, MAR 28, 2019, View Source [SID1234534735]).

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"…This collaboration with ArcherDX will help towards achieving our goal of a more personalised approach to developing cancer treatments."
Professor Charles Swanton, M.D., Ph.D., lead researcher for the TRACERx study
Preliminary findings from the TRACERx clinical study were published in Nature and the New England Journal of Medicine in 2017. In the publication, UCL and the TRACERx investigators demonstrated that a patient-specific approach to circulating tumor DNA (ctDNA) profiling could be used to characterize Minimal Residual Disease (MRD) in patients who have undergone potentially curative surgery for lung cancer. Early detection of changes in ctDNA burden after the initiation of curative therapy has been associated in clinical literature with poor disease free survival. In collaboration with ArcherDX, the UCL and TRACERx investigators aim to expand upon these initial findings by developing patient- specific assays based on anchored multiplex-PCR (AMP) technology to detect low-volume MRD at high levels of sensitivity and characterize the phylogenetic and neoantigen landscape of relapsing NSCLC.

"As we expand upon and progress our research, exploring lung cancer in an unprecedented level of detail, this collaboration with ArcherDX will help towards achieving our goal of a more personalised approach to developing cancer treatments," said Professor Charles Swanton, M.D., Ph.D., lead researcher for the TRACERx study.

"We are thrilled to be working with Professor Charles Swanton and UCL," said Josh Stahl, executive vice president and chief scientific officer of ArcherDX. "This collaboration aligns closely with ArcherDX’s mission to expand access and adoption of personalized medicine in oncology. We’ve spent the last five years developing and continually evolving our technology for complex and groundbreaking applications like those being studied in the TRACERx study. We are especially pleased to be a part of this study as it has the potential to fundamentally transform patient care in early stage lung cancer."