1stOncology™: Cancer Intelligence Service – Page 13720 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Avid Bioservices Reports Financial Results for Quarter and Fiscal Year Ended April 30, 2019 and Recent Developments

On June 27, 2019 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the fourth quarter and full year of fiscal 2019 ended April 30, 2019 (Press release, Avid Bioservices, JUN 27, 2019, View Source [SID1234539009]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Highlights Since January 31, 2019

"Fiscal 2019 was a fundamentally transformative year for Avid, as the team successfully achieved a number of critical goals. Most notably, we converted the losses and negative margins in fiscal 2018 into a sustainable position of financial strength," stated Rick Hancock, interim president and chief executive officer. "Based on our current backlog as well as forecasts from our customers, we believe the company will achieve sustainable growth going forward. Avid is stronger today than it has been at any point in the past.

"With respect to business development, the five new clients signed in late fiscal 2018 contributed significantly to revenue diversification in fiscal 2019. These projects substantially increased capacity utilization, which drove a meaningful improvement in margins during the year.

"Of particular note is the new business we continue to win from existing customers. While some of this business results from the expansion of current projects, many of these projects are completely new, requiring development and/or manufacture of a new molecule. These ‘repeat business’ wins are particularly valuable to Avid as each offers the opportunity for later stage and commercial production, they generally onboard very efficiently and as a result are more profitable, and they provide strong testimonials as to the quality of our work and product."

"Avid finished the year with a strong fourth quarter, growing revenue to $17.1 million while increasing gross margins to 21 percent," said Dan Hart, chief financial officer. "During the fourth quarter we generated $5.6 million in operating cash flow increasing our net cash and cash equivalents by $4.6 million to $32.4 million. Looking ahead, we are encouraged by the forecasted increase in demand which we expect to strengthen the company’s overall financial standing and position us for profitability."

Financial Highlights and Guidance

The company is providing revenue guidance for the full fiscal year 2020 of $64 million – $67 million (ASC 606).

Revenue was $17.1 million for the fourth quarter of fiscal 2019, a 146% increase compared to $6.9 million for the fourth quarter of last fiscal year. This increase is primarily due to growing demand from a more diversified client base. Revenue for the full fiscal year 2019 met guidance at $53.6 million, and was flat compared to full fiscal year 2018.

As of April 30, 2019, revenue backlog was approximately $46 million, the majority of which is expected to be recognized in fiscal year 2020.

Gross margin for the fourth quarter of fiscal 2019 was 21%, and gross margin for full fiscal year 2019 was 13%, both representing significant improvements compared to gross margins of negative 28% during the fourth quarter of fiscal 2018 and negative 5% for full fiscal year 2018. The improvements in gross margins for both fiscal 2019 periods were primarily attributed to our product mix, increased capacity utilization and a reduction in direct manufacturing costs.

Selling, general and administrative expenses ("SG&A") for the fourth quarter of fiscal 2019 were $3.6 million, or 21% of revenue, compared to $4.2 million, or 60% of revenue, for the fourth quarter of last year. For full fiscal year 2019, total SG&A expenses were $12.8 million, or 24% of revenue compared to $16.5 million last fiscal year, or 31% of revenue. The decrease in SG&A was primarily due to a reduction in payroll and related costs, legal fees and other professional consulting fees, and facility costs, which were partially offset by increases in bonuses related to certain achievement levels of corporate goals and stock-based compensation.

During the fourth quarter of fiscal 2019 we generated income from continuing operations of $0.2 million compared to a net loss from continuing operations of $6.1 million for the fourth quarter of fiscal 2018. Fiscal year 2019 loss from continuing operations was $5.1 million compared to a prior year loss from continuing operations of $20.6 million. The decrease during the full fiscal year was primarily due to reductions in both cost of revenues and SG&A resulting in higher profitability margins.

For the fourth quarter of fiscal 2019, the company recorded consolidated net loss attributable to common stockholders of $1.1 million or $0.02 per share, compared to a consolidated net income attributable to common stockholders of $1.6 million or $0.03 per share, for the fourth quarter of fiscal 2018. For full fiscal year 2019, the company recorded a consolidated net loss attributable to common stockholders of $8.9 million or $0.16 per share, compared to a consolidated net loss attributable to common stockholders of $26.5 million or $0.56 per share, for full fiscal year 2018. For both the fourth quarter and full fiscal year 2018, net income and loss were favorably impacted by the sale of the company’s legacy R&D assets to Oncologie, Inc. for $8.0 million and the associated discontinued operations.

Avid reported $32.4 million in cash and cash equivalents as of April 30, 2019, compared to $42.3 million on April 30, 2018.
More detailed financial information and analysis may be found in Avid Bioservices’ Annual Report on Form 10-K, which will be filed with the Securities and Exchange Commission today.

Recent Developments

Signed project expansion orders and new manufacturing projects related to new molecules with current clients during the fourth quarter of fiscal 2019 representing future revenue in the amount of $19.7 million.

Completed a second process validation campaign during fiscal 2019. Completion of a process validation campaign is a critical step in the regulatory product approval process, and is likely to result in future commercial production at Avid.

The first process validation campaign of fiscal 2020 is in progress.
Conference Call

Avid will host a conference call and webcast this afternoon, June 27, 2019, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

Vivoryon Therapeutics AG enters myeloid immune checkpoint drug discovery, and collaborates with the University of Kiel to select cancer therapy candidates from its QPCTL inhibitor portfolio

On June 27, 2019 Vivoryon Therapeutics AG, (Euronext Amsterdam: currently PBD, to be changed to VVY, ISIN: DE0007921835) reported that they have entered into a research collaboration with University Medical Center Schleswig-Holstein, Campus Kiel, to discover and develop first-in-class therapeutics in cancer immunotherapy (Press release, Vivoryon Therapeutics, JUN 27, 2019, View Source [SID1234537422]). Professor Thomas Valerius and his group will qualify Vivoryon’s broad portfolio of small molecule QPCTL inhibitors for their use as modulators of the CD47/SIRP-alpha myeloid immune checkpoint. These inhibitors, some of which have already been clinically tested, originated from the Company’s Alzheimer’s disease drug development program which remains to be a core focus for Vivoryon Therapeutics. Besides, these inhibitors also offer interesting therapeutic options in immuno-oncology.

Recently published and internal research has shown that the Glutaminyl-peptide cyclotransferase-like (QPCTL) enzyme is a powerful therapeutic target to silence the "do not eat me" signal provided by the interaction of CD47 (expressed on cancer cells), with the protein SIRP-alpha (expressed on macrophages and other myeloid cells). Tumor immunotherapy that targets this interaction is a current focus of innovation in cancer drug development. Combining a therapeutic tumor-targeted antibody of choice with the inhibition of the CD47/SIRP-alpha interaction is expected to lead to significant therapeutic improvements. By possessing the broadest portfolio of small molecule QPCTL inhibitors and the clinically most advanced compounds in that field, Vivoryon Therapeutics is uniquely positioned. QPCTL inhibitors are expected to have considerable therapeutic advantages compared to antibody approaches that are currently explored in clinical studies to silence the CD47/SIRP-alpha interactions.

Dr. Michael Schaeffer, CBO of Vivoryon Therapeutics said: "We are very pleased to partner with the University Medical Center Schleswig-Holstein, who is -like us- truly dedicated to accelerating innovative cures for cancer. Professor Valerius is a renowned expert in the field of myeloid effector cells in immunotherapy. This collaboration allows us to engage multiple targets and fully exploit our unique patent position. Undoubtedly, we are now entering into one of the most exciting fields of current drug development."

Within this collaboration Vivoryon Therapeutics will fund focused research with the clear goal of further qualifying its QPCTL inhibitors in cellular cancer models. Vivoryon’s highly active compounds will be tested individually and in combination with therapeutic antibodies.

Prof. Dr. Thomas Valerius, Senior Physician at the Department of Internal Medicine II – Hematology, Oncology of the University Hospital Schleswig-Holstein, added: "Our partnership with Vivoryon Therapeutics fits well with our goal of advancing early-stage therapeutic innovation. We are delighted that we are working on some of the most exciting compounds in myeloid checkpoint inhibition today and are convinced that these molecules could lead to significant improvements in cancer immunotherapy."

The development partners confirm that the cooperation has no effect on sales transactions of the University Medical Center Schleswig-Holstein – in particular procurement processes – and there are no expectations in this connection.

For more information, please contact:

Vivoryon Therapeutics AG
Dr. Ulrich Dauer, CEO
Email: [email protected]

Universitätsklinikum Schleswig-Holstein, Campus Kiel
Medizinische Klinik II, Sektion für Stammzell- und Immuntherapie
Prof. Dr. med. Thomas Valerius
Email: [email protected]

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]

INmune Bio Announces Publication of Data on INKmune Primed NK cells in Peer-Reviewed Journal PLOS ONE

On June 27, 2019 INmune Bio, Inc. (NASDAQ: INMB), an immunotherapy company developing treatments that harness the patient’s innate immune system to fight disease, reported that the peer-reviewed open access scientific journal PLOS ONE published an article titled, "Tumor- and cytokine-primed human natural killer cells exhibit distinct phenotypic and transcriptional signatures," summarizing the different effects between NK cell activation in response to tumor cells and cytokine-mediated activation (Press release, INmune Bio, JUN 27, 2019, View Source [SID1234537326]).

Co-authored by Dr. Mark Lowdell, Chief Scientific Officer and co-founder at INmune Bio, the paper defines the response of natural killer (NK) cells following their encounters with tumor cells and provides insight into tumor-specific NK cell responses; helping the transition toward harnessing their therapeutic potential in cancer. The paper identifies a unique signaling "fingerprint" expressed by NK cells after binding to CTV-1 tumor cells, which is the parent clone of INmune Bio’s own INB16 cells.

Through these observational data, researchers are able to use that knowledge to apply the strategy to build immunotherapy treatments. Priming NK cells with controlled exposure to tumor cells – which is the mechanism of action of INKmune – in the patient is potentially more effective against cancer targets with potentially fewer side effects than the administration of cytokines such as IL-2 or IL-15.

"We are delighted to be sharing these data describing the unique molecular pathways triggered within human NK cells upon priming with INmune Bio’s own INB16 (INKmune) cell line," says Dr. Lowdell. "These data confirm that the primed NK cells generated by INB16 stimulation upregulate genes, which are crucial to NK-mediated killing of patients’ cancer cells, such as CD70 and CXCL10. These differences in gene expression may explain the greater cytotoxic activity of INB16 primed NK cells in vitro compared to cytokine primed cells which may lead to greater clinical efficacy."

"This work has combined expertise across many groups, and it was important to publish these data in a highly-regarded open access journal to ensure that they are available to the widest possible audience," concludes Dr. Lowdell.

Sierra Oncology Launches Campaign Exploring Non-Dilutive Strategic Options to Support Development of its DDR Assets

On June 27, 2019 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported plans to prioritize its existing resources on the development of momelotinib, its differentiated Phase 3 drug candidate for the treatment of patients with myelofibrosis (Press release, Sierra Oncology, JUN 27, 2019, View Source [SID1234537322]). Sierra also announced it has launched a campaign exploring non-dilutive strategic options to support the future continued development of its portfolio of potent and selective DDR (DNA Damage Response) assets, consisting of SRA737 (Chk1 inhibitor) and SRA141 (Cdc7 inhibitor).

"We recently reported compelling proof-of-concept clinical efficacy data for SRA737 at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, demonstrating that this drug candidate has notable anti-cancer activity in multiple indications and a defined clinical path forward towards potential initial registration for the treatment of anogenital cancer, an indication with considerable unmet need. For SRA141, we have demonstrated a potentially novel mechanism of cytotoxicity and successfully completed the IND process with the FDA enabling the commencement of clinical trials," said Dr. Nick Glover, President and CEO of Sierra Oncology. "While we continue to advance the assets in our DDR portfolio and view them as promising oncology drug candidates that warrant further development, we are prioritizing our resources on our lead drug, momelotinib. To support the continued development of SRA737 and SRA141 in the future, we intend to seek non-dilutive strategic options."

About Sierra’s DDR assets: SRA737 (targeting Chk1) and SRA141 (targeting Cdc7)
SRA737 is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell cycle progression and the DNA Damage Response (DDR). Tumors with high levels of replication stress become reliant on Chk1 to mitigate the potentially catastrophic consequences of excess genomic instability. Intrinsic sources of replication stress can include genetic alterations in tumor suppressors, oncogenes or DNA Damage Repair genes. SRA737+LDG is a novel drug combination, where non-cytotoxic low dose gemcitabine (LDG) acts as a potent extrinsic inducer of replication stress.

At the 2019 ASCO (Free ASCO Whitepaper) Annual meeting, Sierra reported preliminary efficacy data for SRA737 including a 30% Overall Response Rate in patients with anogenital cancer treated with SRA737+LDG , an indication for which the second line metastatic setting represents a significant unmet medical need with no approved therapies and very poor life expectancy. Additionally, subjects whose tumors harbored FA/BRCA gene network mutations displayed favorable outcomes across multiple indications, with an Overall Response Rate of 25% and Disease Control Rate of 81%.

Sierra has conducted preclinical research demonstrating SRA737 synergy in combination with other DDR-targeted agents including poly ADP-ribose polymerase (PARP) inhibitors, as well as with immuno-oncology therapeutics. Sierra has an agreement with Janssen Research & Development, LLC (Janssen), under which Janssen has agreed to supply the PARP inhibitor niraparib, facilitating the potential initiation of a combination trial with SRA737 that Sierra has designed for the treatment of prostate cancer. Sierra reported preclinical data in a late-breaking poster presented at the AACR (Free AACR Whitepaper) Annual Meeting 2019 demonstrating that SRA737+LDG activates innate immune signaling and establishes an anti-tumor immune microenvironment that profoundly synergizes with immune checkpoint inhibitors. Sierra has reported having management support from a major immuno-oncology company to potentially supply their leading immunotherapeutic agent to run a combination study with SRA737.

SRA141 is a potent, selective, orally bioavailable small molecule inhibitor of Cell division cycle 7 kinase (Cdc7). Sierra reported preclinical data in a late-breaking poster presented at the AACR (Free AACR Whitepaper) Annual Meeting 2019 highlighting a possible novel mechanism of cytotoxicity for SRA141 that is distinct from other agents, in which SRA141 alters DNA replication dynamics and delays cell cycle progression, leading to apoptotic tumor cell death. This differentiated mechanism of action may support a unique spectrum of clinical opportunities for SRA141 as both monotherapy and in combination with pro-apoptotic and mitotic disrupting agents. Sierra has successfully completed the IND process with the U.S. Food and Drug Administration (FDA) for SRA141 and has designed a potential Phase 1/2 trial with this drug candidate.

Sierra Oncology retains the global commercialization rights to SRA737 and SRA141.

About Sierra Oncology
Sierra Oncology is a clinical stage drug development company advancing targeted therapeutics for the treatment of patients with unmet medical needs in hematology and oncology.

Momelotinib, Sierra’s lead drug candidate, is a potent, selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated therapeutic profile in myelofibrosis encompassing robust constitutional symptom improvements, a range of meaningful anemia benefits, including eliminating or reducing the need for frequent blood transfusions, and comparable spleen control to ruxolitinib. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 800 subjects treated for myelofibrosis.

Sierra plans to launch the MOMENTUM Phase 3 clinical trial in Q4 2019 to support potential registration of the momelotinib on a global basis. The randomized double-blind trial is designed to enroll 180 myelofibrosis patients who are symptomatic, anemic and have been treated previously with a JAK inhibitor. Dr. Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, has been named Chief Investigator of the MOMENTUM trial.

Momelotinib is wholly owned by Sierra Oncology and is covered by patents anticipated to provide potential exclusivity to 2040 in the U.S. The FDA has granted Fast Track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.

Kitov Successfully Completes IND-enabling Studies to advance NT219 for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancers

On June 27, 2019 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a pharmaceutical company focused on advancing first-in-class oncology therapies to overcome tumor drug resistance, increase treatment response rate, and slow tumor progression, reported that it has successfully completed the laboratory phase of the IND-enabling studies for NT219, a first-in-class, dual-inhibitor small molecule, designed to prevent and overcome cancer drug resistance (Press release, Kitov Pharmaceuticals , JUN 27, 2019, View Source [SID1234537321]). The preclinical GLP toxicology studies have demonstrated good tolerability at the highest dose levels expected to be tested in Kitov’s planned Phase 1/2 study treating patients with squamous cell carcinoma of the head and neck (SCCHN).

"We are excited with the completion of the IND-enabling studies for NT219 which advances our growing oncology pipeline to the clinic," stated Isaac Israel, chief executive officer of Kitov. "Our planned development of NT219 is based on strong preclinical evidence demonstrating that the combination of NT219 with the EGFR antibody cetuximab has potential clinical benefits for patients with recurrent or metastatic SCCHN whose cancer has not responded or has become resistant to early-line immuno-oncology or chemotherapy treatments. Pending a smooth regulatory review process, we look forward to initiating a Phase 1/2 trial with NT219 and cetuximab in the U.S. by the end of 2019."

Kitov is preparing for completion of the GMP manufacturing of the drug product and submission of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a dose-escalation Phase 1/2 study to treat SCCHN cancer patients with the combination of NT219 and cetuximab.

About NT-219

NT219, is a first-in-class small molecule designed to prevent and overcome cancer drug resistance. NT-219 is an inhibitor of two signaling proteins involved in drug resistance, Insulin Receptor Substrate 1 and 2 (IRS1/2) and Signal Transducer and Activator of Transcription 3 (STAT3). Efficacy of NT-219 was demonstrated in PDX models in combination with targeted therapies, chemotherapies and immuno-oncology therapies in delaying onset and reversing resistance to anti-cancer drugs in head and neck, colon, lung, and pancreatic cancers. Kitov is planning to initiate a Phase 1/2 open label multi-center study of NT-219 in combination with cetuximab (ErbituxTM) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) by the end of 2019.