On May 12, 2021 Qu Biologics Inc., a private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, reported that expanded its patent portfolio to include the perioperative use of Qu’s SSIs to overcome immune dysfunction in patients undergoing cancer surgery (Press release, Qu Biologics, MAY 12, 2021, View Source [SID1234579799]).

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It has long been observed that "immune paralysis" is a phenomenon that occurs following the physical stress of surgery performed for the removal of cancer. During this post-surgical period, cells of the immune system are suppressed, and this immune suppression provides a dangerous window of opportunity for any cancer cells that have been left behind to spread or metastasize unchecked. As a result, post-operative immune dysfunction can lead to cancer recurrence in cancer patients who have undergone surgery to remove their tumours. There are currently no effective treatments that prevent or relieve this post-surgical immune suppression, leaving patients vulnerable to cancer recurrence and metastasis.

The unique ability of Qu’s SSIs to simultaneously program multiple important immune cells to effectively fight malignancy was hypothesized to offer a potential solution for this critical problem. To test this hypothesis, Qu scientists worked with Dr. Rebecca Auer, a world renown surgical oncologist at the Ottawa Hospital Research Institute, whose research is focused on determining how to overcome post-surgical immune dysfunction to improve outcomes of cancer patients. Preclinical studies performed in Dr. Auer’s lab showed that perioperative administration of Qu’s lung-directed SSI preserved anti-cancer immunity and markedly reduced lung metastases in a surgical model.

Dr. Auer is enthusiastic about the prospect of leading a clinical trial to test the perioperative application of SSIs to improve cancer outcomes, "Post-surgical immune suppression continues to present a critical challenge in oncology. To date very few trials have been conducted in the perioperative period, specifically designed to alleviate this immune dysfunction, which can adversely impact outcomes for patients having undergone cancer excision surgery. Given the large number of patients who undergo surgery for cancer every year, this is a significant unmet clinical need. I am hopeful that the SSI approach can transform perioperative management of cancer patients." Immunologist Dr. Shirin Kalyan, Qu’s Vice President of Scientific Innovation, said, "We have previously shown that SSI treatment, given in the absence of surgery, overcomes cancer-induced immune suppression through innate immune training and NK cell activation, and increases susceptibility of cancer cells to be targeted by immune effector cells. The new evidence from Dr. Auer’s lab that shows perioperative SSI treatment can also serve to overcome post-surgical immune suppression is really akin to hitting two birds with one stone for cancer immunotherapy."

Dr. Hal Gunn, Qu’s CEO, said, "We are very excited about this important discovery. Since the large majority of cancer patients undergo surgery, perioperative SSI treatment has the potential to transform outcomes for cancer surgery patients. Qu looks forward to working with Dr. Auer and her colleagues in conducting a Phase 2 clinical trial to assess the unique potential of SSIs in the context cancer surgery and we welcome discussions with potential investors and licensing partners."

On May 12, 2021 PerkinElmer, Inc. (NYSE: PKI) reported it has entered into an agreement to acquire Nexcelom Bioscience for $260 Million in cash (Press release, PerkinElmer, MAY 12, 2021, View Source [SID1234579798]). The transaction is expected to close during the second quarter of 2021.

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Nexcelom is a leading, global provider of automated cell counting instruments, image cytometry workstations, assays and a variety of cell reagents, consumables, and fit-for-purpose cell counting method selection and development instructions that follow ISO Cell Counting Standards and aid in the development of cell and gene and immuno-oncology therapies, virology drugs and vaccines.

Headquartered in Lawrence, Massachusetts, Nexcelom is founder-led, privately held and has approximately 130 employees around the world based in the U.S., the UK and China. Nexcelom’s expected 2021 revenues are approximately $40 Million.

Commenting on the transaction, Prahlad Singh, president and chief executive officer of PerkinElmer said, "We are looking forward to bringing Nexcelom’s expertise and technologies in drug development together with our passion and solutions for drug discovery. This combination will expand our efforts to help academic, government and biopharmaceutical organizations streamline their complete workflows and support efforts to accelerate time to target and time to market for novel therapies."

Dr. Peter Li, president and chief executive officer of Nexcelom added, "Our team is very excited to be joining forces with PerkinElmer to help scientists resolve some of today’s most pressing health challenges through modernizing cell based assays using the most advanced cell models. Our organization has a deep commitment to innovation and we are looking forward to continuing to grow our technology and customer footprint in combination with PerkinElmer’s strong global presence and infrastructure."

PerkinElmer’s existing biologics, vaccine and cell and gene research solutions feature industry-leading high content, in vivo, and cell painting screening technologies; innovative immunoassays; CRISPR, RNAi and DNA tools and custom cell lines; cell plate readers and advanced automation; microfluidics and analytical platforms.

The agreement to acquire Nexcelom comes just five months after PerkinElmer added Horizon Discovery, a leader in gene editing and modulation. To learn more about PerkinElmer’s full range of life sciences solutions, informatics and OneSource services please visit: View Source

On May 12, 2021 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported financial results for the quarter ending March 31, 2021 and provided a corporate update (Press release, Neoleukin Therapeutics, MAY 12, 2021, View Source [SID1234579797]).

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"The first quarter of 2021 saw continued progress in expanding our de novo protein capabilities, preparing for clinical testing of NL-201, and appointing Priti Patel as Chief Medical Officer," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "It is exciting to begin enrolling patients in the NL-201 Phase 1 clinical trial and to become a clinical stage company."

Recent Updates

NL-201 Phase 1 Trial Underway

In May 2021, Neoleukin announced dosing of the first patient in a Phase 1 trial of NL-201.

NL-201 is a de novo protein that is designed to mimic the therapeutic activity of natural cytokines IL-2 and IL-15, while potentially reducing the toxicities associated with high-dose IL-2. The Phase 1 study is planned to enroll up to 120 patients with advanced, relapsed, or refractory solid tumors. Patients will receive NL-201 as intravenous monotherapy to assess safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. The Phase 1 study will be conducted at multiple sites in Australia and North America.

In addition to the systemic trial, Neoleukin is planning a trial of NL-201 to test local administration in order to achieve higher drug concentrations in the tumor microenvironment. Neoleukin expects the local administration trial to begin by the end of 2021.

De Novo Protein Design for Coronavirus – NL-CVX1

NL-CVX1 is a decoy protein that binds to the spike protein of SARS-CoV-2, the virus that causes COVID-19, and is designed to be resilient to viral mutational escape. In preclinical studies, NL-CVX1 protected Syrian hamsters from a lethal dose of SARS-CoV-2 after intranasal administration. Neoleukin is evaluating a potential first-in-human trial of NL-CVX1, and will continue to assess the program as the SARS-CoV-2 landscape evolves.

Other Research Updates

Neoleukin has multiple research projects underway evaluating the applications of de novo protein technology to develop agonists and antagonists of immune pathways. Neoleukin currently plans to announce additional information about its pipeline program during the second half of 2021.

Executive Appointment

In May 2021, Neoleukin announced the appointment of Priti Patel, M.D., M.S., as Chief Medical Officer. Dr. Patel joins Neoleukin from AstraZeneca, where she served as Vice President, Head of Hematology Clinical Development since 2019. Previously, she served as Senior Medical Director and Executive Medical Director at Acerta Pharma before its acquisition by AstraZeneca, and as Medical Director at Onyx Pharmaceuticals (acquired by Amgen).

Summary of Financial Results

Cash Position: Cash and cash equivalents totaled $178.4 million as of March 31, 2021, compared to $192.6 million as of December 31, 2020.

Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations into 2023.

R&D Expenses: Research and development expenses for the first quarter of 2021 increased to $9.7 million from $5.5 million for the first quarter of 2020. The increase was primarily due to increased expenses incurred from IND-enabling and clinical trial startup activities related to Neoleukin’s lead product candidate, NL-201, and in connection with the advancement of other Neoleukin technologies.

G&A Expenses: General and administrative expenses for the first quarter of 2021 increased to $5.2 million from $3.6 million for the first quarter of 2020. The increase in general and administrative expenses was primarily due to increases in personnel-related costs and professional service fees as Neoleukin continues to grow its operations, along with facility related costs associated with the build-out of its new headquarters in Seattle, Washington.

Net Loss: Net loss for the first quarter of 2021 was $14.9 million compared to a net loss of $8.6 million in the first quarter of 2020 primarily due to Neoleukin’s focus on its lead candidate, NL-201, and its de novo protein platform.

On May 12, 2021 NEC Corporation (NEC; TSE: 6701) reported differences between the consolidated financial forecasts announced on January 29, 2021 and results for the fiscal year ended March 31, 2021 (Press release, NEC, MAY 12, 2021, View Source [SID1234579796]).

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1. Differences between the consolidated financial forecasts and results for the fiscal year ended March 31, 2021 (April 1, 2020 to March 31, 2021)

2. Reasons for differences in forecasts and results
In terms of consolidated revenue, the Network Services business and Public Infrastructure business exceeded expectations due to the full-scale provision of 5G base stations and demand related to GIGA schools. However, due to worsening market conditions caused by the spread of the new coronavirus, the Enterprise businesses and Public Solutions business fell short of expectations, resulting in a decrease in consolidated revenue from the previous forecast.

Regarding consolidated operating profit and consolidated adjusted operating profit, in addition to improvement in the Network Services business from an increase in sales, gains were also recorded from the sale of land and the sale of subsidiary shares, resulting in an improvement over the previous forecast.

Net profit attributable to owners of the parent and adjusted net profit attributable to owners of the parent improved compared to previous forecasts due to improved consolidated operating profit and reduced tax expenses.

Cautionary Statement with Respect to Forward-Looking Statements
This material contains forward-looking statements regarding estimations, forecasts, targets and plans in relation to the results of operations, financial conditions and other overall management of the NEC Group (the "forward-looking statements"). The forward-looking statements are made based on information currently available to NEC and certain assumptions considered reasonable as of the date of this material. These determinations and assumptions are inherently subjective and uncertain. These forward-looking statements are not guarantees of future performance, and actual operating results may differ substantially due to a number of factors.

The factors that may influence the operating results include, but are not limited to, the following:

adverse economic conditions in Japan or internationally;
foreign currency exchange and interest rate risks;
changes in the markets in which we operate;
the recent outbreak of the novel coronavirus;
potential inability to achieve the goals in our medium-term management plan;
fluctuations in our revenue and profitability from period to period;
difficulty achieving the benefits expected from acquisitions, business combinations and reorganizations;
potential deterioration in our relationships with strategic partners or problems relating to their products or services;
difficulty achieving our growth strategies outside Japan;
potential inability to keep pace with rapid technological advancements in our industry and to commercialize new technologies;
intense competition in the markets in which we operate;
risks relating to our concentrated customer base;
difficulties with respect to new businesses;
potential failures in the products and services we provide;
potential failure to procure components, equipment or other supplies;
difficulties protecting our intellectual property rights;
potential inability to obtain certain intellectual property licenses;
our customers may encounter financial difficulties;
difficulty attracting, hiring and retaining skilled personnel;
difficulty obtaining additional financing to meet our funding needs;
potential failure of internal controls;
potentially costly and time-consuming legal proceedings;
risks related to regulatory change and uncertainty;
risks related to environmental laws and regulations;
information security and data protection concerns and restrictions;
potential changes in effective tax rates or deferred tax assets, or adverse tax examinations;
risks related to corporate governance and social responsibility requirements;
risks related to natural disasters, public health issues, armed hostilities and terrorism;
risks related to our pension assets and defined benefit obligations; and
risks related to impairment losses with regard to goodwill.

On May 12, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported its financial results for the quarter ended March 31, 2021 (Press release, Moleculin, MAY 12, 2021, View Source [SID1234579795]). The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

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"Over the course of the first quarter, we continued to make significant progress on multiple fronts. Importantly, we have equipped the Company with the resources to advance our portfolio of drug candidates across a number of oncology indications and viruses. On the clinical front, we have the potential to see up to seven clinical trials this year, including investigator sponsored trials. We believe we are well-positioned to execute our strategy and expect to continue to build momentum and drive shareholder value in the near- and long-term," commented Walter Klemp, Chairman and CEO of Moleculin.

Recent Highlights

Granted Rare Pediatric Disease Designation (RPD) from the U.S. Food and Drug Administration (FDA) to its p-STAT3 inhibitor, WP1066, for the treatment of ependymoma, increasing to a total of four different indications for which a Priority Review Voucher may be granted;
Engaged IQVIA Biotech to manage Moleculin’s effort to begin potential clinical trials of WP1122 for the treatment of COVID-19;
Received Fast Track Designation from the FDA for its drug, Annamycin, for the treatment of soft tissue sarcoma (STS) lung metastases;
Announced a $1.5 million grant was awarded to the Maria Sklodowska-Curie National Research Institute to fund an investigator-initiated Phase 1B/2 clinical trial of Annamycin for the treatment of STS lung metastases;
Successfully closed a public offering, including full exercise of over-allotment option, for gross proceeds of approximately $78.0 million, before deducting underwriting discount and offering expenses;
Announced 100% survival achieved in preclinical study in animals which demonstrated a potentially significant therapeutic benefit of Annamycin against metastatic osteosarcoma; and
Signed an agreement with Catalyst Clinical Research to manage its U.S. clinical trial to study the ability of Annamycin to treat STS that has metastasized to the lungs.
Programs Update

Next Generation Anthracycline – Annamycin

Annamycin is the Company’s "next generation" anthracycline that has recently been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (the standard of care chemotherapy for STS lung metastases). Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of acute myeloid leukemia (AML), so we believe that the use of Annamycin may not face the same usage limitations imposed on doxorubicin. Annamycin is currently in development for the treatment of AML and STS lung metastases.

Upcoming Milestones

2H 2021: Report topline results from ongoing Phase 1/2 study for treatment of AML.
2H 2021: Commence Phase 1/2 study in Europe for the treatment of AML evaluating combination therapy of Annamycin + Ara-C.
2H 2021: Commence Phase 1b/2 clinical trial of Annamycin for the treatment of STS lung metastases in the U.S.
2021: Based on recently announced reimbursement grant awarded in Poland, the Company expects a second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases to be primarily investigator-funded in Europe.
First-in-class p-STAT3 inhibitors – WP1066 and WP1220

WP1066 is one of several Immune/Transcription Modulators, designed to stimulate the immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs) while also inhibiting key oncogenic transcription factors, including p-STAT3 (phosphorylated signal transducer and activator of transcription 3), c-Myc (a cellular signal transducer named after a homologous avian virus called Myelocytomatosis) and HIF-1α (hypoxia inducible factor 1α). These transcription factors are widely sought targets that are believed to contribute to an increase in cell survival and proliferation, and the angiogenesis (coopting vasculature for blood supply), invasion, metastasis and inflammation associated with tumors. They may also play a role in the inability of immune checkpoint inhibitors to affect more resistant tumors. WP1220 is a close analog to WP1066 that the Company has developed as a potential topical therapy for skin-related diseases.

WP1220 is currently being evaluated for the treatment of Cutaneous T-Cell Lymphoma (CTCL) and WP1066 is currently being evaluated for the treatment of pediatric brain tumors, including Diffuse Interstitial Pontine Glioma (DIPG). Additionally, WP1066 + radiation is being evaluated in the treatment of treatment of Glioblastoma Multiforme (GBM).

Upcoming Milestones

2H 2021: Facilitate Phase 1/2 study of WP1066 + radiation for the treatment of GBM.
1H 2022: Facilitate launch of Phase 2 study of WP1066 for the treatment of pediatric brain tumors, including DIPG.
Actively seeking collaboration with a strategic partner in the near term for external funding for the continued development of WP1220 in a Phase 2 clinical trial as a topical therapy for CTCL.
Infectious Disease and Metabolism/Glycosylation Inhibitors- WP1122, WP1096 and WP1097 Portfolio

Moleculin has new compounds designed to target the roles of glycolysis and glycosylation in both cancer and viral diseases. The Company’s lead Metabolism/Glycosylation Inhibitor, WP1122, is a prodrug of 2-DG that appears to improve the drug-like properties of 2-DG by increasing its circulation time and improving tissue/organ distribution. Recent published research has identified that 2-DG has antiviral potential against SARS-CoV-2 in vitro and, based on publicly available information, a recently completed Phase 2 clinical trial by an unrelated company in India has reported efficacy in COVID-19 patients, resulting in the Emergency Use Authorization of 2-DG by the Drugs Controller General of India. Moleculin believes that the improved drug-like properties of WP1122 may allow it to outperform 2-DG in COVID-19 patients and may provide the opportunity for it to become an important drug to potentiate existing therapies, including checkpoint inhibitors. Although the Company has seen superior efficacy for WP1122 over 2-DG against SARS-CoV-2 in vitro, as well as in multiple animal tumor models, WP1122 has yet to be tested in humans so there can be no assurance that this improved preclinical performance will translate into improved clinical outcomes. The Company is also engaged in preclinical development of additional antimetabolites (WP1096 and WP1097) targeting glycolysis and glycosylation.

Upcoming Milestones

2H 2021: Seek to initiate Phase 1a/1b study of WP1122 for the treatment of COVID-19.
2H 2021: Potential to launch Phase 2 pivotal study of WP1122 for the treatment of COVID-19.
2H 2021: File an IND in the U.S. for the treatment of certain cancers such as GBM and pancreatic cancer, with WP1122.
Ongoing preclinical development work in anti-viral indications such as HIV, Zika, and Dengue. IND targeted for 2022.
Summary of Financial Results for First Quarter 2021

Research and development expense was $4.1 million and $3.2 million for the three months ended March 31, 2021 and 2020, respectively. The increase of $0.9 million is mainly related to increased clinical trial activity as described above, increased costs related to sponsored research agreements, and costs related to manufacturing of additional drug product.

General and administrative expense was $1.9 million and $1.8 million for the three months ended March 31, 2021 and 2020, respectively. The increase of $0.1 million is mainly related to an increase in the Company’s insurance, which was offset by a similar decrease in travel expenses.

For the three months ended March 31, 2021 and 2020, the Company reported a net loss of $4.4 million and $1.2 million, respectively, and had net cash flows used in operating activities of $ 3.6 million and $4.3 million, respectively.

The Company ended the quarter with approximately $86.3 million of cash.