On May 7, 2021 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biotech Company focused on the development of novel and highly specific vaccines and antibody-drug conjugates targeting cancer and infectious diseases reported that it begin its trading on the CSE as of today

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The primary objective and business of Defence is the research, development and advancement of three main products using its proprietary Accum technology:
– Dendritic Cell (DC) cancer vaccines using Accum (AccuvacTM).
– A new protein-based vaccine formulation against COVID and infectious disease.
– ADCs (Antibody Drug Conjugates) targeting various cancer.

AccuvacTM: for Dendritic Cell cancer vaccines
Defence has optimized the chemical manufacturing of its experimental antigens to efficiently link the Accum moiety. When used to pulse DCs, these modified antigens were shown to breakdown endosomal membranes leading to efficient processing, presentation and activation of responding T cells. The prophylactic vaccination led to 100% protection against cancer growth. This process was rechallenged three times and led to a continue 100% protection against cancerous tumor growth.

Therapeutic vaccination of animals with pre-established tumors triggered a substantial delay in tumor growth as a stand-alone therapy. Combination of AccuvacTM to the immune-checkpoint inhibitor anti-PD1 cured 70% of treated animals.

To build upon this success, Defence is developing second and third generation Accum moieties to further enhance the potency and the efficacy of the AccuvacTM.
Defence has engineered two Accum variants with direct anti-tumoral effects. The results of the Accum variants displayed efficiency at killing melanoma, lymphoma, colon and breast cancer cells in vitro. In vivo studies are currently ongoing to test the intratumoral delivery of these variants as a means to induce regression of established tumors.

A COVID Vaccine
Defence is using the Accum technology to develop a distinct COVID-19 protein-based vaccine. So far, the vaccine is highly immunogenic in tests with rodent animals with antibody titers lasting for more than 16 weeks. In addition, the generated antibodies "neutralized" the ability of pseudotyped viruses (an artificial virus with COVID-19 S proteins) from infecting cells. Defence is currently preparing the initiation of IND-enabling studies while preparing to begin the Phase I trial.

Antibody Drug Conjugates
Defence has demonstrated that the Accum technology enhances the ability of the ADC Kadcyla (T-DM1) to specifically target and kill breast cancer cells. Defence completed the synthesis of 18 different Accum-variants conjugated to T-DM1 at 10X ratio. A toxicity screening will be performed in the near future on the selected breast cancer cell line to identify additional leads. A Phase 1 clinical trial for breast cancer is currently being prepared.

On May 7, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at the upcoming Bank of America Health Care Conference on Wednesday, May 12, 2021 at 1:15 p.m. EST / 10:15 a.m. PST (Press release, Coherus Biosciences, MAY 7, 2021, View Source [SID1234579456]).

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The audio portion of the Company presentation will be available on the investors page of the Coherus BioSciences website at View Source

On May 7, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) ("Aurinia" or the "Company") reported its financial results for the first quarter ended March 31, 2021. Amounts, unless specified otherwise, are expressed in U.S. dollars (Press release, Aurinia Pharmaceuticals, MAY 7, 2021, View Source [SID1234579477]).

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"2021 started with the FDA approval of LUPKYNIS, the first FDA-approved oral treatment for active lupus nephritis – a devastating complication of lupus," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Our pivotal decision and work to build a world-class commercial infrastructure prior to approval ultimately led to Aurinia being able to make LUPKYNIS immediately available to patients and physicians following approval. Since that time, the Aurinia team has been encouraged by the feedback we are receiving from physicians and patients and our confidence has only grown as we continue to understand the tremendous need and value of LUPKYNIS, and work to accelerate broader adoption across the underserved LN population."

Recent Highlights

FDA Approval and Commercial Launch of LUPKYNIS

On January 22, 2021, the FDA approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.

Commercial Activities

Engaged with over 6,000 rheumatologists and nephrologists;
Received over 250 patient start forms during the first quarter (covering 48 business days post-FDA approval);
Converted nearly 40% of patient start forms to patients on therapy by the end of the first quarter; and
Launched LUPKYNIS Patient Marketing Campaign, Focus on the Fight, in April 2021.
"Since launch, the commercial team has focused on educating their customers on the urgency needed in reducing proteinuria for patients with active LN. With more than 250 patient start forms and 40% of those patients on therapy after the first two months on the market, more than 6,000 clinical interactions, continued gradual expansion of payor coverage, and our Aurinia Alliance patient support program fully operational, the LUPKYNIS trajectory is on track against our internal projections. Furthermore, we anticipate that our market access will continue to improve as the rate of COVID vaccinations in the United States continues to climb and healthcare centers re-open their doors to patients," commented Max Colao, Chief Commercial Officer at Aurinia.

Upcoming Milestones

Anticipate filing a marketing authorization application (MAA) with the European Medicines Agency (EMA) during the first half of 2021 with partner, Otsuka;
Abstracts discussing voclosporin accepted for presentation at the Annual European Congress of Rheumatology (EULAR 2021 Congress), June 2 – 5, 2021, and at the Nephrology Virtual Congress (ERA-EDTA 2021), June 5 – 8, 2021;
Expect to initiate a study of voclosporin in adolescent patients (VOCAL study) during the second half of 2021; and
Anticipate reporting top-line results from the ongoing AURORA-2 continuation study during the first quarter of 2022.
Financial Liquidity at March 31, 2021

As of March 31, 2021, Aurinia had cash and cash equivalents and investments of $360.9 million compared to $422.7 million at December 31, 2020. The decrease is primarily related to the commercial infrastructure spend to support the launch of LUPKYNIS in addition to an upfront payment made as part of a collaborative agreement with Lonza to build a dedicated manufacturing facility (also referred to as "monoplant") and one-time payment to a related party upon achievement of specific milestones.

Net cash used in operating activities was $53.5 million for the quarter ended March 31, 2021 compared to $22.6 million for the quarter ended March 31, 2020. The increase is primarily due to the commercial infrastructure spend to support the launch of LUPKYNIS in addition to a one-time payment to a related party upon achievement of specific milestones. In the prior year, the Company was still in the development phase of LUPKYNIS and as a result, did not incur any material related selling expenses.

The Company believes that it has sufficient financial resources to fund its current plans, which include funding commercial activities, including our FDA related post approval commitments, manufacturing and packaging of commercial drug supply, conducting our planned research and development (R&D) programs, and operating activities into at least 2023.

Financial Results for the Quarter Ended March 31, 2021

For the quarter ended March 31, 2021, Aurinia recorded a net loss of $50.4 million or $0.40 net loss per common share, as compared to a net loss of $25.9 million or $0.23 net loss per common share for the quarter ended March 31, 2020.

Revenues were $0.9 million and $30 thousand for the quarters ended March 31, 2021 and March 31, 2020, respectively. The increase was the result of the commercial sales of LUPKYNIS, which began in January 2021.

Cost of sales were $48 thousand and nil for the quarters ended March 31, 2021 and March 31, 2020, respectively. The increase was the result of commercial sales of LUPKYNIS and drug substance. Gross margin for the quarter ended March 31, 2021 was approximately 95%.

Selling, general and administrative (SG&A) expenses were $39.3 million and $11.1 million for the quarters ended March 31, 2021 and March 31, 2020, respectively. The increase was primarily due to the expansion of the commercial infrastructure, administrative functions and patient assistance programs to support the launch of LUPKYNIS. SG&A share-based compensation expense for the quarter ended March 31, 2021 was $6.6 million.

R&D expenses were $9.8 million and $13.8 million for the quarters ended March 31, 2021 and March 31, 2020, respectively. The decrease was primarily due to lower Contract Research Organization (CRO) expenses and other third-party clinical trial expenses following the approval of LUPKYNIS, including a reduction in NDA preparation costs, capitalization of supply costs following approval, and termination of the dry eye trial during the fourth quarter of 2020. R&D share-based compensation expense for the quarter ended March 31, 2021 was $1.1 million.

This press release is intended to be read in conjunction with the Company’s unaudited condensed consolidated financial statements and Management’s Discussion and Analysis for the quarter ended March 31, 2021 in the Company’s Quarterly Report on Form 10-Q, which is accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Conference Call Details

Aurinia will host a conference call and webcast to discuss the quarter ended March 31, 2021 financial results today, Thursday, May 6, 2021 at 5:00 p.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1-888-506-0062 (toll-free U.S.) or +1-973-528-0011 (international); entry code: 662377. A replay of the conference call will also be available on Aurinia’s website approximately two hours after the live call is completed.

About Lupus Nephritis

LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

On May 7, 2021 Leidos Holdings, Inc. (NYSE: LDOS) ("Leidos"), a FORTUNE 500 science and technology leader, reported the completed acquisition of Gibbs & Cox, Inc. ("Gibbs & Cox") for approximately $380 million in cash (Press release, Leidos, MAY 7, 2021, View Source;Cox/default.aspx [SID1234579493]). The transaction was previously announced on Feb. 23, 2021. Gibbs & Cox will operate as a wholly owned subsidiary and will be combined with Leidos’ maritime systems division.

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Gibbs & Cox-designed DDG-51 Arleigh Burke-class destroyer

Headquartered in Arlington, Virginia, Gibbs & Cox is the largest independent ship design firm focused on naval architecture and marine engineering. The company’s world class naval architects, designers, engineers and program managers develop innovative vessel designs and naval capabilities. The acquisition positions Leidos to provide a broad set of engineering solutions to the US Navy and to an expanding set of foreign Navies.

"We are delighted to welcome the Gibbs & Cox team to the Leidos family," said Leidos Chairman and CEO Roger Krone. "Gibbs & Cox is widely regarded for developing the most talented and experienced naval designers in the world. We look forward to this new era of innovation while combining the best of both companies."

"We are excited to join Leidos, whose employee culture and history of innovation strongly mirror our own legendary 91-year history", said Gibbs & Cox President and Chief Executive Chris Deegan. "Gibbs & Cox will remain the nation’s largest independent provider of maritime services. The combination of our world-class naval architecture, design and engineering services with Leidos’ speed, security and scale will significantly enhance our combined offerings in the fast growing maritime undersea, autonomous and cyber security segments. We look forward to mapping a new Gibbs & Cox with Leidos for the next 90 years."

Advisors

Citigroup Global Markets Inc. served as exclusive financial advisor and Holland & Knight LLP served as legal advisor to Leidos. Houlihan Lokey served as exclusive financial advisor and Greenburg Traurig, LLP served as legal advisor to Gibbs & Cox in connection with this transaction.

On May 7, 2021 AstraZeneca reported that POSEIDON was a Phase III trial of its Imfinzi (durvalumab) plus platinum-based chemotherapy or Imfinzi, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, MAY 7, 2021, View Source [SID1234579432]).

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Positive high-level results from the final analysis of POSEIDON showed the combination of Imfinzi, tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone. This immunotherapy combination also demonstrated a statistically significant improvement in progression-free survival (PFS) versus chemotherapy alone, as previously reported in October 2019. Patients in this arm were treated with a short course of tremelimumab, an anti-CTLA4 antibody, over a 16-week period in addition to Imfinzi and standard chemotherapy.

The Imfinzi plus chemotherapy arm demonstrated a statistically significant improvement in PFS versus chemotherapy in the previous analysis, but the OS trend observed in this analysis did not achieve statistical significance. Patients in the control arm were treated with up to six cycles of chemotherapy, while those in the experimental arms were treated with up to four cycles.

Each combination demonstrated an acceptable safety profile, and no new safety signals were identified. The combination with tremelimumab delivered a broadly similar safety profile to the Imfinzi and chemotherapy combination and did not lead to an increased discontinuation of treatment.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "We are pleased to see the POSEIDON Phase III trial demonstrate, for the first time, a significant and clinically meaningful overall survival benefit for Imfinzi plus tremelimumab with chemotherapy in metastatic non-small cell lung cancer. We were particularly pleased by the safety profile. We’ve seen encouraging uptake of novel combinations in this setting and believe this new approach will add a further option for patients with high unmet medical need. We look forward to discussing next steps with regulatory authorities."

The data will be presented at a forthcoming medical meeting.

Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy and is the global standard of care based on the PACIFIC Phase III trial. Imfinzi is also approved in the US, the EU, Japan and many countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial.

Imfinzi is being further assessed across all stages of lung cancer as part of an extensive Immuno-Oncology programme across NSCLC and SCLC, as well as in other tumour types.

The combination of Imfinzi and tremelimumab is being tested in lung cancer, bladder cancer and liver cancer settings.

Stage IV NSCLC
Lung cancer is the leading cause of cancer death accounting for about one-fifth of all cancer deaths.1 Patients are commonly diagnosed at Stage IV, when the tumour has spread outside of the lung.2

Lung cancer is broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC.2,3 Within NSCLC, patients are classified as squamous, representing 25-30% of patients, or non-squamous, the most common type representing approximately 70-75% of NSCLC patients.2 Stage IV is the most advanced form of lung cancer and is often referred to as metastatic disease.4

POSEIDON
The POSEIDON trial was a randomised, open-label, multi-centre, global, Phase III trial of Imfinzi plus platinum-based chemotherapy or Imfinzi, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of 1,013 patients with metastatic NSCLC. The trial population included patients with either non-squamous or squamous disease and the full range of PD-L1 expression levels. POSEIDON excluded patients with certain epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions.

In the experimental arms, patients were treated with a flat dose of 1,500mg of Imfinzi with up to four cycles of chemotherapy once every three weeks or Imfinzi and 75mg of tremelimumab with chemotherapy, followed by maintenance treatment with Imfinzi, or Imfinzi and one dose of tremelimumab on a once-every-four-weeks dosing schedule. In comparison, the control arm allowed up to six cycles of chemotherapy. Pemetrexed maintenance treatment was allowed in all arms in patients with non-squamous disease if given during the induction phase.

Primary endpoints included PFS and OS for the Imfinzi plus chemotherapy arm. Key secondary endpoints included PFS and OS in the Imfinzi plus tremelimumab and chemotherapy arm. As both PFS endpoints were met for Imfinzi plus chemotherapy and Imfinzi, tremelimumab and chemotherapy, the prespecified statistical analysis plan allowed for independent OS testing for the Imfinzi plus tremelimumab and chemotherapy arm. The trial was conducted in more than 150 centres across 18 countries, including the US, Europe, South America, Asia and South Africa.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to approvals in the curative-intent setting of unresectable, Stage III NSCLC and ES-SCLC, Imfinzi is approved for previously treated patients with advanced bladder cancer in several countries.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer medicines for patients with NSCLC, SCLC, bladder cancer, hepatocellular carcinoma, biliary tract cancer (a form of liver cancer), oesophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer and other solid tumours.

Tremelimumab
Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, SCLC, bladder cancer and liver cancer.

AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines such as the EGFR-TKIs Tagrisso (osimertinib) and Iressa (gefitinib), and the PD-L1 inhibitor Imfinzi (durvalumab); alongside the CTLA-4 inhibitor tremelimumab and the next wave of innovations, including the HER2-directed antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) and the TROP2-directed ADC datopotamab deruxtecan; and a pipeline of new molecules and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer including and beyond treatment.

AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored in immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small, targeted molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.