On July 19, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will report second quarter 2021 financial results after the Nasdaq market closes on Tuesday, August 3, 2021 (Press release, Neurocrine Biosciences, JUL 19, 2021, View Source [SID1234584943]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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!

Participants can access the live conference call by dialing 866-952-8559 (US) or 785-424-1743 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On July 19, 2021 Lonza and CN Bio reported that thay have entered into a distribution agreement whereby Lonza will supply a selection of hepatic cells to be prequalified by CN Bio for use in their PhysioMimix Single-and Multi-Organ MPS to transform the way human-relevant pre-clinical data is generated (Press release, Lifescience Newswire, JUL 19, 2021, View Source [SID1234584942]). With prequalified cells, customers can avoid having to trial numerous cell types in order to be assured of finding ones that will grow and behave functionally in 3D culture and fast-track their route to generating reliable and robust data.

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!

The use of physiologically relevant in vitro models plays an important role in driving down attrition rates and boosting the efficiency and success of drug discovery programs. It is increasingly clear that standard 2D cell culture fails to accurately reflect the complex interactions that take place in the living body, while animal models are slow, expensive and don’t always correlate to the same interactions in humans. Innovative models, such as OOC, offer the way forward and this agreement is a critical step in realizing that vision to bring more physiologically relevant models to the industry.

Maureen Bunger, Senior Product Manager, ADME-Tox Solutions, Lonza Cell and Gene, commented: "Today’s drug discovery success is hugely dependent on performing experiments using the right biological model to best reflect in vivo environments. This new agreement with CN Bio further demonstrates Lonza’s commitment to supporting innovation and to the development of the most advanced cell models for enhanced drug discovery and development success."

The PhysioMimix Single and Multi-Organ MPS allow researchers to recreate an environment that more accurately represents the human body in the laboratory to generate translationally relevant pre-clinical data. Until now, the widespread adoption of OOC technologies has been hampered by a lack of quality control and performance criteria for consistent use of the devices and reproducibility of results between experimental sites. These have posed significant limitations for translational experiments using OOC technology in contexts of use in drug development. To address this, the FDA has worked with CN Bio to demonstrate the robustness and reliability of their technology for drug metabolism and safety toxicity applications.

Dr. Tomasz Kostrzewski, Director of Biology, CN Bio, commented: "We’re delighted to be working with Lonza, a world-leading cell supplier, to ensure that the prevalidated cells we supply for use with our PhysioMimix Single-and Multi-Organ MPS are of reliably high quality and are well-suited to culture in 3D. Using prequalified cells will save our customers valuable time and resource, further helping to accelerate their drug development journey."

Lonza hepatocyte cells meet the high standard of quality required by organ-on-a-chip systems. With a robust manufacturing process and excellent quality control, state-of-the-art facilities and Lonza’s decades of specialist experience and deep expertise, Lonza cells offer a greater chance of reproducible success. Access to a wide variety of large-sized lots gives customers confidence in ongoing cell availability.

On July 19, 2021 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) reported that it has entered into an exclusive, worldwide licensing agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to in-license the late stage monoclonal antibody candidate, suvratoxumab (Press release, Aridis Pharmaceuticals, JUL 19, 2021, View Source [SID1234584941]).

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!

The highlights of the agreement are:

Phase 3-ready candidate. Suvratoxumab monoclonal antibody (mAb) for prevention of pneumonia has been licensed from AstraZeneca. Suvratoxumab extends Aridis’ pneumonia franchise by complementing the existing AR-301 Phase 3 pneumonia treatment program.
Lancet ID publication. Phase 2 data involving n=196 patients recently published in The Lancet Infectious Diseases journal showed safety and a statistically significant (47%) relative reduction of pneumonia in S. aureus colonized, mechanically ventilated patients less than 65 years old, with corresponding reduction in the number of days needed in the ICU and hospital.i
Up to €25 million Euros funding (approximately $30 million). EU Commission’s Innovative Medicines Initiatives (IMI) funding for suvratoxumab Phase 3 clinical trial
AstraZeneca’s equity stake in Aridis. AstraZeneca becomes a shareholder of Aridis through the issuance of common stock and has right of first negotiation for future licensing of suvratoxumab.
Monoclonal
Antibody

Targeting

Disease

Development
Status

Next
Milestone

suvratoxumab or
‘AR-320’

Staphylococcus
aureus alpha
toxin

S. aureus colonized
patients at high risk
of developing
pneumonia

Phase 2
completed

Phase 3
launch

4Q-2021

Deal Highlights

Aridis acquires global exclusive rights for development and commercialization of
suvratoxumab for all indications
AstraZeneca retains rights of first negotiation for future licensing
Aridis will make an upfront payment to AstraZeneca of $11m in cash and Aridis common
stock. AstraZeneca will also receive up to a further $115m on achievement of certain
development and sales-related milestones, in addition to tiered royalties on net sales
Up to €25 million Euros (approximately $30m) from EU Commission’s Innovative Medicines
Initiative (IMI) COMBACTE clinical trial consortium for the Phase 3 trial for suvratoxumab
Development Overview: Suvratoxumab Phase 3 Clinical Study
Suvratoxumab and AR-301 are complementary products. Suvratoxumab’s focus on preventive treatment of S. aureus pneumonia complements Aridis’ AR-301 Phase 3 mAb program which is being developed as a therapeutic treatment of S. aureus pneumonia.

A multinational, randomized, double blinded, placebo controlled Phase 2 study (n=196 patients) showed that mechanically ventilated ICU patients colonized with S. aureus who are treated with suvratoxumab saw a relative risk reduction of pneumonia by 32% in the overall intend to treat (ITT) study population, and by 47% in the under 65 year old population, which is the target population in the planned Phase 3 study. The relative risk reduction in the target population reached statistical significance, and was also associated with a substantial reduction in the duration of care needed in the ICU and hospital.i [see https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30995-6/fulltext]

Aridis believes that suvratoxumab (product code name ‘AR-320’) will be first-line treatment, first to market, first-in-class pre-emptive treatment of S. aureus colonized patients. The same first-line, first to market and first-in-class strategy applies to the acute treatment with the monoclonal antibody AR-301 which the Company believes makes Aridis a globally dominant leader in this space.

Aridis comments
"We are pleased to have been selected as AstraZeneca’s licensee. The strong data from the Phase 2 trial gives us an advantage to define the patient population, primary endpoint, and the Phase 3 clinical study design to support a clear path to the Phase 3 confirmatory trial," said Vu Truong, Ph.D., Aridis’ Chief Executive Officer.

"We intend to efficiently leverage our collaboration with the globally renowned HAP/VAP experts in the EU Commission’s Innovative Medicines Initiative (IMI) COMBACTE consortium and our global network of existing clinical sites to launch the Phase 3 study for AR-320 in the 4th quarter this year," said Hasan Jafri, M.D., Aridis’ Chief Medical Officer. "We are delighted that this Phase 3-ready candidate is supported by IMI through the COMBACTE consortium and are excited to demonstrate the potential for suvratoxumab to fulfill an unmet medical need in a highly vulnerable and high-risk population, while also offering substantial pharmacoeconomic benefits," said Dr. Jafri.

AstraZeneca comments
Mark Esser, Vice President, Microbial Sciences, BioPharmaceuticals R&D, AstraZeneca said: "Suvratoxumab has the potential to transform pulmonary infection management in ventilated patients. We are pleased to complete this licensing deal with Aridis who we believe are well placed to take suvratoxumab forward."

IMI’s COMBACTE consortium comments
"On behalf of IMI’s COMBACTE consortium, I would like to express our continued support and strong enthusiasm for suvratoxumab," said Dr. Marc JM Bonten, MD/PhD, Managing Entity and Scientific and Academic coordinator of COMBACTE (University Medical Center, Utrecht). "We plan to leverage the consortium’s vast network of clinical sites and principal investigators across Europe to facilitate the execution of this important Phase 3 study to its timely completion," said Dr. Bonten.

Dr. Bruno Francois, a world renowned VAP expert and the Academic COMBACTE Lead for the Phase 3 study (University Hospital of Limoges) further added, "After the very promising SAATELLITE phase 2 trial, starting this phase 3 is very exciting as it could bring a new class of molecules to treat severe bacterial infections, to patients. The COVID pandemic has highlighted the importance of having therapeutic options to address emerging infectious threats and antimicrobial resistance (AMR) remains a serious threat. In this context, the AR-320 study is very timely. Lastly, the public-private partnership approach which made the phase 2 study successful, will undoubtedly be one of the major strengths of the coming phase 3 study."

About suvratoxumab (‘AR-320’)
Suvratoxumab (also referred to as MEDI4893) is a fully human, half-life extended IgG1 monoclonal antibody targeting S. aureus alpha toxin. Alpha-toxin is a key virulence factor that is secreted by both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA). It is believed that AR-320 protects against alpha-toxin mediated destruction of host cells, preserving the human immune cells. AR-320’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA and MSSA.

About IMI’s COMBACTE Consortium
The European Commission’s Innovative Medicines Initiative (IMI) is the world’s biggest public-private partnership in the life sciences, whose goal is to develop next generation vaccines, medicines and treatments, such as new antibiotics [see View Source The IMI-funded COMBACTE project aims to give antibiotic drug development a much-needed boost by pioneering new ways of designing and implementing efficient clinical trials for novel antibiotics. COMBACTE forms part of the New Drugs for Bad Bugs (ND4BB) initiative, IMI’s wider program to tackle AMR. The COMBACTE consortium comprises a large network of over 1,000 hospitals in Europe that are potential clinical sites for clinical trial conduction [see View Source

On July 19, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Kite, a Gilead Company (Nasdaq: GILD, "Kite") reported the two companies have entered into a purchase agreement for BioNTech to acquire Kite’s solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD (Press release, BioNTech, JUL 19, 2021, View Source [SID1234584940]). The acquired Gaithersburg facility will provide production capacity to support clinical trials in the United States and will complement BioNTech’s existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The facility will support the development of BioNTech’s expanding pipeline of novel cell therapies, including cancer product candidates based on its CAR-T Cell amplifying mRNA vaccine (CARVac) and NEOSTIM platforms as well as the newly acquired individualized neoantigen TCR program.

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!

"The development of individualized cancer therapies is at the core of our work at BioNTech. The acquisition of the Kite facility and its individualized TCR platform allows us to accelerate the clinical development of our cell therapies in the U.S. and advance at the forefront of individualized cell therapies," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "It also strengthens our presence in the U.S., building on our successful integration of adoptive T-cell and neoantigen TCR therapies as part of our acquisition of Neon Therapeutics last year."

All Kite employees at the Gaithersburg facility will be offered employment with BioNTech prior to the date of closing. To support its growing cell therapy pipeline, BioNTech plans to further invest in the site including hiring additional personnel. Under the terms of the agreement, Kite will receive a one-time upfront payment from BioNTech to purchase Kite’s indiviualized solid tumor neoantigen TCR discovery platform as well as the Gaithersburg R&D and clinical manufacturing facility. Financial terms were not disclosed. Kite’s new manufacturing facility in Frederick, MD for commercial production of CAR T-cell therapy is not part of the purchase agreement.

"In order to serve more patients that need cell therapy today, Kite is rapidly growing both through global expansion and seeking new indications for our existing approved CAR T-cell therapies. This transaction will enable us to focus our energies and investment on accelerating the reach of our current CAR T-cell therapies and midterm pipeline," said Christi Shaw, Chief Executive Officer of Kite. "As a company solely focused on cell therapy for over a decade, our approach to solid tumors and allogeneic cell therapy will progress through a combination of both internal research and external partnerships as we are an excellent partner for likeminded companies that share our vision of the power of CAR T-cell therapy to create better outcomes for patients."

TCR therapy is a type of cellular immunotherapy designed to redirect the patient’s immune system in order to recognize and target tumors. In contrast to CARs that recognize antigens on the cell surface, TCR therapy involves engineering an individual’s T cells to express TCRs that can recognize peptide fragments from both intracellular and extracelluar antigens. As a result, complex TCR therapies may be more effective in the treatment of solid tumors. Neoantigens are immune targets derived from somatic mutations displayed by cancer cells offering the potential for more targeted anti-tumor activity. Kite’s neoantigen TCR platform enables the development of individualized TCR therapies that are custom designed to target individual neoantigens on a patient’s tumor. This program builds and further extends BioNTech’s leadership in individualized neoantigen targeting programs such as BNT122 (iNeST) and BNT221 (NEOSTIM).

Cowen & Company LLC acted as financial advisor to Kite for this transaction.

On July 19, 2021 AstraZeneca reported that it’s Imfinzi (durvalumab) has been approved in China for the 1st-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin or cisplatin) (Press release, AstraZeneca, JUL 19, 2021, View Source [SID1234584937]).

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!

The approval by China’s National Medical Products Administration was based on positive results from the CASPIAN Phase III trial. The trial showed that Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone. In addition, results from the China cohort of patients were consistent with the global results.

Small cell lung cancer (SCLC) is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.1,2 Prognosis is particularly poor, as only 7% of all SCLC patients and 3% of those with extensive-stage disease will be alive five years after diagnosis.3

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Today’s approval of Imfinzi plus chemotherapy brings an important global standard of care to patients with extensive-stage small cell lung cancer in China, who have had few treatment options and a dire prognosis. Physicians can now offer these patients a well-tolerated immunotherapy regimen with sustained overall survival and prolonged treatment response, as well as convenient dosing. This is also the first time physicians have had the choice to combine immunotherapy with cisplatin, a preferred chemotherapy in this setting in China."

The CASPIAN Phase III trial met the primary endpoint of OS for Imfinzi plus chemotherapy in June 2019, reducing the risk of death by 27% versus chemotherapy alone (based on a hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047), with a median OS of 13.0 months versus 10.3 months for chemotherapy alone. These results were published in The Lancet in October 2019.4 Results also showed an increased confirmed objective response rate for Imfinzi plus chemotherapy (68% versus 58% for chemotherapy alone). Imfinzi added to chemotherapy delayed the time for disease symptoms to worsen.4

An updated analysis showed sustained efficacy for Imfinzi plus chemotherapy after a median follow up of more than two years (OS HR of 0.75; 95% CI 0.62-0.91; nominal p=0.0032), with median OS of 12.9 months versus 10.5 months for chemotherapy alone. An estimated 22.2% of patients treated with Imfinzi plus chemotherapy were alive at 24 months versus 14.4% for chemotherapy alone. The safety and tolerability for Imfinzi and chemotherapy were consistent with the known safety profiles of these medicines. No patients tested positive for treatment-emergent anti-drug antibodies to Imfinzi.

Safety and efficacy results in the China cohort of patients were consistent with results in the overall global trial population. Detailed results from this cohort will be presented at a forthcoming medical meeting.

The CASPIAN Phase III trial used a fixed dose of Imfinzi (1500mg) administered every three weeks for four cycles while in combination with chemotherapy and then every four weeks as a monotherapy until disease progression. Based on the trial results, Imfinzi, in combination with etoposide and either carboplatin or cisplatin, is approved in the 1st-line setting of ES-SCLC in more than 55 countries, including the US, Japan and across the EU.

Imfinzi is also being tested following concurrent chemoradiation therapy in patients with limited-stage SCLC in the ADRIATIC Phase III trial as part of a broad development programme. In addition, Imfinzi is also approved to treat non-small cell lung cancer (NSCLC) in the curative-intent setting of unresectable, Stage III disease after chemoradiation therapy in the US, Japan, China, across the EU and in many other countries, based on results from the PACIFIC Phase III trial.

Small cell lung cancer
Lung cancer is the leading cause of cancer death among men and women and accounts for about one-fifth of all cancer deaths.5 Lung cancer is broadly split into NSCLC and SCLC, with about 15% classified as SCLC.6 About two-thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body.3

CASPIAN
CASPIAN was a randomised, open-label, multi-centre, global Phase III trial in the 1st-line treatment of 805 patients with ES-SCLC. The trial compared Imfinzi in combination with etoposide and either carboplatin or cisplatin platinum chemotherapy, or Imfinzi and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone. In the two experimental arms, patients were treated with four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and optional prophylactic cranial irradiation.

The trial was conducted in more than 200 centres across 23 countries, including the US, Europe, South America, Asia and the Middle East. The primary endpoint was OS in each of the two experimental arms. In June 2019, AstraZeneca announced the CASPIAN Phase III trial had met one primary endpoint of demonstrating OS for Imfinzi plus chemotherapy at a planned interim analysis. In March 2020, however, it was announced that the second experimental arm with tremelimumab did not meet its primary endpoint of OS.

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 ES-SCLC and unresectable, Stage III NSCLC, Imfinzi is approved for previously treated patients with advanced bladder cancer in several countries. Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments 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.

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 investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab) and tremelimumab; Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines 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 and other novel antibodies 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.