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.

On May 7, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported that its President and Chief Executive Officer, Christopher U. Missling, PhD, will give a presentation titled, "Clinical Trials for Rare Diseases: Challenges and Opportunities", at the Precision in Clinical Trials Virtual Summit (East Coast) on Monday, May 10that 9:35 a.m. EDT (Press release, Anavex Life Sciences, MAY 7, 2021, View Source [SID1234579429]). The Precision in Clinical Trials Virtual Summit (East Coast) takes place May 10th – 11th 2021.

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On May 7, 2021 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the first quarter of 2021 and provided a corporate update (Press release, Aclaris Therapeutics, MAY 7, 2021, View Source [SID1234579427]).

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"We’re very pleased with the progress of our novel immuno-inflammatory drug development pipeline and look forward to reporting data from our Phase 2a trial of ATI-1777 in the second quarter of 2021," said Dr. Neal Walker, President & CEO of Aclaris. "ATI-1777 is our second development program generated by KINect, our proprietary drug discovery platform. After generating proof of mechanism in inhibiting TNFα, IL1β and IL6 in our Phase 2a trial of ATI-450 in moderate to severe rheumatoid arthritis, we are planning to move ATI-450 forward with a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021 and planning to initiate two additional trials of ATI-450 in hidradenitis suppurativa and psoriatic arthritis."

Research and Development Highlights:

The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

ATI-450, an investigational oral small molecule MK2 inhibitor compound:
ATI-450-RA-201: A Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in 19 subjects with moderate to severe rheumatoid arthritis. The trial consisted of a 12-week treatment period and a 4-week follow-up period. Two subjects withdrew from the trial during the treatment period, one in the treatment arm and one in the placebo arm.
Final per-protocol analysis, which consisted of 17 subjects who completed the treatment period (15 in the treatment arm and two in the placebo arm), confirmed that ATI-450 demonstrated durable clinical activity, as defined by a marked and sustained reduction in DAS28-CRP and improvement of ACR20/50/70 responses over 12 weeks.
Overall, ATI-450 was generally well tolerated. There were no treatment-related serious adverse events and all adverse events were mild to moderate. There was one non-treatment-related serious adverse event (COVID-19) reported in the 4-week follow-up period of the trial in a subject who was no longer receiving treatment. The subject withdrew during the 4-week follow-up period of the trial.
Aclaris intends to progress ATI-450 into a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021.
As part of its planned expansion of its Phase 2 immuno-inflammatory clinical development programs, Aclaris also plans to progress ATI-450 into Phase 2 trials in hidradenitis suppurativa and psoriatic arthritis.
ATI-1777, an investigational topical "soft" Janus Kinase (JAK) 1/3 inhibitor compound:
ATI-1777-AD-201: An ongoing Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to investigate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in 50 subjects with moderate to severe atopic dermatitis. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4.
Enrollment in this trial was completed in March 2021.
Data from this trial are now expected in the second quarter of 2021.
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
Currently being developed as a potential treatment for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease.
Submission of Investigational New Drug Application is expected in the second half of 2021.
Aclaris is also expanding its Scientific Advisory Board with the addition of Dr. Philip Mease. Dr. Mease, a rheumatologist, currently serves as a Director of the Division of Rheumatology Clinical Research at the Swedish Medical Center/Providence St. Joseph Health and is a Clinical Professor at the University of Washington in Seattle. His major clinical and research focus is psoriatic arthritis and axial spondyloarthritis.

Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2021, Aclaris had aggregate cash, cash equivalents and marketable securities of $142.7 million compared to $54.1 million as of December 31, 2020. The primary factors for the change in cash, cash equivalents and marketable securities during the three months ended March 31, 2021 included:

Net proceeds of $103.3 million from a public offering in January 2021 in which Aclaris sold 6.3 million shares of common stock.

Net cash used in operating activities of $12.2 million resulting from net loss of $28.8 million and changes in operating assets and liabilities of $2.9 million, partially offset by non-cash adjustments of $19.4 million which was primarily related to a $16.4 million charge for the revaluation of contingent consideration.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2021 will be sufficient to fund its operations through the end of 2023, including estimated costs for the Phase 2b trial of ATI-450 for moderate to severe rheumatoid arthritis and the planned expansion of its Phase 2 immuno-inflammatory clinical development programs for hidradenitis suppurativa and psoriatic arthritis, without giving effect to any potential business development transactions or financing activities.

Financial Results

First Quarter 2021

Net loss was $28.8 million for the first quarter of 2021 compared to $15.6 million for the first quarter of 2020.

Total revenue was $1.8 million for the first quarter of 2021 compared to $1.4 million for the first quarter of 2020.

Research and development (R&D) expenses were $7.8 million for the quarter ended March 31, 2021 compared to $7.7 million for the prior year period.
The quarter-over-quarter increase of $0.1 million was primarily the result of continued investment in the further development of Aclaris’ immuno-inflammatory drug development pipeline, including ATI-450, ATI-1777 and ATI-2138, partially offset by a reduction in spend for legacy dermatology assets and personnel costs.
General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021 compared to $6.2 million for the prior year period.
The quarter-over-quarter decrease of $1.4 million was primarily the result of lower personnel and non-cash stock-based compensation expenses.
Revaluation of contingent consideration charges related to the Confluence acquisition was $16.4 million for the quarter ended March 31, 2021 compared to $1.8 million for the prior year period.
The quarter-over-quarter increase in contingent consideration of $14.7 million primarily resulted from updates to probability of success and estimated future sales level assumptions following the completion of a Phase 2a clinical trial of ATI-450 in subjects with moderate to severe rheumatoid arthritis.

On May 6, 2021 Hope Medicine reported the completion of a Series B financing US$56 million (Press release, Hope Medicine, MAY 6, 2021, View Source [SID1234632778]). This round of financing was jointly led by Qiming Venture Partners and Grand Flight Investment. HighLight Capital (HLC) co-invested with Sinovation Ventures. The Series A investor，Trust Bridge Partners，continued to subscribe. HaoYue Capital acted as the exclusive financial advisor for this round of financing.

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HopeMed is a global science-driven innovative biopharmaceutical company with R&D bases and offices in Nanjing, Shanghai, and Beijing, China. The company was founded by Professor Rui-Ping Xiao, the dean of the College of Future Technology of Peking University, and an associate editor of New England Journal of Medicine. HopeMed has always followed the founding philosophy of In China, For Global, and has built an international multi-disciplinary team dedicated to global unmet medical needs with first-in-class medicines.

HopeMed focuses on the three major disease areas of women’s health, endocrine, and cardiovascular diseases, and aims at the unmet medical needs, through an independent R&D as well as license-in models, to further establish and enrich our research and development pipelines.

Previously, HopeMed has signed a world-wide exclusive license agreement with Bayer AG on the development and commercialization of a human antibody (HMI-115) targeting the prolactin (PRL) receptor for the treatment of male and female pattern hair loss, endometriosis and other chronic diseases with dysregulated PRL signaling. Under the terms of the license agreement, Hope Medicine will develop and globally commercialize the novel PRL receptor antibody based on intellectual property from Bayer. At present, HMI-115 has completed phase I clinical trials in the European Union, with positive safety results. The global multi-center phase II clinical trials for androgenic alopecia and endometriosis will soon be launched.

‘We have built a world-class professional team and strong global intellectual property rights to develop the best pharmaceuticals for the global market. China’s innovative pharmaceutical research and development have now entered an exciting new era of ‘dare to do, can do, and must do’. The diseases in women health, endocrinology, and cardiovascular fields are our primary battlefields. We will not forget our original purpose and strive for first-in-class medicines with disruptive innovation to benefit patients worldwide. Here we would like to express our sincere thanks to our new and old investors for their precious recognition and trust in HopeMed. This round of financing will provide strong support for the company’s upcoming MRCT international phase II clinical studies and commercial product development.’ Said Rui-Ping Xiao, Founder, and CEO of HopeMed.

Amy Tang, a venture partner with Qiming Venture Partners, said, "China’s innovative drug R&D sector is maturing. As a science-driven innovative drug R&D company, Hope Medicine has formed solid cooperations with world-class scientific research and development platform, such as IMM. The company develops first-in-class drugs to target unmet clinical needs and push forward with this goal. We are honored to cooperate with the visionary company, which is also effective at execution. Qiming hopes to explore the huge R&D potential of Hope Medicine and help their pipeline to go to market as soon as possible, to benefit the patients."

Mr. Jun Yang, Managing Partner of Grand Flight Investment said that they are very optimistic about the development of China’s biomedical industry and are convinced that China’s domestic grown innovative pharmaceutical companies can achieve more First-in-Class innovations. The HopeMed team led by Professor Xiao has a global vision and experience and is committed to the research and development of First-in-Class innovative medicines based on a deep understanding of translational medicine. HopeMed’s HMI-115 antibody has shown very significant effects in the natural NHP model, and human clinical trials have also shown positive safety results. Grand Flight is very optimistic about its follow-up clinical advancement and the expansion of more indications. HopeMed’s innovative pipelines in other disease fields also enrich the company’s future product layout.

‘After ten years of accumulation, the research and development of innovative pharmaceuticals in China has entered the spring of rapid development. We are very excited about the development of China’s medical and healthcare industry in recent years and its long-term prospects, and we are willing to accompany the growth of truly original pharmaceutical companies. HopeMed is a First-in-Class pharmaceutical research and development practice based in China and aiming at the world. Trust Bridge Partners is honored to be the founding investor and partner of HopeMed. This investment is in line with our vision to develop and provide international standard medical products for the Chinese and global markets.’ Said Mr. Feng Ge, the Managing Partner of Trust Bridge Partners.

Mr. Richard Yang, Partner of Sinovation Ventures commented that HopeMed is founded on the remarkable achievements in advanced translational medicine accumulating years of domain know-how led by Professor Xiao. The company develops competitive pipelines in multiple therapeutic areas with the world’s leading research and experiment platforms. Sinovation Ventures is honored to work with Professor Xiao’s team, and is highly confident that HopeMed will create great commercial value and social impact.

Mr. Liu Hao, Founder and CEO of HaoYue Capital, said that ‘we are honored to assist HopeMed in completing this round of financing. HopeMed has a world-class R&D team, including basic research, clinical translation, and CMC manufacturing. HopeMed always focuses on unmet clinical needs and refuses to follow others. HaoYue Capital is also committed to serving the best R&D team and the most innovative biopharmaceutical company in the world. We believe that HopeMed can provide patients with products with true clinical value.’

On May 6, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported it will give a poster presentation at the New York Academy of Sciences 2021 Frontiers in Cancer Immunotherapy meeting, which is being held virtually from May 12-14, 2021 (Press release, Cue Biopharma, MAY 6, 2021, View Source [SID1234608281]). The presentation will highlight clinical and preclinical data supporting the mechanism of action (MOA) for the Immuno-STAT (Selective Targeting and Alteration of T cells) platform, its expanding pipeline, and platform derivatives Neo-STAT and RDI-STAT (Re-Directed Immuno-STATs) to enhance anti-tumor immune responses.

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Presentation details:
Title: Immuno-STAT (Selective Targeting and Alteration of T cells) Platform: Targeting Tumor Heterogeneity and Tumor Escape Mechanisms
Presenter: Steve Quayle, Ph.D., Vice President, Translational Pharmacology, Cue Biopharma
Session: Virtual Poster Session 1
Date and Time: May 12, 2021 at 1:42 p.m. EDT

The poster will be available in the Investor & Media section of the Company’s website under Scientific Publications and Presentations, following the presentation at the New York Academy of Sciences 2021 Frontiers in Cancer Immunotherapy meeting.

Dr. Quayle will discuss how the Immuno-STAT platform and biologics enable selective engagement of tumor-specific T cell repertoires against tumors. He will showcase lead drug candidate, CUE-101, derived from the interleukin 2 (IL-2)-based CUE-100 series of Immuno-STATs that are designed for selective delivery of IL-2 to tumor-specific T cells. CUE-101 has shown favorable signs of tolerability, dose-dependent pharmacokinetic (PK) and pharmacodynamic (PD) activity, and anti-tumor activity in an ongoing Phase 1 monotherapy clinical trial for heavily pretreated patients with HPV+ head and neck squamous cell carcinoma. The presentation will also feature the Company’s second drug candidate, CUE-102, which targets the Wilms tumor (WT1) protein and is expected to reach the clinic in 2022, as well as next-generation platforms, Neo-STAT and RDI-STAT, engineered to address tumor heterogeneity and circumvent tumor escape mechanisms, respectively.

About New York Academy of Sciences (NYAS) Frontiers in Cancer Immunotherapy Meeting
NYAS 2021 Frontiers in Cancer Immunotherapy meeting will convene experts in tumor immunology, cancer genetics and computational biology to discuss innovative methods to analyze both the tumor and the host immune system and highlight the links between tumor genotype, immune phenotype and patient response. Key themes under discussion will include tumor evolution, neoantigens, novel therapeutic targets, and mechanisms driving the emergence of resistance to current therapy.