On June 8, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), the leading developer of LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported an update on its preclinical development pipeline (Press release, Immutep, JUN 8, 2021, View Source [SID1234583751]).

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Under the collaboration project commenced in 2019 with Cardiff University, the Company has advanced the discovery and development of a new generation of small molecule anti-LAG-3 therapies. The ultimate aim of the project is to make an oral treatment available to cancer patients and at a lower cost compared with the current anti-LAG-3 antibodies being developed by several companies.

The project brings together Immutep’s deep experience in LAG-3 biology, with the expertise of Cardiff University Professors Andrew Godkin and Andrea Brancale. Prof Godkin is the University Theme Lead in Immunology in the College of Biomedical Life Sciences and Prof Brancale is Professor of Medicinal Chemistry at the School of Pharmacy and Pharmaceutical Sciences.

"Never has there been a more exciting time to explore new ideas to control the interaction between LAG-3 and MHC class II molecules, following the recent validation of LAG-3 by the pharma industry. We are excited to progress this project with the world leading scientists at Cardiff University and continue our work to develop novel LAG-3 therapeutics, especially as there are already some exciting early results from our joint efforts," said Marc Voigt, Immutep CEO.

"We are delighted to collaborate with Immutep on this important project to develop a small molecule anti-LAG-3 treatment for cancer patients that could offer the convenience of a tablet or capsule, at a fraction of the cost of existing anti-LAG-3 candidates," said Professor Andrew Godkin of Cardiff University.

Professor Andrea Brancale of Cardiff University also added: "Our collaboration with Immutep is a great opportunity to combine a diverse set of skills from multiple teams in what is an exciting area of research. Indeed, we think this cross-functional expertise in chemistry, biology and drug development positions the team very well for a successful collaboration."

Under the Agreement, all intellectual property relating to lead compounds as well as derivatives thereof, will be jointly owned by Immutep and Cardiff University. Immutep will have exclusive rights to develop and commercialise the new molecules in the clinic according to pre-defined licensing terms. The Agreement builds on a Material Transfer Agreement signed by Immutep SAS and Cardiff University in 2015.

"Our collaboration with Cardiff University demonstrates our commitment to continually invest in R&D. We believe that the discoveries arising from this collaboration and our collaboration with Monash University may have a profound impact on the LAG-3 landscape, particularly in respect of the anti-LAG-3 therapies currently in late-stage development," said Immutep‘s CSO and CMO, Dr Frederic Triebel.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

As announced on 31 August 2020, the Australian Research Council (ARC) awarded Immutep and research partner Monash University a grant under the ARC‘s Linkage Project scheme to support their research collaboration into LAG-3 for a further three years. Monash University’s research team for the project is led by Professor Jamie Rossjohn, an ARC Laureate Fellow at the Monash Biomedicine Discovery Institute and Professor in Structural Immunology at Cardiff University.

About Cardiff University

Cardiff University is a UK Russell Group University and was returned as one of the top five universities in the UK government’s last Research Exercise Framework. This collaborative project with Immutep is carried out in the School of Medicine and the School of Pharmacy in the College of Biomedical Life sciences. There is a strong interest in basic and translational biomedical science in the University, which sits well with this collaboration. Prof Andrea Brancale is an internationally recognized expert in medicinal chemistry, and Prof Andrew Godkin runs a laboratory in the Henry Wellcome Building, School of Medicine, focusing on basic and translational cancer immunology.

On June 8, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales of EXPAREL (bupivacaine liposome injectable suspension) and iovera° of $41.2 million and $1.0 million, respectively, for the month of May 2021 (Press release, Pacira Pharmaceuticals, JUN 8, 2021, View Source [SID1234583741]). EXPAREL average daily sales for the month of May 2021 were 162 percent of May 2020 and 105 percent of April 2021. Sales in May 2020 were negatively impacted by significant restrictions that were in place for elective procedures due to the COVID-19 pandemic.

"EXPAREL sales continue to significantly outperform the elective surgery market recovery, with May marking our fourth consecutive month of sequential growth in average daily sales. This growing demand is driven by the increasing entrenchment of EXPAREL as the cornerstone of reliable regional-based enhanced recovery after surgery protocols that successfully facilitate the safe transition of procedures to outpatient settings, as well as the expanding use of EXPAREL in non-elective procedures, such as cesarean sections and cardiovascular surgeries. Our iovera° customer base continues to rapidly expand as our educational and commercial programs highlight the value of this novel, cold technology for drug-free pain control that endures for several months, further solidifying Pacira as a market leader in opioid-sparing pain management," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

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The company’s 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the second quarter or full year 2021.

On June 8, 2021 Pascal Biosciences Inc. ("Pascal" or the "Company") (TSXV:PAS) (OTC:PSCBF), reported that it has been awarded a grant of US$343,750 from the National Cancer Institute of the US National Institutes of Health (NIH) (Press release, Pascal Biosciences, JUN 8, 2021, View Source [SID1234583740]). This two-year award will fund development of Pascal’s antibody drug for Acute Lymphoblastic Leukemia (ALL), which is the most common childhood leukemia.

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Pascal is the first to advance an antibody targeting the highly leukemia-specific protein, VpreB, for treating ALL. "This grant validates our scientific efforts and will accelerate development of a new treatment for leukemia patients", stated CEO Patrick Gray. "The exquisite specificity of our antibody will eliminate many of the hazards of current therapies for ALL. This grant will enable Pascal to bring our product into clinical trials."

More than 6000 patients are diagnosed with Acute Lymphoblastic Leukemia (ALL) each year in Canada and the US. About half of ALL patients are adults and half are children, which makes this disease the most common type of childhood leukemia. Pascal’s drug will be eligible for orphan drug designation, which can enable financial incentives and a seven year marketing exclusivity. Pascal has filed for patent protection for its ALL treatment. While the number of patients with ALL is relatively small, the market potential for Pascal’s drug could be significant. Other cancer products for orphan diseases have proven to be financially successful, selling over $1B each year.

ABOUT ACUTE LYMPHOBLASTIC LEUKEMIA

ALL arises as a consequence of dysregulated proliferation of early-stage B cells. The current treatment for ALL—a chemotherapeutic regimen with four toxic drugs—has not changed in over 40 years. This regimen can be quite effective (85% success in children, 50% in adults). However, short- and long-term side effects can be devastating: young patients may have cognitive or developmental problems and frequently develop additional cancers 20 years after treatment, while older patients tend to have great difficulty coping with side effects. Pascal is developing monoclonal antibodies specific for a cell surface protein found only on ALL cells and on the early-stage cells from which ALL originates. This specificity spares the normal, mature B lymphocytes needed for protecting the patient from infection. Pascal’s lead antibody for drug development binds the tumor target with high affinity and has good biophysical properties for expedient drug development. Patients treated with Pascal’s drug will have the benefit of a highly targeted treatment and will also avoid the detrimental side effects of chemotherapy. The NIH grant, which covers both research and administrative costs for Pascal’s program over a period of two years, will validate a drug product for clinical development to treat this challenging leukemia.

On June 8, 2021 3Brain AG has reported a new technology based on a unique combination of microchips and AI that promises to change the way drug candidates are selected at the preclinical level to enter into clinical trials – and to maximize their chances of success (Press release, Lifescience Newswire, JUN 8, 2021, View Source [SID1234583739]).

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Using CorePlate technology, preclinical cell assays are performed in multiwell plates that integrate a microchip in each well to collect rich information from cells, pre-process cell data and streamline it to the paired software. As a result, much more and better data can be extracted, which can be referred to as cell big data. This is fed to an AI with the aim of simplifying interpretation and enabling researchers to discover more information about drugs being tested.

Preclinical studies are vital for early identification of any safety and efficacy issues, and for increasing the chance of success of those drugs entering clinical trials. However, common estimates show that there is still a lot to improve in this area as 90% of the drugs that enter into human trials fail and never reach the market. Among the factors responsible for this high failure rate are the limitations of conducting preclinical tests on animal models. The vast majority of drugs that pass tests on animals do not later work on humans because disease mechanisms vary significantly between species.

New biotechnologies like human stem cells offer more successful alternatives to animal models. These may be in the form of cell culture assays or more sophisticated spheroid and organoid assays that can be used as testbeds for drugs. Human cell-based assays hold the promise to revolutionize drug development, improving the success rate and pushing animal tests towards extinction.

Whatever cell-based assay one wants to investigate, traditional approaches extract cell information via optical systems or a few sensors embedded in plastic substrates. Typically, these substrates are multiwell plates with 24, 96 or even more wells, where each well houses the cell samples to be measured. From these wells, the acquired information travels on limited bandwidth across long distances (compared to the cell size) before reaching a CPU where it gets processed. Long distances and bandwidth issues affect the quality and quantity of information and, consequently, prevent an accurate inspection of cell networks. The CorePlate technology devised by 3Brain disrupts this paradigm by bringing the processing unit in contact with the cells.

20210604 CorePlate press release_other imgs_1"We want to radically change the way preclinical drug screening is performed, offering pharmaceutical companies the opportunity to manage their pipelines more efficiently," says Mauro Gandolfo, CEO and co-founder of 3Brain AG. "Basically, we take traditional plastic multiwell plates and we turn them into intelligent devices with multi-core processing power, which can be programmed according to research needs. Integrated intelligence is a remarkable distinction from other instruments in the preclinical space. Importantly, despite the large amounts of data CorePlate devices can process, the user can still easily generate results thanks to the AI-driven interpretation of data. With the CorePlate technology, pharmaceutical companies can save time and money by better filtering and prioritizing drug candidates. Our ultimate goal is to provide our users with tools that help them more readily identify new cures for diseases."

20210604 CorePlate press release_other imgs_23Brain AG has been working on microchip technology applied to life science for more than 15 years. Alessandro Maccione, CSO and co-founder of 3Brain AG, says, "We already have results showing that our technology is superior in identifying the effects of compounds on several disease models. We started focusing on brain diseases, such as Alzheimer’s and epilepsy, given the high burden that they represent for our society. In addition, we are expanding to other sectors such as cardiac safety, which is one of the main reasons drugs fail in clinical trials. At the same time, driven by our appetite for innovation, we are very attentive to the opportunities offered by advanced cell models such as spheroids and organoids. That’s why we plan to have our CorePlate devices shipped in two "flavors", a planar one that can work with more traditional cell assays and a three-dimensional one where the sensing layer of the microchip is on microneedles that can collect cell information from the inside of tissues and organoids."

Kilian Imfeld, CTO and co-founder of 3Brain AG, adds, "The processing power we have integrated into a CorePlate device is really striking. You can think of it as a modern multi-core CPU, but where the microchip is specifically designed for biological signals. Consequently, we call it BioSPU, BioSignal Processing Unit. Such power allows us to simultaneously process real-time information coming from hundreds of thousands of cells. This continuous data streaming allows for the observation of even subtle changes induced in the cells during the measurement session, such as those caused by the compound under investigation. At the moment we have developed a 6-well CorePlate and we are working on a 24-well and a 96-well format to be released over the coming years. Along the way, our microchips will continue to integrate more functionalities to align with the increased complexity while also maintaining an easy and efficient user experience."

On June 8, 2021 Francis Medical, Inc., a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, reported positive results from the company’s VAPOR 1 clinical study evaluating the safety and efficacy of the company’s minimally invasive water vapor ablation therapy for treating prostate cancer (Press release, Francis Medical, JUN 8, 2021, View Source [SID1234583733]).

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VAPOR 1 is a prospective, multicenter, single-arm study that treated 15 patients with intermediate- risk, localized prostate cancer at four U.S. clinical sites. The data is from the six-month primary endpoint, including safety and efficacy outcomes, and VAPOR 1 study patients will continue to be followed to one year. Study participants had unilateral cancer (one side of the prostate), with a treatment intent of ablating only the impacted side (hemi ablation). The VAPOR 1 six-month data reported no serious adverse events, no device-related adverse events, and no unanticipated adverse device effects. Additionally, the effectiveness results support findings that demonstrate water vapor technology can reach and treat all prostate regions (apex, mid, base, anterior, and posterior) and eradicate intermediate risk, Grade Group 2 (GG2, Gleason Score 3+4), prostate cancer. In 87% of patients, six-month biopsy results indicate no ≥ GG 2 (clinically significant) disease on the treated side. In three patients, results on the treated side showed a single positive biopsy core with ≤ 5% involvement (low volume) of GG1 (Gleason Score 3+3) disease.

The safety profile reflects low levels of adverse events for the patient population treated, with no patients reporting urinary incontinence requiring pad usage and one (6.7%) patient reporting moderate erectile dysfunction (with medication indicated). These promising results support the intent of this therapy to manage clinically significant disease while decreasing morbidities associated with currently used prostate cancer treatments. Francis Medical will use the safety and efficacy data from the VAPOR 1 study to support a pivotal trial with its next-generation device and U.S. regulatory approval.

"I am excited to be participating in the VAPOR 1 trial," said Dr. Christopher Warlick, head of the Department of Urology at the University of Minnesota and principal investigator in the VAPOR 1 study. "Currently, urologists commonly use water vapor to successfully treat benign prostatic hyperplasia (BPH). The VAPOR 1 results are very encouraging and suggest the viability of water vapor technology to treat prostate cancer as well. This approach has the potential to provide appropriate men a simple outpatient procedure to manage their prostate cancer with minimal risk of the debilitating side effects often seen with other therapies."

As the second most common cancer in U.S. men, the American Cancer Society estimates one in nine American men will be diagnosed with prostate cancer during their lifetime. Prostate cancer is a serious disease for which current treatment options often cause complications such as urinary incontinence and erectile dysfunction. Francis Medical’s water vapor energy technology applies the thermal energy stored in a few drops of sterile water to deliver targeted treatments to the cancerous tissue in a simple transurethral procedure. The therapy is designed to ablate cancer cells while protecting surrounding structures, lessening the likelihood of life-altering side effects common with other prostate cancer treatments.

"We are thrilled with the results from VAPOR 1," said Michael Kujak, Francis Medical president and chief executive officer. "We want to thank all of the VAPOR 1 investigators, their support staff and the patients suffering from prostate cancer who volunteered to participate for the extraordinary efforts required to execute this study through the worst of the COVID-19 pandemic. The excellent results of VAPOR 1 confirm our belief that this groundbreaking technology will ultimately become the first-line treatment of choice for men and their doctors."

"The VAPOR 1 results are the culmination of the hard work and shared vision of the entire Francis Medical team," said Michael Hoey, Francis Medical founder and chief technology officer. "At Francis Medical, the patient is always first and foremost in our minds. Therefore, it is extremely gratifying to provide the patients in VAPOR 1 with not only an effective treatment for their cancer, but also one that produced minimal pain and side effects, allowing them to quickly return to their normal activities. We continue to work hard every day to realize our shared goal to bring this therapy to every man who can benefit from it."

On the heels of these results, Francis Medical is currently in the process of raising Series B financing to fund their VAPOR 2 pivotal study.