On June 8, 2021 CyGenica has reported that it has raised USD $1.4 million in a seed fund investment round, led by global venture capital investor SOSV (Press release, CyGenica, JUN 8, 2021, View Source [SID1234633831]).

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CyGenica’s disruptive technology addresses the problem of delivering large-molecule therapeutics into living cells without damaging them or triggering an adverse immune response.

The current investment seed round of USD 1.4 million was led by venture capital investor SOSV. Other investors participating in the round included the VOYAGER Health-Tech fund, David Rowan, founder of Voyagers.io, and angel investors Sharaf Yamand Sami Mikati.

CyGenica intends to utilize the investment to accelerate the development of its disruptive drug delivery technology for genome editing, seeking to be a key partner of biopharmaceutical companies in the advancement of cutting-edge therapeutics for cancer and rare diseases to improve patient’s health and quality of life.

"The challenge of delivering drugs for cancer and genetic therapies, be it genes/RNAs/CRISPRs across cell membranes without damaging the cells and triggering an adverse immune response remains a complex hurdle in the pharmaceutical industry. Our groundbreaking technology functions like a universal USB drive. It acts as a nanomachine which can deliver multitudes of cargoes carrying molecular information such as drugs and genetic therapeutics in an efficient, targeted manner without any toxicity and minimum immunogenicity. This will revolutionize drug delivery and lead to better patient outcomes," said Dr Nusrat Sanghamitra, Co-founder and CEO of CyGenica, talking about the latest development.

"This current financing round has brought a diversified international network on board. This will help de-risk our technology, expand our leadership team and take us significantly closer to our goal of enabling safe and targeted intracellular delivery of genetic therapies for cancer and rare diseases," Nusrat further said.

"I am delighted to be leading this investment because CyGenica has solved one of the most pressing problems in biotech: delivery. We are incredibly excited to be part of this revolution," said Bill Liao, Partner SOSV.

"Life-changing healthcare innovation isn’t only coming out of the established life-science hubs. The VOYAGERS Health-Tech Fund is particularly excited to support CyGenica, a remarkable company born in Odisha, India, with the potential to transform targeted drug delivery without the normal side effects that cancer and other patients have had to bear. The VOYAGERS community will do all we can to support Dr Nusrat Sanghamitra and her team in their important mission," said David Rowan, Founder of Voyagers.io.

On June 8, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported that Alpine is set to join the broad-market Russell 3000 Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the US market opens on June 28, 2021, according to a preliminary list of additions posted by FTSE Russell on June 4, 2021 (Press release, Alpine Immune Sciences, JUN 8, 2021, View Source [SID1234583700]).

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Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of May 7, ranking them by total market capitalization. Membership in the US all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

For more information on the Russell 3000 Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

On June 8, 2021 Orion Corporation and the Finnish Red Cross Blood Service reported that they have concluded an agreement on research collaboration with the aim of developing chimeric antigen receptor (CAR) T-cell therapy (Press release, Orion , JUN 8, 2021, View Source [SID1234583716]).

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Cancer immunotherapies, with CAR T-cell therapy as one form of therapy, have introduced entirely new possibilities for cancer treatment. In CAR T-cell therapy, the patient’s own white blood cells are genetically modified to attack the cancer and kill it. CAR T-cells are currently used to treat certain haematological cancers.

The first T-cell therapies received marketing authorisation in the USA in 2017 and in Finland in 2019 for the treatment of recurrent acute lymphocytic leukaemia and B-cell lymphoma. Despite the good treatment results, development needs have been identified in CAR T-cell therapies, which is why research related to CAR-T cell therapy is being pursued.

The Blood Service has considerable experience in cell research, in the supply of cord blood and stem cell grafts classified as tissue products, and in the preparation of ATMP cell products classified as medicinal products. The Blood Service also has expertise and the necessary clean rooms for the research and high-quality production of therapeutic cells.

Orion has a solid research infrastructure and has introduced several proprietary drugs to the market in different therapy areas. Orion’s oncology therapy area researches and develops novel proprietary drugs for the treatment of cancer. In recent years, Orion has expanded its research activities to include immuno-oncology therapies.

New possibilities for cancer treatment

The research collaboration is based on new innovations to improve the structure of the CAR T-cell product. Matti Korhonen, Senior Medical Officer, who leads the research at the Blood Service, believes that the collaboration offers a great opportunity to develop new cell therapy products for patient care. According to Oliver Cooper, Ph.D., director of Discovery Sciences at Orion’s R&D, Orion’s drug development expertise will provide the necessary momentum for this project.

"Targeted immunotherapy has opened up entirely new possibilities for the treatment of cancer, and it is important to advance this development in Finland, too. I also believe that as a result of the development work, more and more patients will be able to benefit from this effective treatment," says Matti Korhonen

Project managers Satu Juhila from Orion and Jan Koski from the Blood Service say that the collaboration has got off to a good start: "Both parties are very enthusiastic regarding the opportunities of the collaboration and about advancing the development of cell therapy in Finland. We believe that the collaboration will provide plenty of new opportunities for the development of cell therapy products."

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.

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.