Stem Cell Clinic

Medigene Provides Results for Fiscal Year 2019 and Outlook – Yahoo Finance

Conference call on 26 March 2020 at 4pm CET (Frankfurt) / 11am EDT (New York)

MARTINSRIED, Germany and MUNICH, Germany, March 26, 2020 (GLOBE NEWSWIRE) -- Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies for the treatment of cancer, today published its financial results and Annual Report for the 2019 financial year and its outlook for the current 2020 financial year. The full version of the Annual Report 2019 can be downloaded here: http://www.medigene.com/investors-media/reports-presentations/

Company highlights in 2019 and since period end:

T cell receptor-modified T cell therapies (TCR-Ts)

Dendritic cell (DC) vaccine

Partnerships

Prof. Dolores Schendel, CEO/CSO at Medigene AG: In the past fiscal year we set the course for the expansion of our clinical programs. We are pleased that for our ongoing clinical trial with the TCR-T immunotherapy candidate MDG1011 we were able to treat the first patients and that the activities to improve patient recruitment have borne fruit. Our clear goal is to complete dosing of the first three dose cohorts this year.

In the coming months, we plan to start our second clinical trial with development candidate MDG1021 and we continue intensive work for the innovation of our technologies. Safe and targeted immune therapies are needed, especially for solid tumors, and here we are focusing on potential combinations of approaches for next-generation TCR-T cell therapies with our iM-TCRs and the co-stimulatory receptor PD1-41BB.

The cooperation with IRICoR offers us exclusive access to a still untapped world of potential target antigens for solid tumors. We look forward to progress in our partnerships with bluebird bio and Roivant/Cytovant which we believe should provide both financial and scientific benefits. We currently dont see effects on our business caused by the circumstances due to the Coronavirus crisis but will continue to monitor developments closely. Furthermore, we believe Medigene is well-equipped to cope.

Company outlook:

T cell receptor-modified T cells (TCR-Ts)

Dendritic cell vaccines (DCs)

Partnerships

Key financials in full year 2019 and financial forecast:

The financial forecast for 2020 reflects the Companys focus on and progress in the core business of immunotherapies and does not include potential future milestone payments from existing or future partnerships or transactions, as the timing and extent of such events depends to a large extent on external parties and therefore cannot be reliably predicted by Medigene.

Currently the Company expects no material influence of the recent outbreak of the coronavirus on total revenue, research and development expenses and loss at EBITDA level. Furthermore, in preparation of the financial forecast 2020 the Company has assumed that there will be no significant events which could have a material influence or lasting effect on the operations of the Group such as force majeure (e.g. fire, flood, earthquakes, strike or war) or extraordinary economic events.

Medigene is expecting to generate total revenue of between 7.0 - 9.0 m in 2020. The decrease in comparison to 2019 (10.6 m) is based on the prepayments from Medigenes development partnerships that were collected immediately in 2019 but are not expected in 2020. Due to the progress of the preclinical and clinical development programs in the core area of immunotherapies, including manufacturing costs for clinical trial material and deferred expenses from 2019, the company expects a significant increase of research and development costs to 29 - 34 m (2019: 22.6 m) and a loss at EBITDA level of 24 - 32 m (2019: 17.8 m).

Based on its current planning, Medigene has sufficient financial resources to fund business operations into the second half of 2021.

Conference call:

The Management Board will hold a conference call in English today:

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with a focus on T cell receptor-modified T cells (TCR-Ts) and associated projects currently in pre-clinical and clinical development.

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For more information, please visit http://www.medigene.com

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Contact Medigene AGDr Gary Waanders, Claudia Burmester, Dr Anna NiedlTel.: +49 89 2000 3333 01email: investor@medigene.com

In case you no longer wish to receive any information about Medigene, please inform us by e-mail (investor@medigene.com). We will then delete your address from our distribution list.

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Medigene Provides Results for Fiscal Year 2019 and Outlook - Yahoo Finance

What Does It Mean to Be Immunocompromised? – Dana-Farber Cancer Institute

Immunocompromised individuals are potentially at a higher risk for severe illness from the coronavirus, or COVID-19, according to the Centers for Disease Control and Prevention (CDC). Were here to help here is some general information about what it means to be immunocompromised, and how you can protect yourself.

If you have additional questions regarding either your currentor past treatments, contact your oncologist for more information.

Being immunocompromised means having a weakened immunesystem, which reduces the bodys ability to fight infections and otherdiseases. Cancer patients can become immunocompromised (at least for a periodof time) due to the disease, as a result of treatment they are undergoing, or acombination of both reasons.

As a general guideline, if you have either undergone a stem cell transplant in the last two years (it typically takes 3-12 months, if not longer, for your immune system to recover from your transplant), have chronic graph-versus-host disease (GVHD), or are currently on ongoing, intensive chemotherapy (or a similar potent drug), you are likely immunocompromised.

People who are immunocompromised would have been told this by their oncologist prior to starting treatment, and should be practicing COVID-19 type precautions, according to Joseph H. Antin, MD, chief emeritus of Adult Stem Cell Transplantation at Dana-Farber/Brigham and Womens Cancer Center.

Based on current information available, those at high-riskfor severe illness from COVID-19 include people who are immunocompromised, includingfrom cancer treatment.

Antin encourages all cancer patients, whether they are inactive treatment or not, to adopt more aggressive precautions. It is stillunclear as to what extent (if any) a previous cancer diagnosis increases yourchance of developing severe illness from COVID-19, even if you are no longerimmunocompromised.

Patients who have been told that they are currentlyimmunocompromised should avoid leaving their homes unless it is absolutelyessential and limit their contact with others. In instances where you mustleave your homes (such as for a doctors appointment), you will likely be givenmasks and gloves to wear while youre out. Be sure to change your gloves if youtouch a high traffic item (such as an elevator button or handrail) and washyour hands once you have returned from your destination.

All patients should be in contact with their care teams todetermine if their current care schedule is still appropriate, or if it can betemporarily adjusted.

There are many things you can do to help protect yourself,and those around you, from contracting COVID-19. The best way to preventillness is to avoid being exposed to the virus. It is recommend that you:

If you are caring for or even visiting someone who isimmunocompromised, it is important to also follow these heightened precautions.Remember: Anything you carry can be transferred to the patient. This is whyanyone who will come in contact with an immunocompromised person needs tofollow the same guidelines as someone who is immunocompromised.

Today, it is important to self-quarantine and practicesocial distancing as much as possible. Consider exchanging physicalinteractions with virtual ones; Facebook Messenger, FaceTime, or even videoconferencing applications (such as Zoom) can serve as temporary alternatives.

Both patients and their caregivers need to practice self-care for emotional and physical well-being in this challenging time.Read helpful information on coping day-to-day with COVID-19 uncertainty.

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What Does It Mean to Be Immunocompromised? - Dana-Farber Cancer Institute

Study Shows Development of Young Cells Could be New Option in Cancer Care – BioSpace

Washington University School of Medicinein St. Louis released a newstudyabout the effectiveness of immunotherapy based on the age of the cells used. The study, published in the journalDevelopmental Cell,showed that these natural killer cells seem to be more effective when they are young. Natural killer (NK) cells, as they're called, are used in immunotherapy to treat cancer using the body's immune cells or immune cells from a matched donor.

"We are trying to improve the effectiveness of immunotherapy for more patients," said senior author Christopher M. Sturgeon, Ph.D., an assistant professor of medicine.

Typically, NK cells used in investigational immunotherapy are adult and come from the patient or donor bone marrow. While these therapies can work, they don't work for everyone.

In contrast, young NK cells do not use the patient's cell or donor cells. These early NK cells, typically formed in the yolk sac in the early embryo, are instead able to be created with human pluripotent stem cells. They can be manufactured quickly by most academic medical centers, thus eliminating the time it takes to process patient's or donor's cells for typical NK cell therapy.

"This special source of natural killer cells has the potential to fill some of the gaps remaining with adult NK cell therapy. There is early evidence that they are more consistent in their effectiveness, and we would not need to process cells from a donor or the patient. They could be manufactured from existing cell supplies following the strict federal guidelines for good manufacturing practices. The characteristics of these cells let us envision a supply of them ready to pull off the shelf whenever a patient needs them," Sturgeon said.

Instudieswith mice using the lab-developed human pluripotent stem cells to create early NK cells, researchers found positive results. These cells were significantly better at degranulation than adult NK cells. Even cells from umbilical cord blood did not respond as well as the early NK cells. Additionally, early NK cells are a particular type of short-lived immune cell, meaning that even if the cells cause harm, they aren't in the body for very long. However, NK cells, in general, do not attack the body's healthy tissues significantly, unlike many T cell therapies.

"Based on their unique behavior alone, there is one small clinical trial of these cells that is ongoing. Now that we know how to manufacture them and how they work, it opens the door for more trials and for improving upon their function, " Sturgeon said.

More research will need to be put into understanding why these special cells only show up in the early embryo and where they go after.

The origin and why they work so well is still a complete mystery.

"We can only speculate at this point, but it's possible that during early embryonic development, when there is so much rapid cell division, these cells are there as a surveillance mechanism to protect against pediatric cancers or infection," he said.

In addition to the early NK cells, pluripotent stem cells also have the potential to bring about many other different cell types, creating more possibilities.

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Study Shows Development of Young Cells Could be New Option in Cancer Care - BioSpace

Oscar Saxelby-Lee gets ‘super cells’ after having stem cell transplant from dad to fight off cancer – Ledbury Reporter

A SIX-year-old boy has received his super cells after having a stem cell transplant to fight off cancer.

Oscar Saxelby-Lee received his transplant yesterday (March 13) from his dad, Jamie Lee, who donated his cells to his little boy.

The Hand in Hand for Oscar Facebook page announced the heart-warming news: May these super cells be the beginning of something special just like you Ozzy Bear. We hope this gift will allow you a brand-new start to good health and end the monstrous ordeals you have been faced with. You will always have us by your side, hoping, praying and fighting for the brighter future you so very much deserve.

The emotive post continued: Daddy will always be with you, both inside and out now. How amazing is that. And how utterly amazing are you. You are so so close baby, keep going. Now for the difficult part of growing them and keeping him stable, but hes got this."

Oscar experienced a few slight implications during the transplant due to a reaction, but his parents have assured he is safe and is doing well.

Oscar has been in Singapore with his parents, Olivia Saxelby and Mr Lee, receiving CAR-T therapy after the community backed their appeal to raise 500,000 to afford the life-saving treatment. This is specialised therapy, which is only available in Singapore, to combat his T-cell acute lymphoblastic leukaemia. The young Worcester boy underwent a stem cell transplant last May after a search for a donor which saw thousands across the country to sign-up to a register in a bid to help.

The Worcester News previously reported that Oscar's parents were appealing for blood donations because there's a shortage due to less people donating due to the coronavirus. However, an NHS Blood and Transplant spokesman said blood stock levels are good.

The spokesman said: Our stock levels are good and we dont believe weve seen any effect on appointments. Were asking donors to keep donating as normal and to follow the latest travel and hygiene advice. Donation help us to keep stocks good so we are well prepared for every eventuality. Were regularly reviewing the situation and working closely with the government, Public Health England and the UKs other blood donation services. We're putting in place extra measures and safety is always our number one priority.

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Oscar Saxelby-Lee gets 'super cells' after having stem cell transplant from dad to fight off cancer - Ledbury Reporter

Bone Therapeutics appoints Stefanos Theoharis as Chief Business Officer – Yahoo Finance

Press Release

Gosselies, Belgium, 26March 2020, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that it is further strengthening its management team with the appointment of Stefanos Theoharis, PhD, as Chief Business Officer (CBO).

Stefanos will be responsible for the companys corporate development activities and executing its business strategy. His immediate priorities will be concentrating on partnering Bone Therapeutics products and in-licensing innovations. He will also further develop the commercial strategies for the product portfolio and cell therapy platform.

At this stage of the development of Bone Therapeutics, it is very important to appoint a proven executive with a high level of business experience to achieve our next set of commercial goals, said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. Stefanos has gathered considerable achievements in business development at both rapidly growing biotech and global biopharma companies, coupled with an extensive expertise in cell therapy drug development and manufacturing. His diverse skill set, which includes licensing, M&A transactions and R&D partnerships, will be invaluable to bolster our business initiatives as we continue to advance our mid- to late stage product pipeline through clinical development with a potential commercialization in sight.

Stefanos will contribute more than 15 years of business development experience in the pharma and biotech industry to Bone Therapeutics, specifically in the cell and gene therapy space. This includes his achievements as Senior Vice-President at Cell Medica, a clinical-stage biotech company, where he expanded the companys allogeneic T-cell immunotherapy platform through strategic partnerships with leading research institutions and targeted acquisitions. Prior to Cell Medica, Stefanos was Chief Business Officer at apceth GmbH, a company developing genetically-engineered mesenchymal stromal (MSC) cell products and also acting as a contract manufacturer in the ATMP space. He led all apceths business development activities, including in- and out-licensing and service contracts negotiations. He also held positions as Head of Business Development at the antisense RNA drug specialist Antisense Pharma (now Isarna), and Director Business Development at Roche, focused on partnering activities in emerging science and technologies. Stefanos also worked at Lazard, the global investment bank, advising to a variety of life sciences firms on M&As and financing transactions. Stefanos achieved an MSc. in Molecular Medicine and a PhD in Pathology and Immunology from Imperial College London.

I really wanted to join a cell therapy company where I was able to make a significant difference to the company, the wider field and patients outcomes. With an innovative allogeneic, off the shelf, cell therapy platform and a potentially best-in-class knee osteoarthritic pain treatment, Bone Therapeutics is uniquely positioned to make a meaningful difference in the lives of patients with severe orthopaedic conditions, said Stefanos Theoharis, PhD, Chief Business Officer of Bone Therapeutics. As both products are entering advanced stage clinical trials, Im delighted to join the company at such a critical time and I look forward to working with its talented leadership and scientific teams to take these promising treatments to market.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering PhaseIII development for the treatment of pain in knee osteoarthritis. Positive PhaseIIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) for the pivotal PhaseIII program has been approved by the Danish relevant authorities allowing the start of the study.

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Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the CTA approval by the Belgian regulatory authority, the Company is ready to start the PhaseIIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

Contacts

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: 44 (0)20 8943 4685neil@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics appoints Stefanos Theoharis as Chief Business Officer - Yahoo Finance

Uni kit to help with virus tests – Kent Online

With stricter measures now enforced upon the country, staff and students at the University of Kent are doing their bit to try and help with the coronavirus outbreak.

As the bioscience laboratories at the university are now closed, they're lending specialist equipment to hospitals in Kent to help increase the number of coronavirus tests that can be taken, while more than 30 members of staff, academics and PHD students from the biosciences school have also volunteered to help.

KMTV's Kristina Curtis reports on how students and staff at the University of Kent are doing to help tackle the coronavirus outbreak

Prof. Dan Mulvihill, Head of the School of Biosciences at the university said: "Staff, PHD students, researchers and academics have volunteered to give up their time to help in the labs in NHS hospitals.

"We have a variety of people with molecular biology skills, what we're trained to do here, and theyre able to use these skills working alongside NHS workers so we can expand the number of tests that can be done in any one day.

"Weve all been trained in this particular skill set, theres a need for it now and this is the time for us to step up. Were in the privileged position of being able to help and therefore we are."

Dr. Jill Shepherd, a lecturer in stem cell biology at the university, added: "The first thing I think most people in bio-sciences wanted to do is come forward and see what we can do. Its a great opportunity to be able to use the skills that our workforce have, the molecular biology skills that we use to produce great research science every day, to come into the labs to do something to help with something thats happening at the moment.

"Its an interesting time for us, were feeling very privileged to be a part of this and to be able to help with the effort.

"Its one of the positive things that can come out of something like this, people can work together more closely and relationships can be developed further."

The machines that have been lent to the hospitals are Quantitative PCR machines which allow tests to be undertaken to detect if the patients have coronavirus or not. Although hospitals in the county already have access to the machines, having additional ones is hoped to significantly increase the amount of tests that can be carried out each day.

Prof Mulvihill said: "These machines, which we use in our research labs on a daily basis, theyre extremely sensitive so they allow you to detect within samples a trace, or not, of nucleic acid from the virus itself. So we can identify whether or not theyve been infected with a high degree of certainty.

"Our machines will be able to increase the hospitals capacity to fulfil demand in the coming months."All five of the machines are set to be delivered to the hospitals in Kent this week, with the volunteers ready to put their hard-earned skills and research to practice.

The University of Kent is also set to begin working with Imperial College London on a research project to develop antibodies that target the novel coronavirus with the aim of developing a new therapy for COVID-19.

The research project will look to develop a potential antibody therapy, with the aim of progressing the therapy to be ready to for clinical trials. These trials will determine if the developed therapies can treat coronavirus infections including the COVID-19.

For this project, Kent will be working alongside Hong Kong University and the National Institute for Biological Standards and Control, as well as Imperial College.

Positive results from this research could include vital breakthroughs in actions against the virus, putting the NHS in a stronger position and providing hope for the pandemics eventual close.

For the latest coronavirus news and advice, click here.

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Uni kit to help with virus tests - Kent Online