On October 16, 2019 Amarna Therapeutics, a privately held biotechnology company developing a next-generation SV40-based gene delivery vector platform named SVac that promises to transform gene-replacement and immunotherapy across many disease areas, reported that it has raised €10 million (Press release, amarna therapeutics, OCT 16, 2019, View Source [SID1234542314]). The round was led by Flerie Invest AB, a Swedish investment company with another substantial contribution coming from an innovation credit from the "Netherlands Enterprise Agency" (RVO.nl) and existing shareholder Pim Berger.

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The Company plans to use this funding to progress development of its SVac platform towards a first in man clinical study to commence in two to three years from now.

In addition to raising new funds, Amarna has recruited a new Supervisory Board to help underpin this new ‘clinical’ phase of its growth and development. Thomas Eldered has been appointed as Supervisory Board Chairman. Bernhard Kirschbaum, Maarten de Chateau, Ted Fjällman, Pim Berger and Guillaume Jetten have also joined the Supervisory Board (see biographies at the end of the release).

Ben van Leent, CEO of Amarna said:
"We are very happy to have attracted such strong investors. This significant new funding allows Amarna to accelerate the development of SVac and our lead product AMA001, and to help us achieve our ultimate goal: to become a leading global gene therapy player".
"We would like to extend a warm welcome to all of the members of our new Supervisory Board, led by the outstanding healthcare and biotech pioneer Thomas Eldered. They bring many years of in-depth life science knowledge and entrepreneurship to Amarna".

Thomas Eldered, new Chairman of Amarna’s Supervisory Board, commented:
"I’m very much looking forward to working at Amarna. Its viral gene delivery vector platform has the potential to make major medical breakthroughs possible, so that patients can be actually cured of "significant" diseases for which, to date, effective treatment have not become available. Together with my highly qualified and experienced colleagues in our new Supervisory Board, I’m fully committed to help progress Amarna into the next important clinical stages of development of its groundbreaking technology".

SV40 Vectors are non-immunogenic in humans
Viral gene delivery vectors that are currently used for in vivo gene therapy are ineffective because the particles are instable upon injection (in the case of lentiviral vectors) or because the particles are immunogenic in humans (in the case of AAV vectors). Gene delivery vectors derived from the macaque polyomavirus Simian Virus 40 (SV40) are an attractive alternative to lentiviral and AAV vectors for clinical gene therapy. Humans can be considered naïve to SV40 since the virus only replicates in macaques, where it causes symptomless infections. Replication-defective SV40 vectors are non-immunogenic in humans and moreover, have the capacity to induce immune tolerance to the transgene products. SV40 vectors therefore hold a great potential for clinical applications treating genetic disorders, cancer, allergies and degenerative/inflammatory conditions such as neurodegenerative and psychiatric diseases, atherosclerotic cardiovascular disease, diabetes mellitus, arthritis, chronic obstructive pulmonary disease and many more.

Amarna’s SVac platform: the benefits
Amarna has genetically engineered the SV40 genome used for the production of vector particles and in parallel generated a novel Vero-based packaging cell line named SuperVero that produces similar numbers of vector particles to the currently used packaging cell lines but without contaminating wild type SV40 particles. Since SVac is safe, highly efficient, non-immunogenic in humans and vector particles can be cost effectively produced in SuperVero cells, Amarna’s vector platform paves the way to clinically evaluate a whole new generation of SVac-based therapeutics for today’s major diseases.

On October 16, 2019 Novocure (NASDAQ: NVCR) reported that results from the STELLAR trial were published in The Lancet Oncology (Press release, NovoCure, OCT 16, 2019, View Source [SID1234542313]). The STELLAR trial was a prospective, single-arm trial including 80 patients that studied the use of Tumor Treating Fields, delivered via the NovoTTF-100L System, in combination with pemetrexed plus cisplatin/carboplatin as a first-line treatment for patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM).

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Data showed a median overall survival of 18.2 months (95 percent CI, 12.1 months-25.8 months) for patients treated with NovoTTF-100L and pemetrexed plus cisplatin or carboplatin. One- and two-year survival rates were 62.2 percent (95 percent CI, 50.3 percent-72.0 percent) and 41.9 percent (95 percent CI, 28.0 percent-55.2 percent), respectively. No serious systemic adverse events were considered to be related to the use of NovoTTF-100L. The most common mild to moderate adverse event was skin irritation beneath the transducer arrays.

"The STELLAR trial demonstrated encouraging overall survival results with no increase in systemic toxicity observed in MPM patients treated with Tumor Treating Fields and standard chemotherapy," said Giovanni Luca Ceresoli, MD, Head of Pulmonary Oncology at the Humanitas Gavazzeni Hospital in Bergamo, Italy, and Principal Investigator in the STELLAR trial. "The median overall survival of 18.2 months is impressive given that MPM is a tumor with a dismal prognosis and few effective therapeutic options."

"Mesothelioma is an aggressive cancer that is extremely difficult to treat," said Rupesh Kotecha, MD, Chief of Radiosurgery, Radiation Oncology, Miami Cancer Institute in Florida. "With such limited treatment options, I’m encouraged by the FDA approval of NovoTTF-100L, adding another therapy with the potential to improve outcomes for people with unresectable MPM."

Median progression free survival was 7.6 months (95 percent CI, 6.7 months-8.6 months) for patients treated with NovoTTF-100L and pemetrexed plus cisplatin or carboplatin. There was a 97 percent disease control rate in patients with at least one follow-up CT scan performed (n=72). 40 percent of patients had a partial response, 57 percent had stable disease and 3 percent had progressive disease.

"MPM patients are in need of better treatment options," said Novocure CEO Asaf Danziger. "We are proud that NovoTTF-100L is the first FDA-approved therapy for MPM in more than 15 years. We hope it is just the beginning of continued innovation for patients with this disease."

About Malignant Pleural Mesothelioma (MPM)

Malignant pleural mesothelioma is a rare thoracic solid tumor cancer that has been strongly linked to asbestos exposure. Mesothelioma has a long latency period of 47.9 years on average for men and 53.3 years on average for women following asbestos exposure. There are approximately 3,000 new cases of mesothelioma annually in the United States. Globally, more than 14,000 people are diagnosed with mesothelioma each year. Global mesothelioma incidence is increasing in countries where asbestos is still in use. The prognosis of mesothelioma patients is very poor.

About STELLAR

STELLAR was a phase 2, prospective, single-arm trial designed to study the safety and efficacy of NovoTTF-100L, a Tumor Treating Fields delivery system, and pemetrexed plus cisplatin or carboplatin as a first-line treatment for 80 patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM). The trial was designed for patients to receive Tumor Treating Fields at 150 kHz at least 18 hours a day until disease progression. The primary endpoint of the trial was overall survival. Secondary endpoints included objective response rate, progression-free survival and safety.

Eligible patients had no prior chemotherapy or radiation treatment for MPM, were at least 18 years old, had an Eastern Cooperative Oncology Group performance status of 0-1, and had at least one measurable or evaluable lesion according to the modified RESIST criteria. Adequate hepatic, renal and hematological functions were required, as well as a life expectancy of at least 3 months. The study was conducted at 12 sites in Europe.

About the NovoTTF-100L System

NovoTTF-100L is a noninvasive, antimitotic cancer treatment for MPM. NovoTTF-110L delivers Tumor Treating Fields to the region of the tumor.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.

Approved Indications

The NovoTTF-100L System is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.

Important Safety Information

Contraindications

Do not use the NovoTTF-100L System in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of the NovoTTF-100L System together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

Do not use the NovoTTF-100L System in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with the NovoTTF-100L System may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

The NovoTTF-100L System can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure.

The most common (≥10%) adverse events involving the NovoTTF-100L System in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.

Other potential adverse effects associated with the use of the NovoTTF-100L System include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/skin ulcer.

If the patient has an underlying serious skin condition on the chest, evaluate whether this may prevent or temporarily interfere with the NovoTTF-100L System treatment.

Do not prescribe the NovoTTF-100L System for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of the NovoTTF-100L System in these populations have not been established.

Please visit www.novottf100l.com to see the NovoTTF-100L System Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.

On October 16, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported that company management will be attending the BIO Investor Forum to be held on October 22-23 at the Westin St. Francis, San Francisco (Press release, IMV, OCT 16, 2019, View Source [SID1234542312]).

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BIO Investor Forum Oct. 23 2:00 PM PST / 5:00 PM EST

A live webcast of this presentation will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website and a replay will be available approximately one hour after the presentation. Afterwards, it will be available for approximately 30 days.

On October 16, 2019 Cleveland Diagnostics, Inc., a clinical-stage company focused on developing next-generation diagnostic tests for the early detection of cancers, reported that it has received FDA Breakthrough Device Designation for the IsoPSA Assay, a novel prostate cancer diagnostic test (Press release, Cleveland Diagnostics, OCT 16, 2019, View Source [SID1234542311]). Published studies from multicenter prospective clinical trials suggest that the non-invasive, blood-based IsoPSA assay has significant superior diagnostic accuracy when compared to traditional prostate-specific antigen (PSA) tests in detecting high-grade prostate cancer.

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FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Through the Breakthrough Device Program, Cleveland Diagnostics will work more closely and frequently with FDA to expedite its review of IsoPSA.

"We are very grateful that FDA recognizes the potential of IsoPSA, the first test in our pipeline of simple, affordable, and highly accurate cancer tests that focus on cancer-relevant changes to protein biomarkers in blood," said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics. "We look forward to working closely with FDA to expedite the appropriate approvals and get this important new test into the hands of physicians."

Cleveland Diagnostics has concluded two multicenter clinical trials in top U.S. and international hospitals and clinics, led by Cleveland Clinic, in which the diagnostic accuracy of IsoPSA was compared to that of PSA, the current standard of care in prostate cancer, in men scheduled for prostate biopsy. The results from those studies demonstrated that IsoPSA has superior diagnostic performance to traditional PSA in identifying which patients have high-grade disease.

"The clinical utility of PSA is limited by the relatively poor diagnostic accuracy and predictive value of the test," said Mark Stovsky, M.D., CMO at Cleveland Diagnostics and urologist at Cleveland Clinic. "Clinicians today are using an array of diagnostic tests and procedures to inform decisions about a patient’s prostate health and the risk of prostate cancer. We believe that IsoPSA has the potential to fill a major void in this space."

It is estimated that 1 in 9 men will develop prostate cancer in their lifetime. The results of previous studies have shown that IsoPSA could reduce unnecessary biopsies by at least 45 percent, saving men from unneeded invasive, potentially risky and expensive procedures that can sometimes lead to serious and lasting side effects.

On October 16, 2019 Amphivena Therapeutics, Inc., a private clinical stage immuno-oncology company developing T cell engager therapeutics for cancer, reported dosing of the first patient in a Phase 1 clinical trial in solid tumors evaluating AMV564, a CD33/CD3 T cell engager that selectively eliminates myeloid derived suppressor cells (MDSC), sparing normal neutrophils and monocytes (Press release, Amphivena Therapeutics, OCT 16, 2019, View Source [SID1234542310]).

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"Our lead candidate, AMV564, originating from our platform technology, is a bivalent T cell engager that binds with high avidity and specificity to CD33. AMV564 has been shown to eliminate subsets of activated myeloid cells, including granulocytic, monocytic and immature MDSC, in acute myeloid leukemia patients," said Jeanmarie Guenot, Ph.D., Amphivena Chief Executive Officer and President. "This creates a unique opportunity for Amphivena to evaluate the effect of AMV564 on these immune suppressive cells and the potential therapeutic benefit of relieving this important source of T cell suppression in patients with solid tumors."

The multi-center Phase 1 study is currently open for enrollment at NEXT Oncology (PI: Raghad Karim) in San Antonio, TX, MD Anderson Cancer Center (PI: Sarina Piha-Paul) and Peninsula Cancer Institute (PI: Alexander Starodub) in Newport News, VA. The study will be a multicenter, all-comers solid tumor dose-finding trial with expansion cohorts planned in 2020. AMV564 is being administered to solid tumor patients by subcutaneous injection.

About AMV564

AMV564 is a bivalent, bispecific (2:2) T cell engager that binds CD33 and CD3. To date, over 50 patients have received AMV564 in two Phase 1 clinical trials for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It is currently being evaluated in a First-in-Human Phase 1 trial in patients with relapsed/refractory AML at Washington University School of Medicine, MD Anderson Cancer Center, New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, Fred Hutchinson Cancer Research Center, The Ohio State University Wexner Medical Center, University of Pennsylvania Medical Center, Northwestern Memorial Hospital, and The Johns Hopkins Hospital.

The safety, efficacy and selectivity of AMV564 was highlighted most recently at both the 24th European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Amsterdam (Abstract S877) and at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego, CA last December. Amphivena believes that AMV564 has demonstrated novel clinical activity by rapidly and selectively eliminating leukemic blasts and rare immature, granulocytic and monocytic MDSCs while sparing normal CD33-expressing cells, including neutrophils and monocytes.

AMV564 is also being evaluated in a Phase 1 solid tumor study which is currently open to enrollment.