On August 3, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conference and invited investors to participate by webcast (Press release, Exact Sciences, AUG 3, 2020, View Source [SID1234562679]).

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Canaccord Genuity Annual Growth Conference
Fireside Chat on Wednesday, August 12, 2020, at 2:30 p.m. EDT
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On August 3, 2020 UCL Technology Fund (UCLTF), managed by AlbionVC in collaboration with UCL Business (UCLB) (the university’s commercialisation company and part of UCL Innovation & Enterprise), reported first close of a £100m target Fund 2 (Press release, UCLB, AUG 3, 2020, View Source [SID1234562677]).

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The new fund will continue to support UCL in achieving the full potential of innovations that have prospects for outstanding societal impact and commercial return.

Fund 2 has commitments from a combination of existing and new Limited Partners, including cornerstone commitments from British Patient Capital, the largest UK-based LP investor in venture capital, and UCL itself. The fund’s purpose is to bring UCL’s academic research in life, computer and physical sciences to commercial reality.

UCL is consistently ranked among the top 10 universities in the world and one of only a handful of institutions rated as having the strongest academic reputation and the broadest research impact.

The second fund has an immediate pipeline of opportunities with world-renowned UCL academic researchers. In the life sciences these include innovative preclinical and clinical projects and spinouts. Based on pioneering gene therapy, cell therapy and drug discovery approaches, they are targeting a variety of indications with a global unmet need, including rare diseases, cancer and ophthalmology. In physical and computer sciences the fund also has exciting opportunities from the UCL AI Centre and in advanced materials.

Fund 2 follows the successes of the first fund, which made 45 investments including 27 that became spinout companies and programmes intended for licensing that have subsequently raised external funding exceeding £1bn and creating over 570 jobs. Other success stories from the first fund include:

Two successful Nasdaq IPOs: Orchard Therapeutics (rare disease gene therapies) and MeiraGTx (eye, salivary gland and CNS disease gene therapies)
A potential upcoming IPO: Freeline Therapeutics (liver directed gene therapies)
Bloomsbury AI (NLP technology), which joined Facebook’s London research team in 2018
Dr Celia Caulcott, Vice-Provost, (Enterprise) said: "UCL’s first Technology Fund is playing a vital role in our drive to translate the breakthrough ideas developed by UCL’s talented researchers into applications and products to benefit society and the economy. It’s a great step that we can announce the first close of the second fund. We look forward to this fund investing in intellectual property arising from UCL’s world-class research, taking technologies all the way from proof of concept to commercialisation through licensing and company creation."

Dr Andrew Elder, AlbionVC, said: "UCL is one of the finest research institutions in the world. We have been enormously impressed with the quality and variety of investment opportunities presented by its academics over the past four years and the high number of world class opportunities continues. It is exciting to invest in the ideas and teams with potential to develop new treatments for debilitating diseases or completely change the way we live and work through breakthrough innovations in computer and physical sciences."

Dr Anne Lane, Chief Executive, UCLB, said: "We’ve had great success in commercialising groundbreaking research and finding value when combining our academic and investment expertise. The UCLTF model has helped progress work in physical and life sciences with a real and positive impact on people’s lives. We’re now looking to build on the success of the first fund and invest in the best and brightest ideas within UCL’s extensive research base and realise its innovative potential. During what is a testing time for the global economy, we must look to universities to foster new research and provide them with the right resources to succeed, from proof-of-concept to commercial application."

Catherine Lewis La Torre, CEO British Patient Capital said: "Our cornerstone commitment to UCLTF’s second fund is a key part of our strategy to invest in best in class fund managers that can leverage the world-leading science conducted in universities across the UK. Long-term patient capital can support the commercialisation of such research, helping address some of the most pressing challenges faced by modern society, and deliver compelling returns"

On August 3, 2020 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that it has received approval for insurance coverage for blood-based RAS gene1 mutation testing for colorectal cancer using the OncoBEAMTM RAS CRC Kit (Press release, Sysmex, AUG 3, 2020, View Source [SID1234562676]). 2 The coverage went into effect on August 1, 2020.

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With this regulatory approval, even when it is difficult to obtain in vivo diagnostics (biopsy) on a sample taken from tumor tissue, RAS gene mutation testing using the kit may be performed with a minimal physical and mental burden on patients when it is necessary, owing to the fact that it uses the patient’s blood as a sample. This will have the effect of optimizing decisions on the administration of anti-EGFR3 monoclonal antibody drugs. Receipt of insurance coverage will also make it possible for us to provide more patients with testing to allow physicians to select an appropriate treatment method.

Currently, at the beginning of therapy, colorectal cancer patients treated with medication undergo RAS gene mutation testing using tumor tissue, the results of which inform a decision on whether or not to administer anti-EGFR monoclonal antibody drugs. Several studies have reported that rechallenge of anti-EGFR monoclonal antibody drugs is an effective treatment method for patients with recurrent colorectal cancer after treatment by anti-EGFR monoclonal antibody drugs, and that the RAS gene mutation status may change by the time of re-challenge from what it was in initial therapy. The relevant guidance published by the Japanese Society of Medical Oncology4 indicates that it is desirable to assess the gene mutation status several times over time to make appropriate rechallenge decisions based on the state at the time of relapse. As such, much has been expected from a practical application of liquid biopsy, which checks the RAS gene mutation status using the patient’s blood samples when biopsy may not be performed easily.

The OncoBEAMTM RAS CRC Kit is used to test samples of tumor-derived DNA (circulating tumor DNA, or ctDNA) suspended in the blood of colorectal cancer patients. Using BEAMing technology, the kit detects RAS gene mutations with a high degree of sensitivity (mutant allele frequency of no more than 1% in approximately 30% of mutation cases thus detected).5 As the first colorectal cancer liquid biopsy testing in Japan that provides auxiliary test data to determine the appropriateness of anti-EGFR monoclonal antibody drugs-Cetuximab and Panitumumab (gene recombination)-for patients with colorectal cancer, this product was approved as an in vitro diagnostic reagent in July 2019 and was covered under health insurance from August 1, 2020. Please note that an insurancecovered assay service for colorectal cancer using this product is also due to start in August 2020. Performance of RAS gene mutation testing when it is necessary and with a minimal physical and mental burden on patients for whom biopsy is challenging to perform is expected to optimize the administration of anti-EGFR monoclonal antibody drugs. On the other hand, there is a possibility that this testing may deem patients whose ctDNA is not sufficiently leaked into the blood to have wildtype RAS, even though RAS gene mutation exists in tumor tissue. For patients with lung metastasis only, it is particularly necessary to prioritize testing using tumor tissue. Sysmex will remain committed to the provision of scientific information so that medical institutions may perform testing properly.

Going forward, Sysmex will continue to contribute to the advancement of personalized medicine by working on expanding testing opportunities for patients and providing testing and diagnostic technologies with high diagnostic value.

Details of Insurance Coverage
Classification: E3
Item of measurement: RAS gene mutation (plasma)
Measurement method: High-sensitivity digital PCR method and flow cytometry method
NHI points: 7,500
Product Overview

Name: OncoBEAMTM RAS CRC Kit In vitro diagnostics manufacturing and marketing approval number: 30100EZX00010000 Obtained on July 19, 2019 Manufacture and sale: Sysmex Corporation
Use: To detect RAS (KRAS and NRAS) gene mutations in genomic DNA extracted from plasma (Auxiliary use to determine the appropriateness of Cetuximab or Panitumumab (gene recombination) for patients with colorectal cancer) Target market: Japan
Target institutions: Healthcare institutions and clinical testing centers in Japan, other
References "
Sysmex Obtains First Manufacturing and Marketing Approval in Japan for Blood-Based RAS Gene Mutation Testing for Colorectal Cancer," released on August 2, 2019 View Source

"Sysmex Presents Academic Report Related to the Clinical Utility of RAS Gene Mutation Testing for Colorectal Cancer Using Liquid Biopsy-Details of Report on Clinical Utility of OncoBEAM RAS CRC Kit presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium 2020 (ASCO-GI 2020)," released on March 5, 2020 View Source

Terminology
1. RAS gene: As the likelihood is high that patients with RAS gene (KRAS/NRAS gene) mutations will not benefit (prolongation of life, tumor reduction) from the administration of anti-EGFR drugs, companion diagnostics may be performed to treat the gene mutation first. 2

. OncoBEAMTM: The name of Sysmex’s technology to detect minute gene mutations circulating in the blood with a high degree of sensitivity using BEAMing technology. "BEAM" is an acronym for "bead, emulsion, amplification and magnetics", a gene analysis method developed at Johns Hopkins University combining digital PCR and flow cytometry technologies for highly sensitive analysis of genetic mutations.

3. EGFR: Epidermal growth factor receptors (EGFRs), which exist in large numbers on the surface of colorectal cancer cells, are known to stimulate the proliferation of cancer cells.

4. The Guidance on Genetic Testing in the Treatment of Colorectal Cancer: The Guidance on Genetic Testing in the Treatment of Colorectal Cancer Vol. 4 (December 2019) published by the Japanese Society of Medical Oncology, indicates the necessity of using liquid biopsy for colorectal cancer and the clinical utility of ctDNA testing.

5. Results of multi-facility evaluation in Japan: The results indicate that this new testing method provides detection results on par with conventional RAS gene mutation testing using tumor tissue. Source: British Journal of Cancer volume 120, 982-986 (2019)

On August 3, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has granted conditional marketing authorisation for Rozlytrek (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options (Press release, Hoffmann-La Roche, AUG 3, 2020, View Source [SID1234562675]). The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.1

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"We are excited to announce the approval of Rozlytrek in Europe for two indications, bringing patients with NTRK and ROS1 gene fusions a new effective treatment even when their cancer has spread to the brain," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "This advance represents another important step forward in cancer care by allowing us to treat certain genetic drivers of cancer irrespective of the location of the tumour within the body. Roche is deeply committed to driving personalised healthcare and addressing the high unmet need in patients around the world with rare cancers."

The approval is based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials, and data from the phase I/II STARTRK-NG study. These studies demonstrate that Rozlytrek has durable responses across several NTRK gene fusion-positive solid tumours, including sarcoma, non-small cell lung, salivary MASC, secretory and non-secretory breast, thyroid, colorectal, neuroendocrine, pancreatic, ovarian, endometrial carcinoma, cholangiocarcinoma, gastrointestinal cancers and neuroblastoma, as well as ROS1-positive NSCLC.1 Results showed:

Rozlytrek shrank tumours in more than half of people with NTRK fusion-positive, locally advanced or metastatic solid tumours (overall response rate [ORR]=63.5%; N=74), and objective responses were observed across 13 tumour types (median duration of response [DoR]=12.9 months [9.3 months – not reached], N=21 out of 47 patients defined by ORR).1
In ROS1-positive, advanced NSCLC, Rozlytrek shrank tumours in 73.4% of people with the disease (ORR; N=94 with a minimum of 12 months follow up), with a median DoR of 16.5 months (14.6 – 28.6 months). In a group of 161 patients with a minimum of 6 months follow up, including 29% of patients with central nervous system (CNS) metastases at baseline, ORR was observed to be 67.1%.1
Objective responses to Rozlytrek were seen in people with CNS metastases at baseline, with an intracranial ORR of 62.5% and 79.2% in both NTRK and ROS1 populations, respectively.1
In paediatric patients, Rozlytrek shrank tumours (ORR) in all children and adolescents who had NTRK gene fusions (N=5), with two achieving a complete response (CR). Two patients with primary high-grade tumours in the CNS had objective responses, including one patient with a CR.1 Rozlytrek was well tolerated.
The most common adverse reactions (≥20 percent) with Rozlytrek were fatigue, constipation, altered sense of taste (dysgeusia), swelling (oedema), dizziness, diarrhoea, nausea, nervous system disorders (dysaesthesia), shortness of breath (dyspnoea), anaemia, increased weight, increased blood creatinine, pain, cognitive disorders, vomiting, cough, and fever (pyrexia).1

Rozlytrek has been granted Priority Medicines (PRIME) designation by the EMA for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies.1 NTRK gene fusions have been identified in a range of solid tumour types, and are present in up to 90% of some rare cancer types and less than 1% of other more common tumours, including lung and colorectal.2 ROS1 gene fusions account for 1-2% of NSCLC, the most common type of lung cancer that accounts for up to 85% of all diagnoses.3,4

Biomarker testing for these fusions is the most effective way to identify people who are most eligible for treatment with Rozlytrek. Roche is leveraging its expertise in developing personalised medicines and advanced diagnostics, in conjunction with Foundation Medicine, to develop a companion diagnostic that will help identify people with NTRK and ROS1 gene fusions.

About the integrated analysis
The approval in Europe is based on an integrated analysis including data from 74 people with locally advanced or metastatic NTRK fusion-positive solid tumours (14 tumour types) and 161 people with ROS1-positive NSCLC from the phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials.1 It is also based on data from the phase I/II STARTRK-NG study in paediatric patients. The studies enrolled people across 15 countries and more than 150 clinical trial sites. Safety was assessed from an integrated analysis of 504 people across these four trials.1

About NTRK fusion-positive cancer
NTRK fusion-positive cancer occurs when the NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins (TRKA/TRKB/TRKC) that can activate signalling pathways involved in the proliferation of certain types of cancer.5 NTRK gene fusions are present in tumours irrespective of site of origin. These fusions have been identified in a broad range of solid tumour types, including sarcoma, non-small cell lung, salivary MASC, secretory and non-secretory breast, thyroid, colorectal, neuroendocrine, pancreatic, ovarian, endometrial carcinoma, cholangiocarcinoma, gastrointestinal cancers and neuroblastoma.1

About ROS1-positive NSCLC
ROS1 is a tyrosine kinase, which plays a role in controlling how cells grow and proliferate. When a ROS1 gene fusion occurs, cancer cells grow and proliferate in an uncontrolled manner. Blocking this abnormal signalling can cause tumour cells to shrink or die.3
ROS1 gene fusions account for 1-2% of NSCLC.3 Lung cancer is the leading cause of cancer-related death across the world.6 Each year, more than one and a half million people die as a result of the disease globally, equating to more than 4,000 deaths every day.6 NSCLC is the most common type of lung cancer and accounts for up to 85% of all lung cancer diagnoses.4 While the ROS1 gene fusion can be found in any patient with NSCLC, young never-smokers with NSCLC have the highest incidence of ROS1 gene fusions.3

About Rozlytrek
Rozlytrek (entrectinib) is a tumour-agnostic once-daily oral medicine for the treatment of locally advanced or metastatic solid tumours that harbour NTRK1/2/3 or ROS1 gene fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer.7,8 Rozlytrek can block NTRK and ROS1 kinase activity and may result in the death of cancer cells with NTRK or ROS1 gene fusions.7,8

Rozlytrek was granted accelerated approval in August 2019 by the US Food and Drug Administration (FDA), following receipt of Breakthrough Therapy designation, for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that have a NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy, and was approved for the treatment of adults with ROS1-positive, metastatic NSCLC. In June 2019, Japan’s Ministry of Health, Labour and Welfare (MHLW) also approved Rozlytrek for the treatment of adult and paediatric patients with NTRK fusion-positive, advanced recurrent solid tumours, and later approved Rozlytrek in ROS1-positive NSCLC in February 2020. Rozlytrek has also received approvals by health authorities in Australia, Canada, Hong Kong, Israel, New Zealand, South Korea and Taiwan.

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

On August 3, 2020 AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and prevention of COVID-19, reported the publication of the paper, "An update on GM-CSF and its potential role in melanoma management," in the journal Melanoma Management. Robert O. Dillman, M.D., chief medical officer at AIVITA, authored the article (Press release, AIVITA Biomedical, AUG 3, 2020, View Source [SID1234562674]).

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GM-CSF (granulocyte-macrophage colony-stimulating factor) is a white blood cell growth factor used in cancer care to stimulate the recovery of immune cells in patients who have received chemotherapy. It is also required for differentiating monocytes into dendritic cells and has been used as monotherapy in treatment of cancer, though the efficacy of this practice has not been clinically validated.

In the review. Dr. Dillman discusses the GM-CSF’s investigational uses as an anti-melanoma monotherapy and as an adjuvant for anti-melanoma vaccines, finding a strong rationale for GM-CSF as a vaccine adjuvant. Specifically, it appears of benefit for strategies that directly involve dendritic cells, such as with vaccines in which dendritic cells are loaded with antigen ex vivo and injected admixed with GM-CSF. AIVITA currently utilizes GM-CSF as a vaccine adjuvant in clinical studies of its personalized vaccines.

"Randomized trials have failed to confirm significant anticancer activity for monotherapy GM-CSF, but it appears to provide immune enhancing effects and survival benefit when it is admixed with dendritic cells loaded ex-vivo with autologous tumor antigens," said Dr. Dillman. "Effects were also observed when cytolytic virus that secretes GM-CSF was injected locally into tumors."

AIVITA is currently conducting three independent clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the development of its cancer therapeutic pipeline.

About AIVITA’S Clinical Trials

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.