On October 4, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that company management will participate in the following upcoming investor conferences (Press release, Personalis, OCT 27, 2020, View Source [SID1234569145]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

29th Annual Credit Suisse Virtual Healthcare Conference
Presenting on Tuesday, November 10, 2020 at 4:15 p.m. Eastern Time
Oppenheimer Fall MedTech Summit
Participating on Thursday, November 12, 2020

On October 27, 2020 Physicians from NYU Langone Health and its Perlmutter Cancer Center reported that successfully treated their first patient in an NIH/NCI- sponsored clinical trial using CivaSheet ,to improve lung cancer patients’ outcomes (Press release, CivaTech Oncology, OCT 27, 2020, View Source [SID1234569144]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The NYU Langone team, led by thoracic surgeon Michael Zervos, MD and radiation oncologist Benjamin Cooper, MD, affixed a custom sized CivaSheet to the area of the patient’s lung needing treatment, following a robotic tumor resection. The patient was thereby treated with a full course of radiation in a one-time therapy.

CivaSheet’s integrated shielding protects healthy surrounding organs, enabling a higher dose than can be administered using other treatment options. Implanting CivaSheet was completed in approximately 30 minutes. "CivaSheet provides patients optimal chance for a cure while also preserving lung tissue and maintaining maximum pulmonary function," said CivaTech Oncology’s Chief Medical Officer George Paschal MD.

Approximately 234,000 patients in the U.S. are diagnosed with lung cancer each year, and of those, 30- 55% with non-small cell lung cancer develop recurrence. CivaSheet, a new bio-absorbable, internal radiation treatment, is designed to help prevent a recurrence of lung cancer by delivering a highly targeted dose of radiation directly to the surgical margin where residual cancer cells may remain.

Designed and manufactured by CivaTech Oncology, CivaSheet is a flexible, implantable intra-operative radiation therapy device (brachytherapy), which emits unidirectional radiation using integrated gold shielding. The unidirectional property makes the device active on one side to provide a homogenous radiation dose. This feature is entirely unique to CivaSheet, allowing physicians to safely deliver aggressive radiation doses immediately adjacent to healthy, sensitive tissue. No complications or radiation related side effects have been reported in patients treated to date. Radiation is delivered over the course of several weeks as the isotope naturally decays, eliminating the need for repeat hospital visits, and no follow up procedure is necessary to remove the device.

CivaSheet has broad FDA clearance to include lung cancer and many other malignancies. This multi-center, NIH/NCI- sponsored research protocol will determine CivaSheet’s impact on local control rate. NYU Langone Health is participating in this clinical trial with several other nationally recognized cancer centers in the U.S.

On October 27, 2020 Primmune Therapeutics reported the initial closing of a $27.4 million Series A financing to advance the development of novel orally-administered, small molecule toll-like receptor 7 (TLR7) agonists as therapeutic-adjuvants for acute viral diseases and cancer (Press release, Primmune Therapeutics, OCT 27, 2020, View Source [SID1234569143]). The financing was co-led by CAM Capital and Polaris Partners and included new investors Samsara BioCapital and Oberland Capital as well as existing investors McDermott, BioRock Ventures and BioBrit. The Series A financing included the conversion of $7.4 million in convertible seed capital securities. Concurrent with the closing, Amir Nashat, Managing Partner at Polaris Partners and Andrew Rubinstein, Managing Partner at Oberland Capital will join the board of directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This financing will enable us to move PRTX007 into a short-term pharmacokinetic, pharmacodynamic and tolerability study in humans to be followed by a clinical proof-of-concept study in an acute viral disease setting. We believe that PRTX007 is promising as a unique treatment option for viral diseases and cancer based upon its unique ability to drive an oral dose-dependent systemic poly-interferon response without stimulating inflammatory pathways," said Charlie McDermott, Chairman and Chief Executive Officer of Primmune Therapeutics. "We appreciate the support from this outstanding group of investors, and the Primmune team is highly driven to deliver an oral therapeutic that can have a meaningful impact on the treatment and prevention of acute viral diseases as a single agent and in combination with other therapies or vaccines."

PRTX007, Primmune’s lead candidate, was derived from an extensive internal TLR7 agonist discovery program and has demonstrated sustained dose-dependent innate immune induction in vivo without the production of inflammatory cytokines, such as IL-6 or TNF alpha. In vitro, PRTX007 has shown activity against a broad array of respiratory viruses.

"Primmune’s early data has shown the potential for PRTX007 to drive our natural innate immune response to combat systemic diseases," said Amir Nashat, Managing Partner at Polaris Partners. "Coupled with a leadership team that is rapidly advancing PRTX007 for viral diseases and oncology, we are excited to be part of the next stage of the company’s growth."

On October 27, 2020 Foundation Medicine, Inc. reported that the U.S. Food and Drug Administration (FDA) approved FoundationOneLiquid CDx for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies (Press release, Foundation Medicine, OCT 27, 2020, View Source [SID1234569142]). The new indications are for Piqray (alpelisib) in advanced or metastatic breast cancer; Rubraca (rucaparib) in advanced ovarian cancer; and Alecensa (alectinib) in a certain type of metastatic non-small cell lung cancer (mNSCLC). The FDA also approved a label expansion for FoundationOne Liquid CDx to report additional select copy number alterations and genomic rearrangements.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved in August to provide tumor mutation profiling in accordance with professional guidelines for patients with any solid tumor. Concurrently, it was approved as a companion diagnostic for a poly (ADP-ribose) polymerase (PARP) inhibitor approved by the FDA for the treatment of metastatic castration-resistant prostate cancer patients with qualifying BRCA1/2 alterations, and for three first-line EGFR tyrosine kinase inhibitors (TKIs) for the treatment of non-small cell lung cancer patients.

"FoundationOne Liquid CDx offers oncologists an important and minimally invasive tool to consider when making treatment decisions for their patients, regardless of the type of cancer they have," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "These three additional companion diagnostic claims expand the test’s clinical utility into breast and ovarian cancer, demonstrating our commitment to bringing precision medicine to more patients, and we plan to continue working with our biopharma partners to increase that reach."

Today’s approval expands FoundationOne Liquid CDx’s companion diagnostic indications to include the following targeted therapies:

Piqray (alpelisib), a kinase inhibitor from Novartis indicated for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2- breast cancer have this mutation.1

Rubraca (rucaparib), Clovis Oncology’s poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

An estimated one in four women with epithelial ovarian cancer have a mutation of the BRCA1 or BRCA2 gene.2
Alecensa (alectinib) is a tyrosine kinase inhibitor (TKI) from Genentech, a member of the Roche Group, indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive mNSCLC, as detected by an FDA-approved test.

ALK rearrangements are identified in approximately 5% of NSCLC patients.3
Using a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. FoundationOne Liquid CDx results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. It also enables accelerated companion diagnostic development for biopharma companies developing precision therapeutics.

As a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

About FoundationOne Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

On October 27, 2020 Biopharmaceutical company Alvotech reported that its parent company, Alvotech Holdings SA, has successfully completed a $65 million private placement round (Press release, Alvotech, OCT 27, 2020, View Source [SID1234569141]). This has resulted in the company issuing new shares to a group of new investors and existing shareholders, which will further finance the development and release of its biosimilar candidates. This $65 million round is part of Alvotech’s $100 million private placement round with a second closing expected shortly.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The first round of the private placement raised $65 million in gross proceeds and the transaction attracted strong interest from high quality institutional investors in Asia, U.S. and Europe. The new share issue values Alvotech at $1.5 billion.

"Alvotech has established itself as one of the leading biopharmaceutical companies in the world. Through strategic commercial partnerships with many of the top global and regional pharmaceutical companies, Alvotech is well positioned to accelerate the introduction and adoption of new biosimilars for patients around the world," said Robert Wessman, founder and chairman of Alvotech.

He continues: "I am delighted to welcome such a prestigious group of new investors who all bring significant experience and resources to aid Alvotech in continuing its journey."

The consortium of new investors includes: Shinhan, Baxter and ATHOS (Strüngmann Family Office), together with Alvogen and Aztiq Pharma as existing shareholders. Aztiq Pharma, led by Robert Wessman, remains a majority shareholder of Alvotech, while CVC Capital Partners and Temasek hold a significant stake in the company through its ownership in Alvogen.