On March 20, 2020 Immunovia reported that it has published the annual report for 2019 (Press release, Immunovia, MAR 20, 2020, View Source [SID1234555733]).
Mats Grahn, CEO, comments: "In December 2019, we reached a very important milestone with the results of the "Commercial Test Model Study", which showed 95% accuracy for IMMray PanCan-d, our product for diagnosing pancreatic cancer at an early stage when it is still possible to successfully remove the tumor surgically. This result paves the way for considerable improved treatment and survival rates for patients with this deadly disease. We are now fully focused on launching our blood-based test in Q3 2020.

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As we close 2019, we continue to make great strides and remain on track to launch our lead diagnostic candidate IMMray PanCan-d in the US market during Q3 2020. We ended the year with fantastic results from our "Commercial Test Model Study," which confirmed the very high accuracy of our test in differentiating stages I-IV of pancreatic cancer from clinically relevant control groups that best reflect the commercial and clinical situation (i.e. patients who do not have cancer but show similarly concerning symptoms, including type 2 diabetes, as well as healthy subjects). In 2019, we not only achieved the milestones needed to advance towards the commercialization of IMMray PanCan-d, but we also made progress with our pipeline projects in lung cancer and autoimmune diseases."

Major highlights include:

During the first quarter 2019, Immunovia concluded that for optimal performance of the test, the samples should be stored for a maximum of 24 months. Thanks to Immunovia’s large network of Key Opinion Leaders, access to fresh samples could quickly be secured. This moved the previously communicated timeline for the optimization study forward by about eight weeks and had an effect on the previous plan, which was to start sales in early 2020.
In February, Immunovia announced new cancer centers in Sweden and Spain had joined the PanFAM-1 study, broadening the ethnic and genetic diversity of the samples during the validation of IMMray PanCan-d.
In April, Immunovia and the University College London (UCL) announced the expansion of the prospective collection of blood samples that started with the PanSYM-1 pilot study.
Immunovia continued its strategic initiative of collaborating with primary care physicians in the US. This initiative began in 2018 with Immunovia’s primary care physician training program at Fenway Park during World Pancreatic Cancer Day. The program highlighted the important role of primary care physicians in detecting the early stages of pancreatic cancer in patients. The reception was overwhelmingly positive.
In May, two cancer centers in New York and Chicago joined Immunovia’s PanFAM-1, the largest prospective study to date, to contribute to the validation of the IMM- ray PanCan-d test.
In June, Immunovia announced excellent results from the optimization work on the commercial version of IMMray PanCan-d. The optimization work was successful and significantly improved the test results, which now show accuracy of up to 98% in the differentiation of stages I to IV of pancreatic cancer against the large symptomatic risk groups, i.e. patients with non-specific but concerning symptoms, including type II diabetes, where the cause is not pancreatic cancer. These results are outstanding and have never before been reported for pancreatic cancer. It was then announced that the "start of sales" milestone is planned for Q3 2020.
In July, Erlangen University Hospital became the first cancer center in Germany to join Immunovia’s global network of Key Opinion Leaders for the early detection of pancreatic cancer. In addition to Immunovia’s existing collaborations, Erlangen University Hospital will provide fresh blood samples for the last two steps prior to the launch of IMMray PanCan-d. The head of the blood test collection is Professor Christian Pilarsky from the surgical department at Erlangen University Hospital.
In September, Immunovia held its first online webinar on IMMray PanCan-d with the title: "Differentiating Pancreatic Ductal Adenocarcinoma (PDAC) from individuals with symptoms suggestive of PDAC, including type II diabetes, with ROC AUC values above 0.95". A link to the webinar can be found at www.immunovia.com.
In September, Immunovia and the world-leading university hospital Beth Israel Deaconess Medical Center (BIDMC) concluded a collaboration agreement for the collection of blood samples for pancreatic cancer for IMMray PanCan-d.
At the end of September, Immunovia announced that the company was proceeding according to plan with its "Commercial Test Model Study" for Immunovia’s IMMray PanCan-d, a blood-based test for the early detection of pancreatic cancer. Following the successful results of the Immunovia optimization study for IMMray PanCan-d, the last stages leading up to commercialization were the same: the results of the "Commercial Test Model Study", followed by verification and validation studies. After this, sales can begin during Q3 2020.
In October, Immunovia released an update on its ongoing lung cancer projects: an ongoing study scheduled to be completed during Q2 2020 and an internal program based on studies and Key Opinion Leader collaborations focused on the early detection of lung cancer.
At the end of October, Immunovia provided an update on the company’s rheumatoid arthritis (RA) development project and announced that it had successfully initiated the establishment of a network of Key Opinion Leaders that will support the design of the company’s RA program and provide high-quality blood samples for the various test phases required to get the test through its discovery phase.
Immunovia announced a collaboration with Professor Thomas Huizinga of Leiden University Medical Center’s Rheumatology Department, for a second retrospective study to differentiate patients with RA from individuals who show RA-like symptoms caused by non-RA conditions. The study continues the work of the first study and the use of Immunovia’s platform technology IMMray, which is designed to reflect the clinical environment in which such a test would be used.
In November, Immunovia announced that the company’s lung cancer collaboration had entered the next phase of development, where Immunovia will receive blood samples taken to initiate tests and analyses. The study will be completed during Q2 2020.
In December, Immunovia strengthened its management with the addition of two extremely experienced professionals: Hans Christian Pedersen was appointed Vice President Business Development and Peter Schulz-Knappe as Chief Technology Officer (CTO).
In December, Immunovia announced the excellent results of the company’s "Commercial Test Model Study" conducted on blood tests from 7 different cancer centers in the US and the EU. IMMray PanCan-d showed excellent robustness with samples from all these centers with an accuracy of 95% for the test for the earliest stages, I and II. With these results, the company is proceeding according to plan for the final stages prior to the commercialization of IMMray PanCan-d. The results, in combination with CA19-9, confirmed the accuracy shown in the optimization study performed earlier in 2019 for the differentiation of the early stages of pancreatic cancer from patients with non-specific but alarming symptoms, including type 2 diabetes and healthy people.
The annual report is available on Immunovia’s website: immunovia.com/en/investors/financial-reports/ and is also attached below.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on March 20, 2020.

On March 20, 2020 Novocure (NASDAQ: NVCR) reported that the German Federal Joint Committee, or G-BA, has updated its directive for Contracted Medical Care to include Tumor Treating Fields, establishing national reimbursement for Optune in newly diagnosed glioblastoma (GBM) (Press release, NovoCure, MAR 20, 2020, View Source [SID1234555732]). The G-BA’s announcement follows a comprehensive benefit assessment of the technology.

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"We are extremely pleased by the G-BA final coverage directive as it clearly recognizes the survival benefit provided for patients with newly diagnosed GBM when Optune is added to standard chemotherapy," said Pritesh Shah, Novocure’s Chief Commercial Officer. "In addition to Germany, Optune is broadly reimbursed in the United States, Japan, Austria, Israel, and Sweden. Novocure remains actively involved in reimbursement discussions in other countries and is committed to make Optune available to all patients who may benefit."

The G-BA’s assessment was based on the EF-14 phase 3 pivotal trial data published in JAMA in December 2017. EF-14 demonstrated that patients with newly diagnosed GBM who added Optune to standard chemotherapy, temozolomide, had a greater opportunity to live longer than those who used chemotherapy alone. Patients treated with Optune plus temozolomide experienced overall survival of 20.9 months versus 16 months for patients treated with temozolomide alone. Two and five-year survival rates were better with Optune with 13 percent of patients treated with Optune plus chemotherapy alive at five years versus 5 percent of patients treated with chemotherapy alone. Patients treated with Optune were also able to maintain their mental, emotional and physical well-being longer than those on chemotherapy alone, as measured up to one year.

The G-BA directive mandates reimbursement coverage of Tumor Treating Fields for patients with newly diagnosed glioblastoma by the compulsory health insurance system. Novocure anticipates the initiation of pricing discussions with the Statutory Health Insurance, the umbrella organization representing Germany’s sickness funds, in coming months.

About Optune

Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune 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 GBM and in the U.S. for MPM, 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.

Approved Indications

Optune is intended as a treatment for adult patients with histologically-confirmed GBM.

Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial GBM following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.

For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Important Safety Information

Contraindications

Do not use Optune in patients with GBM with an implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

Use of Optune for GBM together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

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

Warnings and Precautions

Optune 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 Optune in combination with chemotherapy in patients with GBM were thrombocytopenia, nausea, constipation, vomiting, fatigue, convulsions, and depression.

The most common (≥10%) adverse events related to Optune treatment alone in patients with GBM were medical device site reaction and headache. Other less common adverse reactions were malaise, muscle twitching, and falls related to carrying the device.

If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with Optune treatment.

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

On March 20, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA") (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and liquid biopsies for cancer diagnostics, reported that it has signed a Research Agreement (the "Agreement") with a global Top-20 pharmaceutical company (the "customer") to evaluate the full scope of the Company’s linear DNA platform: linear DNA production as part of the customer’s improvement strategy for the manufacturing process of CAR (Chimeric Antigen Receptor) therapy and in conjunction with their non-viral gene transduction technology, the research project will include; the Company’s patented technologies that leverage LifeSensors’ SUMO-fusion technologies to maximize protein expression as well as, Applied DNA’s unique linear anti-CD19 CAR-T construct (for treatment of acute lymphocytic leukemia) (Press release, Applied DNA Sciences, MAR 20, 2020, View Source [SID1234555731]).

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The Agreement is aligned with the customer’s strategy to deploy technologies to improve the efficacy and safety of its CAR therapies development pipeline with an emphasis on non-plasmid, non-viral technologies. Under the terms of the Agreement, the customer cannot be identified, and the financial terms cannot be disclosed. However, the contract will be entirely prepaid in advance.

"This agreement validates our linear DNA platform strategy and evidences growing interest in our manufacturing platform for the development of nucleic acid-based therapies and diagnostics from the highest tier of pharmaceutical manufacturers for applications that range from CAR-T to RNA vaccines," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Whereas interest from our development customer base to date reflects their increasing need for an alternative to plasmids as the source of DNA, the inclusion of an evaluation of our non-viral, plasmid-free LinCART19 CAR-T therapy in this Agreement opens the door for the potential use of linear DNA in the customer’s CAR-T pipeline as well as the a potential for sponsorship for our antiCD19 CAR-T. Successful evaluations across the three components of the Agreement should lead to a scaling of orders over time to establish a base of recurring revenue.

"We believe that a faster, cheaper and potentially safer alternative to plasmids underpins in an entirely new approach to nucleic acid therapies. LinearDNA avoids the potential problems of plasmid-based therapies, including contamination by bacterial toxins and other bacterial substances, accidental inclusion of off-target DNA from the bacteria and plasmids (including the genes associated with antibiotic resistance), and integration into the patient genome. As the sole manufacturer of PCR-produced linear DNA at scale, we believe our platform can be the industry’s sea change," concluded Dr. Hayward.

On March 20, 2020 Oncology Venture A/S ("OV" or the "Company") reported that it has received feedback from its recent pre-NDA meeting with the U.S. FDA regarding a potential path to approval for Dovitinib, one of its top priority programs (Press release, Oncology Venture, MAR 20, 2020, View Source [SID1234555730]).

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The Company attended a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential path to approval for Dovitinib used to treat Renal Cell Carcinoma (RCC) (kidney cancer), the current lead indication for the drug. The Company’s proposal is to seek approval based on "non-inferiority" against the already approved compound Sorafenib (Bayer), based on prior Phase 3 trial results (by Novartis). In the pre-NDA meeting and the subsequent Meeting Memorandum, the FDA indicated that they would accept the NDA filing if submitted, and provided additional guidance regarding the submission, including that the NDA would likely be referred to an Oncologic Drugs Advisory Committee (ODAC)1 for review and recommendation. The FDA provided input on the "non-inferiority" margin against Sorafenib, which had not been pre-defined in the protocol for the prior Phase 3 trial in RCC, and discussed progression free survival (PFS) as an endpoint for "non-inferiority." No other substantive issues were raised by the FDA. In addition, the FDA stated that no additional pre-clinical studies are required, no safety issues were raised, no additional pharmacokinetics (PK), pharmacology, and/or human toxicity studies are required, and no new manufacturing (CMC) requests are necessary.

Oncology Venture plans to use the data from the prior Phase 3 trial to prove that Dovitinib is in fact "non-inferior" to Sorafenib for the treatment of RCC, and expects that Dovitinib will be approved by the FDA as a safe and efficacious drug beneficial to RCC patients as a third line treatment. However, the FDA’s feedback provides guidance only and the review process is unpredictable and may or may not lead to a formal approval. Given the additional guidance, Oncology Venture now plans to file a New Drug Aplication (NDA) for the approval of Dovitinib for the treatment of RCC late in the second half of 2020.

Dovitinib, a pan-tyrosine kinase inhibitor (TKI) originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of Renal Cell Carcinoma. Annual sales of Sorafenib, under the trade name Nexavar, were approximately USD $715 million in 2018. The global RCC market is projected to grow to USD $6.3 billon by 2022. In addition to the RCC market, Dovitinib has promising potential as a monotherapy in a number of other indications, including metastatic breast cancer, hepatocellular cancer, endometrial cancer and gastrointestinal stromal tumors, as well as in combination therapy with other approved drugs, including immune checkpoint inhibitors.

Steve Carchedi, CEO of Oncology Venture, stated "We are excited to move towards U.S. submission of our first oncology portfolio asset and appreciate FDA guidance in the filing process. Mr. Carchedi further noted that "Renal Cell cancer continues to have a high unmet need and we hope that Dovitinib, alone or together with a DRP companion diagnostic that we are validating for the drug, will provide patients with a more effective treatment."

On March 20, 2020 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin therapies, reported its audited Financial Results for 2019 and the company’s 2019 Annual Report (Press release, Molecular Partners, MAR 20, 2020, View Source [SID1234555729]).

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The Audited Financial Results for 2019 and the company’s 2019 Annual Report are available on the investors section of the company’s website.

About the DARPin Difference DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates can engage more than five targets, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate in partnership with Allergan is abicipar, a molecule for which phase 3 data have been filed to the respective regulators in both the US and in Europe. Several DARPin molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of hematological tumors. MP0274, the second-most advanced DARPin candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads to induction of apoptosis. MP0274 is currently in phase 1. The company’s lead immuno-oncology product candidate MP0310 is a FAP x 4-1BB multi-DARPin therapeutic candidate designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator). Molecular Partners has closed a collaboration agreement with Amgen for the exclusive clinical development and commercialization of MP0310. The molecule has entered in phase 1 of clinical development in H2 2019. MP0317 (FAP x CD40), the second tumor-localized immune agonist stemming from the company’s "I/O toolbox", has been nominated as next DARPin protein in Molecular Partners’ immunooncology pipeline. Molecular Partners is further advancing a growing preclinical and research pipeline in immuno-oncology and additional development programs such as novel therapeutic designs to target peptideMHC complexes. DARPin is a registered trademark owned by Molecular Partners AG.