MEVION S250i Proton Therapy System Receives Approval from Health Canada

On April 23, 2020 Mevion Medical Systems reported that the MEVION S250i Proton Therapy System with HYPERSCAN Pencil Beam Scanning (PBS) has received a Medical Device License from Health Canada, opening the door for commercial sales in Canada (Press release, Mevion Medical Systems, APR 23, 2020, View Source [SID1234556546]). The MEVION S250i is the only proton therapy system approved for use in Canada.

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Proton therapy is a superior form of radiation therapy that can reduce the amount of unnecessary radiation exposure to surrounding healthy tissue and sensitive organs at risk. Mevion’s HYPERSCAN Pencil Beam Scanning improves on these benefits by utilizing an adaptive multi-leaf collimator to sharpen the beam and enable a more precise and conformal dose to the tumor than ever before.

"We are pleased to achieve this important milestone toward making our cutting-edge proton therapy technology available to clinicians and patients in Canada," said James Meng, Ph.D., president of Mevion Medical Systems. "It demonstrates our dedication to take the lead and make proton therapy accessible around the world."

A recent article published in the Canadian Medical Association Journal estimates that in 2020, there will be 225,800 new cases of cancer in Canada. Many types of cancer can benefit from proton therapy, such as lung cancer (14% of all new cancer cases), breast cancer (25% of all new cancer cases in women) and prostate cancer (20% of all new cancer cases in men). Proton therapy can be especially beneficial to pediatric patients with cancers in the brain and central nervous systems, which according to the article, are the second most common cancer type, accounting for 19% of new pediatric cases.

The MEVION S250i received US FDA clearance and CE-Marking in 2017 and has been in use at leading cancer centers in the United States and Europe. Mevion’s pioneering single-room technology has allowed hospitals to successfully build and operate proton therapy centers due to its compact size, embedded clinical integration, and low-risk investment strategy. Today, new proton therapy centers in the United States are almost exclusively compact single-room systems. Mevion was the first company to innovate this new approach to proton therapy and have more systems installed and treating patients than any other compact proton therapy manufacturer in the US.

NOXXON Secures Financing of up to € 14.2 Million Through Convertible Bonds From Atlas

On April 23, 2020 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that it has entered into a flexible convertible bond agreement securing access to financing of up to € 14.2 million (gross amount before issuance discount and transaction fees) with Atlas Special Opportunities, LLC (ASO) (Press release, NOXXON, APR 23, 2020, View Source [SID1234556545]). The full financing instrument, if drawn in total, would allow NOXXON to finance its activities to the beginning of 2022 including completion of the brain cancer trial and manufacturing of additional drug supply for upcoming trials.

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Under this financing vehicle, the company will have the option to access capital in twenty-one tranches plus additional tranches for the drug manufacturing by issuing convertible bonds to ASO, drawable at the company’s discretion and subject to customary conditions being met. The first tranche with a nominal value of € 1,300,000 may be followed by up to twenty further tranches, each of a nominal value of € 475,000. Drug manufacturing tranches in a total nominal amount of € 3,400,000 may be drawn during the term of this agreement upon certain milestones being achieved in the brain cancer clinical trial: 1) the Data Safety Monitoring Board shall have agreed that the safety profile of patients receiving the low dose (200 mg/week) in the NOX-A12 brain cancer trial is appropriate to allow increasing the dose; 2) at least three patients have been enrolled in the middle dose cohort (400 mg/week), and 3) the 4-month post-treatment initiation MRI data being available from all brain cancer patients in the low dose group. The company has exercised its right to the first tranche of funding immediately upon signing. The remaining convertible bonds can be issued by the company over the next 24 months following the signing of the agreement.

"This flexible financing, which provides significant level of financial security for NOXXON’s business plan into 2022, enables us to fully focus on bringing our brain cancer trial to completion and preparing for the next phase of the clinical study in pancreatic cancer patients," said Aram Mangasarian, CEO of NOXXON. "We look forward to working together with Atlas Special Opportunities to ensure the best outcome for the patients and the future of NOXXON. We are confident that strengthening our financial position will be welcomed by our long-term shareholders and investors."

NOXXON was advised and supported in this transaction by Marsac Advisors.

Use of Proceeds

The proceeds from this transaction will be used as general working capital and to advance the company’s pipeline. The proceeds may also be used to manufacture drug supply intended for future clinical trials.

Legal Framework of the Transaction

The company is a Dutch public limited liability company whose shares are listed on Euronext Growth Paris, a multilateral trading facility operated by Euronext Paris S.A., with the ticker symbol ALNOX and the International Securities Identification Number (ISIN): NL0012044762. The company has an authorized share capital of € 479,502 divided into 47,950,200 ordinary shares with a par value of € 0.01 each. Immediately prior to completion of the transaction, the company’s issued share capital amounted to 19,014,408 shares with 35,000 ordinary shares held by the company as treasury shares.

On January 2, 2019, the general meeting authorized the company’s Board of Directors subject to approval of the Supervisory Board, to issue ordinary shares in the capital of the company and grant rights to subscribe for ordinary shares in the capital of the company, at any time during a period of 5 years as from the date of such general meeting and therefore up to and including January 1, 2024 up to the maximum available under the authorized share capital as included in the company’s articles of association after all changes proposed at that meeting have been implemented and therefore up to an authorized capital of € 479,502 or € 1,000,000 when the issued share capital will have reached € 400,000 (as per the transitional provision laid down in article 37 of the company’s articles of association). The authorization includes designating the Board of Directors to limit or exclude pre-emptive rights in connection with any issuance under the designation.

Within the framework of such authorization granted by the general meeting of January 2, 2019, on April 22, 2020 the company’s Supervisory Board has approved the transactions laid down in the financing instrument. On April 22, 2020 the Board of Directors has approved the draw-down of the first tranche in an amount of € 1,300,000.

The shares to be issued upon conversion of the convertible bonds shall give ASO access immediately or in the future to the company’s share capital excluding shareholders’ preferential subscription rights.

Issuance of the convertible bonds and of the shares that may be issued upon conversion is not subject to obligation to publish a prospectus to be approved by the Dutch Authority for the Financial Markets (AFM) or the French Financial Markets Authority (AMF).

Moderna to Report First Quarter 2020 Financial Results on Thursday, May 7th, 2020

On April 23, 2020 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 7, 2020 to report its first quarter 2020 financial results and provide a corporate update (Press release, Moderna Therapeutics, APR 23, 2020, View Source [SID1234556544]).

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To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 6698719. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for one year following the presentation.

IDERA PHARMACEUTICALS ANNOUNCES TILSOTOLIMOD PROGRAM UPDATES TO BE PRESENTED AT AACR VIRTUAL ANNUAL MEETING 2020

On April 23, 2020 Idera Pharmaceuticals, Inc. ("Idera") (Nasdaq: IDRA) reported that updates on ILLUMINATE-206 and ILLUMINATE-101, two studies investigating intratumoral tilsotolimod, Idera’s investigational Toll-like receptor 9 (TLR9) agonist, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, to be held April 27-28, 2020, as part of a "Clinical Trial Poster Session (Press release, Idera Pharmaceuticals, APR 23, 2020, View Source [SID1234556543])."

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ILLUMINATE-206 is an ongoing phase 2, open-label, multicohort, multicenter study to test the safety and efficacy of intratumoral tilsotolimod in combination with Yervoy* (ipilimumab) and Opdivo (nivolumab) for the treatment of solid tumors. The trial initiated in September 2019 with the microsatellite stable colorectal cancer (MSS-CRC) cohort. A description of the trial in progress will be presented.

ILLUMINATE-101 was a phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors, which was completed in December 2019. Final results will be presented.

Hani M. Babiker, M.D., from the University of Arizona Cancer Center will present both studies. The abstract titles are as follows:

Abstract # 10614: Tilsotolimod engages the TLR9 pathway to promote antigen presentation and Type-I IFN signaling in solid tumors

Abstract # 10591: A phase 2 multicenter study to evaluate the efficacy of tilsotolimod in combination with nivolumab and ipilimumab for treatment of microsatellite-stable colorectal cancer (ILLUMINATE-206)
"We are very pleased that Dr. Babiker from the University of Arizona Cancer Center will present information from our studies investigating tilsotolimod in solid tumors," stated Elizabeth Tarka, M.D., Idera’s Chief Medical Officer. "We continue to be excited about the broader potential of tilsotolimod beyond melanoma."

The abstracts and video presentations will be available at 12:01 AM ET on Monday, April 27. Video presentations will be available for viewing on demand through the virtual meeting platform.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.

Tocagen Reports First Quarter 2020 Financial Results

On April 23, 2020 Tocagen Inc. (Nasdaq: TOCA), historically a clinical-stage, cancer-selective gene therapy company, reported financial results for the first quarter ended March 31, 2020 (Press release, Tocagen, APR 23, 2020, View Source [SID1234556540]).

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On February 19, 2020, Tocagen announced it had entered into a definitive agreement in which a wholly-owned subsidiary of Tocagen will merge, in an all-stock transaction, with Forte Biosciences Inc., a privately held clinical-stage biopharmaceutical company developing a live biotherapeutic for the treatment of inflammatory skin diseases. Upon stockholder approval, the combined company is expected to operate under the name Forte Biosciences Inc. and trade on the Nasdaq Capital Market under the ticker symbol FBRX. The transaction has been unanimously approved by the Board of Directors of both companies and is expected to close in the second quarter of 2020, subject to customary conditions, including approval by Tocagen and Forte stockholders.

First Quarter 2020 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $3.1 million for the quarter ended March 31, 2020, compared to $12.4 million for the quarter ended March 31, 2019. The decrease of $9.3 million was primarily due to decreases in clinical trial related costs due to wind down activities and a reduction in our workforce.

General and Administrative (G&A) Expenses: G&A expenses were $5.6 million for the quarter ended March 31, 2020, compared to $4.4 million for the quarter ended March 31, 2019. The increase of $1.1 million was primarily due to increased personnel costs, including non-cash stock-based compensation and severance costs in connection with wind down activities and a reduction in our workforce.

Net Loss: Net loss was $10.3 million, or $0.43 per common share (basic and diluted), for the quarter ended March 31, 2020, compared to a net loss of $17.1 million, or $0.74 per common share (basic and diluted), for the quarter ended March 31, 2019. The calculation is based on 23.9 million average common shares outstanding for the first quarter of 2020, compared to 23.0 million average common shares outstanding for the first quarter of 2019.

Cash Position

Cash, cash equivalents and marketable securities were $14.2 million at March 31, 2020 compared to $21.8 million at December 31, 2019.