On April 23, 2020 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer who are appropriate for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform (Press release, Agilent, APR 23, 2020, View Source [SID1234556549]).

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"Our PD-L1 IHC 22C3 pharmDx assay is used by thousands of laboratories around the globe, and now customers in the U.S. can add PD-L1 to their routine IHC workflow on Dako Omnis."

Dako Omnis is Agilent’s fully automated, walk-away solution for staining tumor samples that provides a flexible, high-throughput diagnostic service integrated into the core of the laboratory workflow.

The FDA approval of this CDx demonstrates that Agilent is continuing to enable metastatic NSCLC patients, who previously had few and inefficient therapy options, to gain access to first-line treatment monotherapy with the targeted immunotherapy, KEYTRUDA, providing new hope for patients and their families.

"We are delighted to add the first FDA approval of this important companion diagnostic on Dako Omnis," said Simon Østergaard, Agilent vice president, and general manager of the company’s pathology division. "Our PD-L1 IHC 22C3 pharmDx assay is used by thousands of laboratories around the globe, and now customers in the U.S. can add PD-L1 to their routine IHC workflow on Dako Omnis."

Thanks to extensive clinical validation on NSCLC through concordance with PD-L1 IHC 22C3 pharmDx for Autostainer Link 48, laboratories can implement PD-L1 testing on Dako Omnis with complete diagnostic confidence.

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. Manufactured by Merck, KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

Lung cancer is the leading cause of cancer-related mortality in the United States, with an estimated incidence of 142,000 deaths in 2019 alone. Among these cases, NSCLC accounts for nearly 85% of all diagnoses.2

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.

On April 23, 2020 Paige, the leader in computational pathology which is transforming the diagnosis and treatment of cancer, reported it has received additional funding from Goldman Sachs Merchant Banking Division, which will be added to the recently announced Series B financing round (Press release, Paige AI, APR 23, 2020, View Source [SID1234556548]). Paige will use this new capital to further develop the company’s diagnostic and test products for the biopharma industry, while strengthening its leadership position in clinical AI for pathologists and development of the Paige platform for remote viewing and routine clinical practice. Additionally, Paige has added David Castelblanco, Managing Director at Goldman Sachs, to its Board of Directors. David brings with him a wealth of experience as an investor and board member working with leading cancer treatment centers internationally.

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"We’re thrilled to be working with David Castelblanco and the team at Goldman Sachs as we build our platform and further develop our computational pathology infrastructure," said Leo Grady, CEO at Paige. "With our new funding and leadership additions, we’ll focus on building network effects based on our clinical-grade digital pathology and AI platform."

"Paige is transforming pathology and translational research in the cancer field and is working closely with biopharma companies to create custom diagnostic solutions and drug development technologies to improve patient care," said David Castelblanco. "We look forward to supporting the Company’s important mission of improving cancer care through its AI technology."

Paige is continuing its mission to accelerate the future of pathology by translating cutting-edge cancer research into solutions that help physicians and patients arrive at an accurate diagnosis faster and more cost effectively.

"Paige’s leadership is doing a fantastic job in building a stellar team and seizing opportunities in this exciting market," said Jim Breyer, founder and CEO of Breyer Capital, who invested in both series A and B for the company.

Recent company milestones for Paige include the appointment of R. Martin Chavez, a former Goldman Sachs executive to the board, and a partnership with Invicro LLC, a Konica Minolta company, to provide integrated pathology solutions to support pharmaceutical and biotechnology sponsors with their drug discovery and development initiatives.

ABOUT GOLDMAN SACHS MERCHANT BANKING

Founded in 1869, The Goldman Sachs Group, Inc. is a leading global investment banking, securities and investment management firm. Goldman Sachs Merchant Banking Division (MBD) is the primary center for the firm’s long-term principal investing activity. MBD is one of the leading private capital investors in the world with investments across private equity, growth equity, infrastructure, private debt and real estate.

On April 23, 2020 Regenacy Pharmaceuticals, a clinical-stage biopharmaceutical company developing breakthrough treatments for diabetic and other peripheral neuropathies, reported the appointment of David Michelson, M.D., as Chief Medical Officer (CMO) (Press release, Regenacy Pharmaceuticals, APR 23, 2020, View Source [SID1234556547]). Dr. Michelson has served as Consultant CMO since September 2019.

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"I’m very pleased to officially welcome David to Regenacy’s team," said Simon Jones, Ph.D., Regenacy’s President and Chief Executive Officer. "For the past 7 months, David’s drug development expertise has been invaluable. He provided tremendous contributions and perspectives on our development strategy for ricolinostat as a consultant, and our team looks forward to continuing to work with him."

"Regenacy is pursuing a novel approach to restoring nerve function that addresses a critical unmet need of patients with peripheral neuropathy," said Dr. Michelson. "It has been a pleasure working alongside Regenacy’s tenured leadership team over the last several months and I look forward to applying my drug development experience to advance ricolinostat into the clinic for DPN."

Dr. Michelson brings over 24 years of industry experience to Regenacy. Prior to joining the company, he served as CMO for Proclara Biosciences where he oversaw multiple Phase 1 studies for a program targeting amyloidosis. Before Proclara, he worked at Merck for 11 years as the Neuroscience Therapeutic Area Head and Vice President for Clinical Development. Dr. Michelson began his career at Eli Lilly and Company, where he held positions of increasing responsibility for early and late stage drug development. Dr. Michelson earned his M.D. from the Albert Einstein College of Medicine in New York, and completed his residency in psychiatry at Yale University, where he also served as a chief resident and faculty member prior to joining the National Institute of Mental Health as a research physician.

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.

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).