On June 25, 2021 InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported that China’s National Medical Products Administration (NMPA) has approved the initiation of a Phase I clinical trial of ICP-033, the Company’s novel RTK (Receptor Tyrosine Kinase) inhibitor and its sixth innovative drug to enter clinical development (Press release, InnoCare Pharma, JUN 25, 2021, View Source [SID1234584376]).

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As a novel multi-target RTK inhibitor, ICP-033 is designed to selectively inhibit discoid domain receptor 1/2 (DDR1/2), vascular endothelial growth factor receptor 2/3 (VEGFR 2 /3) and platelet-derived growth factor receptor (PDGFR α/β). Through multiple synergistic mechanisms targeting endothelial cells, pericytes and stroma, ICP-033 can potentially inhibit angiogenesis and tumor cell invasion, normalize abnormal blood vessels, and reverse the immunosuppressive state of the tumor microenvironment for improved anti-tumor effects.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnnoCare, said, "ICP-033 is our second drug approved for clinical trial this year, and it will further enrich our product pipeline in the field of solid tumors and potentially provide another treatment option for cancer patients worldwide."

ICP-033 will be used potentially as monotherapy and/or in combination with immunotherapy and other targeted therapy drugs to treat liver cancer, renal cell carcinoma, colorectal cancer and other solid tumors.

On June 25, 2021 Cambridge start-up Lucida Medical has reported that it has joined the Edison Accelerator, a programme designed by GE Healthcare in partnership with innovation organisation Wayra UK, to support early-stage and technologically advanced businesses developing AI applications for healthcare (Press release, GE Healthcare, JUN 25, 2021, View Source [SID1234584375]).

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Participation in the Edison Accelerator programme is a major advance towards Lucida Medical’s goal to disrupt the cancer diagnostic pathway with technology that finds prostate cancer more accurately by analysing MRI, enabling radiologists to save time and patients to receive the best possible diagnosis and treatment.

Prostate cancer is the most common cancer in men in Europe, Africa and North and South America, with 1.4 million diagnosed worldwide each year and 375,000 deaths. Earlier and better detection saves lives.

The Edison Accelerator creates a collaborative environment for start-ups, research centres, hospitals, clinicians and large corporations across the EMEA region. It aims to foster open innovation and digital transformation of healthcare.

Lucida Medical was invited to join the Edison Accelerator programme for its pioneering work in helping identify prostate cancer and its exceptional development team led by Prof Evis Sala and Dr Antony Rix, both highly experienced in artificial intelligence, or AI, medical technology.

In joining the Edison Accelerator programme, Lucida Medical will:

Receive mentoring on problem validation, business, regulatory and clinical validation, and deployment.
Participate in joint pilots between start-up and healthcare partners.
Access support in customer discovery and product validation.
Access support in adapting, integrating and launching solutions on the Edison marketplace.
Access GE Healthcare global commercial force and customers in various markets.
Receive support for clinical studies and regulatory preparation in target geographies.
Catherine Estrampes, President and CEO, Europe, Middle East & Africa, GE Healthcare, said: "The future of innovation will be about working across silos and collaborating across the healthcare ecosystem, including start-ups, research centres, hospitals and clinicians. The Edison Accelerator brings together leading technology providers, developers and academic institutions under a single, connected ecosystem to create real impact from the bottom line to better patient outcomes."

Dr Antony Rix, CEO and Co-founder, said: "That Lucida Medical has been chosen to join the prestigious Edison Accelerator programme is both a demonstration of confidence in the technology and our team. This development comes soon after our Prostate Intelligence technology received a CE mark. The support of GE Healthcare and Wayra will help us develop further our technology and access new partners and markets."

Co-founder and Chief Medical Officer Prof Evis Sala, Professor of Oncological Imaging at the University of Cambridge, said: "We are tremendously excited by our ability to support radiologists to detect cancer accurately and early. The Edison Accelerator programme will now help us bring our technology into clinical use."

XTX Ventures, the venture capital arm of XTX Markets, provided Lucida Medical with early-stage investment capital from a group of investors in March 2021.

On June 25, 2021 Alliance HealthCare Services, Inc. ("Alliance"), a leading national provider of radiology and oncology solutions to hospitals, health systems and physician groups, reported that it has entered into an agreement to be acquired for $820 million by Akumin Inc. (NASDAQ/TSX: AKU), a premier provider of freestanding outpatient radiology services in the U.S (Press release, Alliance HealthCare Services, JUN 25, 2021, View Source [SID1234584374]). The closing of the transaction is expected in third quarter of 2021, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

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Upon the closing of the transaction, the combined company will offer the most comprehensive radiology and oncology solutions to patients in the U.S., operating in 46 states, with more than 1,000 hospital and health system customers, 154 independent outpatient radiology centers and 34 radiation therapy centers. The combined company expects to have over 4,000 team members serving more than two million radiology and oncology patient visits annually.

"Bringing together the best of both organizations for the benefit of our patients, partners and customers is truly exciting," said Rhonda Longmore-Grund, President and CEO of Alliance. "Alliance brings an over 30-year history of successful radiology and oncology partnerships with hospitals, health systems and physicians; and Akumin has built and continues to grow its premier outpatient imaging practice. Together we will offer patients and customers profound value unlike any other healthcare solutions company – and we can’t wait to get started."

"We have always said Akumin’s vision is to drive patient-centered innovation, service delivery standardization, and exceptional healthcare value, all in an outpatient care setting," said Riadh Zine, President and CEO of Akumin. "The acquisition of Alliance is transformative in a changing healthcare ecosystem that continues to shift toward outpatient, price-transparent, value-based care. There’s no other organization that has the complement of attributes we will offer together as outpatient healthcare services experts, in particular with Alliance’s longstanding hospital and health system relationships and Akumin’s freestanding operational expertise."

"We thank the Alliance team for five years of partnership, and we look forward to the success we know Akumin and Alliance will achieve as a combined organization," said Qisen Huang, Chairman and Founder of Tahoe Investment Group. Tahoe has been majority owner of Alliance since 2016 and will on closing transition to a minority ownership position in the newly combined, publicly traded entity.

The acquisition has been facilitated for Alliance with the assistance of Citigroup Global Markets, Inc. and SVB Leerink LLC, as financial advisors, and Ropes & Gray LLP and Osler, Hoskin & Harcourt LLP, as legal advisors. Stikeman Elliott LLP and McDermott Will & Emery LLP acted as legal advisors, and PricewaterhouseCoopers LLP as financial advisors, to Akumin.

On June 25, 2021 Alvotech Holdings SA reported that it has entered into an amendment and restatement agreement with bondholders of its $300m covertible bond issued on December 14, 2018 (Press release, Alvotech, JUN 25, 2021, View Source [SID1234584373]). Bondholders have exercised their conversion rights on approximately one quarter of the value of the bond, converting $106m of principal and accrued interest into equity at an exercise price that gives the company a pre-money valuation of $2.7bn.

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The company and bondholders also agreed to improve terms on the remaining bond and extend its maturity to 2025, thereby decreasing the company’s cost of capital and freeing resources to apply to the execution of its business strategy. Further terms were amended to add additional capital to the company.

Robert Wessman, Chairman of Alvotech commented: "With this transaction our stakeholders have reiterated their longstanding confidence in and commitment to our mission: to increase access to the highest quality biologics medicines for patients around the world."

In November of 2020, the U.S. Food and Drug Administration and European Medicines Agency accepted Alvotech’s regulatory submissions for AVT02, a candidate interchangeable biosimilar to AbbVie’s Humira. A decision from the FDA regarding the company’s Biologics License Application (BLA) for AVT02 is expected in September of 2021 and an EMA decision for the AVT02 European Marketing Authorization Application (MAA) is anticipated in the fourth quarter of 2021.

In May 2021, Alvotech USA Inc. filed a lawsuit in the Eastern District of Virginia seeking to invalidate four of AbbVie’s key patents. The lawsuit also argues that AbbVie’s patent strategy, which has been under recent Congressional scrutiny, renders its Humira patents unenforceable. Further, the lawsuit points out that AbbVie has failed to sue Alvotech’s US affiliate (the actual BLA applicant) at all. At stake are billions of dollars of cost to the US healthcare system, negatively impacting consumers and taxpayers.

In June of 2021, Alvotech’s switching study for AVT02 reached primary completion. Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira and is executing a switching study to support approval as an interchangeable product. Top-line results from the switching study are expected later this year.

On June 25, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the Committee for Orphan Medicinal Products ("COMP") of the European Medicines Agency ("EMA") has recommended the granting of orphan medicinal product designation ("OMPD") in the European Union ("EU") for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma (Press release, Y-mAbs Therapeutics, JUN 25, 2021, View Source [SID1234584372]). The positive opinion from the EMA’s COMP has been sent to the European Commission ("EC"), which is expected to grant the orphan drug designation within 30 days.

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Obtaining OMPD for 177Lu-omburtamab-DTPA is part of an overall plan to expand the Company’s European development programs and ultimately obtain orphan drug exclusivity to protect 177Lu-omburtamab-DTPA for the treatment of medulloblastoma in the EU.

Under the EMA’s Regulation (EC) No. 141/2000 an orphan medicinal product designation gives companies access to protocol assistance and guidance on preparing a dossier that will meet European regulatory requirements and thereby maximize the chance of approval at the time of marketing authorization. Once approved, an orphan drug is also granted 10 years of market exclusivity during which directly competitive similar products cannot normally be placed on the market.

The EMA grants orphan medicinal product designation based upon several criteria, including: the life threatening and debilitating nature of the condition; the medical plausibility of the proposed orphan indication; a prevalence in Europe of less than five cases for each 10,000 of population; no satisfactory method of diagnosis, prevention or treatment exists or if such method exists the medicinal product will be of significant benefit to those affected by that condition.

Y-mAbs’ founder, Chairman and President, Thomas Gad said, "We are very pleased that the COMP has issued a positive opinion for an orphan drug designation to 177Lu-omburtamab-DTPA which will give us a string of development incentives."

Dr. Claus Moller, Chief Executive Officer further notes, "We believe that the orphan designation strengthens our opportunity to bring 177Lu-omburtamab-DTPA to patients who desperately need alternative methods of treatment. Further, the designation marks a substantial milestone in Y-mAbs’ expansion into European development."

Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.