On September 6, 2022 Illumina, Inc. (NASDAQ:ILMN), reported a decision from the European Commission prohibiting the company’s acquisition of GRAIL (Press release, Illumina, SEP 6, 2022, View Source [SID1234619123]). The company is reviewing the Commission’s order and intends to appeal the decision. The EC decision follows last week’s ruling by US Federal Trade Commission judge in favor of Illumina’s acquisition of GRAIL.

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"We are disappointed with the European Commission’s decision prohibiting us from acquiring GRAIL back to Illumina," said Charles Dadswell, General Counsel of Illumina. "Illumina can make GRAIL’s life-saving multi-cancer early detection test more available, more affordable, and more accessible – saving lives and lowering healthcare costs. As we continue to believe, this merger is pro-competitive and will accelerate innovation. Last week the Chief Judge of the US Federal Trade Commission issued a decision supporting Illumina acquiring GRAIL."

In addition, to prepare for the anticipated divestment order from the European Commission in the coming months, the company will begin reviewing strategic alternatives for GRAIL in the event the divestiture is not stayed pending Illumina’s appeal.

The merger of Illumina and GRAIL would usher in a transformational phase in the detection and treatment of cancer by facilitating equal and affordable access to the life-saving early cancer detection Galleri test.

With a single blood test, Galleri can screen asymptomatic patients for more than 50 types of cancer, many of which have no other form of screening and are often caught too late to treat effectively. In addition, Galleri can identify the tissue in which a cancer has developed. Galleri is unique as a multicancer early detection test suitable for general population screening. There is no other test available for this purpose. Galleri is available today in the US and the UK, but not in the European Union.

Illumina would accelerate GRAIL’s commercial entry into the EU at scale by at least five years, saving tens of thousands of lives in the EU and billions of euros in healthcare costs.

A combined Illumina and GRAIL is key to helping the European Union achieve the goals outlined in Europe’s Beating Cancer Plan, which states: "Early detection through screening offers the best chance of beating cancer and saving lives." Today, 71% of cancer-related deaths are in cancers with no recommended screening. With limited screening, cancer is more likely to be detected in late stages but when we diagnose cancer too late, less than 20% of patients will survive more than 5 years. In contrast, if we diagnose cancer early, approximately 90% of patients are expected to survive beyond five years.1 The GRAIL merger would not only accelerate multicancer early detection in the EU but would also reduce inequity in cancer care by making early diagnosis affordable and widespread, another key priority of Europe’s Beating Cancer Plan.

1 Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov)

Illumina is separately appealing a July 2022 decision by the General Court of the European Union regarding the European Commission’s jurisdiction to challenge the GRAIL deal.

On September 6, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, reported that Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity, will participate in fireside chats at the following investor conferences (Press release, Celularity, SEP 6, 2022, View Source;utm_medium=rss&utm_campaign=celularity-announces-participation-in-upcoming-investor-conferences [SID1234619119]):

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C. Wainwright 24th Annual Global Investment Conference on Monday, September 12, 2022, at 1:30 p.m. ET
Morgan Stanley 20th Annual Global Healthcare Conference on Wednesday, September 14, 2022, at 12:20 p.m. ET
A live webcast of the fireside chats can be accessed on the Investors section of Celularity’s website at View Source A replay of the webcasts will be archived and available following the event for approximately 30 days.

On September 6, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported that Susan Molineaux, Ph.D., the company’s founder, president and chief executive officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference, being held September 12-14 both virtually and in New York, NY (Press release, Calithera Biosciences, SEP 6, 2022, View Source [SID1234619118]).

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The presentation will be available for on-demand viewing starting Monday, September 12, 2022, at 7:00 a.m. Eastern Time, and can be accessed through the Investors section of the Company’s website at www.calithera.com. The replay of the webcast will be available on the Company’s website for 30 days.

On September 6, 2022 Dong-A ST Co., Ltd. (170900: Korea SE), a Korean pharmaceutical company, and Beactica Therapeutics AB, a Swedish precision oncology company, reported that they have mutually agreed to terminate their collaboration and licensing agreement (Press release, Dong-A ST, SEP 6, 2022, View Source [SID1234619115]). The collaboration focused on developing novel candidate compounds against multiple cancer targets of mutual interest. The partnership has been productive, and multiple compound classes are now in various stages of lead generation and optimization.

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As part of the termination, both Dong-A ST and Beactica Therapeutics will gain exclusive global rights for further development and commercialization for different compounds series developed during the collaboration. No obligations to pay milestone payments or royalties will remain for the assets divided between Dong-A and Beactica. For a limited time, each company is entitled to a revenue share from any related future outlicensing activities by the other party. Full financial details remain undisclosed.

"We appreciate the opportunity we have had to collaborate with Beactica Therapeutics over the past five years. Our combined efforts have led to important breakthroughs," said Dr Jae-Hong Park, President and CSO of Dong-A ST. "We will continue to share with Beactica the ambition to make a clinical impact where it is urgently needed."

"We have valued the partnership with Dong-A and are pleased by what we have achieved together. Gaining exclusive global rights to certain compounds is perfectly aligned with Beactica’s ambition to itself become a clinical-stage precision oncology company," said Dr Per Källblad, CEO of Beactica Therapeutics. "We are excited to now add these assets to our pipeline as wholly-owned programmes."

The collaboration between Dong-A ST and Beactica Therapeutics was initiated in October 2016 and expanded in December 2018. In December 2019, a key milestone was achieved.

On September 6, 2022 Pleco Therapeutics BV, a specialty biopharmaceutical company developing novel treatments designed to detoxify the cancer micro-environment reported the final close of its Series A financing, with total funds raised of €17.3 million (Press release, Pleco Therapeutics, SEP 6, 2022, View Source [SID1234619114]). The funds will be used to complete development and commercialise the Company’s novel lead Plecoid Product, PTX-061, to improve the effectiveness of chemotherapy in patients with Acute Myeloid Leukaemia (AML).

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The investments include €3.6 million in new equity committed by Oost NL and a select number of private investors, €5m in government funding from the Netherlands Enterprise Agency (Rijksdienst voor Ondernemend Nederland, RVO), and €8.7 million in equity and R&D project financing from Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) previously announced in late 2021.

In total, at final close, the round exceeds the Company’s goal of €15 million. It provides sufficient funds to complete the development of PTX-061’s regulatory dossier in AML and to be ready for submission to the FDA and EMA as early as 2024, and to accelerate preclinical work in other indications such as Small-Cell Lung Cancer (SCLC).

Pleco’s novel Plecoid therapies are patented, innovative treatments that include chelating agents with different characteristics, that have the potential to positively change the balance of protein expression within the cancer microenvironment, removing the burden of toxic metals within the cell, thereby improving the effectiveness of existing chemotherapy.

Whilst AML is a relatively rare disease, the effectiveness of current chemotherapy may be limited because the leukaemia cells can become resistant to it over time. The majority of patients will relapse, even after an initial successful treatment. Relapses carry a poor prognosis; most patients no longer respond to treatment and die from anaemia, infection, or multiorgan failure. Worldwide the incidence of AML is estimated to be 350,000 cases per year (4.7 cases per 100,000 population)1. In the US, there was an estimated 20,050 new cases of AML in 2022 and 11,540 deaths2.

Pleco’s technology provides a platform for the development of a pipeline of therapies. In addition to PTX-061 for AML, the current pipeline includes additional candidates in preclinical testing for the treatment of other rare diseases such as SCLC.

Ivo Timmermans, Chief Executive Officer of Pleco Therapeutics, commented: "We are delighted to have secured the funds needed to progress our lead drug candidate through development, for the treatment of AML, a blood cancer that carries a very poor prognosis. We welcome our new shareholders and are grateful for the support from Oost NL and RVO."

Pleco’s funding from the RVO is the maximum granted under its Innovation Credit scheme that helps entrepreneurs with promising and challenging innovations with excellent market perspective. It provides special funding, a national and international network, and personal advice for innovative start-ups.

Pleco recently announced its expansion, with the incorporation of its subsidiary, Pleco Therapeutics USA, Inc., and the appointment of Michael Stalhamer as its President and first US-based employee. Mr Stalhamer also serves on the global leadership team as Vice President (VP) Product Development and Regulatory Affairs.

About Acute Myeloid Leukaemia (AML)

AML is a type of heterogenous haematological malignancy that originates from immature white blood cells (blasts) in the bone marrow, which may be derived from either a hematopoietic stem cell or a lineage-specific progenitor cell. AML generally spreads quickly to the bloodstream and can then spread to other parts of the body including lymph nodes, spleen, central nervous system, and testicles. AML is an orphan disease and is the most common type of acute leukaemia in adults and is primarily a disease of the adulthood; the median age of newly diagnosed AML patients is around 67 years. Worldwide the incidence of AML is estimated to be 350,000 cases per year (4.7 cases per 100,000 population, Globocan). In the US, there was an estimated 20,050 new cases of AML in 2022 and 11,540 deaths. Additionally, AML is more common in males. AML can arise de novo or secondarily either due to the progression of other diseases or due to treatment with cytotoxic agents.