On September 22, 2020 Synaffix B.V., a biotechnology company enabling antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported that it has won the "Best ADC Platform Technology" category at the 2020 World ADC Awards ceremony (Press release, Synaffix, SEP 22, 2020, View Source [SID1234565463]).

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Synaffix’ ADC platform consists of GlycoConnect, HydraSpace and toxSYN which comprise site-specific technology and payloads to enable best-in-class ADCs.

Synaffix was presented the award during the 2020 World ADC Digital event. The finalists were shortlisted through a voting pool of over 1,000 individuals, with a panel of distinguished, independent industry experts from across the ADC field, assessing each finalist to decide the winners.

The judging panel highlighted the following three cornerstone features of the Synaffix ADC platform:

Consistent delivery of highly competitive ADC product candidates
Strong commercial and scientific validation (over $420m in out-licensing deals,at least six ADCs in development with two in clinical trials)
Compatible and easy to use with any antibody

On September 22, 2020 AQILION AB reported that TAK1 as the target of the internal drug discovery program Alnitak and will present data from the discovery phase at the international partnering event BIO-Europe 2020 Digital in October (Press release, Aqilion, SEP 22, 2020, View Source [SID1234565462]). Alnitak was initiated as an internal program last year with focus on chronic inflammation and autoimmune diseases in addition to genetically driven cancers.

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The internally generated Alnitak program is aimed at discovering and developing small molecule inhibitors of TAK1. The target TAK1 has been shown to act as a master regulator of inflammatory signaling. The Aqilion team, consisting of experienced former AstraZeneca R&D management team members and scientists, has identified TAK1 as a highly promising drug target. A TAK1 inhibiting drug has the potential to treat inflammatory and autoimmune diseases in addition to certain genetically driven cancers.

Among the key inflammatory processes is the formation of a multi-protein complex called inflammasome. The inflammasomes are part of the innate immune system and they play a vital role that help to recruit immune cells to sites of infection and inflammation. Dysfunctional inflammasomes are involved in harmful inflammations, which can become chronic in many diseases. NLRP3 is the most studied inflammasome in the scientific litterature to date. Recent publications have shown that TAK1 functions as a central mediator of NLRP3 activation in human cells.

Aqilion believes that new research and knowledge regarding human immunology and availability of novel research models, re-evaluates and positions TAK1 as an ideal drug target.

"Using structure-based drug discovery methods in collaboration with leading research laboratories, the project has already developed proprietary best in class inhibitors with excellent druglike properties. This is Aqilion’s first internal project to deliver results since we initiated the implementation of our new strategy with a focus on chronic inflammatory and immunological driven diseases. I am proud of our team and collaborators and very pleased to acknowledge that we have reached an important milestone in the development of Aqilion as a biotech company," says Sarah Fredriksson, CEO of AQILION AB.

On September 21, 2020 Biocure Technology Corp. ("CURE" or the "Company") (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea ("BPK"), a subsidiary of Biocure Technology Inc. ("CURE") reported that BPK has entered into a non-binding MOU with S&B Biopharm ("SBB") located in Sofia, Bulgaria (Press release, Biocure Technology, SEP 21, 2020, View Source [SID1234628816]). This agreement will allow BPK to locally manufacture CD-19 CAR T in Bulgaria and sell to the Eastern European market, including Poland, Turkey and Bulgaria. Expansion into the European market could assist with bringing ALL patients more affordable solutions of CAR T Therapy.

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As part of the agreement, SBB will be required to raise funds the equivalent of USD12Million to cover the clinical trial costs along with the GMP manufacturing facility. Upon the execution of the definitive agreement SBB will have 6 months to allocate the funds and begin the clinical trial. At the completion of the agreement, BPK will be required to transfer its manufacturing technology of CD19 CAR T to the JV for the designated markets, to be defined in the definitive agreement. The manufacturing technology of Lenti virus shall be transferred by a separate agreement afterwards. The initial structure of the JV will be 51:49 between BPK and SBB.

Dr. Sang Mok Lee, CEO and President of Biocure and BPK, states "This MOU is the very first step for the Company to advance it’s entrance into the European market with its CAR T technology. We are about to start a clinical trial in Korea and are confident that if we have positive outcomes from the Korean clinical trial, this should enable the European process to be faster and more efficient. We strongly believe that our business model could enable European ALL patients with an affordable CAR T Therapy to save more lives. We continue to work hard to make this happen as soon as possible."

On September 21, 2021 Oncology Venture A/S ("OV") reported that it will change its company name to Allarity Therapeutics ("Allarity" or the "Company") and will significantly restructure its Board of Directors to align with the company’s current and long-term strategy (Press release, Allarity Therapeutics, SEP 21, 2020, View Source [SID1234586756]). Both the proposed name change and appointment of new Board members are subject to approval of shareholders at the upcoming Extraordinary General Meeting (EGM) planned to be convened on 7 October 2020.

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Following the proposed restructuring, Allarity’s Board of Directors will comprise five members, including existing Directors Mr. Steve Carchedi (CEO), Mr. Duncan Moore (Chairman), and Dr. Magnus Persson, and new members in both the U.S. and Scandinavia, including Mr. Søren Gade (a current member of European Parliament and former Minister of Defense in Denmark) and Ms. Gail Maderis (current CEO of Antiva Biosciences, Inc., Board member of Valitor, Inc., and former CEO of Five Prime Therapeutics, Inc.). New Board members will receive warrants in the Company as part of their compensation package.

The changes to the Company name and composition of its Board of Directors are part of a planned strategic shift towards commercialization for the U.S. oncology and financial markets, while the company maintains its roots and laboratory headquarters in Denmark, which continue to be directly overseen by Dr. Steen Knudsen, Chief Scientific Officer and Founder, and Mr. Thomas Jensen, Senior Vice President of Information Technologies and Founder. The Hørsholm, Denmark facility will serve as the Research & Development global headquarters for the company’s DRP companion diagnostic platform. As part of this strategic shift, current Chief Financial Officer (CFO) Mr. Henrik Moltke will be departing the Company to pursue other opportunities. Mr. James G. Cullem, currently Senior Vice President of Corporate Development, will serve as interim CFO, while the Company conducts an immediate search for a U.S.-based, CFO with Nasdaq experience.

Steve Carchedi, CEO of the Company, noted "Our new company name, Allarity Therapeutics, better reflects our focus on developing promising new cancer therapeutics, together with DRP companion diagnostics, to match cancer patients with the best therapeutic options for their particular cancers, thereby realizing the promise of personalized medicine. We are also very enthusiastic about the planned restructuring of our Board of Directors to strengthen the strategic oversight of the Company and support our Executive Team in achieving our goals. I am thrilled to have Gail Maderis and Søren Gade join our Board, as both will provide valuable connections for us related to international cancer drug development while further expanding the geographic footprint of our Board to both sides of the Atlantic."

Mr. Carchedi further commented, "I also want to thank Henrik for his leadership over the past year. He has been instrumental in adjusting our cost base, cleaning up our balance sheet, and successfully changing our financing strategy towards low-cost equity financing. Henrik’s departure is bittersweet for the Company, but will allow us to find a new CFO who is an ideal match for the many tasks ahead on our continued journey towards bringing healthcare therapies to market for the benefit of patients."

Duncan Moore, Board Chairman of the Company, commented "We are grateful for the efforts and contributions of our prior Board members, Steen Knudsen, Carani Sanjeevi, and Frank Knudsen, as well as CFO Henrik Moltke, and we look forward to working alongside our new Board members, Gail Maderis and Søren Gade, to advance the Company’s mission to improve cancer patient care by realizing truly personalized medicine."

On September 21, 2020 Illumina, Inc. (NASDAQ: ILMN) and GRAIL, a healthcare company whose mission is focused on multi-cancer early detection, reported they have entered into a definitive agreement under which Illumina will acquire GRAIL for cash and stock consideration of $8 billion upon closing of the transaction (Press release, Illumina, SEP 21, 2020, View Source [SID1234577430]). In addition, GRAIL stockholders will receive future payments representing a tiered single digit percentage of certain GRAIL-related revenues. The agreement has been approved by the Boards of Directors of Illumina and GRAIL.

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"Over the last four years, GRAIL’s talented team has made exceptional progress in developing the technology and clinical data required to launch the GalleriTM multi-cancer screening test. Galleri is among the most promising new tools in the fight against cancer, and we are thrilled to welcome GRAIL back to Illumina to help transform cancer care using genomics and our NGS platform," said Francis deSouza, Illumina’s President and Chief Executive Officer. "Together, we have an important opportunity to introduce routine and broadly available blood-based screening that enables early cancer detection when treatment can be more effective and less costly. Multi-cancer early detection is better for patients, their physicians, and payors. As we accelerate our path to clinical leadership and the path to multi-cancer early detection, we will continue to drive significant value creation for our stockholders."

"Cancer is one of society’s most significant challenges, with most cancer being detected too late," said Hans Bishop, Chief Executive Officer of GRAIL. "We believe multi-cancer early detection technology could address a tremendous unmet need and reduce the cancer burden worldwide. Combining forces with Illumina enables broader and faster adoption of GRAIL’s innovative, multi-cancer early detection blood test, enhancing patient access and expanding global reach. We are excited about this next step in our journey to transform cancer detection and outcomes and create value for patients and their families and communities, health care providers and payors, employers, and stockholders."

GRAIL was founded by Illumina in 2016 and was spun out as a standalone company, powered by Illumina’s NGS technology, to develop state-of-the-art data science and machine learning and create the atlas of cancer signals in the blood, enabling multi-cancer early detection tests. GRAIL raised approximately $2 billion to support its innovative technology platform and develop Galleri. An earlier version of Galleri was able to detect more than 50 cancer types, over 45 of which have no recommended screening in the United States. Galleri is expected to launch commercially in 2021 as a multi-cancer, laboratory developed test for early cancer detection from blood. GRAIL plans to follow Galleri with future blood-based tests for cancer diagnosis, detection and post-treatment monitoring of cancer patients.

Strategic Benefits

Increases Illumina’s Directly Accessible Total Addressable Market and Offers Multiple Future Growth Opportunities. GRAIL extends Illumina’s portfolio to include cancer screening, diagnosis and cancer monitoring, creating a portfolio of best-in-class, proprietary tests in each of the major oncology testing application areas. Oncology test utilization and payor coverage is accelerating, and the total NGS oncology opportunity is expected to grow at a CAGR of 27% to $75 billion in 2035.
Accelerates Adoption of NGS-Based Early Multi-Cancer Detection Test to Reach More Patients Faster. Illumina plans to leverage its global scale, manufacturing and clinical capabilities to support GRAIL’s commercialization efforts, realize the total addressable market potential and drive significant growth in the clinical value chain.
Enhances Illumina’s Position in Clinical Genomics. NGS ispoised to revolutionize oncology care, and this acquisition allows Illumina to participate more fully in the high value clinical solutions that are enabled by its NGS sequencing technology. With GRAIL, Illumina will continue as a leading sequencing innovator and partner, while also becoming a proprietary test provider.
Transaction Details

Under the terms of the agreement, at closing, GRAIL stockholders (including Illumina) will receive total consideration of $8 billion, consisting of $3.5 billion in cash and $4.5 billion in shares of Illumina common stock, subject to a collar. Illumina currently holds 14.5% of GRAIL’s shares outstanding, and approximately 12% on a fully diluted basis.

The collar on the stock consideration will ensure that GRAIL stockholders excluding Illumina receive a number of Illumina shares equal to approximately $4 billion in value if the 20-trading-day volume weighted average price of Illumina stock as of 10 trading days prior to closing is between $295 and $399. GRAIL stockholders excluding Illumina will receive approximately 9.9 million Illumina shares if the 20-trading-day volume weighted average price of Illumina stock as of 10 trading days prior to closing is above $399 and approximately 13.4 million Illumina shares if the 20-trading-day volume weighted average price of Illumina stock as of 10 trading days prior to closing is below $295. Upon closing of the transaction, current Illumina stockholders are expected to own approximately 93% of the combined company, while GRAIL stockholders are expected to own approximately 7% based on the mid-point of the collar.

The cash consideration to GRAIL stockholders excluding Illumina of approximately $3.1 billion is expected to be funded using balance sheet cash of both Illumina and GRAIL plus up to $1 billion in capital raised through either a debt or equity issuance. In advance of this anticipated issuance, Illumina has obtained financing commitments for a $1.0 billion bridge facility with Goldman Sachs Bank USA.

In connection with the transaction, GRAIL stockholders will also receive contingent value rights, which will entitle holders to receive future payments representing a pro rata portion of certain GRAIL-related revenues each year for a 12-year period. This will reflect a 2.5% payment right to the first $1 billion of revenue each year for 12 years. Revenue above $1 billion each year would be subject to a 9% contingent payment right during this same period. Illumina will offer GRAIL stockholders the option to receive additional cash and/or stock consideration, in an amount to be determined prior to closing, in lieu of the contingent value rights.

We expect the transaction will be accretive to Illumina revenue starting in 2021, and to meaningfully accelerate revenue growth over time.

Structure and Approvals

The transaction is subject to customary closing conditions, including applicable regulatory approvals. Illumina expects to close the transaction in the second half of 2021.

Following the completion of the transaction, GRAIL will operate as a standalone division within Illumina with a dedicated leadership team to ensure continuation of GRAIL’s success.

Advisors

Goldman Sachs & Co. LLC is serving as exclusive financial advisor and Cravath, Swaine & Moore LLP is serving as legal advisor to Illumina. Morgan Stanley & Co. LLC is serving as exclusive financial advisor and Latham & Watkins LLP is serving as legal advisor to GRAIL.

Conference Call Information

Illumina will host a conference call to discuss the transaction today, September 21, 2020 at 8:00 a.m. EDT.

Interested parties may access the live teleconference through the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing the Toll-Free Dial-In Number: (866) 211-4597, or the International Dial-In Number: (647) 689-6853 outside North America, both with passcode 2245817. Following the call, a replay will be posted on Illumina website and will be available for at least 30 days following posting.