On January 11, 2022 Freenome, a privately held biotech company, reported that Roche has made an investment of $290 million, bringing Freenome’s total funding to more than $1.1 billion since the company was founded in 2014 (Press release, Freenome, JAN 11, 2022, View Source [SID1234598562]). This announcement follows Freenome’s recent Series D financing of $300 million in December.

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Detecting cancer early, when it’s most treatable, improves survival rates. Each year, approximately 53,000 Americans die from colorectal cancer (CRC).[1] If diagnosed early when localized, the survival rate for CRC is over 90%, compared to only 14% once the cancer has spread.[2] Freenome has developed a machine learning-enabled multiomics blood test for CRC screening, which is being validated in PREEMPT CRC, its large, prospective registrational study that is in the final stages of enrollment.

The company is also extending its multiomics platform with biomarkers for other cancer types currently embedded to develop tests in new indications, and recently presented promising data in the detection of pancreatic cancer. Next month, the company will expand and launch additional multicancer clinical studies focused on more tailored baskets of screening tests, based on an individual’s risk.

"With Roche’s investment and expertise, we’ll be able to further accelerate and augment the development of our platform to test for additional cancers, and expand our real-world data programs," said Mike Nolan, chief executive officer of Freenome. "From the beginning, our focus has been on ensuring our tests will be available for everyone and Roche’s support brings us closer to making that a reality."

"We are happy to support Freenome’s innovative approach to early cancer detection," said Thomas Schinecker, CEO of Roche Diagnostics. "We believe blood-based multimodal screening and data-driven medical insights will help deliver personalized healthcare. This investment will be an important step to advance early cancer screening, and we look forward to joining Freenome in this journey."

On January 10, 2022 QV Bioelectronics reported that £2M Pre-Series A financing raised from new and existing VCs (Press release, QV Bioelectronics, JAN 10, 2022, View Source [SID1234632323]).
The funds will facilitate the completion of pre-clinical studies and the further development of GRACE, a first-of-its-kind implanted medical device to treat brain tumour patients with electric field therapy, whilst also expanding expertise of the team.
These steps will move GRACE significantly closer towards the clinic.
QV Bioelectronics, creators of an innovative surgically implanted Electric Field Therapy (EFT) device for the treatment of brain tumours – announces it has secured £2m in Pre-Series A funding from new and existing leading deep tech investors. The round was led by the Science Angel Syndicate and Fink Family Office with participation from Northern Gritstone, Elbow Beach Capital, and existing investors SOSV and Catapult Ventures.

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QV Bioelectronics’ revolutionary EFT implant, GRACE, is currently in pre-clinical development. Their first-of-its-kind technology aims to target dividing cancer cells within the brain, without affecting healthy cells. Implantable bioelectronics is at the forefront of emerging healthcare technology, combining the use of cutting-edge materials and interdisciplinary science. QV Bioelectronics are pioneering its use in cancer care. Their first clinical indication for GRACE will be the most aggressive and deadly primary brain tumour, Glioblastoma (GBM), which has some of the worst outcomes of any cancer. Their technology strives to provide longer, better quality lives for these patients.

QV Bioelectronics is led and co-founded by biomedical engineer Dr Christopher Bullock (CEO), and Dr Richard Fu, a specialty registrar in neurosurgery and brain cancer researcher in the U.K.’s National Health Service (NHS).

QV Bioelectronics will use the funding to support expanded pre-clinical studies to assess the safety and efficacy of the GRACE implant, alongside the completion of device design prior to entering the clinical phase of development. The funds will also support a range of other activities to ensure future commercial and regulatory success.

Its cutting-edge technology combines the use of the nascent area of advanced materials, precision oncology and surgical innovation. GRACE is set to be implanted in patients already undergoing surgery to maximise patient safety and cost-effectiveness. QV have been working with some of the U.K.’s leading neurosurgeons to ensure GRACE meets the needs of clinicians and fits seamlessly into existing patient treatment pathways. QV’s goal is that its device will one day help to enhance the standard of care that patients receive.

Science Angel Syndicate was founded in 2021 with a mission to source world-class scientific discoveries, provide unique scientific due diligence and help our members to identify exceptional investment opportunities that tackle the most important global challenges. Our collective knowledge helps our members invest in the most exciting companies of tomorrow, founded by leading scientists at the forefront of their fields.

The Fink Family office is a single-family office ran by Lord Stanley Fink. Fink, a conservative peer, was the CEO of the largest listed hedge fund Man Group between 2000-2007. The Family Office invests in early-stage venture capital around 5 core areas Fintech, Life Sciences/ Deep Tech, EdTech, PropTech and Impact.

Northern Gritstone is a ground-breaking new investment company, founded by the Universities of Leeds, Manchester, and Sheffield. Having announced its first close of £215m in May, Northern Gritstone aims to be one of the UK’s largest investors into academic spinouts and IP-rich businesses dedicated to financing companies in some of the UK’s fastest growing sectors such as advanced materials, energy, health technology and cognitive computation.

Commenting, Dr Johnathan Matlock said:

"We are delighted to have led this investment round alongside the Fink Family Office. The GRACE device that Chris and Richard are developing is the definition of deep science, requiring expertise across multiple disciplines, that when brought together could dramatically improve outcomes for patients with brain tumours. With this funding round we are helping Chris and Richard move one step closer to the clinic and have set them up to achieve important pre-clinical milestones ahead of a Series A round. We are excited to support Chris, Richard and the wider QV team during the next phase of their development."

Commenting, Lord Stanley Fink said:

"I am thrilled to be investing in QV bio’s latest round. Having suffered from a brain tumour over a decade ago, this is a cause extremely close to my heart. There has been limited progress in brain cancer survival rates over the past decade when compared to the advances in other cancers and I hope QV bio will help bridge this gap."

Commenting, Duncan Johnson, CEO, Northern Gritstone, said:

"QV Bioelectronics is an example of the pioneering start-ups from the north of England that Northern Gritstone is dedicated to supporting. Its medical devices are at the vanguard of innovation with the potential to improve the lives of millions of people with brain tumours. This investment takes the company one step closer to clinical trials and making its research a reality."

Commenting, Vijay Curthan, Investment Director, Catapult Ventures, said:

"This is the third time we’re investing in QV Bioelectronics and is testimony to the advances in deeptech that Chris and his team are delivering. With the support of some of the UK’s most pre-eminent neurosurgeons, the company continues to plough a leading furrow in the use of electric field therapy to treat GBM, in a way that will, hopefully, turn the tide on this devastating disease."

Commenting, Bill Liao, General Partner, SOSV said:

"SOSV is proud to continue our support of this revolutionary technology to treat the scourge of glioblastoma."

Commenting, Dr Richard Fu (Clinical Director and Co-founder) and Dr Chris Bullock (Co-founder & CEO) said:

"Ultimately, we at QV are driven by the challenge to make a meaningful difference to the lives of brain cancer patients around the world. It is our aspiration that GRACE will optimise the treatment effects of electric field therapy, whilst working synergistically alongside other existing and emerging cancer treatments. We are grateful for the belief and support from our new and existing investors and look forwards to working with them and our other partners as we take the next significant steps toward fulfilling this goal."

On January 10, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a pre-clinical biotechnology company developing various immune-oncology products, is pleased to reported the start of its final step in GLP studies on its lead anti-cancer AccuTOXTM molecule at Eurofins Advinus Limited prior to initiate its Phase I trial in breast cancer patients (Press release, Defence Therapeutics, JAN 10, 2022, View Source [SID1234626245]).

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Eurofins Advinus Limited is a leading Drug Discovery and Development Contract Research Organization (CRO) with 30 years of experience testing regulated products under Good Laboratory Practice (GLP). With 400 employees, 80 full Preclinical IND packages completed and over 20,000 GLP Toxicology studies with the full range of required toxicology studies, Eurofins Advinus is one of the most experienced Drug Development Contract Research Organisation.

Eurofins has been mandated by Defence to complete all final GLP studies required by the FDA and Health Canada on its lead AccuTOXTM molecule. The studies will be conducted on both rats (rodent) and dogs (non-rodents) to identify the maximum tolerated dose in addition to evaluate the pharmacokinetic and toxicology profile of the lead compound.

"We are pleased with our very efficient advancement in the AccuTOXTM program. Not only did the AccumTM elicit powerful anti-cancer properties, but in addition we screened a series of variants (>50) to identify the lead AccuTOXTM molecule capable of efficiently killing more than 9 different tumor cell lines of both murine and human origin (lymphoma, melanoma, breast, colon and nonsmall cell lung carcinoma). Completing this set of GLP studies represents therefore the final step before approaching the FDA/Health Canada to initiate a Phase I trial in breast cancer patients in 2022", says Mr. Plouffe, the CEO of Defence.

According to Fortune Business Insights, the Global Breast Cancer Therapeutics Market, which stood at USD 17.8 Billion in 2018, will reach USD 38.5 Billion by the end of 2026, which would represent a CAGR of 10.2% between 2018 and 2026.

The pre-clinical studies conducted by the Defence team on mice revealed how potent is the AccumTM molecule at inhibiting tumor cell growth both in vitro and in vivo. In addition, AccumTM was shown to elicit additive effects in animals when used in conjunction with immune-checkpoint inhibitors such as CTLA-4 and PD-1, two antibodies currently being used in the oncology clinic to treat cancer patients.

On January 10, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported that highlighted its 2021 corporate achievements and outlined its expected milestones for 2022 (Press release, Elevation Oncology, JAN 10, 2022, View Source;utm_medium=rss&utm_campaign=elevation-oncology-highlights-2021-achievements-and-outlines-expected-2022-milestones [SID1234605454]). Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer, will present these corporate priorities on Wednesday, January 12, 2022, at 9:45 a.m. ET at the virtual 40th Annual J.P. Morgan Healthcare Conference.

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"In 2021, Elevation Oncology made outstanding operational progress, marked by the advancement of seribantumab in the Phase 2 CRESTONE study, a successful initial public offering, strong growth in building an industry-leading team, and the launch of a novel partnership with Caris Life Sciences to accelerate the identification of new, actionable genomic targets for potential future drug development," said Dr. Leland. "Looking ahead, 2022 is set to be a transformative year with the planned reporting of our initial clinical data for seribantumab on approximately 10 patients from Cohort 1 in the Phase 2 CRESTONE study in mid-2022. A priority throughout 2022 is to execute on our strategy aimed at expanding our product candidate pipeline, including maximizing the potential of seribantumab, advancing new discoveries through our Caris Life Sciences collaboration, and progressing our ongoing business development activities. We believe we are well-positioned to deliver on our mission to advance precision medicines for patients with genomically defined cancers."

2021 Key Corporate Achievements

Seribantumab

Launched new global clinical trial sites with the Phase 2 CRESTONE study now enrolling patients across the US, Australia, and Canada
Announced an investigator-presented case study under a compassionate use program that highlighted a patient with pancreatic cancer harboring an NRG1 fusion and treated with seribantumab which showed a confirmed partial response and durable clinical benefit
Established 3 grams weekly as the optimized dose for the Phase 2 CRESTONE study
Presented new preclinical data on additional tumor models harboring an NRG1 fusion at AACR (Free AACR Whitepaper) 2021
Published a preclinical manuscript on the effect of seribantumab in NRG1 fusion models in Clinical Cancer Research
Business Objectives

Entered into a joint discovery and development collaboration with Caris Life Sciences whereby the partners will utilize the diagnostic data to accelerate the identification of new, actionable genomic alterations for potential future drug development
Formed new strategic diagnostic collaborations bringing the total diagnostic consortium to a total of 10 patient identification collaborators for the Phase 2 CRESTONE study
Completed a successful initial public offering, raising $106.5 million in gross proceeds, before deducting underwriting discounts, commissions, and estimated offering expenses
Strengthened corporate leadership team with the addition of Joseph Ferra as Chief Financial Officer, the promotion of Valerie Malyvanh Jansen, MD, PhD to Chief Medical Officer and the appointment of R. Michael Carruthers to the Board of Directors
Expected 2022 Milestones and Operational Objectives

Complete enrollment of the first 20 patients in Cohort 1 of the CRESTONE study in mid-2022
Present initial clinical data from approximately 10 patients from Cohort 1 of the CRESTONE study treated with seribantumab at 3 grams weekly at a major medical meeting in mid-2022
Ongoing target evaluation and continued execution of our strategy for future pipeline expansion
Financial Outlook

Elevation Oncology anticipates that cash and cash equivalents totaling $155.2 million as of September 30, 2021 are expected to fund current operations into the second quarter of 2023.

Webcast

A live audio webcast of Dr. Leland’s presentation will be available on January 12, 2022 at 9:45 a.m. ET within the Investors & Media section of the Elevation Oncology website. An archived replay will be accessible following the event for a period of 30 days.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the Phase 2 CRESTONE Study

Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States, Australia, and Canada. For more information visit www.NRG1fusion.com.

On January 10, 2022 Zerion Pharma A/S (ZERION) reported that it has completed a new animal study (in dogs) that clearly demonstrates the potential of its patented Dispersome technology for reducing the amount of drug in tablet formulations (Press release, Zerion, JAN 10, 2022, View Source [SID1234598620]). The Dispersome technology is a leading drug solubility enhancing technology for tablet formulations, resulting in improved bioavailability. ZERION believes that this technology can be applied to a major part of all new oral drugs in development as well as many marketed drug products that suffer from low solubility and as a result low bioavailability. Low solubility is one of the biggest challenges in drug development and the Dispersome technology provides an innovative solution.

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ZERION’s lead program ZN002 is aimed at improving the formulation of a currently marketed cancer treatment by obtaining bioequivalence to the originator product but with a substantial reduction in the amount of active drug, and consequently number of tablets per administration. In the animal study, where ZERION tested Dispersome tablet formulations against a marketed reference tablet formulation, it was shown that the amount of active drug could be reduced by 75% while maintaining the same plasma concentration as the originator product. This corresponds to 4 times increase in bioavailability.

"These are remarkable results that prove that the drug solubility increase provided by our Dispersome technology translates into significant improvements in bioavailability. This is not the first time we have demonstrated this critical link, but these results are the most convincing to date and exceeded our expectations", says Dr. Korbinian Löbmann, Chief Scientific Officer in ZERION.: "We are now further optimizing our formulations to select the most promising Dispersome tablet formulation in a follow up animal study. Our goal is to confirm the results in a human bioequivalence study as soon as possible during 2022."
The study results are positive news for the patients, according to Ole Wiborg, ZERION’s CEO:

"More than anything, this is good news for the millions of patients that struggle with having to take a large number of tablets every day. Many elderly patients suffering from cancer and/or chronic diseases need to take several different medications. This can run up to dozens of tablets daily and in addition to the logistical nightmare, difficulties in swallowing the tablets makes this a real burden for many patients, says Ole Wiborg. "We cannot solve all the challenges associated with complex medications, but we are convinced that the reduction in the amount of active drug ingredient and the number of tablets enabled by our Dispersome technology is an important step on the way."
On a global scale, cancer patients are annually taking more than 100 million tablets containing the originator drug that is improved in ZERION’s ZN002 program. The study results indicate that, everything else equal, this could potentially be reduced to as little as 25 million tablets with a new Dispersome product that is patent protected.

In addition to the benefits to the patients, there will be significant positive environment impact. Cancer drugs are most often very toxic and can be poorly degradable in the environment. The reduction in amount of active drug will therefore result in a lower environmental burden both at the site of manufacture as well as in wastewater, since less unabsorbed drug will be excreted from the patients. In addition, the Dispersome technology is based on using beta-lactoglobulin, which is produced from a sustainable source of whey protein, a by-product from cheese production.