On December 7, 2021 ISA’s very own Chief Scientific Officer, Cornelis "Kees" Melief, M.D., Ph.D., reported that it will be presenting key learnings in cancer vaccine development in an educational session at the ESMO (Free ESMO Whitepaper) Immune-Oncology Congress 2021, taking place on 8th – 11th December 2021 in Geneva, Switzerland and online (Press release, ISA Pharmaceuticals, DEC 7, 2021, View Source [SID1234596554]).

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Key learnings include:

Direct correlation between strength of cancer vaccine-induced immune response and clinical response
Combination therapy of cancer vaccine with standard of care and/or checkpoint blockers necessary for improved outcomes in treatment of late stage cancers
Session: New indications in head and neck (H&N) cancer (incl anaplastic thyroid) (ID 8)
Presentation title: HPV vaccination for H&N cancer therapy (ID 39)
Authors: Cornelis J. Melief
Date & Time: Thursday, 9th December, 15:30pm – 15:50pm CET
Locations: Room C

Kees Melief comments: "Our findings consistently highlight the direct correlation between the strength of the vaccine-induced immune response and the subsequent clinical response in patients with metastatic (HPV16+) cancers, including oropharyngeal cancer (OPC). Moreover, we argue that to overcome the hostile tumour microenvironment in late-stage cancer, combination of SLP-based therapies with platin-based standard of care and/or checkpoint blocking (anti-PD1 in particular) is necessary for improved treatment outcomes."

Gerben Moolhuizen, Chief Executive Officer, said: " We recently announced that we received FDA Fast Track designation for our lead product ISA101b, for treatment of recurrent and metastatic HPV16+ OPC. We are proud to be presenting our compelling findings in cancer vaccine combination therapy development at this influential medical conference, following the start of a next phase 2 clinical trial investigating the combination of ISA101b and Libtayo in advanced HPV16 positive OPC."

On December 7, 2021 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB,OTCQB:BVAXF) ("BioVaxys" or "Company"), a clinical-stage immunotherapy company developing novel approaches to harness T cells to treat cancer and to detect and prevent emerging infectious diseases, reported that it has entered into a major sponsored research collaboration with The Ohio State University ("Ohio State") to further develop BioVaxys’ haptenized viral antigen platform to create a broadly reactive pan-sarbecovirus vaccine (Press release, BioVaxys Technology, DEC 7, 2021, View Source [SID1234596553]). This is the second research collaboration in the SARS-CoV-2 field between BioVaxys and Ohio State, a leading global academic research institute in the fight against SARS-CoV-2. Ohio State’s Wexner Medical Center serves as a site for SARS-CoV-2 multicenter clinical trials.

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Sarbecoviruses, a subset of the Coronaviridae family, include the emerging SARS2 variants Delta and Omicron. Sarbecoviruses are responsible for two pandemics in less than 20 years including SARS-CoV-1 (SARS1) in 2003 and the current Covid-19 pandemic. Additional SARS-like viruses are continuously being found in nature reservoirs.

Kenneth Kovan, President and Chief Operating Officer of BioVaxys, said, "The repeated emergence of SARS-CoV-2 variants and the potential for new coronaviruses increases the urgency for a universal vaccine. Research suggests that a pan-sarbecovirus vaccine could potentially prevent additional emergent variants and help end the Covid-19 pandemic."

The collaboration will leverage BioVaxys’ proprietary haptenized viral antigen platform to create a broadly reactive pan-sarbecovirus vaccine composed of hapten-modified S-spike protein from SARS-CoV-2 and a hapten-modified S-protein from SARS-CoV-1. Ohio State will conduct animal studies with BVX-0320, BioVaxys’ haptenized SARS-CoV-2 S1 protein vaccine and a new haptenized SARS-CoV-1 S1 protein vaccine from BioVaxys. The study will screen the combination for virus-neutralizing antibodies to SARS-CoV-2, SARS-CoV-1, and other sarbecoviruses, including bat SARS-related CoV and pangolin CoV. Initial data are expected by Spring 2022.

The clinical goal of the program is to stimulate virus cross-reactivity and induce immunity against all or most sarbecoviruses by immunizing people who have convalesced from a documented Covid-19 infection or received a full course of any Covid-19 vaccine, leading to a pan-sarbecovirus vaccine that encompasses current and emerging SARS-CoV-2 variants.

The study will be led by virologist Qiuhong Wang, PhD, Associate Professor, Center for Food Animal Health, Department of Animal Sciences, College of Food, Agricultural, and Environmental Sciences and Department of Veterinary Preventative Medicine at Ohio State. Dr. Wang’s research program focuses on the study of enteric caliciviruses and coronaviruses. She received her Bachelor of Medicine from Beijing Medical University, Master of Science from the University of Tokyo, doctorate from Ohio State University and completed postdoctoral training at the Medical College of Wisconsin.

BioVaxys recently filed a patent application for its haptenized viral antigen vaccine platform to elicit a broad cross-reactive immune response against most or all sarbecoviruses.

For greater certainty, BioVaxys is not making any express or implied claims that the Company can currently treat COVID-19.

On December 7, 2021 AstraZeneca reported that it has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for eplontersen, formerly known as IONIS-TTR-LRX (Press release, AstraZeneca, DEC 7, 2021, View Source [SID1234596552]). Eplontersen is a ligand-conjugated antisense investigational medicine currently in Phase III clinical trials for amyloid transthyretin cardiomyopathy (ATTR-CM) and amyloid transthyretin polyneuropathy (ATTR-PN). It is designed to reduce the production of transthyretin (TTR protein) to treat both hereditary and non-hereditary forms of TTR amyloidosis (ATTR).

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The companies will jointly develop and commercialise eplontersen in the US, while AstraZeneca will develop and commercialise it in the rest of the world, except in Latin America.

ATTR-CM is a systemic, progressive and fatal condition that leads to progressive heart failure and death within four years from diagnosis.1 It remains underdiagnosed and its prevalence is thought to be underestimated due to a lack of disease awareness and the heterogeneity of symptoms.2 Hereditary ATTR-PN is a debilitating disease that leads to peripheral nerve damage with motor disability within five years of diagnosis and, without treatment, is generally fatal within a decade.3

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "Eplontersen has the potential to halt the progression of TTR-mediated amyloidosis, irrespective of whether it’s caused by genetic mutations or aging. Thanks to its precise liver-targeting properties, it also has the potential to be a best-in-class treatment for patients suffering from this devastating disease and who currently have limited options."

Hereditary ATTR-PN is expected to be the first indication for which the companies will seek regulatory approval for eplontersen, with the potential to file a new drug application with the US Food and Drug Administration by the end of 2022.

Financial considerations
AstraZeneca will pay Ionis an upfront payment of $200m and additional conditional payments of up to $485m following regulatory approvals. It will also pay up to $2.9bn of sales-related milestones based on sales thresholds between $500m and $6bn, plus royalties in the range of low double-digit to mid-twenties percentage depending on the region. The collaboration includes territory-specific development, commercial and medical affairs cost-sharing provisions.

The transaction will be funded with cash and is expected to be neutral to Core earnings in 2021. It will be accounted for as an intangible asset acquisition, recognised initially at the upfront amount, with any potential future milestone payments capitalised into the intangible asset as they are recognised.

Ionis will continue to manufacture and supply eplontersen for the existing clinical studies and process qualification. AstraZeneca will be responsible for commercial supply, with transition timing to be agreed by both parties. AstraZeneca will book all sales generated under the agreement.

The transaction is expected to close in the fourth quarter of 2021, subject to customary closing conditions and regulatory clearances. The transaction does not impact the AstraZeneca’s financial guidance for 2021.

Notes

Eplontersen
Eplontersen is a ligand-conjugated antisense (LICA) investigational medicine designed to reduce the production of transthyretin, or TTR protein, to treat all types of ATTR, a systemic, progressive and fatal disease.

TTR Amyloidosis (ATTR)
Cardiomyopathy and polyneuropathy due to ATTR are caused by aging or genetic mutations resulting in misfolded TTR protein and accumulation as amyloid fibrils in the cardiac myocardium and peripheral nerves, respectively. In patients with ATTR, both the mutant and wild type TTR protein builds up as fibrils in tissues, such as the peripheral nerves, heart, gastrointestinal system, eyes, kidneys, central nervous system, thyroid and bone marrow. The presence of TTR fibrils interferes with the normal functions of these tissues. As the TTR protein fibrils enlarge, more tissue damage occurs and the disease worsens, resulting in poor quality of life and eventually death. Worldwide, there are an estimated 300,000 – 500,000 patients with ATTR-CM4,5 and 10,000 – 40,000 patients with ATTR-PN2.

On December 7, 2021 HiberCell, a clinical-stage biotechnology company developing therapeutics to address therapeutic resistance, cancer relapse and metastasis, reported that it will present new data from the ongoing phase 2 open-label clinical trial evaluating the company’s odetiglucan (Imprime PGG), in combination with Merck’s anti-PD-1 therapy pembrolizumab, in patients with metastatic breast cancer at the 2021 San Antonio Breast Cancer Symposium (SABCS) from December 7-10, 2021 (Press release, HiberCell, DEC 7, 2021, View Source;utm_medium=rss&utm_campaign=hibercell-to-present-new-data-on-odetiglucan-plus-pembrolizumab-in-ongoing-phase-2-metastatic-breast-cancer-trial-at-san-antonio-breast-cancer-symposium [SID1234596551]).

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Odetiglucan is a Dectin-1, pattern recognition receptor agonist that has been observed to drive a coordinated innate and adaptive anti-cancer immune cell response in metastatic hormone receptor-positive, HER2-negative breast cancers (mBCA). Hibercell’s prior data supports its belief that combining odetiglucan with pembrolizumab will enhance mBCA patient sensitivity to checkpoint inhibitors (CPI) in those patients who have progressed through hormonal therapy with a CDK4/6 inhibitor. The World Health Organization assigned "odetiglucan" as the International Nonproprietary Name (INN) for Imprime PGG as of November 2021.

Odetiglucan plus pembrolizumab has shown encouraging results in preclinical studies and a prior phase 2 clinical trial, called IMPRIME 1. The ongoing phase 2 clinical trial is now recruiting patients at the SUNY Stony Brook Cancer Center, while actively opening additional clinical trial sites in the U.S.

Presentation number: OT1-18-05
Title: A Multicenter, Open-label, Phase 2 Study of Imprime PGG and Pembrolizumab in Patients with Metastatic Breast Cancer (mBCA) Who Have Progressed Through Prior Hormonal Therapy
Presenter: Alison Stopek, M.D., Stony Brook Cancer Center
Time/Date: Wednesday, December 8, 2021: 5:00 pm – 6:30 pm CT
For more information about HiberCell’s clinical trials, visit the website at www.HiberCell.com.

On December 7, 2021 Freenome, a privately held biotech company, reported a Series D funding of $300 million (Press release, Freenome, DEC 7, 2021, View Source [SID1234596550]). This brings the company’s total financing to over $800 million since the company was founded in 2014.

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This round of financing was led by investors Perceptive Advisors and RA Capital Management, joined by existing investors including a16z Life Sciences Growth Fund, the American Cancer Society’s BrightEdge Ventures, Artis Ventures, Bain Capital Life Sciences, Catalio Capital Management, Cormorant Capital, DCVC, Farallon Capital Management, Fidelity Management and Research Company LLC, GV, Janus Henderson Investors, Kaiser Permanente, Novartis, Polaris Partners, Ridgeback Capital Management, Roche Venture Fund, Rock Springs Capital, Sands Capital, Section 32, Soleus Capital Management, with funds and accounts advised by T. Rowe Price Associates, Inc.

In addition, there were several new biotech institutional investors well-placed to support the company’s mission including ArrowMark Partners, Byers Capital, Eventide Asset Management LLC, HBM Healthcare Investments, Intermountain Ventures, Logos Capital, Pura Vida Investments, Suvretta Capital Management, and other undisclosed funds.

The funding will support the advancement of the company’s colorectal cancer (CRC) screening test and expansion of its multiomics platform to other cancers. Freenome’s platform uses a routine blood test to detect cancer in its earliest stages, when it is most treatable.

It is estimated that nearly 53,000 people will die from CRC this year and only 67% of average-risk individuals over the age of 50 are up to date on CRC screening.¹ With recent guideline changes lowering the age from 50 to 45,² even more people need to be screened. Freenome’s multiomics blood test can help address adherence challenges with existing approaches by providing a convenient and patient-friendly option. The test is being validated in PREEMPT CRC, Freenome’s large, prospective registrational study, currently in the final stages of enrollment.

The company is also extending its platform to develop tests for other cancers and recently presented promising data in the detection of pancreatic cancer.

"We appreciate the shared belief our investors have in what is possible when it comes to fighting cancer," said Mike Nolan, chief executive officer of Freenome. "This funding gets us closer to bringing our early cancer detection tests to everyone, ultimately saving lives."

"We’re excited about Freenome’s multiomics platform and its ability to detect not just CRC but also other cancers," said Ellen Hukkelhoven, Ph.D., Perceptive Advisors. "We’re proud to help drive continued progress in bringing Freenome’s tests to the forefront of patient care."

"Freenome’s science backs up their mission, which is really exciting," said Peter Kolchinsky, Ph.D., RA Capital Management. "Detecting cancer when it is most treatable is critical to saving lives, and Freenome’s platform has demonstrated that’s possible."