On March 24, 2022 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (according to IFRS) for fiscal year 2021 (Press release, Epigenomics, MAR 24, 2022, View Source [SID1234610842]).

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OPERATIONAL DEVELOPMENTS

In 2021, Epigenomics started preparations for the FDA clinical trial for the Company’s Epi proColon "Next-Gen" test. Epigenomics expects to start enrollment this summer. The study will require approximately 16,000 participants and will take about two years to complete. If the test receives FDA approval and meets the criteria for blood-based colorectal cancer screening tests set by the Centers for Medicare and Medicaid Services (CMS) – which Epigenomics is confident of – Epi proColon "Next-Gen" will be automatically reimbursed by CMS. The Company will focus its efforts on the activities required to bring Epi proColon "Next-Gen" to market.
Until the FDA approval of Epi proColon "Next-Gen", Epigenomics still has the opportunity to obtain CMS reimbursement for its current test Epi proColon via legislation. Recently President Biden announced a reignition of the Cancer Moonshot, a program launched in 2016 with the mission to accelerate the rate of progress against cancer. The passage of a bill to reimburse a blood test for CRC screening would serve the program’s target as well as two other core goals of the Biden administration: Fighting racial healthcare discrimination and the COVID-19 pandemic, since CRC affects a disproportionate number of People of Color, and the pandemic has significantly reduced CRC screening participation rates in the U.S. As promising as the initiative is, it is currently impossible to make a reliable statement on whether a relevant bill will be passed.
In 2021, the Company has also focused on maximizing its financial position to enable the development of the Epi proColon "Next-Gen" test. In this context, cost-cutting measures were initiated, the sale of a non-essential portion of the Company’s biobank as well as the issuance of convertible bonds in the amount of EUR 22.0 million have strengthened the balance sheet and given Epigenomics the ability to move forward with the FDA trial in 2022. However, the Company will need to raise additional capital to complete the trial and the subsequent FDA approval. The Company is evaluating numerous financing alternatives including exchanges with more potential access to capital.
The Executive Board has added two new members. President and Chief Scientific Officer Andrew Lukowiak, Ph.D., started as President and Chief Scientific Officer in December 2021 and Jens Ravens has taken over the CFO position in February 2022. The Executive Board looks forward to working together and is convinced that Epigenomics is well positioned to master the challenges to achieve the Company’s goals.
Greg Hamilton, CEO of Epigenomics AG: "We are excited about the future of Epigenomics and see our improved Epi proColon "Next-Gen" test as a major untapped opportunity in the cancer screening market. We expect to initiate the clinical trial this summer and to publish preliminary data for the "Next-Gen" test. We believe our blood based "Next-Gen" will be a cost-effective solution in the market."

Financial results 2021

Total revenue increased to EUR 6.2 million (2020: EUR 0.8 million), mainly due to the sale of the blood sample database ("biobank") in August 2021. In contrast, revenues from Epigenomics’ test kits remained low both in the U.S.A. and in Europe, amounting in total in the fiscal year to EUR 0.4 million (2020: EUR 0.6 million) in line with the expectations, due to the pandemic-related reduction of patient office visits.
Selling, general and administrative costs in the amount of EUR 7.5 million remained roughly equivalent to previous year’s level of EUR 7.3 million and is inclusive of the costs related to the biobank sale.
EBITDA (before share-based payment expenses) improved to EUR -1.8 million (2020: EUR -10.5 million) and exceeded the forecast of EUR -3.0 million adjusted in the third quarter due to currency effects.
The net loss for the year fell to EUR -2.4 million (2020: EUR -11.7 million); the loss per share also decreased to EUR -0.22 (2020: EUR -2.02).
Cash consumption improved to EUR -4.2 million in fiscal year 2021 compared to EUR -9.6 million in 2020.
Outlook 2022

Revenue

As the Company is not currently actively marketing Epi proColon due to the lack of CMS reimbursement, Epigenomics estimates its 2022 revenue between EUR 0.3 million and EUR 0.8 million. If Medicare reimbursement is indeed achieved via legislation in 2022, the Company is likely to amend the revenue forecast.

EBITDA / Cash consumption

For EBITDA (before share-based payment expenses), Epigenomics forecasts a range of EUR -15.0 million to EUR -17.0 million. This assumes that the Company initiates the Epi proColon "Next-Gen" trial in the summer of 2022. If this trial is delayed or enrollment is slower than anticipated then the forecast for the adjusted EBITDA is likely to improve. The anticipated spend for the clinical trial in 2022 will be aligned with the Company’s ability to raise funds for the remainder of the trial in 2023 and 2024.
Further information

The Annual Report 2021 is available on the Epigenomics website at: View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 11.00 am (EDT). The webcast can be accessed on the Company’s website: View Source

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

On March 24, 2022 Glycotope GmbH, a biotechnology company developing antibodies against proteins carrying tumor-specific carbohydrate structures, reported that is has completed a re-focusing of its strategy to better deliver value from its powerful, proprietary glycobiology-informed technology platform (Press release, Glycotope, MAR 24, 2022, View Source [SID1234610841]). The Company has also expanded its senior leadership team to accelerate the execution and delivery of this strategy.

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Following the recent spin-out of its services business Glycotope is now entirely focused on drug discovery and development, utilizing its proprietary technology platform to develop uniquely tumor-specific monoclonal antibodies.

As a result of this shift in strategy and to optimize its delivery, the Company has undertaken an expansion of its senior leadership roles. Henner Kollenberg remains as Chief Executive Officer of Glycotope, Antje Danielczyk has been appointed Chief Operating Officer, responsible for Research & Development operations, while Patrik Kehler has been appointed Chief Scientific Officer, leading research and development.

Glycotope’s antibodies target specific tumor-associated carbohydrate structures or protein/carbohydrate combined glyco-epitopes (GlycoTargets). Targeting these specific antigens enables broad indication range, long-term treatment potential and reduced on-target/off tumor toxicity, key elements of highly potent therapies. Based on this unrivalled tumor-specificity, Glycotope’s antibodies are highly suitable for a multi-function platform approach with independent modes of action to provide a tailored therapy format for as many patients as possible.

The Company is currently developing a pipeline of antibody therapeutics which includes in-house and partnered pre-clinical programs:

GT-001: A humanized IgG1 mAb with unrivaled fine-specificity, specifically targeting the tumor-associated Lewis Y (LeY, CD174) carbohydrate antigen. GT-001 binds to a high percentage of breast cancers, non-small cell lung cancer, colorectal cancer, head and neck cancer, small cell lung cancer and ovarian cancer patient samples and is effectively internalized, making it suitable for ADC or CAR development.

GT-002: An IgG1 mAb targeting LYPD3 (C4.4A) with increased tumor-specificity. LYPD3 is expressed in various cancer indications with high medical need, including squamous cell carcinoma of the head and neck (HNSCC). Upon binding to LYPD3, the antibody is effectively internalized. The improved tumor-specificity of GT-002 results in reduced binding to healthy-tissue expressed LYPD3 making it suitable for the development of highly potent therapies like ADCs or CARs.

GT-00A: A humanized IgG1 mAb targeting a carbohydrate/protein combined epitope on MUC1 called tumor-associated (TA)-MUC1. GT-00A is in pre-clinical development as an IL-15-based immuno-cytokine and as an antibody-drug-conjugate (ADC) developed by Daiichi-Sankyo. TA-MUC1 is a novel tumor-specific protein/carbohydrate combined glyco-epitope on the tumor-marker MUC1. The target is expressed on many epithelial tumor types including primary tumor, metastases and cancer stem cells, but is virtually absent on normal cells. The main target indications are ovarian, lung and breast cancers but Glycotope believes GT-00A has further potential for treatment of cervical, endometrial, gastrointestinal, kidney, urothelial and other cancers.

Henner Kollenberg, Glycotope’s Chief Executive Officer, said "We believe there are a wealth of opportunities for our platform to deliver powerful new antibody therapeutics for oncology indications. The recent sale of our services business and the leadership team expansion we are announcing today marks a renewed focus on drug discovery and development. We look forward to the next stage of Glycotope’s development with great excitement about what we will be able to achieve as Company, for our partners and, ultimately, for patients."

On March 24, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that an investigator-initiated trial (IIT) will commence shortly in the US investigating 64Cu SAR-bisPSMA in prostate cancer (NCT05286840)1 (Press release, Clarity Pharmaceuticals, MAR 24, 2022, View Source [SID1234610816]).

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The X-Cancer’s investigator-led trial of SAR-bisPSMA in known or suspected prostate cancer (X-Calibur) is a Phase I/II IIT in up to 150 patients at the Urology Cancer Center and GU Research Network (GURN) in Omaha, Nebraska, sponsored by Dr Luke Nordquist. It will investigate a broad spectrum of prostate cancer patients by imaging with 64Cu-SAR-bisPSMA on the day of administration and at later timepoints. The X-Calibur trial will be assessing the safety of 64Cu SAR-bisPSMA as well as looking at the impact of the product on staging and clinical management of participants with prostate cancer.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to support Dr Nordquist’s trial, who has had first-hand experience with our products in the theranostic 64Cu/67Cu SAR-bisPSMA SECuRE trial (NCT04868604)2. We look forward to continuing to work together on progressing the development of our optimised SAR-bisPSMA agent in prostate cancer and exploring the many benefits of this product as part of Clarity’s Targeted Copper Theranostics (TCT) program in pursuit of our ultimate goal of improving treatment outcomes for cancer patients."

Prostate cancer is a key focus of Clarity’s Targeted Copper Theranostics (TCT) program, where the IIT at GURN is the fourth clinical trial utilising the SAR-bisPSMA agent in prostate cancer. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)2, has been able to successfully image patients with metastatic castrate resistant prostate cancer from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)3, is well underway, with over 50% of participants recruited in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy). The most recent diagnostic 64Cu SAR-bisPSMA trial in the US, COBRA (NCT05249127)4, has received a Study May Proceed Letter from the FDA in February 2022, with recruitment of participants with biochemical recurrence of prostate cancer planned to commence in the second quarter of 2022. Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence.

Dr Luke Nordquist, CEO and Urologic Medical Oncologist at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are very impressed with the PET imaging data collected at GURN from the SECuRE trial which indicates high tumour targeting and retention, especially compared to first-generation PSMA agents that use a single PSMA binding motif and have very short half-lives of 1-2 hours. As such, we were excited to seize the opportunity and continue the development of SAR-bisPSMA in the diagnostic IIT at GURN, continuing to further expand the clinical benefits of the product and to provide our own prostate cancer patients with the very best technologies available.

"In addition to the clinical advantages, we have also been excited about the supply and logistical benefits of SAR-bisPSMA as a TCT, which can be distributed on-demand and in large scale from central manufacturing facilities. TCT can provide universal access to radiopharmaceuticals in every zip-code in the continental US, something that is lacking with current approved agents. GURN has a significant backlog of patients who cannot access sufficient quantities of PSMA imaging agents based on gallium-68 (Ga-68) or fluorine-18 (F-18) due to the logistical issues of short half-life isotopes. We have already experienced the benefits of Cu-64 based products and their longer shelf-life of up to 48 hours with our current trial with Clarity, and we expect minimal delays and interruptions as we look to address the large backlog of treatments, providing up to 150 prostate cancer patients with the critical imaging required to improve patient outcomes."

Dr Taylor said, "This fourth clinical trial of SAR-bisPSMA will build on the exciting data to date as we progress this product towards the market. The trial will also continue to demonstrate the numerous benefits of the centrally manufactured, on-demand distribution model of ready-to use cGMP TCT products over the first-generation short half-life products using Ga-68 and F-18. We look forward to Dr Nordquist advancing the X-Calibur trial and hope it will improve cancer diagnosis and ensure that critical treatments will be available to patients and their treating staff on time and at a convenient location when and where they need it most."

This announcement has been authorised for release by the Executive Chairman.

On March 24, 2022 AstraZeneca reported that The CALLA Phase III trial for Imfinzi (durvalumab) given concurrently with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of improving progression-free survival (PFS) versus CRT alone in the treatment of patients with locally advanced cervical cancer (Press release, AstraZeneca, MAR 24, 2022, View Source [SID1234610807]).

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Bradley Monk, MD, FACOG, FACS, Professor at the University of Arizona College of Medicine and principal investigator in the CALLA Phase III trial, said: "While today’s results were not statistically significant, they underscore the need for further evaluation of novel therapeutic options and will inform future strategies to improve treatment for patients with locally advanced cervical cancer."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "CALLA tested a novel immunotherapy approach in locally advanced cervical cancer, a devastating and complex disease where many patients progress following available treatments. While the results were not what we hoped for, insights from the trial will advance our understanding and application of immunotherapy across our broad clinical development programme, exploring the benefits of Imfinzi in many tumour types."

The safety and tolerability in this trial were consistent between the two arms and no new unexpected safety findings were observed. The data will be presented at a forthcoming medical meeting.

Notes

Locally advanced cervical cancer
Cervical cancer is the eighth most common, and ninth most deadly, cancer worldwide, with approximately 600,000 people diagnosed each year.1 Approximately 40-50% of cervical cancer cases are diagnosed in the locally advanced stage.2 Following current standard-of-care treatment, platinum-based chemotherapy with radiation therapy, patients with locally advanced cervical cancer face an approximately 40% chance of disease recurrence and a five-year survival rate of about 65-70%.2,3 The standard-of-care treatment for these patients has not changed in over two decades.4

CALLA
CALLA is a randomised, multi-centre, double-blind, global Phase III trial in which 770 patients with locally advanced cervical cancer were treated with standard-of-care CRT in combination with either a 1,500mg fixed dose of Imfinzi or placebo every four weeks for up to 24 cycles or until disease progression.

The trial was conducted at 120 centres across 15 countries including in the US, Europe, Latin America, Africa and Asia. The primary endpoint was PFS and key secondary endpoints included overall survival and safety and tolerability. For more information about the trial, please visit Clinicaltrials.gov.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy, and is the global standard of care in this setting based on the PACIFIC Phase III trial.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer based on the CASPIAN Phase III trial.

In the past year, Imfinzi has demonstrated clinical benefit in multiple additional cancer settings with positive Phase III trials in advanced biliary tract cancer (TOPAZ-1), unresectable advanced liver cancer (HIMALAYA) and metastatic NSCLC (POSEIDON).

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with small cell lung cancer, NSCLC, bladder cancer, several gastrointestinal cancers, ovarian cancer, endometrial cancer and other solid tumours.

AstraZeneca in immuno-oncology
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s Immuno-Oncology (IO) portfolio is anchored in immunotherapies that have been designed to overcome evasion of the anti-tumour immune response. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab and other novel antibodies in multiple tumour types, stages of disease and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.

In addition, the ability to combine the IO portfolio with radiation, chemotherapy and targeted small molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On March 23, 2022 Centenaire Biosciences reported the company had attracted a total of 20 billion won in Series A investment from SD Biosensor’s affiliates Bionote and SDB Investment on the 18th (Press release, Centenaire Biosciences, MAR 23, 2022, View Source [SID1234643838]).

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Sanctnaire, which is developing an innovative antibody platform centered on the field of anti-cancer and immune disease treatment, has succeeded in attracting large-scale investment within 10 months of its establishment, and is developing, pipeline expansion, and additional platforms for clinical entry of its core pipeline ‘CTN001’. We plan to use the investment for technology development.

Centenaire, which has the goal of ‘development of innovative new drugs for the era of average lifespan of 100 years’ with the French word ‘Centenaire’ meaning 100 years as its motif, is based on its proprietary antibody platform technology to treat cancer, autoimmune diseases, and brain nerve diseases. We are building pipelines in various fields, including therapeutics.

Santnaire’s core pipeline, the next-generation HER2-targeting antibody ‘CTN001’, is indicated for HER2-low-expressing breast cancer, not HER2-positive breast cancer, which is targeted by existing HER2-targeting antibodies. HER2 low-expression breast cancer is a newly classified cancer type that accounts for more than 50% of all breast cancers, but has great market potential as there is no approved target treatment.

Yang Ki-hyuk, CEO of Sanctnaire, said, "With this Series A investment, we will begin full-scale development and expansion of the antibody pipeline using platform technology," and added, "We will develop safe and effective antibody drugs, starting with our flagship pipeline ‘CTN001’. "We will prove Nair’s differentiated value," he said.

He continued, "CTN001 showed strong efficacy in HER2-low-expressing carcinomas that do not respond to the HER2-targeting antibody Herceptin in preclinical trials," adding, "Antibody-drug complex (ADC) and T-cell engage, which have recently shown positive results and are expanding treatment options for cancer patients. "As there are limits to its use as a combination treatment for early-stage cancer due to safety issues, CTN001 will be an alternative to overcome this," he emphasized.

Meanwhile, Sanctnair is a new bio company established by researchers, including CEO Yang Ki-hyuk, who was a founding member of Medytox and oversaw R&D, to develop a next-generation antibody platform based on innovative antibody technology introduced from Medytox. Sanctnaire is discussing collaboration in various fields with BioNote, which participated in the Series A investment, along with cooperation with its affiliate Medytox, and is pursuing the establishment of a network with several domestic universities and research institutes to improve the efficiency of research and development.