On March 24, 2022 Insilico Medicine ("Insilico"), a clinical stage end-to-end artificial intelligence (AI)-driven drug discovery company, reported it has entered into a strategic collaboration with EQRx, a company committed to developing and delivering innovative medicines to patients at radically lower prices (Press release, Insilico Medicine, MAR 24, 2022, View Source [SID1234610938]).

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The collaboration will combine Insilico’s Pharma.AI platform to advance de novo small molecule design and generation with EQRx’s clinical development and commercialization expertise. EQRx and Insilico will engage in a co-development partnership whereby each party will be eligible for a profit share proportional to its respective level of investment.

Pursuant to the collaboration agreement, the parties will identify and select up to three therapeutics targets leveraging Insilico’s AI-driven platform, Pharma. AI. Insilico will lead the drug discovery from small molecule hit identification through lead optimization and preclinical candidate nomination to Investigational New Drug (IND) application. EQRx will assume responsibility for driving clinical development, regulatory activities and commercialization. Insilico has the option to invest in the product candidate(s) at various clinical development stages in return for increased commercialization profits.

"Both EQRx and Insilico Medicine strive to accelerate the discovery and development of new medicines and make effective therapeutics more accessible and affordable. This partnership will combine our end-to-end AI-powered drug discovery capabilities with EQRx’s innovative partnership model and expertise in clinical development and patient access to accelerate the discovery and development of innovative therapies" said Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine.

"We are pleased to partner with Insilico Medicine, a leader in AI-based drug discovery," said Carlos Garcia-Echeverria, PhD, chief of Rx Creation at EQRx. "This collaboration will further expand our early-stage R&D efforts to fuel potential pipeline growth as we continue to apply the best of today’s innovation in biomedical sciences and digital solutions to discover high-quality, innovative and more affordable medicines."

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 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that its partner Adlai Nortye has advanced to the third and final dose escalation cohort of the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer (Press release, Oncolytics Biotech, MAR 24, 2022, View Source [SID1234610881]). The trial’s first two cohorts have completed their dose escalation evaluation periods and indicated pelareorep in combination with paclitaxel was well-tolerated with no new safety signals observed to date.

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The dosing regimens for the bridging trial’s second and third cohorts are equivalent to those administered in Oncolytics’ randomized North American breast cancer trials, IND-213 and BRACELET-1, respectively. In IND-213, HR+/HER2- breast cancer patients treated with pelareorep and paclitaxel showed a statistically significant, near doubling of overall survival compared to those treated with paclitaxel alone. BRACELET-1, an ongoing phase 2 study evaluating pelareorep-paclitaxel combination therapy with and without a checkpoint inhibitor, is on track for a top-line data readout in Q4 2022 that will inform the design of a registrational study in the United States. Final results from the Chinese bridging trial are expected to accelerate pelareorep’s development in territories such as China, Hong Kong, and Macau, by allowing Adlai Nortye to include data from IND-213 and BRACELET-1 in future submissions to regulators in these jurisdictions.

"The territories covered by our partnership with Adlai Nortye represent an important component of our business development strategy, as China and the other areas in which Adlai Nortye anticipates commercializing pelareorep are among the largest in the world and growing rapidly," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "With the bridging trial entering its final cohort less than six months after dosing began, Adlai is making major strides towards satisfying the regulatory criteria needed to accelerate pelareorep’s development in China. The trial also continues to generate positive safety data, which will serve us well as we collaborate with Adlai Nortye to advance pelareorep towards approval in key global markets."

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the U.S. in 20201. In China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 20202.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) gets worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

On March 24, 2022 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported the publication of preclinical data from MP0317 in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Molecular Partners, MAR 24, 2022, View Source [SID1234610918]). MP0317 is the Company’s second immuno-oncology program to enter clinical studies and is designed to target both FAP (fibroblast activation protein), a protein found in high density around tumors, and the immunostimulatory protein CD40, to enable tumor-localized immune activation.

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The CD40 receptor, which is expressed on dendritic cells, B cells and macrophages, is an attractive target for cancer immunotherapy. However, administration of CD40-targeting monoclonal antibodies has challenges with achieving a meaningful clinical response. Low concentrations result in minimal efficacy, but higher concentrations rapidly lead to systemic toxicity, limiting the therapeutic window achievable with systemic CD40 activation. The DARPin therapeutic candidate MP0317 is designed to specifically induce CD40-mediated immune activation only in the FAP-rich local tumor environment, preventing systemic immune activation.

The published study confirms that MP0317 is inducing FAP-dependent CD40-mediated B and myeloid cell activation, thus supporting the candidate intended mechanism of action of tumor-localized immune activation without the systemic toxicity observed with other CD40-targeting agents. This study suggests that MP0317, as a DARPin therapeutic candidate, has the potential for a broader therapeutic window and thus improved clinical activity compared to CD40 agonist antibodies. The publication can be found in this link.

MP0317 is currently being tested in a Phase 1 clinical trial sponsored by the Company. The open-label dose escalation study is designed to assess the safety and tolerability as well as pharmacokinetics and pharmacodynamics of MP0317 as a monotherapy in patients with solid tumors known to express FAP. In addition to evaluating monotherapy dynamics, the study will gather biomarker data to support the establishment of combination studies of MP0317 with other therapies in specific indications.

Initial data from the ongoing Phase 1 clinical trial are expected in the second half of 2022.

On March 24, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported it will present a poster entitled ‘Preclinical efficacy of the Wnt pathway inhibitor RXC004 in combination with anti-cancer therapies’ on 12 April 2022 at the forthcoming hybrid American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place inNew Orleans, US on 8-13 April 2022 (Press release, Redx Pharma, MAR 24, 2022, View Source [SID1234610843]).

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The poster will present preclinical data on the potential benefits of RXC004, Redx’s lead oncology asset, in combination with clinically relevant standard of care chemotherapy regimens. RXC004 is a potent, orally active porcupine inhibitor in clinical development as a targeted therapy for Wnt-ligand driven cancer. It is currently in Phase 1 clinical studies in combination with nivolumab, an anti-PD-1 antibody, and is also being evaluated as a monotherapy in Phase 2 proof-of-concept clinical studies for the treatment of genetically selected pancreatic cancer, genetically selected metastatic colorectal cancer and unselected biliary cancer.

Title: Pre-clinical efficacy of the Wnt pathway inhibitor RXC004 in combination with anti-cancer therapies
Abstract: 2566
Day/Date: Tuesday 12 April 2022
Session name and category: PO.ET06.09-Cell Cycle, Replication Inhibitors, and Immunotherapy Agents

The abstract is available via the AACR (Free AACR Whitepaper) Annual Meeting website at:View Source!/10517/presentation/15373

The poster will be available from Friday 8 April on the AACR (Free AACR Whitepaper) e-poster website and the investor section of the Company’s website at: View Source