On April 29, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY, ISIN DE0007921835) reported that MorphoSys has not exercised the exclusive option to license Vivoryon’s small molecule QPCTL inhibitors in the immuno-oncology field (Press release, Vivoryon Therapeutics, APR 29, 2020, View Source [SID1234556716]).

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During the option period, MorphoSys conducted preclinical studies to assess the potential of small molecule QPCTL inhibitors in oncology as well as the possible benefits of combining these inhibitors with MorphoSys’ proprietary program, tafasitamab, a compound in late-stage development for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). In parallel, Vivoryon, based on its 2019 research collaboration with the University Medical Center Schleswig-Holstein, Campus Kiel, conducted a similar series of preclinical studies.

Ultimately, the data demonstrated a significant additive effect when QPCTL inhibitors were combined with CD20 and other antibodies, indicating that Vivoryon’s lead drug candidate, PQ912, could represent a novel approach for cancer therapy. Vivoryon’s orally available compounds target the QPCTL enzyme, which has been shown to be a modulator of the CD47-SIRP alpha interaction. Left unchecked, this interaction allows cancer cells to escape the body’s innate immune defense through inhibition of the phagocytic activity of macrophages.

Ulrich Dauer, CEO of Vivoryon Therapeutics commented: "Although we are disappointed by MorphoSys’ decision, we remain optimistic about collaborating with other leading oncology companies to further leverage the strength and versatility of our small molecule therapeutics in oncology."

On April 29, 2020 PharmaMar (MSE:PHM) has reported that it has signed an agreement with Immedica Pharma AB (Immedica) for the exclusive distribution and marketing, if approved, of the anti-tumor drug lurbinectedin for territories that include the UK, Ireland, the Nordic countries, some countries within Eastern Europe, the Middle East and North Africa (Press release, Immedica Pharma, APR 29, 2020, View Source [SID1234556715]).

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Under the terms of the agreement, PharmaMar will receive an upfront payment of €2 million and will also be eligible for additional regulatory milestone payments. In the above territories, PharmaMar will receive 50% of future sales in Europe and 40% of future sales in the Middle East. PharmaMar will retain exclusive production rights for the product, which will be supplied to Immedica for commercial and clinical use. In addition, PharmaMar will retain the rights to distribute and market the product in the rest of Europe.

Luis Mora, General Manager of PharmaMar’s Oncology business unit, said: "This is our second strategic alliance with Immedica, this time for the marketing of lurbinectedin in the above territories for the treatment of small cell lung cancer and other possible indications. This agreement is in line with our commitment to bring innovative therapies to patients worldwide."

Anders Edvell, CEO of Immedica, said: " We are truly happy to further expand our highly successful partnership with PharmaMar, and, pending regulatory approval to be able to provide lurbinectedin to patients with significant medical needs."

On April 29, 2020 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (according to IFRS) for the fiscal year 2019 (Press release, Epigenomics, APR 29, 2020, View Source [SID1234556714]). In addition, the Company announces preliminary unaudited financial results for the first quarter of 2020.

HIGHLIGHTS

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At the end of November 2019, a microsimulation model developed by scientists at Harvard Medical School was published in the journal Cancer Medicine. The results show that patient adherence and screening intervals are decisive factors in a successful colorectal cancer (CRC) screening strategy. When these factors are incorporated into the evaluation of various CRC screening measures, blood tests can play a significant role in reducing the incidence and mortality of colorectal cancer.
On February 28, 2020, the Centers for Medicare and Medicaid Services (CMS) opened the National Coverage Determination (NCD) review of Epi proColon, a further significant milestone for Epigenomics AG on its way to U.S. reimbursement by CMS. With the NCD opening, CMS is required by legal statute to publish a decision on the reimbursement of Epi proColon within a maximum period of nine months, i.e. no later than November 28, 2020. A positive reimbursement decision would be a major breakthrough for the marketing of the blood test in the U.S. market.
To finance its ongoing operations, Epigenomics successfully completed a capital increase by way of a private placement on March 31, 2020. The new shares were fully subscribed by institutional investors from Germany and the U.S.A. The gross proceeds of the capital increase amount to approximately EUR 4.0 million and, together with cost reduction measures initiated in connection with the Covid-19 pandemic, will ensure that the Company will have sufficient liquid funds well into Q1 2021.
The US-American National Comprehensive Cancer Network (NCCN) announced on April 23, 2020 that it has included Epi proColon in its updated 2020 NCCN CRC guidelines. Inclusion in the guidelines underscores the potential of Epi proColon to significantly increase screening rates and thereby reach the over 30 million Americans who are at risk for colorectal cancer but do not participate in screening.
Greg Hamilton, CEO of Epigenomics AG: "We have made tremendous progress in the last six months towards Medicare reimbursement, the key prerequisite for full commercialization of Epi proColon. In November, a pivotal microsimulation model was published demonstrating the effectiveness of Epi proColon and in February, CMS initiated its national coverage determination process for the test. In addition, the NCCN CRC screening guidelines were updated to include Epi proColon in a manner consistent with our FDA indications for use as an option for patients who refuse other screening modalities. We believe this positive momentum will culminate in a positive coverage decision later this year."

Financial results 2019

Total revenue decreased to EUR 1.1 million (2018: EUR 1.5 million), mainly due to the decrease in licensing revenue from China. Product revenue increased to EUR 1.0 million from EUR 0.8 million in 2018.
Selling, general and administrative costs increased from EUR 8.7 million (2018) to EUR 8.9 million, mainly due to greater expenses for sales and marketing. Research and development costs rose from EUR 6.4 million (2018) to EUR 7.3 million, largely because of external costs that arose in connection with carrying out the post-approval study for Epi proColon and the HCC cross-section study in the U.S.A.
The decline in EBITDA (before share-based payment expenses) to EUR -13.3 million (2018: EUR -11.4 million) was mainly caused by temporary cost increases in connection with the clinical studies and non-cash expenses.
The net loss for the year increased to approximately EUR -17.0 million (2018: EUR -12.7 million) and was impacted by a one-off non-cash expense of EUR 2.5 million; the loss per share decreased slightly to EUR -0.46 (2018: EUR -0.47).
Cash consumption rose to EUR -13.5 million in fiscal year 2019 (2018: EUR -9.6 million) due to higher operating cash outflows. Furthermore, the prior-year figure was buoyed by a stronger effect from working capital that no longer applied in the reporting period.

Preliminary financial results Q1 2020

Based on preliminary unaudited figures, Epigenomics AG generated revenues of EUR 0.2 million in the first quarter of 2020 (Q1 2019: EUR 0.3 million).
EBITDA (before share-based payment expenses) improved slightly from EUR -3.0 million (Q1 2019) to EUR -2.6 million.
The net loss for the period also improved slightly from EUR -3.0 million (Q1 2019) to EUR -2.9 million.
Cash consumption decreased by EUR 1.0 million to EUR -3.3 million (Q1 2019: EUR -4.3 million).

Outlook 2020

Revenue

The Company expects revenue for the fiscal year 2020 within the range of EUR 1.0 million to EUR 2.0 million.
EBITDA / Cash consumption

Epigenomics’ EBITDA (before share-based payment expenses) is expected to range from EUR -10.5 million to EUR -12.5 million. Based on the Company’s business plan 2020, cash burn is expected to be in line with EBITDA guidance (before share-based payment expenses).

Further Information

The Annual Report 2019 is available on the Epigenomics website:
View Source." target="_blank" title="View Source." rel="nofollow">View Source The Interim Statement for the first quarter 2020 will be published on May 7, 2020 on the Company’s website.

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 3.00 pm (CET) / 9.00 am (EDT). The webcast can be accessed on the Company’s website: View Source

On April 28, 2020 Incurix and the National Cancer Center (NCC), reported their entry into an exclusive license agreement for the new c-myc inhibitor program that the NCC and the Korea Research Institute of Chemical Technology (KRICT) jointly developed (Press release, Incurix, APR 28, 2020, View Source;idx=68&page=1&code=news [SID1234643568]). Under the agreement, Incurix will receive the rights to develop, manufacture and exclusively commercialize myc inhibitors in consideration of upfront, potential development/regulatory milestones and royalties on net sales of the license program of Myc inhibitor.

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As the transcription factor engaged in the growth and death of cells through interactions with DNAs, the c-myc protein is involved in the occurrence and growth of cancer and is over-expressed in various cancers. Drugs that have already been developed to control c-myc expression have failed in clinical trials because of their low selectivity over target substances and the issues of side effects caused by toxicity. For this reason, there are no c-myc inhibitor drugs that have been commercialized yet. The program that Incurix has in-licensed takes a differentiated approach by having the c-myc protein directly target the DNA interacting site to increase the selectivity against the target and minimize side effects. "We will ensure the success of commercializing the FIC transcription factor-targeting drug, which many global pharmaceutical companies could not yet succeed in," said Dr. Kyung-Chae Jeong, Incurix CEO and Senior Director at the NCC Research Center, who led the study. "If this technology succeeds in the commercialization of a drug that has so far been known as difficult in clinical applications, this will mark a significant milestone to cancer treatment," National Cancer Center Director Lee Eun-sook said. She added, "This licensing agreement is the result of the NCC’s continuous research, and we will continue our efforts for the success in commercialization through a good research cycle of research to commercialization."

Incurix is a case of the NCC’s researcher-led startup and was established in 2018 by the support of bio healthcare company builder New Flight, which leads the commercialization of bio-medical fields.

On April 28, 2020 Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) reported that following positive results from phase 1b and long term toxicity studies, the company is now progressing to a phase 2 study of its oral anti‐fibrotic pan‐Lysyl Oxidase (LOX) inhibitor PXS‐5505 for treatment of the rare bone cancer, myelofibrosis (MF) (Press release, Pharmaxis, APR 28, 2020, View Source [SID1234562006]).

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Pharmaxis has received pre IND feedback from the FDA on the PXS‐5505 program in MF and discussed the trial protocol with key opinion leaders in the US, Europe and Australia. Pharmaxis is currently preparing a full IND application for FDA submission mid‐year and appointing a Clinical Contract Research Organisation with a view to commencing recruitment in Q4 2020. The results of the phase 1b study of PXS‐5505 follow a successful phase 1a study reported in October 2019. The phase 1b was a double‐blind placebo controlled study in 16 healthy subjects divided into two groups with each group receiving a different dose or placebo daily for 14 days. The drug was well tolerated and no safety signals were identified during the study. Importantly for potential clinical benefit and in line with the phase 1a results, the data showed a drug with good pharmacokinetics and a dose related strong inhibition of members of the lysyl oxidase family in tissue and blood. PXS‐5505 is an oral drug that inhibits all lysyl oxidase family members (LOX, LOXL1, 2, 3 & 4). The compound successfully cleared pre‐clinical safety including 6‐month toxicity studies and has shown significant reductions in fibrosis in in‐vivo models of kidney, lung, heart, skin and liver fibrosis in addition to myelofibrosis and pancreatic cancer metastases. A recent publication1 reported that two Pharmaxis pan‐LOX inhibitor compounds have significantly decreased the bone marrow fibrotic burden in two different models of primary myelofibrosis. Myelofibrosis is a cancer with a poor prognosis and limited therapeutic options where only allogeneic stem cell transplantation is curative in a small number of patients who are eligible for such a treatment, while administration of a JAK1/2 inhibitor (e.g. ruxolitinib) provides mainly symptomatic relief but carries a risk of worsening blood cell counts. Pharmaxis CEO Gary Phillips said, "With the successful completion of the phase 1b study, 6‐month toxicity studies, support from clinical key opinion leaders and preliminary regulatory feedback, we can now move confidently into a 6‐month phase 2 study in myelofibrosis with meaningful clinical efficacy and safety endpoints. Pharmaxis believes that the current treatments for MF can be augmented by use of a pan‐LOX inhibitor and be disease modifying in a market that is conservatively worth US$1b per annum. We have ongoing discussions with contract research organisations who are confident of a trial recruitment start by the end of the year despite the impact of Covid‐19 on clinical trials worldwide. A number of contingency plans to maintain this timeline are actively being explored." Mr Phillips added, "The proprietary technology Pharmaxis has developed to measure activity and concentration of LOX and its related family members in tissue and blood enables us to clearly understand the role these enzymes have in fibrotic diseases and cancer and will significantly aid patient selection and proof‐of‐mechanism in the upcoming phase 2 trial. We are still gathering data from our academic collaborators who are investigating other cancers where fibrosis plays a significant role. These include pancreatic cancer, oral cancer, glioblastoma and mesothelioma where there is strong pre‐clinical evidence that several members of LOX family play a critical role." Pharmaxis will provide an update on phase 2 trial design once it has received final regulatory clearance in Q3 2020