On June 11, 2021 The Executive Board of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that it has taken a decision in principle, with the approval of the Supervisory Board, to issue a subordinated mandatory convertible bond in an aggregate principal amount of up to EUR 18,150,000.00 (Press release, Epigenomics, JUN 11, 2021, View Source [SID1234583893]). This will be convertible into up to a total of 15,000,000 no-par value registered shares of the Company with a share of up to a total of EUR 15,000,000.00 in the share capital of the Company.

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The mandatory convertible bond will consist of up to 181,500 notes with a nominal amount of EUR 100.00 each, which will be offered for subscription by means of a rights offering initially to existing shareholders of Epigenomics AG. Shareholders will also be given the option of oversubscription. Furthermore, the Company plans to organize stock exchange trading of the subscription rights. The Company will shortly mandate an investment bank to accompany the issue and will start preparing a securities prospectus if legally necessary for the offering. The dates for the publication of a rights offering and the start of the subscription period will be published in due course.

In addition, today, Epigenomics AG has entered into a back-stop agreement with its shareholder Deutsche Balaton Aktiengesellschaft under which the latter has undertaken to acquire all notes in an aggregate principal amount of up to EUR 18,150,000.00 by exercising its subscription rights and by the acquisition of notes not subscribed via subscription rights and oversubscription rights. The obligation of Deutsche Balaton Aktiengesellschaft shall lapse in particular at the end of October 31, 2021, if the rights offering has not been published in the Federal Gazette by that date.

The notes will be non-interest-bearing (zero coupon) and have a term until 2027. In addition to conversion rights for the holders or creditors of the notes, they will also include a conversion obligation for all outstanding notes not yet converted at maturity.

Subject to any anti-dilution adjustments, the conversion price per share is EUR 1.21, i.e. each note with a nominal amount of EUR 100.00 will be convertible into 82 (eighty-two) no-par value registered shares representing EUR 1.00 per share of the Company’s share capital.

Epigenomics AG plans to use the proceeds from the convertible bond issue to finance its operations. Primarily, this is the completion of the development of the blood-based colorectal cancer screening test Epi proColon Next-Gen by conducting a clinical study in the U.S.A., which is required to obtain approval for the test by the U.S. Food and Drug Administration (FDA).

On June 11, 2021 Imago BioSciences, Inc. ("Imago"), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported updates on two Phase 2 clinical trials of bomedemstat, one in patients with essential thrombocythemia (ET) and, the second in patients with advanced myelofibrosis (MF) (Press release, Imago BioSciences, JUN 11, 2021, View Source [SID1234583909]). The data were presented in two e-poster presentations during the 26th European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress (EHA 2021), taking place June 9-17, 2021.

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Poster title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) in Patients with Essential Thrombocythemia

The presented data show that bomedemstat was generally well-tolerated by patients with ET and demonstrated encouraging clinical activity as a monotherapy, showing symptomatic improvement in patients with significant MPN symptoms. Of the 12 patients dosed with bomedemstat for more than six weeks, 83% displayed substantial improvements in platelet count reduction, achieving platelets ≤ 400×109/L. Of the 10 patients entering the study with elevated white blood cell counts and evaluable at 12 weeks, 80% saw these counts fall within normal ranges. These improvements were achieved while maintaining stable hemoglobin levels. There were no dose limiting toxicities, no safety signals per Safety Advisory Board and one serious adverse event that was deemed unrelated.

"These encouraging data show that bomedemstat was well-tolerated and has the potential to bring meaningful clinical benefits for patients with essential thrombocythemia," said Wan-Jen Hong, M.D., chief medical officer of Imago BioSciences. "We are excited about these preliminary results from our lead asset, and look forward to completing enrollment of this study in order to lay the groundwork for a planned pivotal study in essential thrombocythemia."

Poster title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) in Patients with Advanced Myelofibrosis

The presented data from an ongoing Phase 2 study indicated that bomedemstat as a monotherapy for patients with advanced MF offered a distinct clinical benefit profile, and was generally well-tolerated among participants. Of the 16 patients evaluable at 24 weeks, 94% showed improvements in total symptom scores (TSS), with a reduction of 50% or greater in almost a third of this subset. In an analysis of 34 patients evaluated for mutant allele frequencies (MAFs), MAFs decreased in 44% of patients and were stable in 47%, with no new mutations in up to 660 days of follow-up. Of the 18 patients evaluable for splenomegaly at 24 weeks, 89% had a reduction in spleen volume, with that of one patient decreasing by more than 35%. There were no dose limiting toxicities, no safety signals per Safety Advisory Board, and no progression to acute myeloid leukemia (AML).

"These updated clinical results reveal that bomedemstat continues to offer distinct clinical benefits for patients with advanced MF, showing overall improvement in total symptom scores, spleen volumes and anemia," said Wan-Jen Hong, M.D., chief medical officer of Imago BioSciences. "The study is now fully enrolled, so we look forward to sharing our cumulative data as we continue to advance this investigational program for patients who have few therapeutic alternatives."

Poster presentations are available on the EHA (Free EHA Whitepaper) Virtual Congress platform. The posters will also be available on the Imago website here.

On June 10, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that the first patient has been dosed in a Phase 1b clinical trial of Oasmia’s Docetaxel micellar in patients with advanced prostate cancer (Press release, Oasmia, JUN 10, 2021, View Source [SID1234583814]). The trial is being conducted by the Swiss Group for Clinical Cancer Research (SAKK).

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Oasmia’s Docetaxel micellar is a solvent-free formulation of docetaxel developed to avoid the need for the solubility enhancers in solvent based docetaxel, and the mandatory high-dose steroid premedication, while providing an effective treatment option. Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths.

The SAKK 67/20 trial (NCT04629781) is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in Switzerland, recruiting 18 chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) with adequate bone marrow, liver and renal function. The primary objective of this trial is to determine the maximum tolerated dose of Docetaxel micellar in patients with mCRPC and the secondary objectives are to evaluate safety, assess the preliminary anti-tumor activity, and to characterize the pharmacokinetics in this population.

The Swiss Group for Clinical Cancer Research (SAKK) is a non-profit organization, which has been conducting clinical trials in oncology since 1965. Its primary objective is to research new cancer therapies, to develop existing treatments further and to improve the chances of a cure for patients with cancer. For more information, please visit www.sakk.ch.

Professor Markus Jörger, President Project Group Developmental Therapeutics at
SAKK commented: "It is a significant step to have dosed the first patient in this Phase 1b trial of Docetaxel micellar in advanced prostate cancer patients. Docetaxel micellar has the potential to remove the need for pretreatment with corticosteroids, thereby not adding more steroid to patients who have had significant prior steroid administration leading to marked bone fragility, exacerbated by cancer metastases in the bone, or may have steroid-related metabolic issues."

Heidi B. Ramstad, M.D., Chief Medical Officer of Oasmia, commented: "We are pleased to be partnering with SAKK on this trial which we believe is an important step towards evaluating whether Docetaxel micellar can be a treatment option for patients with advanced prostate cancer, without the mandatory steroid use that is necessary with existing, solvent-based docetaxel formulations."

On June 10, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that members of the Company’s management team will participate in A.G.P.’s Virtual Summer Healthcare Symposium on Thursday, June 17, 2021 (Press release, Onconova, JUN 10, 2021, View Source [SID1234583832]).

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The event will consist of 1-on-1 virtual investor meetings. Investors participating in the virtual conference who are interested in meeting with members of Onconova’s management team should contact their A.G.P. representative.

On June 10, 2021 Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, reported that it has been selected to deliver a presentation on the development program of its lead candidate, PT-112, an immunogenic cell death (ICD) inducer, at 2021 BIO Digital, the premier biotech event (Press release, Phosplatin, JUN 10, 2021, View Source [SID1234583852]). BIO Digital is scheduled June 10-11 and 14-18, 2021, and presentations will be available on-demand throughout the event.

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Robert Fallon, President and Chief Executive Officer, will present the company and its lead clinical candidate, PT-112, a novel small molecule conjugate of pyrophosphate with a pleiotropic mechanism of action that promotes immunogenic cell death (ICD) in the tumor microenvironment. The presentation will be available to registered attendees beginning at 9 am ET on June 10.

"We’re looking forward to presenting PT-112 at BIO so that investors and potential partners can understand our encouraging results to date, which include drug responses in several tumor types of heavily pre-treated patients with advanced metastatic disease," said Fallon. "Data reported from three Phase 1 studies demonstrate feasibility and activity, both as a monotherapy and in combination with PD-L1 immune checkpoint inhibition. We’re currently in Phase 2 clinical trials evaluating PT-112’s optimal dosing for a planned pivotal study, as well as preliminary evidence of efficacy, alongside extensive correlative research using sophisticated liquid sampling technology platforms."

Attendees at BIO Digital will be able to view Phosplatin’s Company Presentation before live meetings in the BIO One-on-One Partnering system begin on June 14. To meet with Phosplatin at BIO Digital, information is available here.

About PT-112

PT-112 is a novel small molecule conjugate of pyrophosphate that possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents the best-in-class small molecule inducer of this immunological form of cancer cell death and is currently under Phase II development. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase Ib dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase I study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) is the third completed Phase I study of PT-112. Monotherapy phase 2 development is ongoing in mCRPC, and the PD-L1 combination study is ongoing in a dose confirmation cohort of non-small cell lung cancer (NSCLC) patients.