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Kangpu Biopharmaceuticals Successfully Completed Phase I Study of Novel CRL4-CRBN Modulator KPG-818 in the U.S.

On October 11, 2019 Kangpu Biopharmaceuticals reported that it has successfully completed a first-in-human phase I single ascending dose (SAD) clinical study of KPG-818 conducted in the United States (Press release, Kangpu Biopharmaceuticals, OCT 11, 2019, View Source [SID1234540934]).

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This randomized, double-blind, placebo-controlled study evaluated the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants following oral administration. A total of 40 subjects were randomized to receive active drug or placebo in a double-blind fashion (8 subjects in each dose cohort, 6 subjects randomized to receive active drug and 2 subjects randomized to receive placebo). Five dose levels (2, 5, 10, 20 and 30 mg) were investigated.

In the completed phase I study, there were no safety or tolerability concerns. No serious adverse events (SAE) were reported at any dose level studied. No stopping criteria were met. KPG-818 was well tolerated at all tested dose levels. KPG-818 also demonstrated a favorable pharmacokinetic profile supporting once-daily oral dosing. The phase I results also revealed that dosing under fed conditions does not have significant influence on the exposure of KPG-818 as compared to fasted conditions.

The study results will assist Kangpu Biopharmaceuticals in identifying appropriate doses of KPG-818 that can be administered in subsequent clinical trials in patients with systemic lupus erythematosus (SLE) or hematological malignancies.

About KPG-818

KPG-818 is a novel small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN. In preclinical studies, KPG-818 demonstrated outstanding in vitro anti-inflammatory and anti-proliferative properties as well as remarkable in vivo efficacy in myeloma and lymphoma animal models. KPG-818 is currently being developed by Kangpu Biopharmaceuticals for the treatment of SLE and hematological malignancies.

Nordic Nanovector launches a private placement of new shares

On October 17, 2019 Nordic Nanovector ASA (OSE: NANO) ("Nordic Nanovector" or the "Company"), a biopharmaceutical company dedicated to extending and improving the lives of patients with haematological cancers through the development and commercialisation of innovative targeted therapeutics, reported the launch of a private placement of new shares (the "Offer Shares") representing up to approximately 20% of the outstanding share capital of the Company at this date (the "Private Placement") (Press release, Nordic Nanovector, OCT 17, 2019, View Source [SID1234553443]). DNB Markets and Jefferies International Limited are acting as Joint Global Coordinators and joint bookrunners (the "Joint Global Coordinators"), and ABG Sundal Collier ASA is acting as joint bookrunner (together with the Joint Global Coordinators, the "Managers") in connection with the Private Placement .

Nordic Nanovector intends to use the net proceeds from the Private Placement for the following purposes:

Continued clinical development, (including completion of enrolment of the PARADIGME study), and commercial preparation of Betalutin.
Manufacturing development activities for Biological License Application (BLA) readiness.
General corporate purposes.
The subscription price and the number of shares to be issued in the Private Placement will be determined through an accelerated bookbuilding process. The bookbuilding period and the application period for the Private Placement commence today at 16:30 hours CEST and will close at 08:00 hours (CEST) on 18 October 2019 (the "Application Period"). The Company and the Managers reserve the right to close or extend the Application Period at any time and for any reason. If the Application Period is shortened or extended, any other dates referred to herein may be amended accordingly.

The Company’s largest shareholder, HealthCap VI L.P., has informed the Company that it will participate in the Private Placement.

The minimum subscription and allocation amount in the Private Placement will be the NOK equivalent of EUR 100,000, provided that the Company may, at its sole discretion, allocate an amount below EUR 100,000 to the extent applicable exemptions from the prospectus requirement pursuant to applicable regulations, including the Norwegian Securities Trading Act and ancillary regulations, are available. Allocation of the Offer Shares will be determined at the end of the bookbuilding process, and the final allocation will be made by the Company’s Board of Directors (the "Board") at its sole discretion, following advice from the Managers.

The Offer Shares will be issued based on an authorisation granted to the Company’s Board at the Company’s annual general meeting on 25 April 2019 (the "Authorisation").

The Board has considered alternative structures for the raising of new equity. Following careful considerations, the Board is of the view that it will be in the common interest of the Company and its shareholders to raise equity through a private placement setting aside the pre-emptive rights of the shareholders. By structuring the transaction as a private placement, the Company will be in a position to raise capital in an efficient manner, with a lower discount to the current trading price and with significantly lower risks compared to a rights issue. In addition, the Private Placement is subject to marketing through a pre-sounding and a publicly announced bookbuilding process. By this, a market based subscription price will be achieved. The Company will also consider whether or not to commence a repair offering towards the existing shareholders who did not participate in the Private Placement.

The Private Placement will be directed towards Norwegian and international investors, in each case subject to and in compliance with applicable exemptions from relevant prospectus or registration requirements. Notification of allotment and payment instructions is expected to be issued to the applicants on or about 18 October 2019 through a notification to be issued by the Managers.

The Private Placement is divided into two tranches:

· A number of Offer Shares corresponding to approximately 10% of the Company’s share capital will be settled with existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange, pursuant to a share lending agreement between DNB Markets (on behalf of the Managers), the Company and HealthCap VI L.P., in order to facilitate delivery of listed shares to investors on a delivery versus payment basis (the "Tranche 1 Offer Shares"). The Tranche 1 Offer Shares will be tradable from allocation. The Managers will settle the share loan with a corresponding number of new shares in the Company to be issued by the Board pursuant to the Authorisation, on or about 24 October 2019.

· The Managers are expected to pre-fund the subscription price for the rest of the Offer Shares (the "Tranche 2 Offer Shares") to facilitate a swift registration of the share capital increase in the Norwegian Register of Business Enterprises (the "NRBE"). The Tranche 2 Offer Shares will be tradable from registration of the share capital increase in the NBRE, expected to be on or about 22 October 2019. Delivery of the Tranche 2 Offer Shares will be on a delivery versus payment basis to the investors. The Tranche 2 Offer Shares will be issued by the Board pursuant to the Authorisation.

The Company has agreed with the Managers to a lock-up on future share issuances for a period of 180 days from the closing date, subject to customary exceptions. The Company’s Board and Executive Management have all agreed with the Managers to a lock-up on existing shareholdings for a period of 180 days from the closing date, subject to customary exceptions. In addition, the Company’s largest shareholder, HealthCap VI L.P. has agreed with the Managers to a lock-up for a period of 90 days from the closing date, subject to customary exceptions.

The Company will announce the final number of Offer Shares placed and the final subscription price in the Private Placement in a stock exchange announcement expected to be published before opening of trading on the Oslo Stock Exchange tomorrow, 18 October 2019. Completion of the Private Placement is subject to final approval by the Company’s Board.

Company update

The pivotal PARADIGME trial investigating Betalutin in relapsed/refractory non-Hodgkin’s lymphoma is now recruiting patients at 85 sites in 24 countries. Despite a slower than expected start, PARADIGME is now recruiting in line with the company’s expectations and in line with previous clinical trials in similar patient populations; with 32 patients enrolled to-date, the company aims to complete recruitment of the targeted 130 patients in H2 2020.

The company, working with the trial Contract Research Organisation (CRO), has initiated a suite of actions to meet this enrolment target. Specific actions include applying key learnings from high-recruiting sites, increased visits by senior management, other site engagement programmes and intensified efforts to raise the profile of PARADIGME and Betalutin with key opinion leaders, referrers and influencers.

Nordic Nanovector believes that these initiatives position PARADIGME strongly to reach its key enrolment milestone of 130 patients in H2 2020.

Gilead Sciences to Release Third Quarter 2019 Financial Results on Thursday, October 24, 2019

On October 10, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its third quarter 2019 financial results will be released on Thursday, October 24, after the market closes (Press release, Gilead Sciences, OCT 10, 2019, View Source [SID1234540971]). At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the third quarter 2019 and provide a business update.

The live webcast of the call can be accessed at the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 6094972 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, October 26, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 6094972. The webcast will be archived on www.gilead.com for one year.

Aptose to Participate at 5th International Conference on Acute Myeloid Leukemia of the European School of Haematology (ESH)

On October 10, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, and Jotin Marango, M.D., Ph.D., Senior Vice President and Chief Business Officer, will participate at the 5th International Conference on Acute Myeloid Leukemia "Molecular and Translational" Advances in Biology and Treatment, and present preclinical data for CG-806, its oral, first-in-class pan-FLT3/pan-BTK inhibitor, in a poster presentation on October 24th, 2019 in Estoril, Portugal (Press release, Aptose Biosciences, OCT 10, 2019, View Source [SID1234540957]).

"We are gratified by the enthusiasm of the AML community surrounding our mutation-agnostic kinase inhibitor CG-806," said Dr. Rice. "As we approach initiation of a new clinical study of CG-806 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), we wish to highlight at this ESH conference the ability of CG-806 to suppress multiple oncogenic signals, to potently kill a diverse range of AML cells, including those resistant to various FLT3 inhibitors, and to enhance the activity of other anticancer agents. CG-806 is currently in a Phase 1 a/b clinical trial in patients with B-cell malignancies and to date, no drug-related toxicities have been observed."

CG-806 Poster Presentation Details:

CG-806 Pan-FLT3 / Pan-BTK Inhibitor Simultaneously Suppresses Multiple Oncogenic Signaling Pathways to Treat AML
Date & Time: Thursday, October 24th, 2019, 6:40 p.m. – 8:15 p.m. WEST (1:40 p.m. – 3:15 p.m. EDT)
Session Title: Acute myeloid leukemia – Biology & Translational Research
Abstract Number: 16594
Location: Estoril Congress Center, Avenida Amaral, 2765-192, Estoril, Portugal

The poster will be available on the Aptose website at the beginning of the poster session here.

About CG-806
CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor and is in a Phase 1 clinical trial for the treatment of hematologic malignancies. This small molecule, in-licensed from CrystalGenomics Inc. in Seoul, South Korea, demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), cures animals of AML in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML and other myeloid malignancies. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser (C481S) mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL/SLL, FL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent or other non-covalent BTK inhibitors. Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.

Geron Announces First Patient Dosed in IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes

On October 10, 2019 Geron Corporation (Nasdaq: GERN) reported that the first patient has been dosed in the IMerge Phase 3 clinical trial to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS) (Press release, Geron, OCT 10, 2019, View Source [SID1234540956]).

"Patients with lower risk MDS become dependent on serial transfusions which leads to iron overload, heart and kidney complications, decreases in quality of life and shorter overall survival. Reducing transfusion burden and achieving transfusion independence remain significant medical needs for this disease," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "Dosing of the first patient in the IMerge Phase 3 clinical trial is an important step in developing imetelstat as a potential alternative for patients with lower risk MDS who have limited treatment options available today."

IMerge is a two-part Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with lower risk MDS who are relapsed after or refractory to erythropoiesis-stimulating agents (ESAs). The Phase 3 is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of red blood cell transfusion independence (TI). A target patient population of non-del(5q) lower risk MDS patients who are naïve to treatment with hypomethylating agents (HMAs) and lenalidomide was identified in Part 1 of IMerge, or the Phase 2 portion, and will be enrolled in the Phase 3. The trial is planned to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia. The primary endpoint is 8-week TI rate, which is defined as the proportion of patients achieving transfusion independence during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of transfusion independence lasting at least 24 weeks, or 24-week TI rate, durability of transfusion independence and the amount and relative change in transfusions.

Recently reported Phase 2 data from Part 1 of IMerge suggested meaningful and durable transfusion independence, as well as potential disease-modifying activity and transfusion independence across different MDS patient subgroups, potentially achievable with imetelstat treatment. Many key aspects from Part 1 of IMerge remain the same for the Phase 3, including the primary and secondary endpoints, the dose and schedule of imetelstat administration, the target patient population, and a majority of the participating clinical sites.

Based upon current planning assumptions, Geron expects top-line results for the IMerge Phase 3 clinical trial to be available by mid-year 2022.

To learn more about the IMerge Phase 3 clinical trial and whether the study is enrolling patients in your area, please visit www.clinicaltrials.gov.

About Myelodysplastic Syndromes

Myelodysplastic syndromes are a group of diverse blood disorders that develop because bone marrow cells do not mature into healthy blood cells. Many patients develop chronic anemia, the predominant clinical problem in lower risk MDS, and become dependent on red blood cell transfusions. There are approximately 60,000 people living with the disease in the United States.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis (MF). Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.