On October 1, 2020 Imago BioSciences, Inc. ("Imago") a clinical-stage biopharmaceutical company developing innovative treatments for myeloid diseases, reported that the first patient has been dosed in the first Imago-sponsored Phase 2b clinical trial of bomedemstat (IMG-7289) for the treatment of essential thrombocythemia (ET) (Press release, Imago BioSciences, OCT 1, 2020, View Source [SID1234567853]).

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"We are excited to start this study. There are many patients with essential thrombocythemia in need of alternatives to the current standards of care. Bomedemstat has the potential to serve as a new option for such patients," said Hugh Young Rienhoff, Jr. MD, CEO, Imago BioSciences.

This Phase 2b multi-center, open-label study is designed to assess the safety, efficacy, and pharmacodynamics of bomedemstat, an oral inhibitor of the epigenetic enzyme lysine-specific demethylase 1 (LSD1) (www.clinicaltrials.gov Identifier NCT04254978). Eligible patients aged 18 or older with ET who have failed at least one standard therapy and require treatment in order to lower their platelet count will be considered for participation in this study. Exploratory assessments include the serial measurement of mutant allele frequencies and changing plasma cytokine profiles. The trial is being conducted in the United States, the United Kingdom, Europe, New Zealand, and Australia.

About Bomedemstat (IMG-7289)

In addition to the ET study, bomedemstat is being evaluated in an open-label Phase 2 clinical trial for the treatment of advanced myelofibrosis (MF), a bone marrow cancer that interferes with the production of blood cells. MF patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor are eligible for the study of bomedemstat as monotherapy. The endpoints include spleen volume reduction and symptom improvement at 12 and 24 weeks of treatment. Preliminary results have been presented at meetings of the European Hematology Association (EHA) (Free EHA Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper).

Bomedemstat is an orally available small molecule discovered and developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, bomedemstat demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat is an investigational agent currently being evaluated in ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185, NCT04262141 and NCT04081220). Bomedemstat has FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, Orphan Drug Designation for treatment of acute myeloid leukemia and PRIME designation by the European Medicines Agency for the treatment of MF.

On October 1, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the open-label Expanded Access Program, sEAPort, for eligible U.S. patients, is formally open (Press release, Oncopeptides, OCT 1, 2020, View Source [SID1234567852]). Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma. The sEAPort program is available to adults, age 18 and older, who have received at least two prior lines of therapy and whose multiple myeloma is refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients).

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The Expanded Access Program was initiated following the Company´s June 30 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for the treatment of adult patients with triple-class refractory multiple myeloma. The NDA and the sEAPort program are primarily supported by data from the pivotal phase 2 HORIZON study, which demonstrates that melflufen in combination with dexamethasone, has a potential to provide a therapeutic option for patients with relapsed refractory multiple myeloma who are hard to treat and have a poor prognosis, including patients with triple-class refractory multiple myeloma and patients with extramedullary disease.

"Despite therapeutic advances, multiple myeloma remains incurable," said Paula O’Connor, U.S. Head of Medical Affairs at Oncopeptides. "There is an urgent need for more therapies as patients become multi-resistant earlier in their treatment journey. Our Expanded Access Program enables us to provide access to melflufen as a potential treatment for eligible patients while our application is under review by the U.S. Food and Drug Administration."

EAPs are designed to provide patients living with serious or life-threatening conditions access to investigational medicines when no comparable or satisfactory treatment options are available, alternative therapies have been exhausted or the patient is ineligible for ongoing interventional trials.

Forty to fifty medical sites in the U.S. are expected to enroll 100-200 patients in the sEAPort program.

This information was submitted for publication at 08.00 (CET), October 1, 2020.

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.

On October 1, 2020 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that it has entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development and commercialization of DNA-based individualized neoantigen vaccines for the treatment of cancers (Press release, Vaccibody, OCT 1, 2020, View Source [SID1234567850]). Vaccibody will conduct development through the end of Phase 1b and Genentech will be responsible for development and commercialization thereafter. The transaction will combine Genentech’s global cancer immunotherapy research, development and commercial leadership with Vaccibody’s targeted DNA-based vaccine platform to realize a potential new treatment paradigm of individualized cancer vaccines.

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Michael Engsig, CEO of Vaccibody, said: "We are very excited to have entered into this transformative agreement that marks the start of a new era for Vaccibody. Genentech is widely recognized as one of the foremost leaders in leveraging the immune system to develop therapies for cancer and is a scientific pioneer within the neoantigen cancer vaccine space. They are therefore the partner of choice for the further development and commercialization of our innovative next-generation cancer vaccine platform for generating individualized therapies."

Under the terms of the agreement, Vaccibody will receive USD 200 million in initial upfront and near-term payments. Additionally, Vaccibody will be eligible to receive up to a further USD 515 million in potential payments and milestones, plus low double-digit tiered royalties on sales of commercialized products arising from the partnership. Following completion of the Phase 1b study, Genentech will have responsibility and bear all costs for clinical, regulatory, manufacturing and commercialization activities.

James Sabry, Global Head of Roche Pharma Partnering said: "We are committed to evaluating emerging classes of cancer immunotherapies, and we believe targeting neoantigens has the 2 potential to transform the treatment landscape for many types of cancers. We are pleased to collaborate with Vaccibody to help realize the full potential of its individualized neoantigen vaccine technology with the shared goal of broadening the number of people who may benefit from immunotherapy treatment."

Through this partnership, Genentech and Vaccibody will progress Vaccibody’s investigational product, VB10.NEO, into clinical trials in the U.S. and in Europe. VB10.NEO, an individualized DNA-based neoantigen vaccine, uniquely targets encoded antigens to antigen presenting cells which are essential for generating potent T cell responses required for cancer therapy. The vaccine is designed to be produced on-demand according to the neoantigen profile of an individual patient. Neoantigens are proteins generated by tumor-specific mutations not present in normal tissues, and are thus an attractive target for cancer immunotherapy as they may be recognized as foreign by the immune system.

"It is widely believed that the clinical use of cancer vaccines has been limited by the ability to efficiently present the antigens to the immune system and the limited insight into what constitutes clinically relevant antigens. Vaccibody’s immunotherapy platform has been shown to address those challenges with preclinical and clinical data indicating induction of unique CD4+ and importantly CD8+ tumor-specific T cell responses against selected antigens essential for clinical responses," said Agnete B. Fredriksen, Co-Founder, President & Chief Scientific Officer of Vaccibody.

The consummation of the transactions contemplated by the agreement is subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as amended, and is expected to occur in the second half of 2020.

Vaccibody future R&D focus and strategy (also see separate press release, issued today for further detail) The payments and milestones received under the terms of this licensing agreement will enable Vaccibody to accelerate and expand its other internal R&D programs under the Vaccibody technology platform. As further detailed in the accompanying press release today, Vaccibody will focus its R&D efforts on further development of VB10.16 and explore other shared neoantigen cancer vaccines; infectious diseases vaccines and in addition, leverage its in-house expertise and deep know-how to develop novel immunotherapeutic products in new strategic areas. Webcast Michael Engsig, CEO, and Agnete B. Fredriksen, President & Chief Scientific Officer, will host a webcast on October 01, 2020 at 4 p.m. CET to discuss the partnership with Genentech and 3 provide an update on Vaccibody’s future R&D focus and strategy. A presentation will be available on Vaccibody’s website, www.vaccibody.com, before the webcast.

About VB10.NEO
VB10.NEO, is a proprietary therapeutic DNA vaccine which uses the patient’s own neoantigens for the personalized treatment of cancer patients. VB N-01, a Phase I/IIa neoantigen clinical trial is being conducted for patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck. The drug candidate has demonstrated positive initial responses in patients. VB10.NEO has demonstrated the ability to induce strong tumor specific immune responses which leads to clinical responses in several patients with locally advanced or metastatic disease. Interim results from Phase I/IIa clinical trial suggests a clear link between selection of high quality neoepitopes, generation of strong neoepitope-specific CD8+ T cell responses and clinical responses. VB10.NEO is exclusively licensed to Genentech.

The VB N-01 clinical trial is a multi-centre, open-label clinical trial. The trial is fully enrolled. The clinical trial has the ClinicalTrials.gov Identifier: NCT03548467.

On September 30, 2020, Plus Therapeutics, Inc. (the "Company") reported that it entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park has committed to purchase up to $25 million of the Company’s common stock, $0.001 par value per share (Filing, 8-K, PLUS THERAPEUTICS, SEP 30, 2020, View Source [SID1234572291]).

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Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $25.0 million of the Company’s common stock. Such sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date that a registration statement covering the resale of shares of common stock that have been and may be issued under the Purchase Agreement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth in the Purchase Agreement are satisfied.

Lincoln Park has no right to require the Company to sell any shares of common stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions. There are no upper limits on the price per share that Lincoln Park must pay for shares of common stock. Actual sales of shares of common stock to Lincoln Park will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Company’s common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be used for working capital and general corporate purposes.

On June 16, 2020, the Company received stockholder approval pursuant to Nasdaq Listing Rules 5635(a), 5635(b) and 5635(d) to permit issuances of the Company’s common stock (including the issuance of more than 19.99% of the Company’s common stock) to Lincoln Park pursuant to the Purchase Agreement. Based on the closing price of the Company’s common stock of $1.05 per share on March 16, 2020 (the Company’s lowest closing sale price since January 1, 2020 as reported on Nasdaq.com) the maximum number of shares the Company could issue and sell under the Purchase Agreement is approximately 23.8 million shares. Accordingly, the Company requested and received stockholder approval for the issuance of up to 23.8 million shares of the Company’s common stock under the Purchase Agreement. The Company would seek additional stockholder approval before issuing more than 23.8 million shares.

The Company has agreed with Lincoln Park that it will not enter into any "variable rate" transactions with any third party for a period defined in the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company’s shares.

As consideration for Lincoln Park’s irrevocable commitment to purchase shares of the Company’s common stock upon the terms of and subject to satisfaction of the conditions set forth in the Purchase Agreement, upon execution of the Purchase Agreement, the Company issued 180,701 shares of its common stock to Lincoln Park as commitment shares.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, Lincoln Park does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by Lincoln Park, until such event of default is cured. In addition, in the event of bankruptcy proceedings by or against the Company, the Purchase Agreement will automatically terminate.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibits 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

On September 30, 2020 Theralase Technologies Inc. ("Theralase" or "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug formulations intended to safely and effectively destroy various cancers, reported that the Company proposes to extend the expiry date of 3,157,059 share purchase warrants, all of which are exercisable at $0.50 per share (collectively, the "Warrants") (Press release, Theralase, SEP 30, 2020, View Source [SID1234569760]).

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The Warrants were issued on October 3, 2018 pursuant to a private placement involving the issuance of 3,157,059 units of the Company. The Company proposes to extend the expiry date of the Warrants that remain outstanding from the original expiry date of October 3, 2020 to October 3, 2022.

All other terms and conditions of the Warrants will remain unchanged. The Warrant expiry date extension is subject to final acceptance by the TSX Venture Exchange.