ImmunoPrecise’s Talem Therapeutics Enters into an LOI with AgonOx Pharma in the Advancement of Novel, Immuno-Oncology Therapeutics

On September 24, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF), an industry leader in the discovery of novel, therapeutic antibodies, reported that Talem Therapeutics, its wholly-owned subsidiary, has entered into an LOI to form a Joint Venture as it partners in the continued development of antibody therapeutics to target T cell mediated anti-tumor activity, with AgonOx, a clinical-stage biopharma company (Press release, ImmunoPrecise Antibodies, SEP 24, 2019, View Source [SID1234539745]). AgonOx specializes in identifying and developing immuno-oncology therapeutics.

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AgonOx’s approach to target discovery begins with genomic and proteomic analyses of tumor-infiltrating lymphocytes isolated from human tumor biopsies. Candidates are further validated in the laboratory by utilizing an array of in vitro and in vivo systems. The partnership with Talem is addressing targets involved in T cell mediated anti-cancer activity, with therapeutics that, in preliminary, in vivo-validated animal models of established tumors, have demonstrated significant tumor reduction.

This partnership will advance two of AgonOx’s top 10 candidates to emerge from its translational science platform focused on modulation of the tumor microenvironment and, if commercialized, may result in approximately $720 million USD comprised of licensing fees, as well as development and commercial milestones in addition to royalties on worldwide sales.

Andrew Weinberg, President and CSO of AgonOx, stated, "Collaborating with Talem strengthens our efforts to develop immuno-oncology drug candidates by leveraging IPA’s ability to address challenging targets, with the deep mining of the immune repertoire in a species agnostic manner. This LOI supports AgonOx’s mission of discovering and delivering science that can change the standard of care for patients with cancer. ImmunoPrecise has first-rate scientists that we hope to work with for years to come."

Talem will leverage the internal development capabilities of ImmunoPrecise, including high throughput, rapid identification of candidates through single cell interrogation, as well as accessing synthetic and natural immune phage libraries, and its bispecific platform, Abthena. All of these technologies integrate seamlessly with IPA’s integrated Artemis Intelligence Metadata (AIM) capabilities to enable rapid turnaround on additional outputs in therapeutic optimization, stability, affinity, and manufacturability.

Both companies will aid in the functional analyses of the candidates, while AgonOx also pulls from its experience in pre-clinical and clinical development, built, in part, on access to physicians and relevant samples through their alignment with the Earl A. Chiles Research Institute at the Providence Cancer Institute.

"We look forward to advancing the development of these candidates toward an Investigational New Drug filing. AgonOx has extensive expertise in validating the expression and function of biologically relevant immuno-oncology targets" said Jennifer Bath, CEO of ImmunoPrecise. "We see significant advantages from Talem and AgonOx leadership sharing knowledge across antibody discovery, development, pre-clinical and clinical trials. This partnership will enhance the companies’ pipelines of novel, monoclonal antibodies that could transform the standard of care for patients with advanced cancers."

Corporate presentation

On September 24, 2019 Constellation Pharmaceuticals presented the Corporate presentation (Presentation, Constellation Pharmaceuticals, SEP 24, 2019, View Source [SID1234539744]).

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Cellectar Receives Orphan Drug Designation from the European Commission for CLR 131 in Multiple Myeloma

On September 24, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the European Commission has awarded CLR 131 orphan designation for the treatment of multiple myeloma (Press release, Cellectar Biosciences, SEP 24, 2019, View Source [SID1234539742]).

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Orphan designation is given to medicinal products that represent a significant benefit over existing treatments; are intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; and where prevalence of the condition in the EU is less than 5 in 10,000 persons.

"We are very pleased to receive Orphan Drug Designation from the European Commission as it is another important acknowledgement of the potential benefits of CLR 131 in multiple myeloma," said James Caruso, president and CEO of Cellectar Biosciences. "This designation complements our U.S. orphan drug designation and U.S. fast track designation already granted by the FDA. CLR 131 has shown encouraging results to date in the treatment of late line relapsed/refractory multiple myeloma as demonstrated in our recent presentation at the International Myeloma Workshop. We look forward to sharing additional data from our clinical trials later this year."

The European Medicines Agency (EMA) plays a central role in facilitating the development and authorization of medicines for rare diseases. Orphan designation benefits include protocol assistance, reduced EU regulatory filing fees and 10 years of market exclusivity. Designated orphan medicines are also eligible for conditional marketing authorization. Detailed information on orphan designation can be found here.

About CLR 131

CLR 131 is a small-molecule, cancer-targeting radiotherapeutic Phospholipid Drug ConjugateTM (PDC) designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. CLR 131 is the company’s lead therapeutic PDC product candidate and is currently being evaluated in both Phase 2 and Phase 1 clinical studies. The FDA granted orphan drug designation for CLR 131 for the treatment of multiple myeloma as well as orphan drug and rare pediatric disease designations for CLR 131 for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. In addition to the ongoing Phase 1 dose-escalation study and the Phase 2 (CLOVER-1) trial, the company recently initiated a Phase 1 open-label, dose-escalating study in pediatric solid tumors and lymphoma to evaluate the safety and tolerability of a single intravenous administration of CLR 131 in up to 30 children and adolescents with cancers including neuroblastoma, sarcomas, lymphomas (including Hodgkin’s lymphoma) and malignant brain tumors.

BioCryst Pharmaceuticals to Present at Cantor Global Healthcare Conference

On September 24, 2019 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported that the company will present at the Cantor Global Healthcare Conference in New York on Friday, October 4, 2019 at 12:35 p.m. ET (Press release, BioCryst Pharmaceuticals, SEP 24, 2019, View Source [SID1234539741]).

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Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com.

Aeterna Zentaris Announces Closing of Approximately $5.0 Million Registered Direct Offering

On September 24, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, principally through out-licensing arrangements, reported the closing of its previously announced offering whereby the Company entered into a securities purchase agreement with institutional investors in the United States to purchase approximately $5.0 Million (before placement agent’s fees and expenses) of its common shares in a registered direct offering and warrants to purchase common shares in a concurrent private placement (together, the "Offering") (Press release, AEterna Zentaris, SEP 24, 2019, View Source [SID1234539740]). The combined purchase price for one common share and one warrant was $1.50.

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Under the terms of the securities purchase agreement, Aeterna sold 3,325,000 common shares. In a concurrent private placement, Aeterna issued warrants to purchase up to an aggregate of 3,325,000 common shares. The warrants will be exercisable commencing six months from the date of issuance, will have an exercise price of $1.65 per share and will expire 5 years following the date of issuance.

The gross proceeds from the registered direct offering and concurrent private placement were approximately $5.0 Million before deducting placement agent’s fees and expenses.

Maxim Group LLC acted as sole placement agent in connection with the offering.

In approving the Offering and listing the common shares issued and issuable thereunder, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual available to "Eligible Interlisted Issuers", since the Company’s common shares are also listed on the NASDAQ Capital Market and had less than 25% of the overall trading volume of its listed securities occurring on all Canadian marketplaces in the twelve months immediately preceding the date on which application was made to TSX to approve the Offering.

The common shares described above were offered by Aeterna Zentaris pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232935) previously filed and declared effective by the Securities and Exchange Commission (SEC). The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities law.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the common shares in connection with the offering. A prospectus supplement relating to the shares of common shares has been filed by Aeterna with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.