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

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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.

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.

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.

On September 24, 2019 Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported a partnership with Illumina, Inc. (Nasdaq: ILMN) to develop in-vitro diagnostic (IVD) test kits for Adaptive’s current and future portfolio of next-generation sequencing (NGS)-based immunodiagnostics (Press release, Adaptive Biotechnologies, SEP 24, 2019, View Source [SID1234539739]).

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The test kits under development would expand the availability of Adaptive’s clonoSEQ Assay for assessing and monitoring minimal residual disease (MRD) for the management of patients with certain blood cancers and immunoSEQ Dx Assay for pipeline applications. Clinicians currently order clonoSEQ to monitor MRD as a test performed at Adaptive’s lab in Seattle. The planned IVD test kits will make it possible for hospitals and health systems to run Adaptive’s clonoSEQ and immunoSEQ Dx assays in their local laboratories across the United States.

"We are proud to partner with Illumina to deliver on our promise to develop distributable kits for our novel immunodiagnostics to reach more patients," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "These IVD test kits will further validate Adaptive as a valued partner for standardized MRD monitoring and immune profiling solutions from research to the clinic."

Adaptive’s immune medicine platform is uniquely suited for the development of standardized IVD test kits. Under the non-exclusive agreement, Adaptive will develop the clonoSEQ and immunoSEQ Dx IVD test kits to run on Illumina’s NextSeq 550Dx system. Adaptive will be responsible for obtaining necessary regulatory approvals for each IVD test kit and for their subsequent commercialization.

"By making Adaptive’s clonoSEQ more accessible to patients, we are ensuring health care providers have access to a valuable part of a growing genomics ecosystem. Partnerships that bring exceptional clinical content to customers and patients represent an exciting opportunity in clinical genomics," said Dr. Phil Febbo, Chief Medical Officer of Illumina. "We are committed to unlocking the power of the genome through our work with Adaptive which will expand access to genomic-based testing in order to improve patient outcomes."

About the clonoSEQ Assay

The clonoSEQ Assay was granted de novo designation and marketing authorization by FDA for the detection and monitoring of minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow

samples. clonoSEQ is the first and only FDA-authorized in vitro diagnostic assay for MRD testing. It is also the first clinical diagnostic powered by immunosequencing to receive FDA clearance. clonoSEQ leverages Adaptive’s proprietary immunosequencing platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes are strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with ALL and MM. clonoSEQ testing is covered by Medicare and an expanding list of private payors in alignment with the FDA label.

clonoSEQ is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.