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ORIC Pharmaceuticals Presents Preclinical Data on CD73 Inhibitor at the American Association for Cancer Research (AACR) Virtual Annual Meeting

On April 27, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported research that led to the discovery of potent and orally bioavailable small molecule inhibitors of CD73 at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I (Press release, ORIC Pharmaceuticals, APR 27, 2020, View Source [SID1234561053]).

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The preclinical data on ORIC’s CD73 program were presented in the "Advances in Cancer Drug Design and Discovery" session in an oral presentation titled "Orally Available Small Molecule CD73 Inhibitor Reverses Immunosuppression Through Blocking of Adenosine Production" (Abstract #1242, presentation 1037).

Many cancers usurp the anti-inflammatory adenosine pathway to avoid detection by the immune system, thereby reducing the effectiveness of certain chemotherapy- and immunotherapy-based treatments. Accumulation of adenosine in the tumor microenvironment is implicated in local immune suppression that leads to tumor growth. CD73 is an enzyme that controls the rate at which extracellular adenosine is produced and its overexpression is associated with poor prognosis in several cancers, including triple negative breast cancer, non-small cell lung cancer, melanoma and prostate cancer, among others. Therefore, reducing the level of adenosine via inhibition of CD73 has become a potential strategy for cancer treatment.

ORIC’s small molecule inhibitor of CD73 demonstrated more potent adenosine inhibition compared to an antibody approach in preclinical studies. Further studies showed CD73 inhibition impacted T cell proliferation and cytokine production in the context of adenosine-mediated immunosuppression. ORIC’s research program led to the discovery of clinical candidate ORIC-533, an orally bioavailable small molecule inhibitor of CD73, which in preclinical studies demonstrated significant anti-tumor single agent efficacy when dosed once a day, with corresponding reduction of adenosine levels in the tumor microenvironment. ORIC expects to file an IND for ORIC-533 in the first half of 2021.

IMMUNOMEDICS ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK

On April 27, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates, reported it has commenced an underwritten public offering of $350,000,000 of shares of its common stock (Press release, Immunomedics, APR 27, 2020, View Source [SID1234556912]). In addition, Immunomedics expects to grant the underwriters a 30-day option to purchase up to an aggregate of an additional $52,500,000 of shares of common stock sold in connection with the offering at the public offering price.

Immunomedics intends to use the net proceeds from this offering primarily to support the commercial launch of Trodelvy in the United States in metastatic triple-negative breast cancer, continue to expand the clinical development programs for Trodelvy, invest in the broader clinical development of the platform (including IMMU-130 and IMMU-140), continued scale-up of manufacturing and manufacturing process improvements, as well as for working capital and general corporate purposes.

Cowen, BofA Securities, Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 that Immunomedics filed with the Securities and Exchange Commission on June 11, 2018 and that became effective upon filing. A preliminary prospectus supplement and the accompanying prospectus relating to this offering are being filed with the SEC and will be available at the SEC’s website located at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, Attention: Prospectus Department, or by telephone at (800) 747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

BIOGEN PRICES $3.0 BILLION OF SENIOR UNSECURED NOTES

On April 27, 2020 Biogen Inc. (Nasdaq: BIIB) reported the pricing of two series of senior unsecured notes for an aggregate principal amount of $3.0 billion (Press release, Biogen, APR 27, 2020, View Source [SID1234556700]). The notes will mature as follows:

$1.5 billion will mature on May 1, 2030 and will bear interest at an annual rate of 2.25%

$1.5 billion will mature on May 1, 2050 and will bear interest at an annual rate of 3.15%
The offering is expected to close on April 30, 2020, subject to customary closing conditions.

Biogen intends to use the net proceeds from the sale of the notes to redeem in full $1.5 billion in aggregate principal amount of its outstanding 2.90% Senior Notes due September 15, 2020, and all accrued and unpaid interest thereon, to fund, together with cash on hand, repurchases of its common stock under its share repurchase plans and for working capital and other general corporate purposes.

Goldman Sachs & Co. LLC, BofA Securities, Inc. and J.P. Morgan Securities LLC are acting as joint book-running managers and representatives of the several underwriters. A copy of the preliminary prospectus supplement and the accompanying base prospectus, which is filed as part of Biogen’s effective shelf registration statement on Form S-3 filed on April 24, 2020 (File No. 333-237819), may be obtained from any of the representatives by calling Goldman Sachs & Co. LLC toll-free at 1 (866) 471-2526, BofA Securities, Inc. toll-free at 1 (800) 294-1322 or J.P. Morgan Securities LLC at 1 (212) 834-4533.

An electronic copy of the preliminary prospectus supplement and the accompanying base prospectus may also be obtained at no charge at the Securities and Exchange Commission’s website at www.sec.gov.

This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any state or other jurisdiction where such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction, where the offer, solicitation or sale of these securities would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering of the notes may be made only by means of a prospectus supplement and the accompanying base prospectus.

Iovance Biotherapeutics to Host First Quarter 2020 Financial Results Conference Call and Webcast on Tuesday, May 5, 2020

On April 27, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its first quarter 2020 financial results on Tuesday, May 5, 2020 (Press release, Iovance Biotherapeutics, APR 27, 2020, View Source [SID1234556699]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. EDT.

To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 4564469. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will also be available for one year in the Investors section at www.iovance.com.

Personal Genome Diagnostics Receives FDA Clearance for PGDx elio™ tissue complete, the First Comprehensive Genomic Profiling Diagnostic Kit for Oncology

On April 27, 2020 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner (Press release, Personal Genome Diagnostics, APR 27, 2020, View Source [SID1234556662]). By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

"Nearly 80% of patients aren’t getting the clinical insights they need to inform their treatment path, or they aren’t being tested in a window of time that makes a difference in determining their care," said Megan Bailey, Chief Executive Officer, PGDx. "PGDx elio tissue complete responds to this unmet need by bringing genomic cancer testing of the highest quality directly to healthcare providers. Since the founding of our company we have been united in our mission to empower the fight against cancer, and an integral part of that is establishing standardized testing as a core element of patient care. Today is an incredible milestone for us, but more importantly for the millions of people living with cancer."

PGDx elio tissue complete detects single nucleotide variants (SNVs) and small insertions and deletions (indels) in 500+ genes, select amplifications and translocations, and genomic signatures including microsatellite instability (MSI) and tumor mutation burden (TMB). Collectively, the information from this diagnostic kit is intended for use by healthcare professionals to help tailor clinical management for patients based on their tumor’s unique genomic profile in accordance with professional guidelines. The broad genomic profiling assay includes biomarkers to help inform the use of targeted cancer therapies and immunotherapies and can help oncologists identify patients for clinical trial participation. This FDA clearance was supported by a magnitude of data that demonstrates robustness and consistency of performance across multiple lab sites, and accuracy data across all variant classes in clinical samples from 35 tumor types.

"There has not, until this point, been one standardized test for all kinds of cancer that any lab across the country can perform," said Dr. Pranil Chandra, Chief Medical Officer of Genomic and Clinical Pathology Services, PathGroup, an early collaborator for PGDx elio tissue complete. "With this clearance, labs across the country will for the first time have an option for a regulated, standardized test that examines a broad view of cancer pathways and genomic signatures across advanced cancers. PGDx elio testing features automated bioinformatics that ensures consistent results and quality of testing, resulting in fast and reliable clinical insights to enable oncologists to match patients with the best therapies to fight their cancer."

"Personal Genome Diagnostics is pioneering an integrated healthcare ecosystem that furthers the availability and opportunities of precision medicine," said Dr. Michael Hanbury, Chief Operating Officer, PathGroup. "Developing insights into genomic drivers of cancer can provide physicians expanded understanding of patient-specific tumor genetics and improve targeted therapies to save lives and improve outcomes. This clearance demonstrates the benefits of focused collaborative efforts between medical device manufacturers and pathologists to advance the diagnosis and treatment for thousands of patients with advanced tumors. We are pleased to partner with PGDx and offer this new test to our community of clients, physicians and patients."

PGDx elio tissue complete

PGDx elio tissue complete is an FDA-cleared diagnostic kit and accompanying software for molecular labs that provides comprehensive genomic profiles of all solid tumors. PGDx elio tissue complete detects single nucleotide variants (SNVs) and small insertions and deletions (indels) in 500+ genes, select amplifications and translocations, and genomic signatures including microsatellite instability (MSI), and tumor mutation burden (TMB). Designed to be used locally at the lab of choice, PGDx elio testing and automated bioinformatics ensures both consistency and quality of testing regardless of location.