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LyseNTech completed MTA and CDA with Y-Biologics

On April 27, 2020 LyseNTech completed MTA and CDA with Y-Biologics to develop advanced anticancer phage technology (Press release, LyseNTech, APR 27, 2020, View Source;no=7 [SID1234644210]).

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Y-Biologics is a Korean biotech company focusing on the discovery & development of novel antibody therapeutics based on its human antibody library and Bi-specific antibody platform technology.

Acquired ODD status for liver cancer and intrahepatic bile duct cancer and License-In for additional Indications

On April 24, 2020, NewG Lab Pharma reported that it received the status of Orphan Drug Designation (ODD) for liver cancer and intrahepatic bile duct cancer from KoDiscovery (Press release, NewG Lab Pharma, APR 27, 2020, View Source;page=1 [SID1234625568]). This acquisition of ODD status is based on a joint agreement with KoDiscovery. and Primocure. Primocure Inc., a 100% subsidiary of KoDiscovery, already received an Orphan Drug designation from the FDA for the treatment of liver and intrahepatic bile duct cancer in 2013.
In addition to obtaining ODD status, NewG Lab Pharma signed an in-licensing contract to commercialize KAT (Kodiscovery Anti-cancer therapeutics) for gallbladder and intrahepatic bile duct cancer. Therefore, NewG Lab Pharma has received the commercialization right for a total of 6 indications including liver cancer, breast cancer, bladder cancer, and melanoma.
In September 2019, NewG Lab Pharma signed a pre-clinical research contract including the ODD Program with Covance, a global contract research organization. Currently, a GLP-Tox Study on an investigational metabolic cancer drug, KAT, is in progress. In parallel with pre-clinical trials, NewG Lab Pharma and Covance have applied for an Orphan Drug in a subgroup of melanoma this February and waited for the result.

Orphan drugs are drugs that :
(A) treat diseases and conditions affecting fewer than 200,000 patients in the United States, or
(B) shows no reasonable expectation that costs of development and marketing of the drug can be recovered by selling medicines for the disease or symptom that affect more than 200,000 people in the United States.

ODD qualifies the sponsor company for various incentives such as
1) Eligibility for 7 years of marketing exclusivity regardless of patent period
2) Up to 50% Tax credit on the cost of clinical trials
3) Exemption of fees for registration
4) Support of Office of Orphan Products Development (OOPD) during the development period
5) Eligibility for applications for clinical development cost assistance programs.
It also offers eligibility for a fast track drug development program, priority review, and accelerated approval.

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]).

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.