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Sapience Therapeutics Commences Dosing in Final Dose-Escalation Cohort of Ongoing Phase 1-2 Study of ST101

On July 29, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that it has commenced dosing in the final dose-escalation cohort of an ongoing Phase 1-2 study of its lead program, ST101, for the treatment of patients with advanced and metastatic solid tumors (Press release, Sapience Therapeutics, JUL 29, 2021, View Source [SID1234585411]).

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In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the sixth dose cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of this year.

"ST101 is a very important program for Sapience and it has performed quite well in its initial Phase 1 clinical study," said Dr. Barry Kappel, Founder and Chief Executive Officer of Sapience Therapeutics. "ST101 has been well tolerated, non-immunogenic, and has a pharmacokinetic profile to support a once weekly dosing regimen. We are thrilled that ST101 has demonstrated early signs of clinical activity in several tumor types and we look forward to advancing ST101 into Phase 2 later this year."

Dr. Alice Bexon, Sapience’s Chief Medical Officer, added, "The efficacy and safety of ST101 demonstrated in Phase 1 is very promising. We have not seen dose limiting toxicity to date, and we now have patients with nearly 1 year of exposure. ST101 is well positioned to be an exciting novel weapon against refractory cancers and to deliver a clinical benefit to patients."

In addition to the clinical update, Sapience also announces today that the European Commission (EC) granted orphan medicinal product designation to ST101 for the treatment of glioma. Orphan Drug Designation in the European Union ("EU") is granted by the EC based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products. To qualify, an investigational medicine must be intended to diagnose, prevent or treat a chronically debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU, and there must be sufficient non-clinical or clinical data to suggest the investigational medicine may produce clinically relevant outcomes. EMA orphan drug designation provides companies with certain benefits and incentives, including protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees and 10 years of market exclusivity. Sapience previously announced receipt of orphan drug product designation from the U.S. Food and Drug Administration (FDA) in 2020.

About ST101
ST101 is a peptide antagonist of C/EBPβ, and in July 2020 it entered into a Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). C/EBPβ is a transcription factor overexpressed or activated in many cancers, but not active in normal cells (post-differentiation), providing a unique therapeutic opportunity. In tumors, C/EBPβ promotes survival and proliferation and regulates cellular differentiation. ST101 significantly decreases the expression of C/EBPβ target genes/proteins involved in oncogenesis including BCL-2, BIRC5/survivin, cyclins and ID family of proteins. As a result, ST101 induces selective cancer cell cytotoxicity across a variety of tumor types, including but not limited to breast cancer, melanoma, prostate cancer, GBM, lung cancer, and AML.

Aethlon Medical to Release First Quarter Financial Results and Host Conference Call on August 9, 2021

On July 29, 2021 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on unmet needs in global health, reported that it will issue financial results for its first quarter fiscal year 2022, ended June 30, 2020, at 4:15 p.m. EST on Monday, August 9, 2021 (Press release, Aethlon Medical, JUL 29, 2021, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-first-quarter-financial-results-and-host-conference-call-on-august-9-2021-301344571.html [SID1234585410]).

Management will host a conference call on Monday, August 9, 2021 at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

A replay of the call will be available approximately one hour after the end of the call through September 9, 2021. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 10159282.

Miravo HealthcareTM Ireland Enters into Suvexx® License and Supply Agreement with SK Chemicals Co., Ltd. for South Korea

On July 29, 2021 Nuvo Pharmaceuticals Inc. (TSX: NRI) (OTCQX: NRIFF) d/b/a Miravo Healthcare ("Miravo" or the "Company"), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported that its wholly owned subsidiary, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare ("Miravo Ireland"), reported that it has entered into an exclusive license and supply agreement (the "License Agreement") with SK Chemicals Co., Ltd. ("SK Chemicals") for the exclusive right to commercialize Suvexx in the Republic of South Korea (the "Territory") (Press release, Nuvo Pharmaceuticals, JUL 29, 2021, View Source [SID1234585409]).

SK Chemicals is headquartered in Seongnam, South Korea and is part of the SK Group, a major South Korean conglomerate that generated over US$105 billion in revenue in 2020. SK Chemicals generated US$1.0 billion in sales in 2020 and has Korean partnerships with many multinational pharmaceutical companies including Eli Lilly, AstraZeneca and Janssen.

The commercial launch of Suvexx in the Territory is anticipated to commence in 2023, subject to receipt of regulatory approval from the local regulatory authorities. Upon regulatory approval, Suvexx is anticipated to be entitled to 6 years of marketing exclusivity in the Territory. The South Korean prescription acute migraine treatment market was valued at over US$20 million in 2020 based on IQVIA domestic data.

"This agreement with SK Chemicals provides Suvexx with access to the dynamic and growing acute migraine market in South Korea," said Jesse Ledger, Miravo’s President & CEO. "SK Chemicals is a strong partner for Suvexx in South Korea with their complementary CNS product portfolio, and we are pleased to add them to our growing roster of Suvexx partners."

License Agreement Details

The License Agreement grants SK Chemicals the exclusive rights to commercialize Suvexx in the Territory. SK Chemicals will be responsible for obtaining and maintaining the marketing authorizations for Suvexx in the Territory and will also manage all Territory specific commercial activities. Miravo Ireland will receive up to EUR 1.1 million in upfront consideration, regulatory and sales-based milestone payments, as well as royalties on net sales of Suvexx in the Territory and revenue pursuant to the supply of product. Suvexx is currently manufactured by the Company’s contract manufacturing partner in the United States.

About Suvexx

Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan that was originally developed by the Aralez Pharmaceuticals Inc. wholly owned subsidiary POZEN, Inc. ("POZEN") in collaboration with Glaxo Group Limited, d/b/a GSK ("GSK"). The product is formulated with POZEN’s patented technology (now owned by Miravo) of combining a triptan, sumatriptan 85 mg, with an NSAID, naproxen sodium 500 mg and GSK’s RT Technology in a single tablet. In 2008, the U.S. Food and Drug Administration ("FDA") approved Treximet (the U.S. brand name for Suvexx) for the acute treatment of migraine attacks, with or without aura, in adults. Treximet is currently commercialized in the U.S. by Currax Holdings USA LLC. Miravo owns the product and intellectual property rights to Suvexx in Canada and Miravo Ireland owns the intellectual property rights to Suvexx outside of Canada.

Centene Corporation Prices Offering of Senior Notes

On July 29, 2021 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has priced its previously announced underwritten public offering of $1,800,000,000 aggregate principal amount of senior notes (Press release, Centene , JUL 29, 2021, View Source [SID1234585408]). The $1,800,000,000 offering of senior notes will include $500,000,000 aggregate principal amount of additional 2.450% senior notes due 2028 (the "Additional 2028 Notes") at a premium to yield 2.31% and $1,300,000,000 aggregate principal amount of new 2.625% senior notes due 2031 (together with the Additional 2028 Notes, the "Notes"). The Additional 2028 Notes will have the same terms as the Company’s existing 2.450% senior notes due 2028 (the "Existing 2028 Notes"), other than the issue date and the issue price. The offering is expected to close on or about August 12, 2021, subject to customary closing conditions.

Centene intends to use the net proceeds from the offering of the Notes, together with a portion of the proceeds of certain term loans under the Company’s proposed amended and restated credit agreement and cash on hand to redeem all of its outstanding 5.375% senior notes due 2026 and all of WellCare Health Plans, Inc.’s, a Delaware corporation and a wholly-owned subsidiary of the Company, outstanding 5.375% senior notes due 2026 (together, the "Note Redemptions"), including all premiums, accrued interest and costs and expenses related to the Note Redemptions. Pending the application of the net proceeds of the offering for the foregoing purposes, net proceeds may be temporarily used for general corporate purposes. The foregoing does not constitute a notice of redemption or an obligation to issue a notice of redemption for the outstanding notes of any series.

The Notes will be senior unsecured obligations of the Company and will be equal in right of payment with all of the Company’s existing and future senior indebtedness and will be senior in right of payment to all of the Company’s existing and future subordinated debt. The Notes will not be guaranteed by any of the Company’s subsidiaries.

J.P. Morgan, Barclays, BofA Securities, Truist Securities and Wells Fargo Securities are acting as joint book-running managers for the offering of the Notes.

This offering is being made pursuant to an effective shelf registration statement and prospectus and a related preliminary prospectus supplement filed by the Company with the Securities and Exchange Commission (the "SEC"). Before you invest, you should read the prospectus and the related preliminary prospectus supplement, the registration statement and other documents that Centene has filed with the SEC for more complete information about Centene and this offering.

Copies of the prospectus supplement and related prospectuses for this offering can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling +1 (866) 803-9204; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by calling (888) 603-5847; from BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; from Truist Securities by email at [email protected]; and from Wells Fargo Securities, LLC, 550 S. Tryon Street, 5th Floor, Charlotte, North Carolina 28202, Attention: Leveraged Syndicate.

This press release is neither an offer to purchase nor a solicitation of an offer to buy any securities, including the Notes. There shall not be any sale of the securities described herein in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Omega Therapeutics Announces Pricing of Initial Public Offering

On July 29, 2021 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-stage biotechnology company leveraging its OMEGA Epigenomic Programming platform to harness the power of epigenetics to develop a new class of DNA-sequence-targeting, mRNA-encoded programmable epigenetic medicines, reported the pricing of its initial public offering of 7,400,000 shares of its common stock at a price to the public of $17.00 per share (Press release, Omega Therapeutics, JUL 29, 2021, View Source [SID1234585407]). All of the shares of common stock are being offered by Omega. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Omega, are expected to be approximately $125.8 million, excluding any exercise of the underwriters’ option to purchase additional shares. Omega’s common stock is expected to begin trading on the Nasdaq Global Select Market under the ticker symbol "OMGA" on July 30, 2021. The offering is expected to close on August 3, 2021, subject to satisfaction of customary closing conditions. In addition, Omega has granted the underwriters a 30-day option to purchase up to an additional 1,110,000 shares of common stock at the initial public offering price less underwriting discounts and commissions.

Goldman Sachs & Co. LLC, Jefferies LLC and Piper Sandler are acting as joint book-running managers of the offering. Wedbush PacGrow is acting as lead manager.

A registration statement on Form S-1 (File No. 333-257794) relating to the offering has been filed with the Securities and Exchange Commission and became effective on July 29, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; or Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

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