April 19, 2022 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the United States, reported that the amended ENVASARC protocol approved by the U.S. Food and Drug Administration ("FDA") in February has now been approved by institutional review boards or ethics committees at all 30 clinical sites: 29 in the United States and one in the United Kingdom (Press release, Tracon Pharmaceuticals, APR 19, 2022, https://ir.traconpharma.com/news-releases/news-release-details/tracon-pharmaceuticals-announces-amended-envasarc-protocol [SID1234612497]).

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In February, the FDA approved the amended ENVASARC protocol following the Independent Data Monitoring Committee (IDMC) recommendation based on the highly tolerable safety profile and the significantly higher objective response rate observed in lower weight patients in ENVASARC, to increase the dose of envafolimab to 600 mg every three weeks (Q3W), which is double the original envafolimab dose of 300 mg Q3W. Initial dosing under the amended protocol commenced in March, and more than 10 patients have been enrolled under the amended protocol at the 600 mg Q3W dose less than two months following FDA clearance. Each of the 29 U.S. cancer centers have approved the amended protocol and are open for accrual. An additional site in the United Kingdom, Royal Marsden Hospital, has also approved the amended protocol and is open for accrual. TRACON expects to report results of IDMC mandated interim safety reviews and the interim efficacy review in the second half of 2022.

"We are pleased to have opened every site under the amended ENVASARC protocol that increases the envafolimab dose to 600 mg within two months of FDA approval in February," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to the interim ENVASARC safety and efficacy data reviews by the IDMC in the second half of 2022."

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first subcutaneously injected PD-(L)1 inhibitor approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

On April 19, 2022 Alvotech Holdings S.A. ("Alvotech"), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, reported that, subject to the completion of the announced business combination (the "Business Combination") between Alvotech, Alvotech Lux Holdings S.A.S. ("the Company") and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS) ("OACB"), a special purpose acquisition company with approximately $250 million of cash in trust sponsored by an affiliate of Oaktree Capital Management, L.P., the Company has secured a Standby Equity Purchase Agreement ("SEPA") facility from YA II PN, Ltd ("Yorkville") and signed a binding term sheet for a debt facility from Sculptor Capital Management ("Sculptor") (Press release, Alvotech, APR 19, 2022, View Source [SID1234612513]).

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The two facilities are intended to provide access of up to $250 million and are expected to be used to replace potential redemptions by OACB shareholders that may occur as part of the Business Combination. The Yorkville SEPA facility provides for up to $150 million of equity financing at the Company’s option (subject to certain limitations). Additionally, the binding term sheet with Sculptor provides for $75 million – $125 million in debt, with the exact amount to be finalized based on the level of net proceeds generated as a result of the closure of the Business Combination.

Alvotech and OACB have also agreed to reduce the minimum cash condition set forth in the merger agreement between the two companies such that, subject to certain conditions, the minimum cash condition would be satisfied through the existing private placement ("PIPE") commitments of approximately $175 million and the new loan facility from Sculptor (subject to final agreement), thereby providing enhanced deal certainty for the Business Combination.

"We believe the added facilities will strengthen Alvotech’s capitalization profile when the merger with OACB is finalized," said Robert Wessman, Founder and Chairman of Alvotech. "Specifically for the equity line, we intend to utilize the facility in amounts that are equal to or less than what we may experience in redemptions from the trust. This facility may also provide additional free float of our ordinary shares, should we experience higher than expected redemptions."

On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol "ALVO."

On January 18, 2021, Alvotech announced an upsized PIPE totaling approximately $175 million, raised entirely as ordinary shares, at $10.00 per share. Investors in the PIPE include top-tier investors such as Survretta Capital, Athos (the Strüngmann Family Office), CVC Capital Partners, Temasek Holdings, YAS Holdings, Farallon Capital Management, and Sculptor Capital Management, among others.

On April 19, 2022 Alkermes plc (Nasdaq: ALKS) reported that it commenced binding arbitration proceedings in respect of two license agreements with Janssen Pharmaceutica N.V. ("Janssen"), a subsidiary of Johnson & Johnson (Press release, Alkermes, APR 19, 2022, View Source [SID1234612462]). Under these agreements, Janssen received access and rights to Alkermes’ small particle pharmaceutical compound technology, known as NanoCrystal Technology, which enabled a number of successful products, such as INVEGA SUSTENNA, INVEGA TRINZA, INVEGA HAFYERA and CABENUVA. Janssen partially terminated the agreements in the United States effective as of February 2022.

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The purpose of the arbitration is to settle, among other things, whether, notwithstanding its partial termination of the agreements, Janssen has a continuing obligation to pay royalties on sales in the United States of products developed under the agreements. Janssen has refused to pay any royalties required by the agreements in the United States since the effective date of the partial terminations. Alkermes strongly disagrees with Janssen’s position and contends that it continues to owe royalties. Alkermes remains committed to enforcing its contractual rights and addressing any unauthorized use of its intellectual property.

Following receipt of the notices of partial termination, Alkermes triggered dispute resolution provisions in the license agreements. The company has engaged with Janssen in an effort to come to a mutually agreeable settlement. No resolution has been achieved. Alkermes remains open to a mutually agreeable resolution.

Under the agreements, the arbitration will be conducted pursuant to the Institute for Conflict Prevention and Resolution (CPR) Rules for Non-Administered Arbitration before a panel of three arbitrators. The arbitration will be confidential, subject to the parties’ disclosure obligations under applicable law. Other than pursuant to these obligations, Alkermes does not intend to comment or provide additional information regarding the arbitration until an order on the merits or other material order is issued in the arbitration or the arbitration is otherwise concluded.

On April 19, 2022 Eli Lilly and Company (NYSE: LLY) reported its first-quarter 2022 financial results on Thursday, April 28, 2022 (Press release, Eli Lilly, APR 19, 2022, View Source [SID1234612481]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On April 19, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release financial results for the first quarter of 2022 after the close of market on Tuesday, May 3, 2022 (Press release, Veracyte, APR 19, 2022, View Source [SID1234612498]). Company management will host a conference call and webcast to discuss financial results and provide a general business update at 4:30 p.m. Eastern Time on the same day.

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The conference call will be webcast live from the company’s website and will be available via the following link: View Source A webcast replay will be available following the conclusion of the live broadcast and will be accessible on the company’s website at View Source