On August 18, 2022 Jemincare, a leading pharmaceutical company from China, reported that it and its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., have entered into an exclusive worldwide license agreement with Roche (SIX: RO, ROG;OTCQX: RHHBY) and Genentech, a member of the Roche Group, for the development and commercialization of its androgen receptor degrader, JMKX002992 (Press release, Shanghai Jemincare Pharmaceutical, AUG 18, 2022, View Source [SID1234618480]).

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Under the terms of the agreement, Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs. In return, Genentech will pay Jemincare a USD 60 million upfront payment. Jemincare is also entitled to receive up to USD 590 million in additional payments upon achievement of certain development, regulatory and sales-based milestone targets. Jemincare is also entitled to receive tiered royalties on net sales.

JMKX002992 is a novel oral degrader of the androgen receptor, a confirmed disease driver in prostate cancer. JMKX002992 has the potential to treat patients with prostate cancer who have developed resistance to current therapies.

"We are delighted to enter into collaboration with Roche, one of the world’s leading pharmaceutical companies providing transformative innovative solutions across major disease areas, and Genentech, a worldwide leading innovator in oncology. We trust this partnership could significantly enhance and accelerate the development and potential commercialization of JMKX002992 to benefit patients. This is our third innovative therapy partnered globally. We are proud of this achievement within only four years since the establishment of our R&D center. Jemincare will continue to realize our commitment to benefit patients with innovative solutions." said Mr. Hong Liang, President of Jemincare Pharmaceutical Group.

"Prostate cancer remains a leading cause of death in men worldwide," said James Sabry, Global Head of Roche Pharma Partnering. "Certain forms of prostate cancer can be particularly difficult to treat. Jemincare’s novel oral androgen receptor degrader will complement our efforts to develop new treatment options for patients with advanced prostate cancer."

On August 18, 2022 Targovax reported its first half and second quarter 2022 results (Presentation, Targovax, AUG 18, 2022, View Source [SID1234618481]).

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On August 18, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that it will present updated data from the expansion phase of its ongoing Phase 1 trial of BCA101, a bifunctional antibody designed to target the TGFβ trap to EGFR+ tumors, in an oral presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 (Press release, Bicara Therapeutics, AUG 18, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-clinical-data-from-lead-precision-tumor-modulator-program-bca101-at-esmo-congress-2022 [SID1234618479]). The meeting is being held at the Paris Expo Porte de Versailles in Paris, France and virtually from September 9-13, 2022.

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Details of the oral presentation are as follows:

Session Category: Mini Oral session: Investigational immunotherapy
Presentation Title: A phase 1 trial of the bifunctional EGFR/TGFβ fusion protein BCA101 alone and in combination with pembrolizumab in patients with advanced solid tumors
Presenter: Glenn J. Hanna, MD
Date/Time: Saturday, September 10, 2022 at 2:55 p.m. GMT (8:55 a.m. EST)

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/1b clinical trial of BCA101, initiated in July 2020, has enrolled cohorts of patients in a dose-escalation study with BCA101 as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor and a recommended dose for expansion has been declared. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.

On August 18, 2022, Amgen Inc. (the "Company") reported that issued and sold $1,250,000,000 aggregate principal amount of the Company’s 4.050% Senior Notes due 2029 (the "2029 Notes"), $750,000,000 aggregate principal amount of the Company’s 4.200% Senior Notes due 2033 (the "2033 Notes"), and $1,000,000,000 aggregate principal amount of the Company’s 4.875% Senior Notes due 2053 (the "2053 Notes" and, together with the 2029 Notes and the 2033 Notes, the "Notes") (Filing, 8-K, Amgen, AUG 18, 2022, View Source [SID1234618477]). The Notes are registered under an effective Registration Statement on Form S-3 (Registration No. 333-236351) (the "Registration Statement"), filed on February 10, 2020, and were issued pursuant to an indenture, dated as of May 22, 2014 (the "Indenture"), between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee, and an officer’s certificate, dated as of August 18, 2022 (the "Officer’s Certificate"), setting forth the terms of the Notes. Net proceeds to the Company from the offering were approximately $2,976,217,500, after deducting underwriters’ discounts and estimated offering expenses payable by the Company.

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The relevant terms of the Notes are set forth in the Indenture, included as Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on May 22, 2014, and incorporated herein by reference, and the Officer’s Certificate (including the forms of the Notes) attached hereto as Exhibit 4.2 and incorporated herein by reference.

The 2029 Notes will pay interest at the rate of 4.050% per annum, the 2033 Notes will pay interest at the rate of 4.200% per annum and the 2053 Notes will pay interest at the rate of 4.875% per annum, which, in the case of the 2029 Notes, shall be payable in cash semi-annually in arrears on February 18 and August 18 of each year, beginning on February 18, 2023 and, in the case of the 2033 Notes and 2053 Notes, shall be payable in cash semi-annually in arrears on March 1 and September 1 of each year, beginning March 1, 2023. The 2029 Notes will mature on August 18, 2029, the 2033 Notes will mature on March 1, 2033 and the 2053 Notes will mature on March 1, 2053.

In the event of a change in control triggering event, as defined in the Officer’s Certificate, the holders of the Notes may require the Company to purchase for cash all or a portion of their Notes at a purchase price equal to 101% of the principal amount of Notes, plus accrued and unpaid interest, if any. The descriptions of the Indenture, the Officer’s Certificate and the Notes in this report are summaries and are qualified in their entirety by the terms of the Indenture, the Officer’s Certificate and the Notes, respectively.

The Notes will rank equal in right of payment to all of the Company’s other existing and future senior unsecured indebtedness, senior in right of payment to all of the Company’s existing and future subordinated indebtedness, effectively subordinated in right of payment to all of the Company’s subsidiaries’ obligations (including secured and unsecured obligations) and subordinated in right of payment to the Company’s secured obligations, to the extent of the assets securing such obligations.

On August 18, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases – including COVID-19, the disease caused by the SARS-CoV-2 virus – reported the commencement of its Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer ("LAPC") (AMP-270) following receipt of Institutional Review Board ("IRB") approval for the trial protocol (Press release, AIM ImmunoTech, AUG 18, 2022, View Source [SID1234618476]).

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AIM Chief Executive Officer Thomas K. Equels commented, "We are pleased to reach this important step in the development of Ampligen. Receiving IRB approval for our Phase 2 study of Ampligen for the treatment of LAPC is the pivotal precursor to the recruitment, enrollment and treatment of patients with locally advanced pancreatic cancer. We look forward to providing further updates on the development of this important therapy."

The Company’s Phase 2 study Investigational New Drug ("IND") application was previously cleared by the U.S. Food and Drug Administration ("FDA"). An IRB is a group that operates under FDA regulations and ensures, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

The AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe. The Buffett Cancer Center at the University of Nebraska Medical Center and Erasmus MC in the Netherlands are expected to be the primary study sites.

"We expect study sites to be open and recruiting patients in late Q3/early Q4 of 2022, with every hope of first dose in the first patient by the end of Q4 2022," commented Kazem Kazempour, Ph.D., President and CEO of Amarex Clinical Research, LLC, AIM’s Contract Research Organization for AMP-270.

For more information about the AMP-270 please visit ClinicalTrials.gov and reference identifier NCT05494697.

The Company recently reported new, positive data following evaluation of the initial data reported from the single-center, named patient program at Erasmus for both metastatic and LAPC patient populations, analyzing the subset of patients with LAPC. While the predominance of the data collected by Erasmus is in metastatic cancer and those data show high statistical significance, a small cohort of five (5) LAPC patients also exhibited marked improvement with the Ampligen maintenance therapy following FOLFIRINOX. The overall survival from the start of FOLFIRINOX therapy of two (2) of the patients was 34 and 43 months and one patient was still surviving at the last reported checkup in April 2022 at 54 months See: AIM Press Release July 20, 2022.

About Ampligen

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies.

Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Ampligen is being used to treat pancreatic cancer patients in an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in SARS-CoV-2/COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.