On January 12, 2024 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of first-in-class immune-modulatory antibodies for cancer immunotherapy, reported that its early discovery partner Exelixis, Inc. has provided a notice of termination for the option and license agreement for novel antibodies for use in immuno-oncology therapeutics (Press release, BioInvent, JAN 12, 2024, https://www.bioinvent.com/en/press/bioinvent-regains-rights-immuno-oncology-targets-exelixis-2191491 [SID1234642491]). It follows a recently announced corporate restructuring program within Exelixis, prioritizing its pipeline of clinical and near-clinical programs. BioInvent regains the full rights to all targets and resulting candidates developed under the collaboration.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have appreciated the excellent partnership with Exelixis which has identified very interesting new pathways," said Dr. Martin Welschof, CEO of BioInvent. "These novel targets, generated from our proprietary F.I.R.S.T platform, formed the basis for generation of unique antibodies for immuno-oncology therapy. BioInvent has a long track record of successful collaborations and the positive progress on these exciting immuno-oncology targets opens the door to further opportunities."

The companies will collaborate on a wind-down and effective transition over the next 90 days. Today’s news has no material financial impact on BioInvent.

On January 12, 2024, Eagle Pharmaceuticals, Inc. (the "Company"), reported to have entered into a Limited Waiver and First Amendment to Third Amended and Restated Credit Agreement (the "Amendment Agreement") with JPMorgan Chase Bank, N.A., as administrative agent (the "Agent"), and the lenders party thereto (the "Lenders"), which (i) provides a waiver of previously disclosed defaults and events of default that occurred and were continuing under the Company’s Third Amended and Restated Credit Agreement, dated as of November 1, 2022 (the "Credit Agreement") and (ii) amends the Credit Agreement (the Credit Agreement as amended by the Amendment Agreement, the "Amended Credit Agreement") (Filing, 8-K, Eagle Pharmaceuticals, JAN 12, 2024, View Source [SID1234639257]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pursuant to the terms of the Amendment Agreement, the Agent and the Lenders have agreed to a limited waiver subject to the terms and conditions described below and set forth in the Amendment Agreement, with respect to, among other things, the defaults and events of default that occurred in connection with (i) the non-reliance determination by the Company in respect of the Company’s financial statements for the quarter ended June 30, 2023 and (ii) the Company’s failure to timely deliver financial statements for the fiscal quarter ended September 30, 2023. As previously disclosed in the Company’s Current Report filed with the SEC on Form 8-K filed on December 15, 2023, the Company was required to deliver to the Agent and lenders, by not later than November 14, 2023, quarterly financial statements certified by one of its officers as presenting fairly in all material respects the financial condition and results of operations of the Company and its consolidated subsidiaries for the fiscal quarter ended September 30, 2023 (the "September 2023 Financials") pursuant to a covenant requiring delivery of quarterly financials within 45 days of the end of each of the first three fiscal quarters of each fiscal year. The Company failed to timely deliver the September 2023 Financials, which such failure constituted a default under the Credit Agreement, subject to a 30-day cure period ending December 14, 2023. The Company failed to timely deliver the September 2023 Financials and accordingly failed to cure such default within the 30-day cure period, which gave rise to an event of default under the Credit Agreement. In addition, in connection with the planned restatement of the financial statements for the quarter ended June 30, 2023 (the "June 2023 Financials"), the Company concluded that the June 2023 Financials previously delivered to the Agent and lenders did not present fairly in all material respects the financial condition and results of operations of the Company and its consolidated subsidiaries and accordingly were not prepared in accordance with generally accepted accounting principles, which gave rise to events of default under the Credit Agreement.

Pursuant to the terms of the Amended Credit Agreement, the Company is required to deliver to the Agent and the Lenders, by not later than February 29, 2024, quarterly financial statements for the fiscal quarters ended June 30, 2023 and September 30, 2023, in each case certified by one of its officers as presenting fairly in all material respects the financial condition and results of operations of the Company and its consolidated subsidiaries for the respective quarter (the "Financial Statement Requirement").

Pursuant to the terms of the Amendment Agreement, until the Company satisfies the Financial Statement Requirement, (i) availability under the Amended Credit Agreement will be reduced from $100 million to $50 million, (ii) the Company will not be permitted to utilize any negative covenant flexibility that is based on a pro forma compliance with any of the Fixed Charge Coverage Ratio, Senior Secured Net Leverage Ratio and/or the Total Net Leverage Ratio test (each as defined in the Amended Credit Agreement), which restricts the Company’s flexibility to, among other things, incur certain additional indebtedness, complete certain corporate transactions, including certain acquisitions and dispositions, or make certain additional restricted payments and (iii) compliance with the minimum liquidity covenant shall be waived.

Pursuant to the terms of the Amended Credit Agreement, failure to timely satisfy the Financial Statement Requirement will result in an event of default. During the continuance of an event of default, the Agent may, with the consent of the required lenders, and shall, at the request of the required lenders, by notice to the Company, terminate undrawn commitments, declare the loans then outstanding to be due and payable in full and/or exercise other remedies available to it, among other things. In addition, the Company’s obligations under the Amended Credit Agreement are secured by a pledge of substantially all of the Company’s assets. If the Company is unable to pay its obligations, the Agent on behalf of the lenders could proceed to protect and enforce their rights under the Amended Credit Agreement, including by foreclosure on the assets securing the Company’s obligations under the Amended Credit Agreement. The foregoing would materially and adversely affect the Company’s business and financial condition. There can be no assurance that the Company will be able to satisfy the Financial Statement Requirement on the required timing or at all, or comply with the terms of the Agreement Amendment and the Amended Credit Agreement.

The foregoing description of the Amendment Agreement is not intended to be complete and is qualified in its entirety by reference to the full text of the Amendment Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K.

On January 12, 2024 GENESIS Pharma, a leading regional biopharma company operating in Europe, and Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported an exclusive distribution agreement for RIPRETINIB in 14 European markets in Central and Eastern Europe (Press release, Genesis Pharma, JAN 12, 2024, View Source [SID1234639222]). Under the terms of the agreement, GENESIS Pharma will exclusively commercialize RIPRETINIB for the treatment of fourth-line gastrointestinal stromal tumor (GIST) in: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, and Slovenia.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

RIPRETINIB is approved in the European Union for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Ms. Margarida Duarte, Senior Vice President, Head of International, Deciphera Pharmaceuticals stated: "We are excited to partner with GENESIS Pharma to distribute RIPRETINIB across Central and Eastern Europe, ensuring fourth-line GIST patients in these countries have access to this standard-of-care treatment. Deciphera is committed to commercializing RIPRETINIB globally, and our agreement with GENESIS Pharma builds upon the significant progress we have already made launching the therapy in Europe, positioning us well for continued growth as we work together to improve the lives of GIST patients".

Mr. Constantinos Evripides, Managing Director of GENESIS Pharma stated: "We are pleased to expand the network of our international partners and honored that Deciphera recognized our expertise and track record in the commercialization of innovative biopharmaceutical products targeting severe and rare diseases. This agreement is an important step forward in expanding our geographical reach and delivering our mission to ensure that such products are made available to patients in the countries we operate. We look forward to joining forces with Deciphera to enable access to this important innovative therapy for eligible patients in Central and Eastern Europe".

About Gastrointestinal stromal tumor (GIST)

Gastrointestinal stromal tumor (GIST) is a rare neoplasm of the gastrointestinal tract affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST is the most frequent sarcoma of the gastrointestinal tract, with a reported incidence of 10-15 cases per million per year. The majority of GISTs are driven by two oncogenic protein kinases, KIT and PDGFRA gain-of-function mutations. The most common primary mutations are in KIT kinase, representing approximately 80% of cases, or in PDGFRA kinase, representing approximately 5-10% of cases. Current therapies are unable to inhibit the full spectrum of primary and secondary mutations, which drives resistance to most tyrosine kinase inhibitors (TKIs) therefore leading to disease progression. Estimates for 5-year survival rate range from 48% to 90%, depending on the stage of the disease at diagnosis.

On January 12, 2024 PharmaLogic Holdings Corp. ("PharmaLogic"), a leading radiopharmaceutical contract development and manufacturing organization, and ARTBIO, a clinical-stage radiopharmaceutical company developing a new class of alpha radioligand therapies (ARTs), reported a manufacturing and supply agreement for ARTBIO’s lead-212 (212Pb) based radiopharmaceutical candidate, AB001, for the treatment of prostate cancer (Press release, ARTBIO, JAN 12, 2024, View Source [SID1234639221]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, PharmaLogic will assist ARTBIO with radiochemistry and supply of the finished radiopharmaceutical product for future Phase I and II clinical trials of AB001 from their facility in New York, using ARTBIO’s proprietary AlphaDirect 212Pb isolation technology.

"Through this partnership, we are able to leverage PharmaLogic’s extensive and broad expertise in manufacturing radiopharmaceuticals and diagnostics, which complement well ARTBIO’s proprietary AlphaDirect technology to isolate 212Pb and discovery of novel alpha radioligand therapies," said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. "Our combined capabilities, along with our shared goal to improve as many lives as possible, position us well to deliver safe and effective alpha radioligand therapies to the patient bedside."

212Pb is an alpha-emitting radioisotope that has gained attention for its potential applications in therapeutic medicine, particularly in targeted alpha radioligand therapy, due to the radioisotope’s attractive short-half life and other properties. Preliminary studies of radiopharmaceuticals labeled with 212Pb have been promising, indicating that 212Pb has the potential to address unmet clinical needs.

"Consistent with our mission to bring transformative radiopharmaceuticals to patients, we are pleased to partner with ARTBIO to manufacture and supply AB001 for future clinical trials," said D. Scott Holbrook, Chief Strategy Officer and General Manager for PharmaLogic. "By combining our expertise, we aim to make significant strides in the field of therapeutic radiopharmaceuticals and ultimately improve the lives of patients.

On January 12, 2024 RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, reported recently that its independently developed mesothelin (MSLN)-targeting antibody-drug conjugate (ADC), RC88, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers (Press release, RemeGen, JAN 12, 2024, View Source [SID1234639220]). This marks another significant development following the FDA’s approval to RC88’s international multicenter Phase II clinical trials last month.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

RC88 consists of a recombinant humanized anti-MSLN monoclonal antibody linked to the microtubule inhibitor monomethyl auristatin E (MMAE), which acts as a microtubule inhibitor. It has a high affinity for MSLN, which can specifically bind to overexpressing MSLN tissues, and has clearly displayed a terminating effect on tumor cells with various expression levels of MSLN.

Epithelial ovarian cancer (EOC) is the leading cause of cancer-related deaths in women, often diagnosed late and prone to relapse within two years, with their disease evolving from platinum-sensitive to resistant. The later the stage and the more aggressive the ovarian cancer, the higher the expression rate of MSLN, and current treatment options are limited. RC88 uniquely targets MSLN, offering a novel approach to this challenging medical condition.

FTD is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose behind this is to get important new drugs to the patient earlier.

Reflecting on this process, Dr. Jianmin Fang, CEO of RemeGen, said, "The FDA’s FTD accelerates the development and review process of RC88, which affirms our commitment to pioneering treatments that address the urgent needs of those facing challenging disease. Moving forward, RemeGen will continue to accelerate the development of its ADC products, with the aim of bringing more and better solutions to patients globally."

The Company is poised to initiate international multicenter phase II clinical studies across the United States, China, the European Union, and other regions, aiming to further clarify the optimal dosage, effectiveness, and safety of RC88 monotherapy.