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ERYTECH to Present at the LifeSci Partners 10th Annual Healthcare Corporate Access Event

On January 4, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that CEO, Gil Beyen, will present at the LifeSci Partners 10th Annual Healthcare Corporate Access Event on Wednesday, January 6th at 9am EST /2pm GMT /3pm CET. The format will be a virtual presentation with the opportunity for Q&A at the conclusion (Press release, ERYtech Pharma, JAN 4, 2021, View Source [SID1234573378]).

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Antengene Submits NDA for ATG-010 (Selinexor) in South Korea for rrMM and rrDLBCL

On January 3, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, reported that it has submitted a New Drug Application (NDA) with Orphan Drug Designation (ODD) to the South Korean Ministry of Food and Drug Safety (MFDS) for ATG-010 (selinexor, XPOVIO) in combination with low dose dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM) and for ATG-010 (selinexor, XPOVIO) as monotherapy to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) (Press release, Antengene, JAN 3, 2021, View Source [SID1234573372]). ATG-010 (selinexor, XPOVIO) was granted orphan drug designation in South Korea in October 2020 and our US partner Karyopharm received U.S. Food and Drug Administration (FDA) approval for the treatment of patients with multiple myeloma after at least one prior therapy on December 18, 2020.

The NDA submission includes positive data from the pivotal STORM and SADAL studies, which both demonstrated significant and meaningful efficacy with a manageable safety profile for ATG-010 (selinexor, XPOVIO). The STORM study is a Phase 2b, open-label, single-arm study evaluating ATG-010 (selinexor, XPOVIO) plus low-dose dexamethasone in patients with rrMM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody. The SADAL study is a Phase 2b, open label study evaluating ATG-010 (selinexor, XPOVIO) in patients with rrDLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, who have received at least two prior therapies.

ATG-010 (selinexor, XPOVIO) is a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) and it is the first drug approved by the FDA for use in both multiple myeloma and diffuse large B-cell lymphoma. In December 2020, the National Comprehensive Cancer Network (NCCN) added three different triplet ATG-010 (selinexor, XPOVIO) combination regimens, including SVd (selinexor, bortezomib and dexamethasone), SPd (selinexor, pomalidomide and dexamethasone) and SDd (selinexor, daratumumab and dexamethasone) to its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for previously treated multiple myeloma in the US. Antengene has submitted NDAs to the Health Sciences Authority (HSA) of Singapore and to the Australian Therapeutic Goods Administration (TGA) for ATG-010 in patients with rrMM and in patients with rrDLBCL.

"The incidence of blood cancers increases with age, yet many healthcare providers still do not have sufficient innovative therapies available to help people with hematological malignancies, such as rrMM and rrDLBCL," Dr. Jay Mei, Founder, Chairman and CEO of Antengene said, "We are excited about the regulatory filing of ATG-010 in APAC markets, including South Korea. We believe that oral ATG-010 will expand and improve treatment options for hematological malignancies and therefore presents a significant advancement for patients requiring treatment of these life threatening diseases."

About ATG-010 (selinexor, XPOVIO)

ATG-010 (selinexor, XPOVIO), a first-in-class and only-in-class oral selective inhibitor of nuclear export compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including the Greater China, South Korea, Australia, New Zealand and the ASEAN countries. In July 2019, the US Food and Drug Administration (FDA) approved selinexor (XPOVIO) in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor (XPOVIO) as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor (XPOVIO) in this same rrMM indication. On December 18, 2020, the supplemental New Drug Application (sNDA) with a request for an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA. Selinexor (XPOVIO) is so far the first and only oral SINE compound approved by the FDA and is the first drug approved by the FDA for the treatment of both MM and DLBCL. Selinexor (XPOVIO) is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral selinexor (XPOVIO) versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of selinexor (XPOVIO) in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned without any modifications. Top-line SIENDO study results are expected in the second half of 2021.

Antengene is conducting two registrational Phase 2 clinical trials of ATG-010 (selinexor, XPOVIO) in China for relapsed/refractory multiple myeloma (MARCH) and for relapsed/refractory diffuse large B-cell lymphoma (SEARCH), and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).

Bristol Myers Squibb Provides Update on Status of Contingent Value Rights

On January 1, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies remains under review by the U.S. Food and Drug Administration (FDA) and the company has not received a decision (Press release, Bristol-Myers Squibb, JAN 1, 2021, View Source [SID1234573367]). As previously announced, the FDA has not provided a new action date for this application. Bristol Myers Squibb continues to work closely with the FDA to support the ongoing review of the BLA for liso-cel and is committed to bringing this therapy to patients.

Since the FDA approval of liso-cel did not occur by December 31, 2020, one of the three required milestones for payment of the Bristol Myers Squibb Contingent Value Right (CVR) (NYSE: BMY-RT) was not met. As a result, on January 1, 2021, the Contingent Value Rights Agreement (CVR Agreement), pursuant to which the CVRs were issued, terminated automatically in accordance with its terms and the CVRs are no longer eligible for payment under the CVR Agreement. The CVRs will no longer trade on the NYSE.

For additional information, please refer to: View Source or call EQ Shareowner Services at 1-833-503-4131.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming people’s lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

NETRIS PHARMA ANNOUNCES FIRST PATIENT DOSED IN PHASE IB/II

On December 31, 2020 NETRIS Pharma, a clinical-stage biopharmaceutical company developing therapeutics based on dependence receptor biology, reported that the first patient has been dosed in its GYNet Phase 1b/II clinical study (Press release, Netris Pharma, DEC 31, 2020, View Source [SID1234611185]).

GYNet is a randomized, multicenter, open label Phase Ib/II study that will enroll up to 240 patients with locally advanced/metastatic endometrial carcinoma or cervix carcinoma progressing/relapsing after at least one prior systemic chemotherapy. In the Phase1b part, the study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NP137 administered in combination with KEYTRUDA and/or chemotherapeutic agents. The Phase 2 part will assess the clinical activity of the combination in both tumor types. More information on GYNet study can be found at View Source (NCT04652076).

NP137 is a monoclonal antibody that targets netrin-1, which is a protein overexpressed in over 80% of uterine tumors. In early clinical studies, NP137 monotherapy demonstrated encouraging clinical signs of efficacy as measured by objective response and prolonged stable disease. In addition, preclinical data confirmed that netrin-1 interference via NP137 alleviates resistance to chemotherapy and immune checkpoint inhibitors, reinforcing the strong scientific rationale of this combination trial.

"We look forward to seeing the first clinical result of the GYNet trial, given the anti-tumor activity as single agent observed in the Phase 1a trial and unique mode of action of NP137," said Professor Isabelle Ray Coquard, MD, Ph.D. from the Centre Leon Bérard in Lyon, France and Principal Investigator of the trial.

Patrick Mehlen, CEO and Founder of NETRIS Pharma added: "The inclusion of the first patient in this phase 1b/2 clinical trial is a new milestone in the development of Netris. We look forward to seeing the results of this study as well as additional clinical advances in the near future."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About NP137
NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers.

In preclinical studies, NP137 inhibited tumor growth and had a significant impact on tumoral plasticity, which potentiates the efficacy of chemotherapies and immune checkpoint inhibitors. In the phase 1 dose-escalation study, NP137 was found to be safe and very well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT). In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective responses.

Entry into a Material Definitive Agreement

On December 31, 2020 (the "Closing Date"), Paratek Pharmaceuticals, Inc. (the "Company"), through its wholly-owned subsidiary PRTK SPV2 LLC, a Delaware limited liability company (the "Subsidiary"), reported that it entered into a royalty and revenue interest-backed loan agreement (the "Loan Agreement") with an affiliate of R-Bridge Healthcare Investment Advisory, Ltd. (the "Lender") (Filing, 8-K, Paratek Pharmaceuticals, DEC 31, 2020, View Source [SID1234573411]). Pursuant to the terms of the Loan Agreement, the Subsidiary borrowed a $60.0 million term loan, secured by, and repaid with proceeds from, (i) royalties from the Company’s license agreement with Zai Labs (Shanghai) Co., Ltd. (the "License Agreement", and such royalties, the "Royalty Interest") and (ii) a revenue interest based on the Company’s United States sales of NUZYRA in an initial amount of two and a half percent (2.5%), which amount may adjust under certain circumstances up to five percent (5%), of the Company’s net United States sales, subject to an annual cap of $10.0 million, which may adjust under certain circumstances to $12.0 million (the "Revenue Interest").

Under the Loan Agreement, the outstanding principal balance will bear interest at an annual rate of 7.0%. Payments of the obligations outstanding under the Loan Agreement will be made quarterly, beginning with the payment due in respect of the quarter ending March 31, 2021, out of the Royalty Interest payments and Revenue Interest payments received by the Subsidiary during such quarter (the "Collection Amount"). On each payment date, after payment of certain expenses, the Collection Amount shall be applied first to accrued interest, with any excess up to $15.0 million per annum applied to repay principal until the balance is fully repaid. Amounts in excess of the $15.0 million annual cap shall be shared between the Company and the Lender based on a formula set out in the Loan Agreement. Following repayment in full of the loan, the first $15.0 million per annum in Collection Amount shall be paid to the Company and any amounts in excess shall be shared between the Company and the Lender based on a formula set out in the Loan Agreement.

Prior to the eighth (8th) anniversary of the Closing Date, the Loan Agreement will automatically terminate once the Subsidiary has paid to the Lender, in the form of regularly scheduled payments or as a voluntary prepayment, a capped amount of up to 190% of the $60.0 million the loan commitment amount. After the eighth (8th) anniversary of the Closing Date, the Revenue Interest can be terminated but the Royalty Interest payments shall continue until maturity of the Loan Agreement on December 31, 2032, at which time, the outstanding principal amount of the loan, together with any accrued and unpaid interest, and all other obligations then outstanding, shall be due and payable in cash by the Subsidiary.

The Company’s subsidiary, PRTK SPV1 LLC, a Delaware limited liability company and owner of the Subsidiary’s capital stock, has entered into a Pledge and Security Agreement in favor of the Lender, pursuant to which the Subsidiary’s obligations under the Loan Agreement are secured by PRTK SPV1 LLC’s pledge of all of the Subsidiary’s capital stock.

The Loan Agreement contains certain customary affirmative covenants, including those relating to: use of proceeds; maintenance of books and records; financial reporting and notification; compliance with laws; and protection of Company intellectual property. The Loan Agreement also contains certain customary negative covenants, barring the Subsidiary from: certain fundamental transactions; issuing dividends and distributions; incurring additional indebtedness outside of the ordinary course of business; engaging in any business activity other than related to the License Agreement; and permitting any additional liens on the collateral provided to the Lender under the Loan Agreement.

The Revenue Interest Purchase Agreement contains negative covenants applicable to the Company, including restrictions on the sale or transfer of the assets of the Company related to NUZYRA and giving rise to the Revenue Interest, each subject to the exceptions set forth therein.

The Loan Agreement contains customary defined events of default, upon which any outstanding principal and unpaid interest shall be immediately due and payable by the Subsidiary. These include: failure to pay any principal or interest when due; any uncured breach of a representation, warranty or covenant; any uncured failure to perform or observe covenants; any uncured cross default under a material contract; any uncured breach of the Company’s representations, warranties or covenants under its Contribution and Servicing Agreement with the Subsidiary; any termination of the License Agreement; and certain bankruptcy or insolvency events.

The net proceeds of the term loan were used by the Subsidiary to purchase from the Company the Royalty Interest and Revenue Interest, pursuant to the terms of the Revenue Interest Purchase Agreement and the Contribution and Servicing Agreement, respectively. The Company has used the proceeds from the sale of the Royalty Interest and Revenue Interest, together with cash on hand, to prepay in full all obligations of the Company outstanding under its Amended and Restated Loan and Security Agreement dated as of June 27, 2019, as amended, with Hercules Technology III, L.P., certain other lenders and Hercules Capital, Inc. (as agent).

The foregoing description of the terms of the Loan Agreement, the Revenue Interest Purchase Agreement and the Contribution and Servicing Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Loan Agreement, the Revenue Interest Purchase Agreement and the Contribution and Servicing Agreement, copies of which are filed herewith and incorporated herein by reference.