On June 7, 2021 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported the presentation of Phase 1 data for BDB001 in combination with pembrolizumab in advanced solid tumors at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Seven and Eight Biopharmaceuticals, JUN 7, 2021, View Source [SID1234583648]).

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BDB001 is an immune modulator capable of activating dendritic cells to initiate both innate and adaptive immunity against cancer. BDB001 is a first-in-class TLR7/8 agonist delivered intravenously, allowing for broader treatment of solid tumors. Previously, Seven and Eight Biopharma reported that intravenous administration of BDB001 as monotherapy showed favorable tolerability and robust systemic immune activation leading to durable clinical responses.

The poster discussion session at ASCO (Free ASCO Whitepaper) for Abstract #2512 revealed new interim safety and efficacy results for a Phase 1 dose escalation / expansion trial of BDB001 in combination with pembrolizumab in advanced solid tumors (NCT03486301). The results show that BDB001 in combination with pembrolizumab was well tolerated, and induced robust immune activation leading to clinical responses. Based on these results, the recommended Phase 2 dose (RP2D) of BDB001 was determined and is currently being further evaluated in an ongoing dose expansion phase.

"It is encouraging to see that BDB001 in combination with pembrolizumab can be safely delivered intravenously and produces clinical responses in heavily pre-treated tumors" said lead author and study investigator Dr. Manish R. Patel, of Florida Cancer Specialists/Sarah Cannon Research Institute.

"These promising interim results show that BDB001 in combination represents a novel and viable treatment for advanced solid tumors. It is especially encouraging to see responses in PD-L1 negative and refractory tumors" said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma. "We continue to enroll subjects in the dose expansion part of this trial, to further evaluate safety, efficacy, and immune modulatory effects in the tumor microenvironment."

"We are very excited about the clinical data for BDB001 in combination with pembrolizumab, as we continue to advance our robust immuno-oncology pipeline in treatments beyond anti-PD-(L)1, including preclinical platform programs in TLR Ligand Antibody Conjugation" said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.

Presentation Details:

Abstract Title: BDB001, an intravenously administered toll-like receptor 7 and 8 (TLR7/8) agonist, in combination with pembrolizumab in advanced solid tumors: Phase 1 safety and efficacy results.

Abstract Authors: Manish R. Patel, Anthony W. Tolcher, Drew W. Rasco, Melissa Lynne Johnson, Angela Tatiana Alistar, Lixin Li, Alexander H. Chung, Robert H.I. Andtbacka

Session Title: Poster Discussion Session, Developmental Therapeutics—Immunotherapy

On-Demand Session Release Date and Time: 6/4/2021, 9:00 AM-10:00 AM

Abstract Number: 2512

The poster presentation will be available on the ASCO (Free ASCO Whitepaper) Meeting Library and on the Company’s website at www.7and8biopharma.com.

Abstract Summary:

– Seven and Eight Biopharma’s systemic delivery of the TLR 7 and 8 dual agonist BDB001 is first in class.

– BDB001 was delivered safely intravenously in combination with pembrolizumab.

– BDB001 in combination with pembrolizumab showed robust dose dependent immune activation without increased risk of CRS, as evidenced by minimal increase in pro-inflammatory/CRS cytokines, IL-6, IL-10, and TNF-α.

– Overall, BDB001 was well tolerated and over 21% of subjects did not have any treatment related adverse events. There were few Grade 3 and no grade 4 or 5 adverse events.

– At BDB001 Levels 3 and 4, 19 subjects were evaluable for efficacy. There was evidence of:

Rapid and deep clinical responses were observed in tumors with low response rate to anti-PD-1 therapy based on their PD-L1 negative, MSI-stable, and TMB-low status.

5 clinical responses including 1 Complete Response (CR)

Overall Response Rate (ORR) was 26%; Disease Control Rate (DCR) of 58%

Clinical responses were seen in subjects with cholangiocarcinoma, hepatocellular carcinoma, melanoma, ovarian carcinoma, and triple negative breast cancer.

Robust anti-tumor immune activation via IP-10 (CXCL10) upregulation, which correlated with clinical responses.

– BDB001 in combination with pembrolizumab is a promising novel therapeutic option for patients with advanced solid tumors and is being evaluated in an ongoing dose expansion trial

On June 7, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that it will host a key opinion leader ("KOL") webinar on MB-106 CD20-targeted CAR T cell therapy, which is being developed for high-risk B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"), on Tuesday, June 15, 2021, at 1:00 p.m. Eastern Time (Press release, Mustang Bio, JUN 7, 2021, View Source [SID1234583664]).

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The webinar will feature a presentation by Mazyar Shadman, M.D., M.P.H., Associate Professor at the Fred Hutchinson Cancer Research Center ("Fred Hutch"), who will discuss interim results from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 CD20-targeted CAR T for B-NHL and CLL. These data have been selected for an e-poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress ("EHA2021"), which is being held June 9-17. Dr. Shadman, along with colleague Brian Till, M.D., also an Associate Professor at Fred Hutch, will be available to answer questions following the formal presentations.

Mustang’s management team will also provide more details on the planned MB-106 Phase 1/2 clinical trial to be conducted under Mustang’s Investigational New Drug ("IND") application. The Company recently announced that the U.S. Food and Drug Administration ("FDA") accepted its IND to initiate a multicenter Phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB-106 for relapsed or refractory B-NHL and CLL.

To participate in the webinar, please register here.

About Dr. Shadman
Mazyar Shadman, M.D., M.P.H., is an Associate Professor at the University of Washington ("UW") and Fred Hutch. He is a hematologic malignancies expert who specializes in treating patients with lymphoma and CLL.

Dr. Shadman is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cells), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies.

Dr. Shadman received his M.D. from Tehran University in Iran. He finished an internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his fellowship training in hematology and medical oncology at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for the National Cancer Institute’s cancer research training program at Fred Hutch, where he studied cancer epidemiology.

About Dr. Till
Brian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.

On June 7, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health," the "Company" or the "Offeror") reported the results to date of its pending cash tender offer (the "Tender Offer"), to purchase any and all of its outstanding 7.00% Senior Secured Notes due 2024 (the "Notes"), as well as the anticipated early settlement date for the Tender Offer on June 8, 2021 (the "Early Settlement Date") (Press release, Bausch Health, JUN 7, 2021, View Source [SID1234583680]).

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The terms and conditions of the Tender Offer are described in an Offer to Purchase dated May 24, 2021 (as it may be amended or supplemented from time to time, the "Offer to Purchase"). All terms and conditions of the Tender Offer remain unchanged as set forth in the Offer to Purchase.

As of 5:00 p.m., New York City time, on June 7, 2021 (the "Early Tender Date"), the aggregate principal amount of Notes validly tendered and not validly withdrawn is $545,079,000. The Offeror expects to accept for purchase all of the Notes validly tendered prior to the Early Tender Date, subject to the satisfaction of the conditions to such Tender Offer. The Offeror expects that the conditions to the Tender Offer will be satisfied as of the Early Settlement Date.

The total consideration for each $1,000 principal amount of Notes is $1,019.25 plus accrued and unpaid interest (the "Total Consideration") and is expected to be paid on the Early Settlement Date to the holders of Notes tendered and accepted for purchase as of the Early Tender Date. The Total Consideration includes an early tender premium of $30.00 per $1,000 principal amount of Notes accepted for purchase as of the Early Tender Date. In addition to the Total Consideration, all Holders of Notes accepted for purchase pursuant to the Tender Offer will also receive accrued and unpaid interest on the Notes from the last interest payment date to, but not including, the Early Settlement Date.

The Tender Offer remains open and will expire at 11:59 p.m., New York City time, on June 21, 2021 (such date and time, as it may be extended, the "Expiration Date"). No tenders will be valid if submitted after the Expiration Date. The Offeror expects to purchase any remaining Notes tendered following the Early Settlement Date that have been validly tendered at or prior to the Expiration Date and accepted for purchase, subject to all conditions to the Tender Offer having been either satisfied or waived by the Offeror, promptly following the Expiration Date (the date of such acceptance and purchase, the "Final Settlement Date"). The Final Settlement Date is expected to occur on the second business day following the Expiration Date, assuming the conditions to the Tender Offer and the Solicitation have been either satisfied or waived by the Offeror at or prior to the Expiration Date and all of the outstanding Notes are not purchased on the Early Settlement Date.

The Tender Offer is subject to, and conditioned upon, the satisfaction or waiver of certain conditions described in the Offer to Purchase, including the completion of the Company’s previously announced private offering of $1.6 billion aggregate principal amount senior secured notes, on terms acceptable to the Company.

The deadline for holders to validly withdraw tenders of Notes has passed. Accordingly, Notes that were already tendered at the Early Tender Date and any additional Notes that are tendered at or prior to the Expiration Date may not be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

If, following the consummation of the Tender Offer, any Notes remain outstanding, the Offeror intends to redeem such Notes in accordance with terms of the Notes and the indenture, dated as of March 21, 2017 (as amended or supplemented), among Bausch Health, the subsidiaries signatory thereto, The Bank of New York Mellon, as trustee, and the notes collateral agents party thereto under which the Notes were issued.

Goldman Sachs & Co. LLC is acting as the dealer manager in the Tender Offer. Global Bondholder Services Corporation has been retained to serve as both the depositary and the information agent for the Tender Offer. Persons with questions regarding the Tender Offer should contact Goldman Sachs & Co. LLC at (collect) (212) 902-5962 or (toll free) (800) 828-3182. Requests for copies of the Offer to Purchase and other related materials should be directed to Global Bondholder Services Corporation at (toll-free) (866) 470-3800 or (collect) (212) 430-3774.

None of the Offeror, its board of directors or officers, the dealer manager, the depositary, the information agent or the trustee with respect to the Notes, or any of their respective affiliates, makes any recommendation that holders tender or refrain from tendering all or any portion of the principal amount of their Notes, and no one has been authorized by any of them to make such a recommendation. Holders must make their own decision as to whether to tender their Notes and, if so, the principal amount of Notes to tender. The Tender Offer is made only by the Offer to Purchase. This news release is neither an offer to purchase nor a solicitation of an offer to sell any notes in the Tender Offer. The Tender Offer is not being made to holders of Notes in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction. In any jurisdiction in which the Tender Offer is required to be made by a licensed broker or dealer, the Tender Offer will be deemed to be made on behalf of the Offeror by the dealer manager or one or more registered brokers or dealers that are licensed under the laws of such jurisdiction.

Any securities issued pursuant to the financing transactions described above will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. Such securities have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the securities in Canada will be made on a basis which is exempt from the prospectus requirements of such securities laws.

On June 7, 2021 Cilag GmbH International, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, reported its decision not to continue the collaboration and license agreement with argenx for cusatuzumab, an investigational therapeutic antibody that targets CD70 (Press release, Johnson & Johnson, JUN 7, 2021, View Source [SID1234583649]).

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The decision is based upon Janssen’s review of all available cusatuzumab data and in consideration of the evolving standard of care for the treatment of acute myeloid leukemia (AML). Final results from Janssen’s clinical studies of cusatuzumab will be presented in the future.

Janssen will work with argenx to transition the cusatuzumab program back to argenx. Patients currently enrolled in ongoing cusatuzumab clinical trials will continue to be supported through treatment and follow-up.

Janssen entered into the worldwide collaboration and license agreement with argenx in December 2018 to develop and commercialize cusatuzumab in AML and potential additional indications.

On June 7, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, reported a new agreement to commercialize the Moderna COVID-19 Vaccine across Central Eastern Europe and Israel (Press release, Moderna Therapeutics, JUN 7, 2021, View Source [SID1234583665]).

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The agreement covers the following countries: Poland, Czech Republic, Romania, Hungary, Bulgaria, Slovenia, Slovakia, Croatia, Estonia, Latvia, Lithuania, Serbia, Ukraine, Moldova, Albania, Bosnia and Herzegovina, Kosovo, North Macedonia, Montenegro, and Israel.

"We are excited to partner with Moderna in 20 markets, covering over 175 million lives across the entire Central Eastern Europe region and in Israel," said Meir Jakobsohn, Founder and CEO of Medison Pharma. "Moderna’s breakthrough mRNA vaccine and Medison’s international commercialization platform for highly innovative treatments, makes our partnership a natural fit."

"We appreciate this new partnership with Medison Pharma to ensure successful delivery of our mRNA COVID-19 vaccine to market," said Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna. "Working together with our partners, we remain steadfast in our commitment to fighting the pandemic by delivering our vaccine to populations globally."