On June 29, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody (Press release, Johnson & Johnson, JUN 29, 2022, View Source [SID1234616390]). Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting both GPRC5D, a novel drug target, on multiple myeloma cells and CD3 on T-cells. This distinction for talquetamab follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) on January 29, 2021, and an Orphan Drug Designation (ODD) from the FDA on May 3, 2021. Today’s milestone marks the 12th BTD received by Janssen in oncology and the third such designation for the company’s portfolio of bispecific antibodies.

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"This Breakthrough Therapy Designation marks an important step in the continued development of talquetamab, a first-in-class bispecific antibody T-cell engager using GPRC5D, a novel target for the treatment of patients with relapsed or refractory multiple myeloma," said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. "Despite the therapies available for patients with relapsed or refractory multiple myeloma, new targets and treatments are needed because of the heterogeneity of the disease, which can impact a patient’s response to treatment. We are resolute in our commitment to advance science and develop new therapies and regimens for patients with the goal of delivering the best possible outcomes while driving toward cures."

The Breakthrough Therapy Designation is supported by data from the Phase 1/2, first-in-human dose-escalation MonumenTAL-1 study of talquetamab (Phase 1: NCT03399799; Phase 2: NCT04634552) for the treatment of heavily pretreated patients with relapsed or refractory multiple myeloma.1

Data from the MonumenTAL-1 study were featured during the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress as an oral presentation (Abstract #S182)2 and were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #8015).3

The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement in at least one clinically significant endpoint over available therapy.4

About Talquetamab
Talquetamab is a potential first-in-class, investigational T-cell redirecting bispecific antibody targeting both GPRC5D, a novel multiple myeloma target that does not shed over time, and CD3, a component of the T-cell receptor.1 CD3 is involved in activating T-cells, and GPRC5D is highly expressed on multiple myeloma cells.5,6 Results from preclinical studies in mouse models demonstrate that talquetamab induces T-cell-mediated killing of GPRC5D-expressing multiple myeloma cells through the recruitment and activation of CD3-positive T-cells and inhibits tumor formation and growth.7

Talquetamab is currently being evaluated in a Phase 1/2 clinical study for the treatment of relapsed or refractory multiple myeloma (NCT03399799) and is also being explored in combination studies (NCT04586426).

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects white blood cells called plasma cells, which are found in the bone marrow.8 When malignant, these plasma cells rapidly spread and replace normal cells in the bone marrow. In 2020, an estimated 176,000 people worldwide were diagnosed with multiple myeloma.9 In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.10 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.11

On June 29, 2022, Exact Sciences Corporation (the "Company"), reported that through a wholly-owned special purpose entity, Exact Receivables LLC ("Exact Receivables"), entered into an accounts receivable securitization program (the "Securitization Facility") with PNC Bank, National Association ("PNC"), as administrative agent, with a scheduled maturity date of June 29, 2024 (Filing, 8-K, Exact Sciences, JUN 29, 2022, View Source [SID1234616407]). The Securitization Facility provides Exact Receivables with up to $150.0 million of borrowing capacity, subject to maintaining certain borrowing base requirements, by collateralizing the customer accounts receivable of Exact Sciences Laboratories, LLC and Genomic Health, Inc.

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PNC serves as the lender pursuant to a Loan Agreement with the Company dated November 5, 2021, under which a revolving line of credit of up to $150.0 million is available to the Company, until a scheduled termination date of November 5, 2023.

On June 29, 2022, Exact Receivables borrowed $50.0 million under the Securitization Facility.

Outstanding loans under the Securitization Facility accrue interest at a rate equal to a daily SOFR rate, a term SOFR rate or a base rate, in any case, plus an applicable margin. Additionally, Exact Receivables will pay certain fees to the agents and the lenders under the Securitization Facility.

The Securitization Facility contains certain customary representations, warranties, affirmative covenants and negative covenants, subject to certain cure periods in some cases, including the eligibility of the receivables, as well as customary reserve requirements, events of default, termination events, and servicer defaults. The Securitization Facility termination events permit the lenders to terminate the Receivables Financing Agreement upon the occurrence of certain specified events, including, among others, failure by Exact Receivables to pay amounts when due, certain defaults on other material indebtedness, certain judgments, a change of control, certain events negatively affecting the overall credit quality of transferred receivables and bankruptcy and insolvency events.

The Securitization Facility consists of, among other agreements, (i) a Receivables Financing Agreement (the "Receivables Financing Agreement") among Exact Receivables, PNC, as administrative agent, and the lenders and other parties party thereto, (ii) a Receivables Purchase Agreement (the "Company Purchase Agreement") among the Company and certain subsidiaries of the Company and (iii) a Receivables Purchase Agreement (the "Borrower Purchase Agreement") among Exact Receivables and the Company. The foregoing descriptions of the Receivables Financing Agreement, the Company Purchase Agreement and the Borrower Purchase Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements, copies of which are filed herewith as Exhibit 10.1, Exhibit 10.2, and Exhibit 10.3, respectively, and the terms of which are incorporated herein by reference.

On June 29, 2022 Abbott (NYSE: ABT) reported that it will announce its second-quarter 2022 financial results on Wednesday, July 20, 2022, before the market opens (Press release, Abbott, JUN 29, 2022, View Source [SID1234616356]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On June 29, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its second-quarter 2022 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. ET on Thursday, July 28 (Press release, Merck & Co, JUN 29, 2022, View Source [SID1234616373]). During the call, company executives will provide an overview of Merck’s performance for the quarter and outlook.

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Investors, journalists and the general public may access a live audio webcast of the call via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com.

Participants may join the call by dialing 877-692-8955 (USA Toll-Free) or 234-720-6979. If you are calling from other countries, visit this weblink. All dial-in participants can use the access code 1857604. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team.

On June 29, 2022 Generian Pharmaceuticals, Inc. ("Generian") and Mitobridge, Inc. (a wholly owned subsidiary of Astellas Pharma Inc.) reported that they have entered into a collaboration and exclusive license agreement to discover and develop novel small molecules for undruggable therapeutic targets by using a proprietary drug discovery platform for diseases that have limited treatment options (Press release, Astellas Pharma, JUN 29, 2022, View Source [SID1234616391]).

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Under the terms of the agreement, the companies will jointly conduct research and preclinical development activities to identify novel monovalent small molecules that modulate target proteins through activation, stabilization or degradation as potential development candidates. Astellas will be solely responsible for clinical development, manufacturing and commercialization of all products arising from the joint research activities. Generian will receive an upfront payment and is eligible to receive success-based milestone payments that could result in payments of over $180 million, along with single digit royalties on global net sales of those products.

"We are excited to collaborate with Astellas and believe our strategy can successfully mine for candidate drugs for therapeutically relevant targets that are currently considered undruggable," said Hank Safferstein, PhD, JD, Chief Executive Officer of Generian. "Our small molecule discovery approach allows us to rapidly screen and identify potential drug candidates in an entirely new way in order to develop first-in-class medicines."

"Our collaboration with Generian is an exciting and transformative opportunity to accelerate our drug discovery activities in the area of undruggable target space," said David Barrett, Ph.D., Division Head and President of Mitobridge. "We are very excited to work with a world-class team of collaborators to deliver significant new treatment options for patients suffering from currently intractable or poorly served diseases."