On October 1, 2020 The Scripps Research Institute reported that The U.S. Food and Drug Administration has granted Fast Track designation to a novel "switchable" CAR-T cell therapy in a move to accelerate the drug development and review process (Press release, The Scripps Research Institute, OCT 1, 2020, View Source [SID1234567889]). The therapy is currently being evaluated as a treatment for B-cell malignancies, a class of blood cancers that includes non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.

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FDA’s Fast Track designation, which enables enhanced access to the agency during development, is designed to bring important new drugs to patients that address unmet medical needs in serious or life-threatening conditions.

The CAR-T cell therapy known as "CLBR001 + SWI019," has begun enrolling subjects in a Phase 1 trial assessing the safety and tolerability of the cell therapy. The study is being conducted at multiple sites in the United States.

"This important designation will enable Calibr to interact with the agency on study-related items, such as appropriate data collection and study design to support the approval of this innovative therapy," says Pamela Garzone, PhD, chief medical officer of Calibr, who is leading the clinical study of the therapy and was the primary author of the Fast Track application.

Calibr’s investigational CAR-T cell therapy leverages patients’ own immune cells to treat cancer, putting the cells under control of a novel molecular "switch" that seeks to mitigate potentially life-threatening side effects that have hampered the use of cell therapies to date.

"The versatility and potential for greater safety enabled by this switchable platform can yield significant benefits for patients and we look forward to the opportunity to accelerate its development," says Travis Young, PhD, Calibr’s vice president of biologics and leader of its CAR-T program.

CAR-T, short for chimeric antigen receptor T-cell, is a relatively new form of cancer therapy that has achieved remarkable responses in patients with blood- or bone marrow-based diseases such as leukemias and lymphomas. It works by genetically engineering a patient’s T cells—a cell type which plays a key role in anti-tumor immunity—to seek and destroy cancer within the body. However, some patients who receive T-cell therapies experience an adverse effect called cytokine release syndrome, which occurs when the immune system reacts too strongly.

Calibr’s switchable CAR-T cell platform incorporates an antibody known as "SWI019" that acts as a switch, activating the engineered cells (CLBR001) and directing them to engage the cancer target. This may allow doctors to have more control over the therapy which could provide a significant safety advantage. In preclinical studies, the approach proved highly effective at eliminating tumors while controlling the level of cytokines produced in response to treatment. Further, by switching the CLBR001 cells "on" and "off" the approach allows the engineered cells to "rest", which in preclinical models afforded greater efficacy.

The current clinical trial is enrolling patients with blood-based cancers that have returned after remission or didn’t respond to initial treatments. However, Calibr’s switchable CAR-T cell platform employs a universal design that can be applied to solid-tumor cancers and other types of blood cancers in the future—providing potential advantages in an area that CAR-T cell therapies have not been as successful in the past.

The switchable CAR-T cell platform was invented at Scripps Research and progressed to the clinical testing stage with support from the Wellcome Trust. Calibr has partnered its platform with biopharmaceutical company AbbVie, which holds certain rights to commercialization. The clinical trial is the third to be run independently by the institute and the fifth originating from Calibr’s research.

Patients interested in enrolling in the clinical trial (NCT04450069) can learn more on the National Institutes of Health (NIH) clinical trials portal.

On October 1, 2020 SOPHiA GENETICS, global leader in Data-Driven Medicine, reported the closing of a $110 million financing round to enter into the next stage of its expansion, with a focus on supporting the growing clinical and biopharma demand for Data-Driven Medicine worldwide (Press release, Sophia Genetics, OCT 1, 2020, View Source [SID1234567888]).

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This Series F round was led by aMoon, a leading health-tech & life sciences venture fund based in Israel, and Hitachi Ventures, a venture arm of Japanese Hitachi Group. The company also received the trust of prime financial institutions Credit Suisse and the Pictet group. Existing investors Swisscom Ventures, Endeavour Vision, Generation Investment Management, Alychlo, and Eurazeo Growth participated in the round, as well as newcomers ACE & Company and Famille C Invest.

Having established the world’s largest Data-Driven Medicine community network through its universal and collaborative AI platform, SOPHiA GENETICS supports healthcare professionals by translating multiple sources of complex medical data into valuable clinical insights. The SOPHiA Platform is used by over 1’000 healthcare institutions and has analyzed 600’000 genomic profiles; up to 17’000 new profiles a month. Through continual learning and network effects, experts worldwide are empowered to act with confidence for better patient management.

The new funding round will boost the company’s penetration in both the US and Asian markets. Proceeds will also be dedicated to increasing the platform multimodal capabilities and its adoption by healthcare institutions worldwide. Leveraging this momentum, SOPHiA GENETICS will be best positioned to power biopharma’s effort to optimize and accelerate the development of new targeted therapies.

As SOPHiA enters this new phase of rapid expansion, Didier Hirsch, former CFO at Agilent, joins the company’s Board of Directors. He will also chair the company’s Audit Committee, ushering SOPHiA GENETICS toward its next important milestones.

"The overall demand for Data-Driven Medicine is rapidly growing, and the next step is to successfully combine multiple sources of data to better address clinicians’ needs," said Dr. Tomer Berkovitz, Partner & CFO of aMoon. "With this shift, more complex data will be generated, and we believe that SOPHIA’s decentralized model will play a pivotal role in empowering health organizations to offer better patient care".

Keiji Kojima, Executive Vice President and General Manager of Hitachi’s Smart Life Business Division, added: "Over the years, SOPHiA GENETICS has emerged as a leader in Data-Driven Medicine and we look forward to supporting the company expand its footprint in the Japanese market and beyond."

"SOPHiA has established an impressive track record of disrupting healthcare and enabling a decentralized approach. This new funding round will further strengthen SOPHiA’s already unique offering, performance, and life-changing impact on patients and targeted therapies," said Troy Cox, Chairman of the Board of Directors of SOPHiA GENETICS.

"Since inception, we knew that leveraging a wide range of data modalities powered by cutting-edge technologies was key to sustainably deliver better outcomes to the global healthcare community", concluded Jurgi Camblong, CEO and Founder at SOPHiA GENETICS. "Now, with this new funding round, we can embark on the next stage of our development and take our collaborative approach further, delivering intelligent medicine, together."

On October 1, 2020 Covis Group S.à r.l. ("Covis") and AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported that they have entered into a definitive agreement under which Covis will acquire AMAG for $13.75 per share in cash, or approximately $498 million on a fully diluted basis and approximately $647 million on an enterprise basis, including debt obligations expected to be assumed or repaid net of cash (Press release, AMAG Pharmaceuticals, OCT 1, 2020, View Source [SID1234567886]). The offer represents a premium of approximately 46% to the closing price of AMAG’s common stock on September 30, the last full trading day prior to the announcement.

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Commenting on the transaction, Covis CEO Michael Porter said, "AMAG’s category leading treatments are strong strategic complements to our existing therapeutic portfolio. Through this combination, we believe we will be able to unlock value for all of our stakeholders, employees and patients through the effective and efficient management of these products, coupled with our two companies’ longstanding commitment to expanding patient access to therapy and putting patient interests first. At Covis, we never lose sight that our patients are our paramount concern. We look forward to engaging with the talented team at AMAG as we work together to plan the integration of our two organizations."

AMAG CEO Scott Myers added, "In the beginning of 2020, AMAG announced that the company had undertaken a strategic review of our product portfolio and strategy, the guiding principles of which included driving near- and long-term profitability and enhancing shareholder value. This strategic review resulted in the company pursuing and accomplishing the divestiture of its women’s health assets, and other efforts to streamline and strengthen the core business to position AMAG for the future. Following this initial transformation, our Board of Directors and management team, together with independent legal and financial advisors, thoroughly evaluated the transaction with Covis as well as other strategic options and concluded that it represents the most compelling opportunity for shareholders, providing them certain and immediate cash value. We believe Covis is the right partner for AMAG, especially in light of Covis’ shared commitment to ensuring that our therapies will reach patients in need. We are confident the work we’ve done will continue to thrive under Covis’ leadership."

The completion of the tender offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of AMAG’s common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the tender offer, an indirect, wholly owned subsidiary of Covis will merge with AMAG (the "merger") and the outstanding AMAG shares not tendered in the tender offer will be converted into the right to receive the same $13.75 per share in cash paid in the tender offer. The tender offer is expected to commence in October 2020. Covis plans to finance the transaction with cash on hand, and a combination of committed debt and equity financing. There is no financing condition to the obligations of Covis to consummate the transaction.

As part of the transaction, Covis intends to enter into an amended and restated credit facility with its current lenders (the "Lenders"), pursuant to which the Lenders will provide up to a $460 million senior secured incremental term loan and a $55 million secured revolver (the "Covis Debt Financing"). The proceeds from the Covis Debt Financing, plus equity commitments from Covis’ equity sponsor, will be used to pay the cash purchase price for the transaction and repay any of the existing AMAG debt that is not assumed. The Covis Debt Financing amount will be added to Covis’ current $450 million term loan facility with the Lenders. As the merger will result in a change of control under the terms of AMAG’s Indenture governing its 3.25% Convertible Senior Unsecured Notes Due 2022 (the "Convertible Notes"), the holders of the Convertible Notes will have the right to put at par the Convertible Notes held by them for a period of twenty business days following the closing of the merger.

All Board members and executive officers of AMAG have agreed to tender their shares in favor of the transaction. The transaction, which has been unanimously approved by the Board of Directors of each company, is expected to close in November 2020, pending Hart-Scott-Rodino (HSR) approval and the conditions to the tender offer being satisfied.

Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Goodwin Procter LLP is acting as legal advisor to AMAG. Paul, Weiss, Rifkind, Wharton and Garrison LLP is acting as legal advisor to Covis.

On October 1, 2020 Nascent Biotech, Inc. (OTCQB:NBIO) reported that It has continued to reduce its liabilities through stock conversion and payment of accounts payable and accrued liabilities (Press release, Nascent Biotech, OCT 1, 2020, View Source [SID1234567885]). The reduction was achieved through the conversion of debt to equity and the reduction of liabilities, including its last convertible note. The convertible note’s principal is now $11,250 down from $161,250, a reduction of $150,000.

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Nascent’s CEO Sean Carrick states," The reduction of debt puts Nascent in a stronger position to move forward with the clinical trials which are to begin soon. Further liability management is a primarily objective of the Company."

On October 1, 2020 Teneobio, Inc. and its affiliate TeneoTwo, Inc. reported that their investigational new drug application (IND) for TNB-486, a bispecific T-cell engaging antibody for the treatment of B-Cell Non-Hodgkin’s lymphoma (B-NHL) was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on September 30, 2020 (Press release, TeneoBio, OCT 1, 2020, View Source;utm_medium=rss&utm_campaign=teneobio-announces-us-fda-clearance-of-investigational-new-drug-application-for-tnb-486-and-the-initiation-of-phase-i-clinical-studies-in-patients-with-b-cell-malignancies [SID1234567881]).

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TNB-486 is a fully human bispecific antibody that binds CD19 with one arm and incorporates a unique anti-CD3 on the other. In preclinical studies, TNB-486 induced T-cell dependent killing of CD19-positive B-cell leukemia and lymphoma cells while inducing minimal cytokine secretion, a feature that could limit immune mediated toxicities while retaining cytotoxic activity.

Benjamin Buelow, CMO of Teneobio, Inc., added, "We are excited to bring our differentiated T-cell engager therapy to relapsed and/or refractory lymphoma patients, for whom a safe and effective therapeutic option remains an unmet need. The unique anti-CD3 arm in Teneobio’s T-cell engagers uncouples toxic cytokine release from tumor cell killing and is designed to maximize the therapeutic window for this class of therapies. TNB-486 also has a predicted half-life of over two weeks that enables a patient- and provider-focused dosing schedule. An off-the-shelf CD19-targeted therapy with a convenient dosing regimen will be a tremendous boon to the fight against this terrible disease."