On January 30, 2024 2seventy bio, Inc. (Nasdaq: TSVT), reported that it is transforming the Company to focus exclusively on the commercialization and development of Abecma (idecabtagene vicleucel), its BCMA-targeted CAR T therapy for multiple myeloma (Press release, 2seventy bio, JAN 30, 2024, View Sourcenews-releases/news-release-details/2seventy-bio-announces-new-strategic-path-forward" target="_blank" title="View Sourcenews-releases/news-release-details/2seventy-bio-announces-new-strategic-path-forward" rel="nofollow">View Source [SID1234639700]). The actions announced today follow an extensive evaluation of the Company’s business and strategic alternatives by its Board of Directors. As a result of this strategic re-alignment, the Company expects annual savings of approximately $150 million in 2024 and approximately $200 million in 2025, inclusive of one-time restructuring costs of approximately $8 million. The Company expects to have extended cash runway beyond 2027.

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In connection with the Company’s strategic re-alignment, and as announced in a separate press release today by Regeneron Pharmaceuticals, Inc., the Company has entered into an asset purchase agreement ("APA") with Regeneron to sell the Company’s oncology and autoimmune research and development programs, clinical manufacturing capabilities, and related platform technologies.

"Together with the Board, we have completed a thorough assessment of our business and strategic options. Based on this process, 2seventy has decided to focus our mission on the growth and success of Abecma," said Nick Leschly, outgoing chief kairos officer and incoming board chair. "As part of this decision, we will divest our research and development programs, with the majority of our stellar R&D team transitioning to Regeneron. While the decision to reshape 2seventy was driven by a series of challenging realities, it has resulted in an outcome that we believe is right for patients, employees, and our shareholders. The Board is confident that the actions announced today will maximize value for shareholders and best position our assets to deliver for patients. We believe deeply in the potential of our innovative science and are pleased that it is going to Regeneron, who are building a visionary cell-based medicines center based on the people and science from 2seventy. I also have a great deal of confidence in Chip and the team at the new, streamlined 2seventy, and that under their leadership and in partnership with BMS, Abecma will return to growth commercially and deliver value for shareholders."

"Moving forward, 2seventy will be sharply focused on Abecma, with a streamlined team and a dramatically different cost structure and financial profile," said Chip Baird, incoming chief executive officer. "We believe this approach will give 2seventy the financial runway to continue to work closely with our partners at BMS to support a potential third-line launch of Abecma later this year and a return to growth for the commercial business. In addition to the approximately 160 members of the team transitioning to Regeneron, we have made the hard decision to reduce the remaining workforce to better align with the reshaped focus of the Company and reduce expenses overall. I want to thank the incredible members of the 2seventy bio team: those whose tremendous contributions will allow our important research and development work to continue at Regeneron, those who will be staying on to help realize the full value of Abecma, and those who will be departing the organization."

2seventy bio’s Focused Strategy on Abecma

2seventy bio will focus exclusively on the development and commercialization of Abecma, which offers significant clinical benefits and long-term potential in the treatment of patients with multiple myeloma. The Company’s go-forward organization will include approximately 65 employees, primarily in quality and supporting functions.

2seventy bio, in partnership with Bristol Myers Squibb (BMS), is taking actions to return Abecma to commercial growth in 2024. The Company expects a final PDUFA action following the planned Oncologic Drugs Advisory Committee (ODAC) meeting on the supplemental Biologics License Application (sBLA) for Abecma based on the KarMMA-3 clinical study, which, if approved, would expand the label into the larger third line setting. 2seventy bio and BMS are expanding its Abecma site footprint to enable more patients to access the treatment. This includes educating physicians on treatment sequencing and the emerging data supporting the use of BCMA-directed CAR Ts before other BCMA-targeted therapies, and competitively differentiating Abecma’s real-world safety, efficacy and product reliability and predictability profile. The Company will continue to support the quality control of the lentiviral vector (LVV) manufacturing for Abecma and support the transition to suspension LVV which will deliver additional efficiencies and cost savings.

Management Team and Board of Directors

Upon closing of the transaction with Regeneron, Chip Baird, chief operating officer, will become chief executive officer of 2seventy bio. The newly formed 2seventy bio leadership team will also include Vicki Eatwell, currently senior vice president of finance, who will become chief financial officer and Jessica Snow, senior vice president, quality and head of operations.

Additionally at closing, 2seventy bio’s Board of Directors will be comprised of Nick Leschly, chairman; Denice Torres, lead independent director, a former Johnson & Johnson executive with deep experience on public and private company Boards; Chip Baird, incoming chief executive officer of 2seventy bio; Sarah Glickman, chief financial officer of Criteo; Wei Lin, M.D., CMO of Erasca; Dan Lynch, Google Ventures; and Marcela Maus, Mass General Cancer Center. After 13 years of service on the bluebird bio and 2seventy bio Board of Directors, Dan Lynch will step down from the Board in June and will continue in an advisory role for 2seventy bio.

Regeneron Asset Purchase Agreement

Under the terms of the APA, Regeneron intends to purchase 2seventy bio’s research and development pipeline, including its bbT369 program in b-NHL, SC-DARIC33 in AML, MUC16 in ovarian cancer, MAGE-A4, autoimmune, and several unnamed targets. Upon closing of the transaction, Regeneron will assume 100% of the ongoing program, infrastructure and personnel costs related to these programs. In consideration, 2seventy bio will receive an upfront payment of $5 million, a milestone payment for the first major market approval of the first approved product and royalties on revenues generated by the products. In addition, Regeneron has agreed to sublease a portion of the office, lab and manufacturing space in Cambridge, Mass. and sublease the entire facility in Seattle, Wash. The asset purchase is expected to close in the first half of 2024 subject to certain closing conditions including SEC-filings required by 2seventy bio and landlord consent of the sublease agreements.

As part of this agreement, approximately 160 2seventy bio employees will transition to Regeneron, including chief scientific officer, Philip Gregory and chief medical officer, Steve Bernstein.

Conference Call Information

2seventy bio will host a conference call and live webcast today, January 30, at 8:00 a.m. ET to discuss today’s announcement. To join the live conference call, please register at: https://register.vevent.com/register/BIe0fdf7cfb0b34b4cabf30021f343eb38. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: View Source A replay of the webcast may be accessed from the "News and Events" page in the Investors and Media section of the Company’s website at View Source and will be available for 30 days following the event.

On January 29, 2024 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) ("LIXTE" or the "Company"), reported the dosing of the first patient in a Phase 1b/2 clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC) (Press release, Lixte Biotechnology, JAN 29, 2024, View Source [SID1234639712]).

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The clinical trial was initiated by and is being conducted at The University of Texas MD Anderson Cancer Center. LIXTE is providing LB-100; GSK is providing dostarlimab-gxly and financial support for the clinical trial.

The clinical trial (NCT06065462) is based on the observation by the lead clinical investigator of the trial, Amir Jazaeri MD, Professor of Gynecologic Oncology at MD Anderson, that a genetically acquired reduction in PP2A may enhance sensitivity to immunotherapyi. This raises the possibility that reducing PP2A pharmacologically with LB-100 may enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody, dostarlimab-gxly, in patients with OCCC lacking the genetic reduction in PP2A.

On January 29, 2024 (the "Closing Date"), Akebia Therapeutics, Inc. ("Company" and collectively with any Company affiliates that are made party to the Credit Agreement as a borrower, "Borrower") reported to have entered into an Agreement for the Provision of a Loan Facility (the "Credit Agreement") with Kreos Capital VII (UK) Limited ("Kreos" or "Lender Representative"), which are funds and accounts managed by BlackRock, and provides for a senior secured term loan facility in the aggregate principal amount of up to $55.0 million (the "Term Loan Facility") (Filing, 8-K, Akebia, JAN 29, 2024, View Source [SID1234639701]). An initial tranche of $37.0 million (the "Initial Loan") was funded under the Term Loan Facility on the Closing Date. In addition to the Initial Loan, the Term Loan Facility includes additional tranches available as follows: $8.0 million available in a single draw through December 31, 2024 (the "Tranche B Loan") and $10.0 million available in a single draw through December 31, 2024 (the "Tranche C Loan" and, together with the Initial Loan and the Tranche B Loan, the "Term Loans").

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Each Term Loan draw is subject to various conditions precedent, including (x) the absence of any defaults or events of default and Borrower’s continued compliance with the terms and provisions of the Credit Agreement, (y) in the case of the Tranche B Loan and Tranche C Loan, receipt of marketing approval for vadadustat from the United States Food and Drug Administration ("Vadadustat FDA Approval") and (z) in the case of Tranche C, receipt of a certain amount of cumulative gross cash proceeds after the Closing Date in the form of equity or equity linked securities in one or more series of transactions. The Term Loan Facility has an initial maturity date of March 31, 2025, which shall be automatically extended to January 29, 2028 if Company receives Vadadustat FDA Approval on or prior to June 30, 2024 (the "Maturity Date").

Borrower’s net proceeds from the Initial Loan were approximately $34.5 million, after deducting estimated debt issuance costs, fees and expenses. On the Closing Date, the Company repaid in full the Borrower’s prior term loan from Pharmakon (as defined in Item 1.02 below), including payment of certain termination fees and other expenses incurred in connection therewith (as described in Item 1.02 below). All obligations under the Term Loan Facility are secured by a perfected first priority security interest in substantially all of the existing and after-acquired assets of the Borrower and its material subsidiaries, subject to customary exceptions.

Interest Rate, Amortization and Fees

The Term Loan Facility will accrue interest at a floating annual rate equal to the sum of (x) term Secured Overnight Financing Rate ("SOFR") for a tenor of one month (subject to a floor of 4.25% per annum) plus (y) a margin of 6.75% per annum (subject to an overall cap of 15.00% per annum on the all-in interest rate). During the continuance of any payment event of default under the Credit Agreement, the interest rate on such overdue sum will automatically increase by an additional 3.0% per annum, and may be subject to an additional late fee of 2.0% of such overdue sum.

The Term Loan Facility shall not amortize during the period commencing on the Closing Date and ending on December 31, 2025 (which may be extended to December 31, 2026 at the Borrower’s option) (the "Interest Only Period"). The Borrower shall pay interest and, after the Interest Only Period, principal, on the first calendar day of each month.

In the event of certain prespecified events, the repayment schedule will be accelerated. For example, if Vadadustat FDA Approval is not obtained on or prior to June 30, 2024, the Interest Only Period will automatically terminate on October 1, 2024, and the Borrower shall repay the Term Loans in seven equal monthly payments (comprised of principal and interest), commencing on October 1, 2024 and ending on the Maturity Date.

The Term Loan Facility also includes customary transaction fees and exit fees. The Company may prepay the outstanding Term Loans in full (not in part), subject to a customary prepayment premium ranging from 1.0 to 4.0% of the amount prepaid. If prepayment is made during the first year, the Company also is required to pay the amount of otherwise due interest payments for the twelve-month period following prepayment.

Warrant Coverage

On the Closing Date, the Company entered into a warrant agreement with Kreos Capital VII Aggregator SCSp, an affiliate of the Lender Representative (the "Warrant Holder"), pursuant to which the Company (i) issued a warrant to Warrant Holder to purchase 3,076,923 shares of the Company’s common stock, at an exercise price per share of $1.30 (subject to standard adjustments for stock splits, stock dividends, rights offerings and pro rata distributions) (the "Exercise Price"), and (ii) will issue at the time of drawdown of the Tranche C Loan, if applicable, a warrant to Warrant Holder to purchase 1,153,846 shares of the Company’s common stock, at an exercise price per share equal to the Exercise Price. Each warrant shall be exercisable for eight years from date of issuance.

The warrants and the common stock issuable upon the exercise of such warrants were not registered under the Securities Act of 1933, as amended (the "Securities Act") and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and/or Rule 506(b) promulgated thereunder. Accordingly, the holder thereof may only sell common stock issued upon exercise of such warrants pursuant to an effective registration statement under the Securities Act covering the resale of those shares, an exemption under Rule 144 under the Securities Act or another applicable exemption under the Securities Act.

Representations, Warranties, Covenants, and Events of Default

The Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants, financial covenants, events of default and other provisions and conditions that are customarily required for similar financings. The financial covenants under the Credit Agreement require the Borrower to either (i) maintain cash and cash equivalents, measured as of the last day of each fiscal month, greater than or equal to $15,000,000 or (ii) earn consolidated revenue, measured as of the last day of each fiscal month for the trailing twelve-month period, of $150,000,000. If an event of default occurs and is continuing under the Credit Agreement, the Collateral Agent is entitled to take enforcement action, including acceleration of amounts due under the Credit Agreement.

The foregoing summary of the Term Loan Facility and the warrant agreement are not complete and are qualified in their entirety by reference to the full text of the Credit Agreement and the form of warrant agreement, respectively, copies of which the Company expects to file with its Annual Report on Form 10-K for the year ended December 31, 2023.

On January 29, 2024 2seventy bio, Inc. (the "Company") reported to have entered into an asset purchase agreement (the "Purchase Agreement") with Regeneron Pharmaceuticals, Inc. ("Regeneron") (Filing, 2seventy bio, JAN 29, 2024, View Source [SID1234639699]). Subject to the terms and conditions of the Purchase Agreement, the Company has agreed to sell to Regeneron (the "Asset Sale") the Company’s oncology and autoimmune research and development programs, clinical manufacturing capabilities, and related platform technologies (collectively, the "Programs" and such assets, the "Transferred Assets"). Pursuant to the Purchase Agreement, in consideration for the Transferred Assets, at the closing of the Asset Sale (the "Closing"), Regeneron will make an upfront payment to the Company of $5 million in cash and also assume certain liabilities of the Company arising after Closing, including liabilities related to the conduct of the Programs, under transferred contracts and with respect to certain of the Company’s employees (collectively, the "Assumed Liabilities"). Regeneron also agreed to sublease the Company’s facilities in Seattle, Washington and a portion of the Company’s facilities in Cambridge, Massachusetts. In addition to the upfront consideration, Regeneron has agreed to pay the Company a one-time $10 million milestone payment upon receipt of regulatory approval for the first product candidate within the Transferred Assets in certain specified countries and agreed-upon royalty payments based on net sales of the product candidates if commercialized.

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The Purchase Agreement contains customary representations, warranties and covenants of each of the Company and Regeneron. The Purchase Agreement further provides that, subject to certain limitations, the Company and Regeneron will each indemnify the other for certain losses arising from such breaches of representations, warranties and covenants and liabilities allocated to such party pursuant to the terms of the Purchase Agreement. Effective as of the Closing, the existing collaboration agreement between the Company and Regeneron regarding certain of the Programs will terminate.

The Closing is subject to customary closing conditions, including, among others: (a) the absence of laws enjoining, making illegal or otherwise prohibiting the Asset Sale; (b) the accuracy of the other party’s representations and warranties, subject to certain customary materiality standards; (c) compliance in all material respects by the other party with its obligations under the Purchase Agreement; and (d) no Material Adverse Effect (as defined in the Purchase Agreement) having occurred with respect to the Transferred Assets and Assumed Liabilities, taken as a whole, since the date of the Purchase Agreement. Upon the Closing, the parties will enter into certain ancillary agreements, including a transition services agreement, a license agreement and sublease agreements for the Company’s facilities as described above.

The foregoing descriptions of the terms of the Purchase Agreement and the Asset Sale do not purport to be complete and are qualified in their entirety by reference to the terms and conditions of the Purchase Agreement, which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2024.

On January 29, 2024 Eilean Therapeutics LLC, a biopharmaceutical company dedicated to discovering and developing best-in-class and first-in-class small molecule inhibitors to target escape mutations in hematologic and solid malignancies, reported the clearance from the Human Research Ethics Committee in Australia to begin human dosing in the Phase 1 clinical program of eiletoclax, a highly potent and selective BCL2 inhibitor (Press release, Eilean Therapeutics, JAN 29, 2024, View Source [SID1234639696]).

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"The first in human dosing of eiletoclax in Australia represents another important milestone for Eilean Therapeutics, as we progress, with an accelerated development of our portfolio of best-in-class agents targeting hematological malignancies," stated Iain Dukes, Chief Executive Officer of Eilean Therapeutics. "The highly differentiated pre-clinical profile of eiletoclax emphasizes important advantages over venetoclax-like molecules in safety, tolerability and feasibility of outpatient treatment, enabling the molecule to safely target AML and CLL patients alone and in combination with other targeted therapies."

About Eiletoclax

Eiletoclax (ZE50-0134) has earlier reported best-in-class potency and selectivity against BCL2, a key pro-survival protein that is overexpressed in many cancers. This clinical candidate demonstrated equivalent in vivo anti-tumor efficacy as venetoclax in B cell and myeloid malignancy cell lines and in vivo models. Compared to venetoclax, eiletoclax exhibits significantly less suppression of non-malignant immune cell populations, a result that suggests superior selectivity and an improved safety profile.