bluebird bio Announces Definitive Agreement to be Acquired by Carlyle and SK Capital

On February 21, 2025 bluebird bio, Inc. (NASDAQ: BLUE) ("bluebird") reported that it has entered into a definitive agreement to be acquired by funds managed by global investment firms Carlyle (NASDAQ: CG) and SK Capital Partners, LP ("SK Capital") in collaboration with a team of highly experienced biotech executives (Press release, bluebird bio, FEB 21, 2025, View Source [SID1234650448]). David Meek, former CEO of Mirati Therapeutics and Ipsen, is expected to become CEO of bluebird upon closing. Carlyle and SK Capital will provide bluebird primary capital to scale bluebird’s commercial delivery of gene therapies for patients with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy.

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Under the terms of the agreement, bluebird stockholders will receive $3.00 per share in cash and a contingent value right per share, entitling the holder to a payment of $6.84 in cash per contingent value right if bluebird’s current product portfolio achieves $600 million in net sales in any trailing 12-month period prior to or ending on December 31, 2027, for a potential total value of up to $9.84 per share in cash, subject to the tender of a majority of the outstanding shares of bluebird, receipt of applicable regulatory approvals, and other customary closing conditions. bluebird’s Board of Directors (the "bluebird Board") unanimously approved the agreement and recommends that stockholders tender their shares. Following a comprehensive review of bluebird’s strategic alternatives, including meeting with more than 70 potential investors and partners over a period of five months, and a third and final denial by the Federal Drug Administration of bluebird’s appeal for a priority review voucher, the bluebird Board determined that, absent a significant infusion of capital, bluebird is at risk of defaulting on its loan covenants. The bluebird Board has decided that this transaction is the only viable solution to generate value for stockholders. Additional details on the process will be available in bluebird’s Solicitation/Recommendation Statement on Schedule 14D-9, which will be filed with the U.S. Securities and Exchange Commission ("SEC").

"For more than a decade, bluebird has been at the forefront of gene therapy, delivering groundbreaking treatments to patients facing life-threatening genetic diseases," said Andrew Obenshain, current CEO of bluebird. "However, as our financial challenges mounted, it became clear that securing the right strategic partner was critical to maximizing value for our stockholders and ensuring the long-term future of our therapies. After an extensive review process, this acquisition represents the best path forward – maximizing value for stockholders and bringing significant capital, commercial expertise, and a commitment to provide more patients the opportunity to benefit from potentially transformative gene therapies."

David Meek commented, "bluebird is built on an extraordinary legacy of scientific breakthroughs, and we are committed to unlocking its full potential for patients. With the backing of Carlyle and SK Capital, we will bring the capital and commercial capabilities needed to accelerate and expand patient access to bluebird’s life-changing gene therapies."

"Carlyle’s healthcare and Abingworth teams have significant experience investing in biopharma and are excited about what lies ahead for bluebird. We look forward to working with David and SK Capital to drive bluebird’s future growth and mission of delivering its therapies to improve patient outcomes," said Joe Bress, Carlyle Partner and Global Co-Head of Healthcare. Bali Muralidhar, Partner and Chief Investment Officer & COO of Abingworth, Carlyle’s life sciences investment franchise, added, "Over the past decade, we have tracked and been impressed by bluebird’s success in researching and developing breakthrough gene therapies for large, unmet medical needs. Joining forces with Carlyle enables us to collaborate in supporting companies like bluebird in commercializing their innovations for patients."

Aaron Davenport, Managing Director at SK Capital, commented, "SK Capital has deep experience in the life sciences sector. We have long admired bluebird’s scientific leadership, dedicated focus on severe genetic diseases, and track record of successful product development and launch. We are excited to partner with David and Carlyle to invest in and accelerate the delivery of bluebird’s pioneering gene therapies to needing patients."

Transaction Details

Under the terms of the agreement, bluebird stockholders will receive $3.00 per share in cash and a contingent value right per share, entitling the holder to a payment of $6.84 in cash per contingent value right if bluebird’s current product portfolio achieves $600 million in net sales in any trailing 12-month period prior to or ending on December 31, 2027.

The transaction is expected to close in the first half of 2025, subject to the tender of a majority of the outstanding shares of bluebird, receipt of applicable regulatory approvals, and other customary closing conditions. bluebird has also entered into amendments to its loan agreement with Hercules Capital, Inc. to facilitate adequate liquidity to position it to maintain operations through the closing.

Upon completion of the transaction, bluebird will become a privately held company, and shares of bluebird common stock will no longer be listed on any public market.

Leerink Partners is acting as bluebird’s financial advisor, and Latham & Watkins LLP is serving as legal counsel to bluebird. Bourne Partners is acting as financial advisor to Carlyle and SK Capital, and Wachtell, Lipton, Rosen & Katz, Kirkland & Ellis LLP, and Orrick, Herrington & Sutcliffe are serving as legal advisors to Carlyle and SK Capital.

Estrella Immunopharma Completes First Dose Cohort in STARLIGHT-1 Trial and Receives Approval to Initiate Higher Dose Cohort

On February 21, 2025 Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported the successful completion of the first dose cohort in its ongoing STARLIGHT-1 Phase I/II clinical trial (Press release, Estrella Biopharma, FEB 21, 2025, View Source [SID1234650445]). Following a review of safety and efficacy data, the Data and Safety Monitoring Board (DSMB) has approved the initiation of the second dose cohort, which will administer 5 million receptor-positive T cells per kilogram of body weight of EB103 CD19-Redirected ARTEMIS T-cell therapy.

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The first dose cohort included patients with relapsed/refractory B-cell non-Hodgkin lymphoma ("NHL") who have failed multiple prior lines of therapy. Preliminary data from this cohort demonstrated a favorable safety profile, with no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) observed. Additionally, tumor response, were noted in all patients at Month 1.

The STARLIGHT-1 trial is an open-label, dose-escalation, multi-center study designed to evaluate the safety, tolerability, and preliminary efficacy of EB103 in adult patients with relapsed/refractory B-cell NHL. The trial follows a standard 3+3 dose-escalation design, with the goal of evaluating the safety profile, the pharmacokinetics of EB103 and determining the Recommended Phase II Dose (RP2D).

"The safety and early efficacy data from the first dose cohort are encouraging. We look forward to evaluating the higher dose cohort to further understand the potential of EB103 as a transformative therapy for patients with relapsed/refractory B-cell NHL." said Cheng Liu, Ph.D., President and CEO of Estrella Immunopharma.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them.

GRAIL to Present at TD Cowen 45th Annual Health Care Conference

On February 21, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that company management will present at the TD Cowen 45th Annual Health Care Conference in Boston on Tuesday, Mar. 4 at 9:10 a.m. ET (Press release, Grail, FEB 21, 2025, View Source [SID1234650444]).

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Live and replay webcasts may be accessed in the investor relations section of GRAIL’s website at investors.grail.com. The webcast will be archived and available for reply for at least 30 days after the event.

Geron to Participate at Upcoming Investor Conferences in March 2025

On February 21, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company, reported that members of the management team are scheduled to participate in fireside chats at the following investor conferences (Press release, Geron, FEB 21, 2025, View Source [SID1234650442]):

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TD Cowen 45th Annual Health Care Conference
Monday, March 3rdat 3:10pm ET (Boston, MA)

Leerink Global Healthcare Conference
Monday, March 10th3:00pm ET (Miami, FL)

Barclays 27thAnnual Global Healthcare Conference
Tuesday, March 11th10:30am ET (Miami, FL)

A live webcast of each fireside chat will be available through the Investors & Media section of the Geron’s website under Events. A replay of the webcast will be archived and available on Geron’s website for 30 days.

Kelun-Biotech’s Novel ADC SKB445 Receives IND Approval from NMPA in China

On January 21, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company has received a clinical trial notice approving the investigational new drug application for the innovative drug SKB445 developed by the Company from the Center for Drug Evaluation of the National Medical Products Administration (Press release, Kelun, FEB 21, 2025, View Source [SID1234650307]).

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SKB445 is a novel ADC drug with proprietary intellectual property rights developed by the Company based on the biological characteristics of the target and using the technology of the OptiDC platform, which has demonstrated promising efficacy and safety window in preclinical studies and is intended to be used for the treatment of advanced solid tumors.