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Enliven Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants

On June 13, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported that it has priced its previously announced underwritten public offering of 8,394,737 shares of its common stock at a price to the public of $19.66 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase up to 1,780,263 shares of Enliven’s common stock at a price to the public of $19.659 per pre-funded warrant, which represents the per share public offering price of each share of Enliven’s common stock less the $0.001 per share exercise price for each pre-funded warrant (Press release, Enliven Therapeutics, JUN 13, 2025, View Source [SID1234653886]). All of the shares and pre-funded warrants are being sold by Enliven. The gross proceeds from the offering are expected to be approximately $200 million before deducting underwriting discounts and commissions and other offering expenses. The offering is expected to close on or about June 16, 2025, subject to satisfaction of customary closing conditions. In addition, Enliven has granted the underwriters a 30-day option to purchase up to an additional 1,526,250 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Jefferies, Goldman Sachs & Co. LLC, TD Cowen and Mizuho are acting as joint book-running managers for the offering. LifeSci Capital is acting as lead manager for the offering.

The offering is being made pursuant to a Registration Statement on Form S-3, including a base prospectus, previously filed with and declared effective by the SEC and a related registration statement that was filed with the SEC on June 13, 2025 pursuant to Rule 462(b) under the Securities Act of 1933, as amended (and became automatically effective upon filing), and Enliven has filed with the SEC a preliminary prospectus supplement and accompanying prospectus relating to the offering. A final prospectus supplement and accompanying prospectus relating to the offering will also be filed with the SEC. These documents can be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (833) 297-2926 or by email at [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, by telephone at (212) 205-7600 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of any such state or jurisdiction.

Johnson & Johnson’s dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma

On June 13, 2025 Johnson & Johnson (NYSE: JNJ) reported the first clinical data from an ongoing Phase 1b study for JNJ-90014496 (JNJ-4496), an investigational dual-targeting anti-CD19/CD20 bispecific autologous chimeric antigen receptor (CAR) T-cell therapy, being studied in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) who have not been previously treated with CAR T-cell therapy (Press release, Johnson & Johnson, JUN 13, 2025, View Source;johnsons-dual-targeting-car-t-cell-therapy-shows-encouraging-first-results-in-large-b-cell-lymphoma-302480701.html [SID1234653885]). Findings demonstrate the potential of JNJ-4496 in the treatment of patients with R/R LBCL, including R/R diffuse large B-cell lymphoma (DLBCL) – the most common type of aggressive lymphoma, a blood cancer that originates in the lymphatic system.1,2 These data were presented as an oral presentation at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress (Abstract #S239).1

JNJ-4496, formerly known as C-CAR039, is a dual-targeting CAR T designed to bind to both CD19 and CD20 antigens — two cell surface proteins commonly expressed on malignant B-cells. This design, including a 4-1BB costimulatory domain, is intended to enhance binding strength and persistence, also potentially addressing common mechanisms of resistance in relapsed or refractory disease.

In the Phase 1b dose confirmation study (NCT05421663) in patients with R/R LBCL, data at the recommended Phase 2 dose (RP2D) were reported in patients with a median follow-up of 4 months. Results informed a RP2D of JNJ-4496 at 75 million CAR+ T-cells. Among the 22 patients in the RP2D group where efficacy was assessed, those who received one prior line of therapy (n=10) had an objective response rate (ORR) of 100 percent and a complete response rate (CRR) of 80 percent (95 percent confidence interval (CI), 69, 100). In the patients who had received two or more prior lines of therapy (n=12), the ORR was 92 percent and the CRR was 75 percent (95 percent CI, 62, 100).1

"There is a pressing need to continue advancing therapies for patients with relapsed or refractory diffuse large B-cell lymphoma. Only about 40 percent of patients have long-term remissions with currently available single-antigen-targeting CD19 CAR T therapies," said Krish Patel*, M.D., Director of Lymphoma Research, Sarah Cannon Research Institute (SCRI), and principal study investigator. "The data presented today show encouraging clinical activity and promising safety, and represent a step forward in delivering a potential new treatment option to patients living with the most common type of aggressive lymphoma."

Within the RP2D safety group (n=25), 52 percent of patients (n=13) received two or more prior lines of therapy, and 56 percent (n=14) received bridging therapy. In the RP2D cohort studied, no cases of Grade 3 or 4 cytokine release syndrome were observed. Two patients had immune effector cell-associated neurotoxicity syndrome (ICANS), one Grade 1 and one Grade 3. The Grade 3 event occurred in a patient with central nervous system (CNS) lymphoma. Overall, 84 percent of patients (n=21) had Grade 3/4 treatment-emergent adverse events (TEAEs), and 28 percent (n=7) reported serious TEAEs. The most common Grade 3/4 TEAE was neutropenia, a reduction in white blood cells (72 percent). One patient experienced a Grade 3 infection.1

"We’re really excited to share the first results for our dual-targeting anti-CD19/CD20 CAR T-cell therapy in relapsed or refractory large B-cell lymphoma, underscoring our more than decade-long commitment to addressing unmet needs for patients with B-cell malignancies," said Jeffrey Infante, M.D., Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine. "As we continue to unlock the full potential of CAR T-cell therapies through novel next-generation approaches, these promising data reinforce earlier long-term findings and highlight the potential of JNJ-4496 to improve outcomes for patients."

These data are advancing our pipeline of CAR T therapies for the treatment of B-cell malignancies and are an extension of our worldwide collaboration and licensing agreement initiated with AbelZeta Inc. (formerly Cellular Biomedicine Group, Inc.) in 2023 to develop and commercialize next-generation CAR T-cell therapies (excluding Greater China). A Phase 1 study for C-CAR039 was conducted in China for the treatment of patients with B-cell non-Hodgkin lymphoma (predominantly LBCL).3 Johnson & Johnson is also evaluating the safety and efficacy of this asset (known as JNJ-4496 outside of Greater China) through a separate study involving a global patient population.4 In addition to the oral presentation of JNJ-4496 at EHA (Free EHA Whitepaper), the global clinical study data will be presented at the 2025 International Conference on Malignant Lymphoma from June 17—21.

About large B-cell lymphoma
Large B-cell lymphoma is a type of non-Hodgkin lymphoma (NHL), a blood cancer that originates in the lymphatic system, arising from abnormal B cells, a type of white blood cell responsible for producing antibodies to fight infections.2 The malignant cells grow rapidly in lymph nodes or other organs and can spread quickly throughout the body.2 These abnormal cells are larger than normal, healthy B-cells.2 Diffuse (D) LBCL is the most common and aggressive type where cells are spread out (diffuse) rather than grouped together when they are examined under a microscope.2 DLBCL accounts for approximately 40 percent of all NHL cases globally and is estimated to have 150,000 new cases diagnosed each year.5 While some patients respond to initial treatment, up to 40 percent can relapse or become refractory to therapy.6 LBCL and DLBCL patients often face limited treatment options and a poor prognosis, highlighting the urgent need for innovative therapies. Common symptoms include rapidly growing lymph nodes, fever, night sweats, weight loss, and fatigue.

AstraZeneca enters strategic collaboration with CSPC Pharmaceuticals focused on AI-enabled research

On June 13, 2025 AstraZeneca reported to have entered a strategic research collaboration with Shijiazhuang City-based CSPC Pharmaceuticals Group Limited (Press release, AstraZeneca, JUN 13, 2025, View Source [SID1234653884]). Working together on high priority targets, the collaboration aims to advance the discovery and development of novel oral candidates, with the potential to treat diseases across multiple indications.

Under the terms of the agreement, AstraZeneca and CSPC agree to discover and develop pre-clinical candidates for multiple targets with the potential to treat diseases across chronic indications, including a pre-clinical small molecule oral therapy for immunological diseases.

Sharon Barr, Executive Vice President and Head of BioPharmaceuticals R&D said: "This strategic research collaboration underscores our commitment to innovation to tackle chronic diseases which impact over two billion people globally. Forming strong collaborations allows us to leverage our complementary scientific expertise to support the rapid discovery of high-quality novel therapeutic molecules to deliver the next-generation medicines."

The research will be carried out by CSPC, in Shijiazhuang City and will utilise their AI-driven, dual-engine efficient drug discovery platform. This platform uses AI technology to analyse the binding patterns of target proteins with existing compound molecules, conduct targeted optimization, with the aim of selecting highly effective small molecules with excellent developability.

The collaboration furthers AstraZeneca’s presence in China following the $2.5bn investment in Beijing announced earlier this year and strengthens the ongoing collaboration with CSPC.

Financial considerations
Under the terms of the agreement, CSPC will receive an upfront payment of $110 million, and is also eligible to receive up to $1.62 billion in potential development milestone payments and up to $3.6 billion in sales milestone payments, plus potential single digit royalties based on annual net sales of the products.

Under the agreement, AstraZeneca will have rights to exercise options for exclusive licenses to develop and commercialise worldwide candidates identified under this agreement.

Aptevo Participating in the BIO International Convention

On June 13, 2025 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that the Company is participating in the BIO International Convention occurring June 16-19, 2025, in Boston, MA (Press release, Aptevo Therapeutics, JUN 13, 2025, View Source [SID1234653883]).

The conference is known for being the largest biotechnology industry conference of the year and is expected to attract more than 18,000 attendees from around the world. Attending from Aptevo are Michelle N. Nelson, Ph.D., Director of Immunobiology and SoYoung Kwon, SVP, General Counsel and Head, Business Development.

BIK Therapeutics and Medicilon Sign Strategic Collaboration Agreement to Accelerate Oncology Drug Innovation.

On June 13, 2025 BIK Therapeutics, a South Korean biotech company pioneering next-generation oncology therapies, reported to have entered a strategic collaboration with Medicilon to accelerate preclinical development of its lead candidates (Press release, Shanghai Medicilon, JUN 13, 2025, View Source [SID1234653880]). Under the agreement, Medicilon will provide BIK Therapeutics with integrated preclinical research services, including pharmacokinetics, toxicology, and oncology pharmacology research. This includes key studies such as the U87-MG-luc orthotopic model and U87-MG S.C. xenograft model, aiming to accelerate the R&D of innovative oncology drugs and assist in completing IND filings.

The signing ceremony was attended by key representatives from both companies, including Jaeho Jung (CDO & VP), Kideok Shin (Director of R&D Center) of BIK Therapeutics, and Jianglin Hu (Co-CEO & CSO), Renzhong Xie (VP of Toxicology Research Department), Hanjun Zou (Executive Director of Toxicology Research Department) of Medicilon.

Complementary Strengths for Oncology Drug Development.
Founded in 2009, BIK Therapeutics has established proprietary drug R&D systems and technology platforms such as its ELiTE-DDS (drug delivery system). The company has strategically evolved from a radiopharmaceutical developer to a therapeutic innovator, focusing on biomarker-driven anti-tumor drugs.

Medicilon, as a one-stop preclinical R&D service platform, offers comprehensive evaluation services for oncology drugs and has systematically established over 480 tumor models. It can provide comprehensive evaluations for new anti-tumor drugs, including cytotoxic and targeted small molecules, monoclonal and bispecific antibodies, ADCs, and CAR-T/CAR-NK cell therapies.

Through this collaboration, both sides will fully leverage their core technological advantages to build a new ecosystem for oncology drug R&D.

Jaeho Jung, CDO and VP of BIK Therapeutics: "Medicilon’s technical capabilities and experience in oncology are impressive. We look forward to leveraging their innovation to enhance our R&D efficiency. We believe that our joint efforts will bring more breakthrough solutions to the field of precision oncology."

Jianglin Hu, Co-CEO and CSO of Medicilon: "This partnership is a perfect synergy of BIK Therapeutics’ innovation and Medicilon’s technical platform. Together, we aim to drive the biopharmaceutical industry forward in the era of precision oncology."