On June 16, 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 closed its underwritten public offering of 9,920,987 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 1,526,250 additional shares of its common stock, at a price to the public of $19.66 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,780,263 shares of its 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 16, 2025, View Source [SID1234653927]). All of the shares and pre-funded warrants were sold by Enliven. The gross proceeds from the offering were approximately $230 million before deducting underwriting discounts and commissions and other offering expenses.

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

The offering was 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 final prospectus supplement and accompanying prospectus relating to the offering. These documents can be accessed for free through the SEC’s website at www.sec.gov. 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 Prospectus [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.

On June 16, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported that Dr. Sari Fishman, Vice President of Business Development, will present an update on the Company’s ongoing Phase IIa study in pancreatic cancer during partnering meetings at the 2025 BIO International Convention, taking place June 16–19 in Boston, MA (Press release, Can-Fite BioPharma, JUN 16, 2025, View Source [SID1234653912]).

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The Phase IIa clinical trial is open-label study evaluating Namodenoson in patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one prior line of therapy. The study is assessing the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson, administered orally at a dose of 25 mg twice daily in continuous 28-day cycles. Approximately 20 evaluable patients are expected to be enrolled.

The trial is led by Prof. Salomon Stemmer, a prominent Oncologist and Key Opinion Leader at the Davidoff Center, Rabin Medical Center, Israel. Namodenoson has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

"We are pleased to report that 50% of the planned patient cohort has already been enrolled and that Namodenoson has demonstrated a favourable safety profile," stated Prof. Salomon Stemmer. "There is a critical unmet need for safe and effective treatment options for patients with advanced pancreatic cancer who have exhausted standard therapies. This study gives us the opportunity to advance a novel therapeutic approach for this challenging disease, stated Dr. Sari Fishman, VP of Business Development at Can-Fite."

Can-Fite looks forward to engaging with potential partners and collaborators at BIO 2025 as it continues to progress its clinical pipeline.

On June 16, 2025 Shasqi, Inc. ("Shasqi"), a biotech company whose mission is to make cancer drugs more effective with pre-targeting enabled by click chemistry, reported the publication of a manuscript detailing the preclinical development and translation of SQ3370 to a first-in-human dose-escalation clinical trial in patients with advanced solid tumors (Press release, Shasqi, JUN 16, 2025, View Source [SID1234653928]).

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The manuscript titled, Development of a first-in-class click chemistry-based cancer therapeutic, from preclinical evaluation to a first-in-human dose escalation clinical trial, was published today in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

"This groundbreaking clinical validation marks a paradigm shift in oncology—we’ve demonstrated for the first time that in vivo click chemistry can be used in humans to pre-target and concentrate therapeutics at tumor sites," said Dr. Sangeetha Srinivasan, Director of In-Vivo Biology at Shasqi. "By decoupling tumor targeting from the payload, our CAPAC platform enables delivery of 12-fold higher doses of doxorubicin per cycle compared to conventional approaches, while reducing systemic toxicity."

Shasqi’s Click Activated Protodrugs Against Cancer (CAPAC) platform is a pre-targeting technology composed of a tumor binding agent and a protodrug. Administered sequentially, these components are designed to only click with each other via a click chemistry reaction occurring directly at the tumor site. This releases high concentrations of cancer drugs at the tumor while sparing healthy tissues.

The manuscript describes the development and first-in-human study of SQ3370, an intratumorally injected biopolymer paired with a doxorubicin payload, and the first in vivo click chemistry based therapeutic to be tested in humans. In the study, 12x the standard dose of doxorubicin was administered per cycle with mild and manageable toxicities, including less than anticipated myelosuppression. The lack of immunosuppression and high drug doses enabled T-cell-dependent immune responses, including cytotoxic CD8 + T-cell expansion and activation in tumors and systemically.

"The significance of this work expands far beyond the current study, as it demonstrates that click chemistry can be harnessed inside the human body to redefine how therapeutics are activated in the body," said Carolyn Bertozzi, PhD, Professor of Chemistry at Stanford University, and winner of the Nobel Prize for Chemistry in 2022 for the development of click and biorthogonal chemistry. "This study shows that biorthogonal chemical groups and their reaction products are tolerated in humans, unlocking a new frontier for oncology innovation and beyond."

"This breakthrough study shows, for the first time, that click chemistry can be used inside the human body to activate cancer drugs at the tumor," said Jason S. Lewis, PhD, whose work as the Emily Tow Chair in Oncology and Deputy Director of Sloan Kettering Institute (OSET) at Memorial Sloan Kettering Cancer Center in New York is focused on pre-targeting radiopharmaceutical therapies using click chemistry. "This opens up new opportunities for targeted delivery of other cancer therapeutics such as radiopharmaceutical therapy."

On June 16, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing circular RNA technology for gene and cell therapy and mutant RAS-targeting cancer vaccines, reported that interim data from the TG01 phase 1/2 clinical trial in multiple myeloma at Oslo University Hospital (OUS) has been presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 annual meeting in Milan, Italy (Press release, Circio, JUN 16, 2025, View Source [SID1234653913]).

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The results show preliminary signals of clinical efficacy for TG01 vaccination and confirm an excellent safety profile, thus providing justification for continued clinical development for a major unmet medical need. The trial is a collaboration between OUS and Circio to test TG01/QS-21 vaccination as a monotherapy in 20 KRAS or NRAS mutated multiple myeloma patients with remaining measurable disease after completion of standard of care treatment. The aim is to assess whether T-cell responses to mutant RAS induced by TG01 can enhance and prolong the clinical benefit. OUS is the study sponsor, with Dr. Hanne Norseth as the primary investigator.

"RAS-mutant multiple myeloma has poor prognosis and there are currently no available targeted treatment options for this patient population," said Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group "Interim data from the first twelve patients demonstrate the capability of TG01 to induce RAS-specific T-cell responses in a subset of patients, and suggest that these responses are associated with disease stabilization. This is an important early indication of clinical benefit. We look forward to completing the study, including a broad set of genetic and immunological analyses, which will help us build the understanding of how TG01 vaccination can fit as a future treatment option to deepen and prolong responses in this underserved patient population."

Oncogenic RAS mutations drive up to 30% of all cancers and an estimated 15-20% of multiple myelomas, and remain a major unmet medical need with few effective treatment alternatives. Circio has previously been awarded two prestigious research grants from Innovation Norway and the Norwegian Research Council to advance the TG mutant RAS cancer vaccine program. These grants have provided funding towards two active clinical studies, including the present multiple myeloma study at OUS, Norway, and a phase 2 trial at Georgetown University, Washington D.C. USA, where TG01 is tested in pancreatic and lung cancer.

"Consistent with our prior observations in pancreatic cancer, it is very reassuring that this early-stage multiple myeloma trial has generated results showing immunological activity of the TG01 vaccine associated with clinical benefit," said Dr. Victor Levitsky, Chief Scientific Officer of Circio Holding ASA. "The biomarker findings are consistent with the current understanding of tumor immune control requiring a proper match between the characteristics of the tumor and the of patient´s genetic buildup. This important connection provides a mechanistic validation of clinical benefit and suggests specific biomarkers to select patients who can benefit most from TG01 treatment in follow-up clinical studies. We will continue to pursue our strategy to develop TG01 through external partnerships in parallel with our core in house circular RNA program."

Poster title:
The phase I/II TG01-study: Vaccinating against RAS-mutated Multiple Myeloma

Presentation date and location:
14 June 2025, EHA (Free EHA Whitepaper) 2025 Annual Meeting, Milan – Italy

The main conclusions from the poster presentation were as follows:

Available data demonstrate excellent tolerability and safety of TG01/QS-21 vaccination
50% (6/12) of vaccinated patients show vaccine-induced specific T-cell responses against mutant K/N-RAS-peptides
50% (6/12) of patients remain on study with stable disease (SD), no objective responses have so far been observed
67% (4/6) of patients with SD had a K/N-RAS-peptide specific immune response by ELISPOT (1/2 negative patients fell very narrowly below positivity threshold)
Enrollment and analysis of the TG01 vaccine-specific responses are ongoing

On June 16, 2025 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", SSE: 600196, HKEX: 02196) reported that the companies, through their respective subsidiaries, have entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy (Press release, Teva, JUN 16, 2025, View Source [SID1234653929]). Teva’s internally developed ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications.

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Under the terms of the agreement, which aims to accelerate clinical data generation, Fosun Pharma is granted an exclusive license to develop, manufacture and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR and Taiwan region and select Southeast Asian countries. Teva retains all development, manufacturing and commercialization rights to the licensed molecule in the rest of the world. The strategic partnership presents a significant step forward in the global development of TEV-56278, giving Teva the opportunity to leverage Fosun Pharma-generated data in other geographies.

"This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring acceleration of our pipeline," said Eric Hughes, MD, PhD, Executive Vice President, Teva Global R&D and Chief Medical Officer. "TEV-56278 demonstrates the strength of Teva’s innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients."

Anti-PD1-IL2 fusion proteins like TEV-56278 represent a novel approach to cancer immunotherapy. TEV-56278 is designed to deliver IL-2 selectively to PD-1+ T cells, thus amplifying anti-tumor T-cell activity while minimizing off-target systemic toxicities. The targeted approach holds promise for improving outcomes for patients with a variety of oncology diseases.

"We are pleased to partner with Teva on the development of TEV-56278," said Xingli WANG, MD, PhD, Executive President of Fosun Pharma and CEO of the Global R&D Center, "This collaboration brings together Teva’s expertise in innovative drug development with Fosun Pharma’s strong oncology development experience and commercial capabilities in the China market, creating a powerful synergy to accelerate the delivery of this important therapy to patients globally."

About TEV-56278

TEV-56278 is an anti-PD-1 antibody-cytokine fusion protein designed to selectively deliver an interleukin-2 (IL-2), i.e., ATTENUKINE, to PD-1-expressing T cells within the tumor microenvironment. This targeted approach aims to amplify anti-tumor T-cell activity while minimizing systemic toxicities. TEV-56278 is being evaluated as a monotherapy and in combination with pembrolizumab. Preclinical data has demonstrated tumor regression, enhanced T-cell infiltration, and durable immune memory.