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Regeneron Announces Investor Conference Presentations

On April 21, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, APR 21, 2025, View Source [SID1234651993]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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BofA Securities 2025 Health Care Conference at 10:00 a.m. PT (1:00 p.m. ET) on Tuesday, May 13, 2025
2025 RBC Capital Markets Global Healthcare Conference at 11:00 a.m. ET on Tuesday, May 20, 2025
Bernstein 41st Annual Strategic Decisions Conference at 11:00 a.m. ET on Wednesday, May 28, 2025
Goldman Sachs 46th Annual Global Healthcare Conference at 10:40 a.m. ET on Monday, June 9, 2025

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

Jazz Pharmaceuticals Completes Acquisition of Chimerix

On April 21, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz" or the "Company") reported the successful completion of its acquisition of Chimerix, Inc. ("Chimerix") for approximately $935 million in cash (Press release, Jazz Pharmaceuticals, APR 21, 2025, View Source [SID1234651992]). Chimerix is now a wholly owned subsidiary of Jazz.

"Bringing Chimerix into Jazz adds a novel medicine to our oncology portfolio and advances our efforts to address unmet patient needs," said Bruce Cozadd, chairman and chief executive officer of Jazz. "Dordaviprone has the potential to become the first and only FDA-approved therapy for patients with H3 K27M-mutant diffuse glioma and offers a promising near-term commercial opportunity, if approved. We are excited to welcome Chimerix’s talented team as we collectively continue to advance dordaviprone, leveraging our development and commercial capabilities to deliver this therapy to patients as soon as the second half of this year."

The addition of dordaviprone, a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, further diversifies and adds near-term commercial opportunity to Jazz’s oncology pipeline. Dordaviprone is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for August 18, 2025. If approved in the U.S., the therapy may be eligible for a Rare Pediatric Disease Priority Review Voucher (PRV). Dordaviprone is also being studied in the ongoing Phase 3 ACTION trial to evaluate its use in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting.

Transaction Details

Jazz’s tender offer for all outstanding shares of common stock, par value $0.001 per share, of Chimerix expired at one minute after 11:59 p.m., Eastern Time, on April 17, 2025. Jazz has accepted for payment of $8.55 per share, in cash, without interest and subject to reduction for any applicable withholding taxes, all shares that were validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Jazz completed the acquisition of Chimerix through the merger of Pinetree Acquisition Sub, Inc., a Delaware corporation, an indirect wholly owned subsidiary of Jazz ("Purchaser") with and into Chimerix (the "Merger"). As a result of the Merger, the separate existence of Purchaser ceased, and Chimerix continued as the surviving corporation and an indirect wholly owned subsidiary of Jazz. Additional details regarding the tender can be found in a form 8-K filed by Jazz today with the SEC.

About Dordaviprone

Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2). Dordaviprone’s unique mechanism of action includes alterations of key epigenetic modifications such as reversal of H3 K27me3-loss, which is the hallmark of H3 K27M-mutant gliomas.

IMUNON Announces IMNN-001 Abstract Accepted for Oral Presentation at 2025 ASCO Annual Meeting

On April 21, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, reported that an abstract highlighting new, highly encouraging, Overall Survival data from the Phase 2 OVATION 2 Study of IMNN-001 to treat women with newly diagnosed advanced ovarian cancer was accepted for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, IMUNON, APR 21, 2025, View Source [SID1234651991]). The meeting is being held May 30 – June 3, 2025, in Chicago, Illinois and virtually. IMUNON recently announced alignment with the U.S. Food and Drug Administration (FDA) on the study protocol for the Phase 3 OVATION 3 clinical trial of IMNN-001 and has initiated trial site activation.

IMNN-001, based on the company’s proprietary TheraPlas technology platform, is an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system, enabling cell transfection followed by persistent, local production and secretion of the IL-12 protein in the tumor microenvironment. IL-12 is a powerful pluripotent cytokine known for inducing strong anti-cancer immunity by promoting T-lymphocyte and natural killer cell proliferation while inhibiting tumor-mediated immune suppression. IMNN-001 is the first and only IL-12 immunotherapy to achieve a clinically effective response including overall survival benefit in frontline treatment in patients with advanced (Stage III/IV) ovarian cancer.

"We are pleased to have the opportunity to present new data from the Phase 2 OVATION 2 Study of IMNN-001 in an oral presentation at ASCO (Free ASCO Whitepaper)’s Annual Meeting," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "This recognition underscores the significant potential of IMNN-001 to transform the treatment of women with newly diagnosed advanced ovarian cancer, an underserved population that has not seen treatment innovation in over 25 years, as we advance our Phase 3 program. We look forward to sharing more about our progress during this pivotal stage of development."

About the OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant (NACT) and adjuvant chemotherapy (ACT) of paclitaxel and carboplatin (N/ACT) in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of ACT to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

ImmunityBio to Showcase Advances for Bladder and Prostate Cancer at American Urological Association (AUA) Annual Meeting

On April 21, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported new clinical findings for ANKTIVA (nogapendekin alfa inbakicept-pmln) in non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS) and updated data on papillary disease without CIS at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29 (Press release, ImmunityBio, APR 21, 2025, View Source [SID1234651990]). The company will also host an educational and peer-networking event to discuss ImmunityBio’s approach to treatment of NMIBC CIS and papillary disease and how they have impacted patients.

"ImmunityBio has made remarkable strides in 2025, marked by groundbreaking long-term efficacy data for ANKTIVA and the launch of our Expanded Access Program to help end the BCG shortage," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, Global Chief Scientific & Medical Officer of ImmunityBio. "With these critical advancements, we are eager to connect, collaborate, and drive meaningful discussions with the urology community at AUA 2025, shaping the future of bladder and prostate cancer care together. In addition, ImmunityBio has applied for Expanded Access for the use of ANKTIVA as a ‘BioShield’ in patients receiving chemotherapy, radiation, and immunotherapy to enable access to ANKTIVA across the country for patients in need."

Oral Presentations by Key Opinion Leaders:

Presented research will continue to demonstrate long-term duration of response with ANKTIVA + BCG in an updated analysis of the pivotal QUILT 3.032 trial in CIS and papillary BCG-Unresponsive NMIBC.

An Update on QUILT 3.032: Complete Responses to N-803 plus BCG Therapy in BCG-Unresponsive Bladder Carcinoma in Situ (CIS) With or Without Ta/T1 Papillary Disease (PD12-12)
Chang S. Oral Podium Presentation. Session: Bladder Cancer: Non-Invasive II, Saturday, April 26, 3:30 pm – 5:30 pm PDT, Galileo 1001, The Venetian Convention & Expo Center
Keynote Events by Dr. Soon-Shiong at AUA

Patrick Soon-Shiong, M.D., will participate in a series of presentations showcasing the power and potential of immunotherapy in shaping the future of urological cancers.

Embracing the Future: The Power of Innovation in a Changing World
Dr. Patrick Soon-Shiong, Keynote. AUA Innovation Nexus Conference, Friday, April 25, 1:00-1:45 pm PDT, The Venetian Convention & Expo Center
The Science of the Triangle Offense: NMIBC Patient and Prostate Cancer Experience
Educational and peer-networking event with Drs. Patrick Soon-Shiong, ImmunityBio Chief Medical Officer Sandeep "Bobby" Reddy, and Senior Vice President of Medical Affairs Bruce Brown, Saturday, April 26, 6:30 pm – 9:00 pm PDT, The Venetian Convention & Expo Center
The Missing Link: Overcoming Lymphopenia through NK & Memory T Cells to Achieve Durable Responses in Urological Diseases – ALC Matters, Duration Matters, the Immune System Matters
Dr. Patrick Soon-Shiong, ImmunityBio Product Theater, Sunday, April 27, 1:30 pm – 2:30 pm PDT, Science & Technology Hall, The Venetian Convention & Expo Center
About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder’s Vision) and Anktiva.com.

Axcynsis Therapeutics to Present Two Posters on Anti-CLDN6 and Anti-ALPP/ALPPL2 Antibody Therapeutics at American Association for Cancer Research (AACR) Annual Meeting 2025

On April 21, 2025 Axcynsis Therapeutics that is at the forefront of developing cutting-edge Antibody Drug Conjugate (ADC) therapies, reported two upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Axcynsis Therapeutics, APR 21, 2025, View Source [SID1234651989]). This meeting will be held in Chicago from April 25th to 30th 2025.

The company will present the following two assets:

AT65474 is a highly selective anti-CLDN6 ADC with a proprietary payload
Session Category: Experimental and Molecular Therapeutics

Session Title: Antibody-Based Cancer Therapeutics 4

Session Date and Time: April 30, 2025, 9:00 AM to 12:00 PM (Local Time)

Location: Poster Section 16

Poster Board Number: 7

Published Abstract Number: 6741

CLDN6 is a membrane-bound oncofetal protein and a promising target for cancers such as ovarian and testicular cancer. AT65474 is an antibody drug conjugate (ADC) candidate composed of a highly selective humanized anti-CLDN6 antibody conjugated to a proprietary payload, namely TCS132, with a drug-to-antibody (DAR) ratio of 4. The antibody is engineered to incorporate AxcynCYSTM technology for site-specific conjugation which can reproducibly achieve high DAR4 ratios of greater than 97% by HIC analysis.

The payload, TCS132, is derived from an FDA approved drug and when compared to the parent drug, demonstrates increased potency with broad sub-nanomolar activities across a wide range of cancer cell lines including those resistant to paclitaxel, DM1, MMAE and DXd. Additionally, TCS132 was chemically optimized for better PK properties and demonstrates a much-improved safety profile despite its increased potency over the parent drug.

AT2604 is a highly efficacious ADC targeting alkaline phosphatases ALPP and ALPPL2
Session Category: Experimental and Molecular Therapeutics

Session Title: Antibody-Based Cancer Therapeutics 4

Session Date and Time: April 30, 2025, 9:00 AM to 12:00 PM (Local Time)

Location: Poster Section 16

Poster Board Number: 17

Published Abstract Number: 6751

Placental alkaline phosphatases, ALPP and ALPPL2, are highly homologous, membrane-bound proteins involved in fetal development. Despite having limited expression in normal tissues, they are highly differentiated in multiple tumor cells making them ideal targets for antibody drug conjugate (ADC) development.

AT2604 is an ADC incorporating an anti-ALPP/ALPPL2 antibody conjugated to monomethyl auristatin E (MMAE) with high DAR 4 homogeneity; and displays strong tumor growth inhibition at low doses in CDX models of gastric and pancreatic cancer. In patient-derived xenograft models of gastric cancer with moderate- and low-antigen expression, AT2604 achieves near-complete tumor regression at 3 and 6 mg/kg (QWx3), respectively. A preliminary toxicity assessment in non-human primates concluded a well-tolerated dose of 10 mg/kg (Q3Wx3) without exhibiting any non-reversible adverse effects and good plasma stability; implying that AT2604 possesses an improved safety profile over other vedotin-based ADCs.