On November 13, 2024 Curium, a world leader in nuclear medicine, reported that its ECLIPSE trial met its primary endpoint (Press release, Curium Pharma, NOV 13, 2024, View Source [SID1234648264]). ECLIPSE is a pivotal Phase 3, multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T (INN: lutetium (177Lu) zadavotide guraxetan) versus hormone therapy in patients with metastatic castration-resistant prostate cancer.

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The ECLIPSE trial demonstrated a statistically significant and clinically meaningful improvement in the median radiographic progression-free survival (rPFS) of patients with prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with up to 6 doses of 200 mCi (7.4 GBq) of 177Lu-PSMA-I&T in patients previously treated with an androgen receptor pathway inhibitor (ARPI) compared to a change in ARPI.

Sakir Mutevelic, MD, Curium’s Chief Medical Officer said: "This is a significant accomplishment for Curium, demonstrating in the pivotal confirmatory ECLIPSE trial a statistically significant and clinically meaningful benefit of PSMA-targeted radioligand therapy with 177Lu-PSMA-I&T for patients with mCRPC. ECLIPSE is the first Phase 3 trial investigating a 200 mCi (7.4 GBq) dose of 177Lu-PSMA-I&T administered every six weeks for up to six doses, demonstrating clinical benefit, in mCRPC patients before receiving taxane-based chemotherapy. Curium will continue to work with the FDA as the clinical trial data matures, on a regulatory submission plan for this potentially important product for patients, their caregivers, and the healthcare providers treating prostate cancer."

Michael Patterson, CEO, Curium North America added: "The ECLIPSE achievement of its primary endpoint represents an important clinical milestone in the development of our prostate theranostic program. This underscores Curium’s continued commitment and focus on nuclear medicine diagnostics and therapeutics. Further, the announcement of the opening of Curium’s Netherlands facility for the production of 177Lutetium in September 2024, bolsters Curium’s supply chain and ensures manufacturing reliability. Curium will continue to work to fulfill its mission of redefining the experience of cancer through our trusted legacy in nuclear medicine by ensuring unrestricted access to this important product, if approved."

On November 13, 2024 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported an update on the company’s development pipeline and announced financial results for the third quarter ended September 30, 2024 (Press release, Quince Therapeutics, NOV 13, 2024, View Source [SID1234648285]).

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Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "We are pleased to report accelerating enrollment of our pivotal Phase 3 NEAT clinical trial in Ataxia-Telangiectasia (A-T). As of today, we have enrolled 32 patients with A-T across clinical sites in the U.S., U.K., and European Union. Additionally, the majority of planned NEAT study sites are now activated and open for enrollment. We expect enrollment momentum to continue as we work toward our commitment to complete enrollment in the second quarter of 2025 and report topline results in the fourth quarter of 2025."

Pivotal Phase 3 NEAT Clinical Trial

Enrolled 32 participants to date in the company’s Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T; IEDAT-04-2022/NCT06193200) clinical trial to evaluate the neurological effects of EryDex in patients with A-T.
Quince plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older.
Participants who complete the full treatment period, complete study assessments, and provide informed consent will be eligible to transition to an open label extension study, which will begin in the fourth quarter of 2024.
Pivotal Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
Expect to report Phase 3 NEAT topline results in the fourth quarter of 2025 with a New Drug Application (NDA) submission to the FDA and a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) in 2026, assuming positive study results.
NEAT is an international, multi-center, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of the company’s lead asset, EryDex (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells), in patients with A-T.
Participants will be randomized (1:1) between EryDex or placebo and treatment will consist of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in a rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo as per the SPA agreement with the FDA.
Pipeline and Corporate Updates

Participation at scientific congresses, including a poster presentation of safety data from the previously completed ATTeST study at the 53rd Child Neurology Society Annual Meeting. Quince is also sponsoring and participating at the 2024 International Congress for Ataxia Research in November 2024 with two poster presentations, including growth and bone mineral density in patients with A-T treated with EryDex, and an analysis of the International Cooperative Ataxia Rating Scale (ICARS) subcomponent scores in patients with A-T.
Generating Phase 2 clinical trial study designed to evaluate EryDex for the potential treatment of patients with Duchenne muscular dystrophy (DMD), including those with corticosteroid intolerance, who represent the majority of the DMD population. Quince plans to initiate a DMD Phase 2 study in 2025, which the company expects to conduct utilizing capital efficient study approaches.
Completed evaluation process of other potential rare disease indications beyond A-T and Duchenne muscular dystrophy for EryDex where chronic corticosteroid treatment is – or has the potential to become – a standard of care, if there were not corticosteroid-related safety concerns. The prioritized list of other potential rare disease targets under consideration includes: 1) autoimmune hepatitis, 2) dermatomyositis, 3) pemphigus vulgaris, 4) Hashimoto’s encephalopathy, 5) Becker muscular dystrophy, 6) pediatric lupus, 7) juvenile idiopathic arthritis, 8) myasthenia gravis, 9) limb-girdle muscular dystrophy, 10) chronic inflammatory demyelinating polyradiculoneuropathy, and 11) pulmonary sarcoidosis.
Third Quarter and Year-to-Date 2024 Financial Results

Reported cash, cash equivalents, and short-term investments of $47.8 million for the third quarter ended September 30, 2024. Quince expects its existing cash runway to be sufficient to fund the company’s capital efficient development plan through Phase 3 NEAT topline results and into 2026.
Expect strong cash position to fully fund lead asset, EryDex, through Phase 3 NEAT topline results in the fourth quarter of 2025 and prepare for NDA and MAA submissions in 2026, assuming positive study results. This includes approximately $20 million for the NEAT clinical trial and approximately $15 million in direct trial costs for an open label extension study.
Reported research and development (R&D) expenses of $4.9 million for the third quarter ended September 30, 2024. R&D expenses during the quarter primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs.
Reported general and administrative (G&A) expenses of $3.6 million for the third quarter ended September 30, 2024. G&A expenses for the quarter primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs.
Reported a net loss of $5.5 million, or a net loss of $0.13 per basic and diluted share, for the third quarter ended September 30, 2024. Weighted average shares outstanding for the quarter were 43.2 million.
Reported net cash used in operating activities of $24.4 million for the nine months ended September 30, 2024, which included a net loss of $44.4 million for the period, adjusted for $22.4 million of non-cash items, including $17.1 million goodwill impairment charge, $2.1 million change in the fair value of contingent consideration liabilities, $3.6 million in stock-based compensation, a net increase in operating assets of $2.5 million, and a net increase in accounts payable, accrued expenses, and other current liabilities of $0.1 million. Additionally, Quince made a cash milestone payment of $5 million to EryDel shareholders in the third quarter of 2024 following the achievement of the first patient enrolled in the NEAT study in the second quarter of 2024.

On November 13, 2024 Continuity Biosciences, LLC, a new bioscience company dedicated to developing and commercializing cutting-edge technologies for cell reprogramming, immune modulation, and drug delivery, reported its official launch (Press release, Continuity Biosciences, NOV 13, 2024, View Source [SID1234648309]). The company seeks to bridge biopharmaceutical and medical technologies, establishing a new standard for patient-focused treatments for chronic and complex diseases.

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Founded by a team of experienced scientists and industry leaders, Continuity Biosciences aims to enhance emerging therapies, such as cell therapy, by fully leveraging delivery technology. The team includes Bob Whitehead (Executive Chairman), a veteran in the bioscience field known for successful strategic exits and initiatives; Ramakrishna Venugopalan, PhD (Co-Founder & CEO), a former senior executive at AbbVie with expertise in drug delivery for products like Skyrizi and Vyalev; and Alessandro Grattoni, PhD (Chief Scientific Advisor), Chair and Professor of the Department of Nanomedicine at Houston Methodist Hospital and a leader in advanced drug delivery.

"We are thrilled to have licensed several technology platforms from Houston Methodist Hospital and to introduce Continuity Biosciences to the biotechnology and investment communities," said Ramakrishna Venugopalan, Co-Founder & CEO. "There is immense potential at the intersection of biopharmaceuticals and medical technologies, especially in creating combination products that enhance novel therapies. We plan to expand our technology portfolio to provide our partners with diverse strategies for delivering their treatments."

Dr. Grattoni’s pioneering research, along with Continuity’s licensed technologies, focuses on developing implantable nanofluidic systems. These technologies facilitate cell reprogramming, molecular sieving, immune modulation, and sustained therapeutic release over ultra-long periods. Supported by significant funding from organizations like the National Institute of Health, Department of Defense, United States Agency for International Development, Juvenile Diabetes Research Foundation (now Breakthrough T1D), ISS National Lab, and key pharmaceutical partners and foundations, these platforms have vast potential for preventing and treating chronic conditions including cancer, autoimmune, metabolic and infectious diseases. They also offer versatile applications for long-acting drug delivery and in vivo cell reprogramming systems suited for advanced cell and gene therapies.

On November 13, 2024 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported new and updated data from its hematology pipeline will be shared across 23 abstracts at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2024 Annual Meeting, taking place from December 7-10 in San Diego, CA (Press release, Regeneron, NOV 13, 2024, View Source [SID1234648286]). The latest research advances demonstrate the potential of Regeneron’s diverse pipeline, which aims to address unmet needs in ten types of blood cancers and disorders. These innovative and differentiated approaches include CD3 bispecific antibodies, costimulatory bispecific antibodies, and a pioneering combination of a monoclonal antibody and small interfering RNA (siRNA).

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"Our presentations at ASH (Free ASH Whitepaper) demonstrate the progress we are making toward transforming care for a range of blood cancers and disorders where advancements are desperately needed," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President and Hematology Clinical Development Unit Head at Regeneron. "These include new head-to-head data exploring a novel combination that aims to maximize disease control in paroxysmal nocturnal hemoglobinuria compared to a standard-of-care treatment, as well as initial results from our confirmatory odronextamab trial in first-line follicular lymphoma. Together, our presentations underscore our commitment to work towards translating scientific breakthroughs to differentiated medicines for hematology patients."

At ASH (Free ASH Whitepaper), abstracts in blood disorders include an oral presentation from an exploratory cohort of a Phase 3 trial investigating a novel combination of pozelimab with cemdisiran compared to ravulizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH) who were naïve to complement inhibition at baseline. Notably, the presentation will detail interim results from patients who were initially randomized to ravulizumab but crossed over to the combination in an open label extension portion of the trial.

Progress on the odronextamab development program will be featured in twelve abstracts. Among them are initial results in patients with previously untreated follicular lymphoma (FL) from Part 1 of the Phase 3 OLYMPIA-1 confirmatory trial, which consists of a non-randomized safety run-in (Part 1) followed by a randomized efficacy portion (Part 2) comparing odronextamab monotherapy to rituximab plus standard-of-care chemotherapies. Two oral presentations on the ELM-1 and pivotal ELM-2 trials will feature new analyses in settings with significant unmet needs: one in patients with diffuse large B-cell lymphoma (DLBCL) who progressed after CAR-T therapy and the other in relapsed/refractory (R/R) marginal zone lymphoma (MZL).

Other notable abstracts include the latest linvoseltamab efficacy and safety results from the pivotal LINKER-MM1 study in R/R multiple myeloma (MM), preclinical data evaluating a CD38xCD28 costimulatory bispecific antibody in combination with linvoseltamab, and preclinical data on TMPRSS6 inhibition in beta-thalassemia.

The full list of Regeneron presentations at ASH (Free ASH Whitepaper) includes:

Abstract Title Abstract Presenter Session Date/Time (PT)
Odronextamab
Efficacy and Safety of Odronextamab Monotherapy in Patients (Pts) with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing after CAR T-Cell Therapy: Primary Analysis from the ELM-1 Study Abstract #866
Oral Presentation
Session

Matthew Matasar Monday, December 9, at 2:45-4:15 pm

Marriott Marquis San Diego Marina, Pacific Ballroom Salons 15-17
Efficacy and Safety of Odronextamab in Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL): Data from the R/R MZL Cohort in the ELM-2 Study Abstract #862
Oral Presentation
Session

Tae Min Kim Monday, December 9, at 2:45-4:15 pm

Marriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13
Odronextamab Monotherapy in Previously Untreated Patients with High-Risk Follicular Lymphoma (FL): Results of the Safety Lead-in of the Phase 3 OLYMPIA-1 Study Abstract #4411
Poster Presentation
Session
Elizabeth Brem

Monday, December 9, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Efficacy and Safety of Odronextamab in Rare Subtypes of Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (B-NHL): Data from a Dedicated Cohort of Other B-NHLs in the ELM-2 Study Abstract #4502
Poster Presentation
Session Emmanuel Bachy Monday, December 9, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Treatment Duration and Risk of Fatal Infections in Patients with B-Cell Non-Hodgkin Lymphoma Achieving Complete Response with Odronextamab Abstract #3080
Poster Presentation Gottfried von Keudel

Monday, December 9, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Dynamics of Complete Responses in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma Treated with Odronextamab in the ELM-2 Study Abstract #4486
Poster Presentation
Session
Sabarish Ayyappan

Monday, December 9, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Long-Term Efficacy and Safety of Odronextamab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Pooled Analysis from ELM-1 and ELM-2 Studies Abstract #3118
Poster Presentation
Session
John N. Allan Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Evaluation of CAR-HEMATOTOX Scoring as a Predictor of Infection Risk following Treatment with Odronextamab (a CD20×CD3 Bispecific Antibody) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma Abstract #3076
Poster Presentation
Session
Mathew Matasar Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Evaluation of Baseline CAR-HEMATOTOX Scores to Predict Increased Severe Infection Risk in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Odronextamab Abstract #1650
Poster Presentation
Session
Matthew Matasar Saturday, December 7, at 5:30-7:30 pm

San Diego Convention Center, Halls G-H
Dynamics of Complete Responses in Patients with Relapsed or Refractory Follicular Lymphoma Treated with Odronextamab in the ELM-2 Study Abstract #1628
Poster Presentation
Session
Stefano Luminari Saturday, December 7, at 5:30-7:30 pm

San Diego Convention Center, Halls G-H
Trial in Progress: Odronextamab for the Treatment of Patients with Relapsed/Refractory Mantle Cell Lymphoma following Prior BTK Inhibitor Therapy – A Cohort of the ELM-2 Study Abstract Publication Only Srikanth Ambati N/A
Matching-Adjusted Indirect Comparisons (MAICs) of Odronextamab Versus Mosunetuzumab and Epcoritamab for the Treatment of Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) after Two or More Lines of Systemic Therapy Abstract Publication Only

Deepa Jagadeesh N/A
Linvoseltamab
Linvoseltamab in Patients with Relapsed/Refractory Multiple Myeloma: Longer Follow-Up and Selected High-Risk Subgroup Analyses of the LINKER-MM1 Study Abstract #3369
Poster Presentation Mansi R. Shah Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Soluble BCMA Dynamics in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Linvoseltamab in LINKER-MM1 Abstract #3310
Poster Presentation Anasuya Hazra Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Characterization of Linvoseltamab’s BCMA Binding Epitope and Efficacy Against BCMA Mutations in Relapsed/Refractory Multiple Myeloma Abstract #3265
Poster Presentation Ken Lee & Yi Zhou Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
A CD38xCD28 Costimulatory Bispecific Antibody Demonstrates Potent Preclinical Combinatorial Activity with a BCMAxCD3 T Cell-Engager Abstract #3283
Poster Presentation Kara Olson & David J. DiLillo Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Reducing Time Toxicity for Anti-B-Cell Maturation Antigen (BCMA) Bispecific Treatment: Evidence from Pivotal Single-Arm Trial Data on Teclistamab, Elranatamab, and Linvoseltamab for Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)
Abstract #2271
Poster Presentation Session
Sikander Ailawadh Saturday, December 7, at 5:30-7:30 pm

San Diego Convention, Halls G-H
Exposure-Response Analyses of Various Efficacy and Safety Endpoints in Support of Registrational Dose Selection of Linvoseltamab in Patients with Relapsed/Refractory Multiple Myeloma Abstract Publication Only Oleg Milberg N/A
Comparative Effectiveness of Linvoseltamab Versus Current Real-World Standard-of-Care Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma Treated at IMWG Sites Abstract Publication Only

Shaji Kumar N/A
Comparative Effectiveness of Linvoseltamab Versus Current Real-World (RW) Standard-of-Care (SOC) Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM): Key Subgroups Analysis Abstract Publication Only

Shaji Kumar N/A
Additional Presentations
Efficacy and Safety of Pozelimab Plus Cemdisiran vs Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria who are Naïve to Complement Inhibition* Abstract #306
Oral Presentation Session Christopher Patriquin Saturday, December 7, at 4 – 5:30 pm

San Diego Convention Center, Room 11
TMPRSS6 Inhibition Rapidly Reverses Liver Iron Overload and Prevents an Increase of Splenic Pro-Inflammatory Macrophages in a Mouse Model of Beta-Thalassemia Abstract #2473
Poster Presentation Session

Heinrich E. Lob Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
The Reality of Beta Thalassemia and Iron Chelation Therapy – A Qualitative Study Unveiling the Patient Burden Abstract Publication Only

Chris Hartford
*Agreement with Alnylam Pharmaceuticals, Inc.

Linvoseltamab as well as the combination of pozelimab and cemdisiran are investigational, and the potential uses of odronextamab in R/R MZL and rare subtypes of R/R aggressive B-cell non-Hodgkin lymphoma are also investigational and have not been approved by any regulatory authority. Odronextamab is approved in the European Union as Ordspono to treat R/R FL or DLBCL after two or more lines of systemic therapy, but the safety and efficacy of odronextamab have not been fully evaluated by any other regulatory authority.

About Regeneron in Hematology
At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.

Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.

Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s Co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985.They were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV (casirivimab and imdevimab), Dupixent (dupilumab), Libtayo, Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb), Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz (pozelimab-bbfg).

On November 13, 2024 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ: ZLAB; HKEX: 9688), an innovative, commercial-stage biopharmaceutical company, reported that it has commenced an underwritten public offering of $200.0 million of American depositary shares ("ADSs"), each representing ten ordinary shares of the Company with a par value of $0.000006 per share (Press release, Zai Laboratory, NOV 13, 2024, View Source [SID1234648310]). All ADSs will be offered by Zai Lab. Zai Lab expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the ADSs sold in the public offering at the public offering price less underwriting discounts and commissions. Zai Lab intends to use the net proceeds from this offering for general corporate purposes.

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Goldman Sachs (Asia) L.L.C., Jefferies and Leerink Partners are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

The offering will be made pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on April 19, 2024. A preliminary prospectus supplement related to the proposed ADS offering is being filed with the SEC.

Copies of the registration statement on Form S-3ASR, the preliminary prospectus supplement and the accompanying prospectus may be obtained from: (i) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY, facsimile: 212-902-9316 or by emailing [email protected], (ii) Jefferies LLC, c/o Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] and (iii) Leerink Partners LLC, c/o Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

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