On February 5, 2024 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that findings from Patient-Reported Outcomes (PROs) of participants in the phase 2/3 QUILT 3.032 study of N-803 plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) were published by the peer-reviewed journal Urology Practice (Press release, ImmunityBio, FEB 5, 2024, View Source [SID1234639844]). These PROs support the positive interim results from the study published in NEJM Evidence, wherein 71% of patients in cohort A with CIS with or without Ta/T1 disease achieved a complete response.

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The published PROs based on a May 16, 2022 data cutoff indicate that both physical function and global health as self-reported by QUILT 3.032 participants with BCG-unresponsive NMIBC CIS (cohort A) or papillary disease (cohort B), remained stable over the 2-year course of the study for patients who completed the PRO questionnaires and reached 24 months on-study. In addition, overall both cohort A and B participants who reached month 24 on-study and also completed an NMIBC-specific questionnaire focusing on the challenges of bladder cancer, also reported no decline of their health or urinary tract-related symptoms while in the study. Overall, participants who achieved a complete response with the novel combination therapy reported better physical function by month six of the study than those who did not achieve a complete response.

"The self-reported stability of health and physical function over the course of the study by the participants reflect another aspect of safety and tolerability of this new combination therapy," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "Taken together with the positive response rate in cohort A of over 70%, the persistence of responses and cystectomy avoidance, these QoL findings suggest a favorable risk-benefit ratio for this potential new therapeutic option for patients with BCG-unresponsive bladder cancer."

The finding of relative stability of global health and physical function during the course of the study is similar to that reported by others for BCG monotherapy, suggesting the novel combination is as tolerable as treatment with BCG alone.

"Many current therapies for bladder cancer slow disease progression but can cause debilitating side effects," said Principal Investigator Karim Chamie, M.D., Associate Professor of Urology at UCLA. "The data from the QUILT 3.032 Quality of Life study suggest that many patients not only have a durable response but also report no decline in physical function, which is very important for these patients."

QUILT 3.032 Study Details

The ongoing phase 2/3 open-label multicenter registrational study QUILT 3.032 (NCT03022825) is evaluating the safety and efficacy of the investigational interleukin-15 superagonist N-803 (also known as Anktiva and nogapendekin alfa inbakicept, NAI) in combination with a standard therapy for NMIBC, bacillus Calmette-Guerin (BCG), in patients who failed or in whom cancer returned after BCG monotherapy, and thus were diagnosed as BCG-unresponsive. The study comprises three cohorts, with cohort A enrolling patients with carcinoma in situ (CIS) with or without Ta/T1 disease and cohort B enrolling patients with high grade Ta/T1 papillary disease. Both cohorts A and B received combination N-803 plus BCG therapy. Cohort C patients, with CIS +/- Ta/T1 disease received N-803 monotherapy.

The primary end point is the incidence of CR at the 3- or 6-month assessment visit for cohorts A and C, and the disease-free survival (DFS) rate at 12 months for cohort B.
Durability, cystectomy avoidance, progression-free survival, disease-specific survival (DSS), and overall survival are secondary end points for cohort A.
Cohort C was discontinued due to a low response rate with N-803 monotherapy, per study design.
The FDA has accepted for review ImmunityBio’s resubmission of its biologics license application (BLA) for N-803 plus BCG for the treatment of BCG-unresponsive NMIBC CIS with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024.
Bladder cancer is the 10th most-commonly diagnosed cancer, with approximately 80% of newly diagnosed cases being NMIBC. Intravesical (directly to the bladder) instillation of BCG after removal of cancer tissue from the lining of the bladder (transurethral resection of the bladder tumor; TURBT) is Standard-of-Care (SoC) for intermediate and high-risk NMIBC patients, but up to 40% of patients will fail BCG therapy and ~50% will relapse after an initial response and given a diagnosis of being BCG-unresponsive. Therapies approved by the FDA for this indication include pembrolizumab, nadofaragene, combined gemcitabine and docetaxel, and valrubicin. Radical cystectomy – surgical removal of the bladder – is also an option for these patients. QUILT 3.032 is being conducted to address the need for a safe, effective therapeutic option for BCG-unresponsive NMIBC patients that provides an opportunity for avoidance of radical cystectomy.

N-803 is investigational. Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.

On February 5, 2024 Immix Biopharma, Inc. (Nasdaq: IMMX) (the "Company"), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Immix Biopharma, FEB 5, 2024, View Source [SID1234639843]). All of the shares of common stock in the underwritten public offering are to be sold by the Company. The Company also expects to grant the underwriters a 30-day option to purchase additional shares of common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company intends to use the net proceeds from the proposed offering for NXC-201 clinical trials, working capital and general corporate purposes.

Titan Partners Group, LLC, a division of American Capital Partners, LLC, is acting as sole book-running manager for the offering.

A shelf registration statement relating to the shares of common stock to be issued in the proposed offering was filed with the Securities and Exchange Commission ("SEC") and declared effective by the SEC. A preliminary prospectus supplement relating to the proposed offering has been filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement describing the terms of the proposed offering will be filed with the SEC. The offering will be made only by means of the preliminary prospectus supplement and the accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. Copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Titan Partners Group, LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by email at [email protected], or by calling (929) 833-1246.

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

On February 5, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that in January 2024, the first patient was enrolled and dosed in the Phase 2a expansion portion of the Company’s Acclaim-1 clinical study of Reqorsa Therapy (quaratusugene ozeplasmid) in combination with AstraZeneca’s Tagrisso to treat patients with late-stage non-small cell lung cancer (NSCLC) (Press release, Genprex, FEB 5, 2024, View Source [SID1234639842]).

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"We are encouraged by the very promising Phase 1 results in the Acclaim-1 trial, which demonstrated the combination of REQORSA and Tagrisso was well tolerated at all three dose levels with evidence of efficacy observed in patients with non-small cell lung cancer (NSCLC) whose disease has progressed on Tagrisso," stated Mark Berger, Chief Medical Officer of Genprex. "We are excited to begin the Phase 2a expansion portion of Acclaim-1, which will examine the toxicity profiles of different cohorts as well as efficacy and other clinical endpoints."

Data from the Phase 1 dose escalation portion of the Acclaim-1 study were presented at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC International Conference for Molecular Targets and Cancer Therapeutics Meeting in October 2023. The data reported results from twelve patients with advanced, epidermal growth factor receptor (EGFR) mutant NSCLC whose disease progressed after Tagrisso treatment. REQORSA was generally well tolerated, as there were no dose limiting toxicities.

While the Phase 1 portion of the clinical trial was designed primarily to assess safety, promising efficacy results were also observed. One patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed, and Tagrisso, had a partial remission (PR) by investigator evaluation and treatment is now ongoing in the trial after 28 cycles, which is approximately 19.5 months. Another patient who is at the 0.09 mg/kg dose level, previously treated with Tagrisso, had stable disease and treatment was ongoing after 14 cycles, or approximately 10 months. And a third patient previously treated with cisplatin, pemetrexed, carboplatin, and Tagrisso at the 0.12 mg/kg dose level has stable disease and is continuing to receive REQORSA after 14 cycles, or approximately 10 months. The extended progression free survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early stage clinical trials of REQORSA, and is not expected with treatment with Tagrisso alone after progression on Tagrisso1. PFS is the primary endpoint of both the Phase 2a expansion portion and the Phase 2b randomized portion of the Acclaim-1 study.

"Advancing Acclaim-1 marks an important milestone for Genprex. We are proud of the progress we have made thus far and are encouraged by REQORSA’s potential to improve outcomes for patients battling NSCLC. We look forward to an interim analysis from the Phase 2a study in 2025 and expect those results will further validate our novel gene therapy approach to treating lung cancer patients," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.

REQORSA, the Company’s lead product candidate, is being evaluated in three clinical trials as a treatment for NSCLC and small cell lung cancer (SCLC). Each of the three lung cancer clinical programs has received a Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of that patient population, and the SCLC program has also received an FDA Orphan Drug Designation.

About Acclaim-1 Clinical Trial

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor ("EGFR") mutations whose disease progressed after treatment with Tagrisso.

The Phase 1 dose escalation portion of the Acclaim-1 trial has been completed. The Phase 2a expansion portion of the study is expected to enroll approximately 66 patients, half of whom will have received only Tagrisso treatment and the other half will have received Tagrisso treatment and chemotherapy, to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. The Phase 2b randomized portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or platinum-based chemotherapy. The primary endpoint of the Phase 2b portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 28 events.

About Reqorsa Therapy
REQORSA (quaratusugene ozeplasmid) for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex’s ONCOPREX Nanoparticle Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.

Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Tagrisso is a registered trademark of AstraZeneca plc.

On February 5, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported that it will host Part I of a virtual KOL investor event series on Tuesday, February 13, 2024 at 10:30 AM ET (Press release, FibroGen, FEB 5, 2024, View Source [SID1234639841]).

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The event will feature Andrew Ko, MD (University of California San Francisco (UCSF), UCSF’s Helen Diller Family Comprehensive Cancer Center) and Vincent Picozzi, MD, MMM (Virginia Mason Digestive Disease and Cancer Institutes, Virginia Mason Medical Center), who will discuss the unmet medical need and current treatment landscape for pancreatic cancer, as well as the clinical development program for pamrevlumab*, a potential first-in-class monoclonal antibody targeting connective tissue growth factor (CTGF) for pancreatic cancer treatment.

The event will include information on the mechanism of action of pamrevlumab as well as a review of the pre-clinical and Phase 1/2 data for pamrevlumab and the two ongoing trials: the innovative Precision Promise℠ Phase 2/3 trial being conducted by the Pancreatic Cancer Action Network (PanCAN) for metastatic pancreatic cancer, and the LAPIS Phase 3 trial in locally advanced pancreatic cancer.

A live question and answer will follow the formal presentations.

The second event in the series, to be scheduled at a later date, will include a review of the development program for FG-3246; a Phase 2 ready CD46 targeting antibody-drug conjugate (ADC) for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

This series is intended for investor audiences only.

About Andrew Ko, MD
Andrew Ko, MD completed his medical training at the Johns Hopkins School of Medicine (Baltimore, MD) and Beth Israel Hospital/Harvard Medical School (Boston, MA) before moving out west to complete his oncology training at Stanford University. He is currently a Professor of Medicine and Associate Chief of the Division of Hematology/Oncology at the University of California San Francisco (UCSF) and a member of UCSF’s Helen Diller Family Comprehensive Cancer Center. His primary clinical and research interests center on gastrointestinal cancers, with a particular emphasis on pancreatic and gastroesophageal malignancies. He has been responsible for developing and leading numerous clinical trials evaluating novel therapeutic strategies for these disease indications (ranging from novel cytotoxics to molecular targeted agents to immunotherapies) supported by industry collaborators, the National Cancer Institute, and various consortia/foundations. His work also entails efforts to identify individual patient/tumor characteristics that influence prognosis and response to specific therapies, including both tissue- and blood-based biomarkers. In addition to his role as Associate Editor for the Journal of Clinical Oncology since 2016, he is currently chair of the NCI’s Pancreatic Cancer Task Force; has served on the scientific program committee, grants committee, and specialty editorial board for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper); has played a leadership role within the GI Committee of the Alliance for Clinical Trials in Oncology to shepherd new trial concepts in pancreatic cancer through this national cooperative group; and sits on the National Comprehensive Cancer Network Pancreatic Cancer guidelines committee.

About Vincent Picozzi, MD, MMM
Vincent Picozzi, MD, MMM is Director for the Pancreas Center of Excellence, Virginia Mason Digestive Disease and Cancer Institutes, Virginia Mason Medical Center. A summa cum laude, Phi Beta Kappa graduate from Yale University, Dr. Picozzi obtained his MD degree from Stanford University, did his internship and residency at Harvard University (Brigham and Women’s Hospital), and fellowships in hematology and oncology again at Stanford. He also holds a masters degree in medical management Delta Omega, from Tulane University. Dr. Picozzi was an instructor in hematology and oncology at Stanford for two years before joining Virginia Mason, where he has been for the past 38 years. Dr. Picozzi directs an active, comprehensive clinical and translational research program in pancreaticobiliary cancer at Virginia Mason. He has one of the largest pancreaticobiliary oncology practices in the United States. He has published over 150 papers and abstracts, and is currently the principal investigator of 3 registration trials in pancreatic cancer. Dr. Picozzi has been a featured speaker at virtually every major clinical oncologic meeting in the United States, including ASCO (Free ASCO Whitepaper) (the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)), ASH (Free ASH Whitepaper) (the American Society of Hematology (ASH) (Free ASH Whitepaper)), ASTRO (the American Society of Therapeutic Radiation Oncology), Digestive Diseases Week, AHPBA (The American HepatoPancreaticobiliary Association), ACOS ( the American College of Surgeons), the Best of ASCO (Free ASCO Whitepaper), the GI Oncology Symposium and the World Pancreas Symposium. Dr. Picozzi also has held a number of leadership positions with national and regional organizations, including ASCO (Free ASCO Whitepaper), ASH (Free ASH Whitepaper), the American College of Surgeons Oncology Group (ACOSOG), the Pancreatic Cancer Action Network (PanCAN) (current board member and formal national chairman), the Pancreas Cancer Research Team (PCRT-Executive Committee), the Washington State Medical Oncology Society (WSMOS- Past President x 2), and the Providence Hospice of Seattle (Executive Board). He is currently the Co-Principal investigator of the Precision Promise Clinical Initiative, sponsored by GCAR, in metastatic pancreatic cancer.

About Pamrevlumab
Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF). Pamrevlumab is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). The U.S. Food and Drug Administration has granted Orphan Drug Designation for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC), and Fast Track designation to pamrevlumab for the treatment of patients with LAPC. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in LAPC and metastatic pancreatic cancer. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about our pamrevlumab studies please visit www.clinicaltrials.gov.

On February 5, 2024 Catalent, Inc. (NYSE: CTLT), a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, reported that they have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis (Press release, Catalent, FEB 5, 2024, https://www.catalent.com/catalent-news/novo-holdings-to-acquire-catalent/ [SID1234639838]).

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TRANSACTION OVERVIEW
Novo Holdings will acquire all outstanding shares of Catalent for $63.50 per share in cash. The purchase price represents a premium of 16.5% to the closing price of Catalent’s common stock as of February 2, 2024, the last trading day prior to this announcement, and a 47.5% premium to the 60-day volume-weighted average price as of February 2, 2024.
In addition, the purchase price represents a premium of 39.1% to the closing price of Catalent’s common stock on August 28, 2023, the last trading day prior to Catalent’s announcement that its Board of Directors formed a Strategic and Operational Review Committee to conduct a review of Catalent’s business, strategy and operations, as well as Catalent’s capital-allocation priorities with a view towards maximizing value for all Catalent stockholders.
Of Catalent’s more than 50 global sites, Novo Holdings intends to sell three Catalent fill-finish sites and related assets acquired in the merger to Novo Nordisk (CPH: NOVO), in which Novo Holdings has a controlling interest, shortly after the closing of the merger. These three sites are located in Anagni, Italy; Bloomington, Indiana, USA; and Brussels, Belgium.
This transaction is aligned with Novo Holdings’ strategy of investing in established life science companies with strong long-term potential.
Alessandro Maselli, President and Chief Executive Officer of Catalent, said: "Over the past several years, Catalent has built a comprehensive end-to-end offering of services and capabilities to drive innovation in the healthcare system and improve patient outcomes. This transaction is a testament to our team’s hard work and dedication to this mission, and I am incredibly excited for this next step in our journey. We look forward to benefiting from Novo Holdings’ significant resources to accelerate investment in our business and enhance key offerings as we continue to offer premium development and manufacturing solutions for pharma and biotech customers."

John Greisch, Executive Chair of the Catalent Board and Chair of the Strategic and Operational Review Committee, said: "This transaction delivers significant, certain and premium value to our stockholders. Novo Holdings believes in our vision and will provide Catalent with a strong foundation as we continue developing, manufacturing and supplying top products."

Novo Holdings has a proven track record of successfully investing in the broader life sciences sector. Importantly, Novo Holdings’ core mission is to contribute to the improvement of people’s health and the sustainability of society and the planet by generating strong capital returns on behalf of the Novo Nordisk Foundation.

Kasim Kutay, CEO of Novo Holdings, said: "We are excited to partner with Catalent as it enters a new phase of growth and accelerates its mission to develop, manufacture and supply products that help people live better and healthier lives. With our expertise and track record of investing in high quality life sciences businesses, we believe Catalent is a very good strategic fit. We are excited to support the Company’s stakeholders in the years ahead, especially employees and customers as they work to develop new products to benefit patients. As engaged investors committed to productive relationships with all our partners, we look forward to working with the Catalent team to realise the Company’s full potential.

Importantly, our acquisition of Catalent is aligned with our mandate to invest in high quality life sciences companies for the benefit of the Novo Nordisk Foundation’s mission and philanthropic causes."

Marc Steinberg, Partner at Elliott Investment Management L.P., said: "As a significant investor in Catalent, Elliott fully supports the transaction announced today. We believe that this transaction, which is the culmination of a process led by the Strategic and Operational Review Committee of the Catalent Board, clearly maximizes value for Catalent stockholders. We commend Catalent’s Board and management team for delivering this outstanding outcome."

TRANSACTION DETAILS
The merger is expected to close towards the end of calendar year 2024, subject to customary closing conditions, including approval by Catalent stockholders and receipt of required regulatory approvals. The transaction is not subject to any financing contingency.

Following an evaluation of possible value-maximizing alternatives, the Catalent Board unanimously determined that the transaction with Novo Holdings, which delivers a premium and certain cash value, is in the best interest of Catalent. Accordingly, the Catalent Board unanimously recommends that Catalent stockholders vote in favor of the merger.

In addition, Elliott Investment Management L.P. and certain of its affiliates have entered into a support agreement pursuant to which they have agreed to vote their shares of Catalent common stock in favor of the merger.

Following the closing of the merger, shares of Catalent will no longer trade on the New York Stock Exchange and Catalent will become a private company.

SECOND QUARTER 2024 FINANCIAL RESULTS
Catalent’s second quarter 2024 earnings results are expected to be issued on February 9, 2024. In light of the announced transaction, Catalent will not host an earnings conference call. Catalent’s second quarter 2024 earnings press release will be available on its investor relations website at http://investor.catalent.com.

ADVISORS
Citi and J.P. Morgan are acting as financial advisors to Catalent. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor to Catalent and Jones Day is serving as legal advisor to the Catalent Board of Directors. Morgan Stanley is acting as financial advisor to Novo Holdings and Goodwin Procter LLP is serving as legal advisor to Novo Holdings.