On February 27, 2023 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported the closing of its previously announced underwritten public offering of 1,050,000 shares of its common stock at a public offering price of $5.25 per share (Press release, Aprea, FEB 27, 2023, View Source [SID1234627736]). Gross proceeds from the offering before deducting underwriting discounts and commissions and offering expenses are approximately $5.5 million. In addition, Aprea has granted the underwriter a 30-day option to purchase up to an additional 157,500 shares of common stock.

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The net proceeds received from the public offering will enable the Company to continue developing its clinical asset, ATRN-119, its pre-clinical asset ATRN-W1051 and for general corporate purposes.

Maxim Group LLC acted as sole book-running manager for the offering.

The public offering was made pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-250041), previously filed with the U.S. Securities and Exchange Commission (SEC) on November 12, 2020 and declared effective on November 30, 2020. The final terms of the offering are disclosed in the final prospectus supplement which has been filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus relating to the public offering may also be obtained by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at [email protected].

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

On February 27, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics reported that Dan Faga, interim president and chief executive officer, will present at the Cowen and Company 43rd Annual Health Care Conference on Monday, March 6, 2023, at 2:50 p.m. ET / 11:50 a.m. PT (Press release, AnaptysBio, FEB 27, 2023, View Source [SID1234627735]).

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A live audio webcast of the presentation will be available on the investor section of the AnaptysBio website at View Source A replay of the webcast will be available for at least 30 days following the event.

On February 27, 2023 Leidos (NYSE: LDOS) reported the appointment of Thomas Bell as Chief Executive Officer, expected to be effective May 3, 2023 (Press release, Leidos, FEB 27, 2023, View Source [SID1234627732]).

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Bell, current President – Defense Rolls-Royce plc; Chairman & Chief Executive Officer, Rolls-Royce North America, Inc., will succeed current Chairman and CEO, Roger Krone, who has served in the role since 2014.

Krone will retire as Chairman at the time of the Leidos 2023 annual meeting of stockholders, and CEO when Bell’s appointment becomes effective. The Board expects to appoint Robert S. Shapard independent, non-executive chair after the 2023 annual meeting of stockholders and will also nominate Mr. Bell to the Board.

To facilitate a seamless leadership transition, Krone will continue as a fully employed advisor through July of this year.

Bell was selected by the company’s Board of Directors following a thorough and thoughtful process to select a successor.

"Tom’s exceptional track record in harnessing the power of technology to drive growth and innovation, with his strong leadership skills and focus on understanding the needs of the customer, has resulted in a consistent record of success and value creation in both products and services," said Bob Shapard, lead director of the company’s board. "His deep understanding of many of our customers will facilitate a smooth transition."

Prior to his current role, Bell was senior vice president of global sales & marketing for defense, space & security at The Boeing Company. Before joining Boeing in 2015, he was President of Rolls-Royce Defense Aerospace, having joined as President, Customer Business, North America in mid-2012. Previously he spent more than two decades with Boeing in a variety of leadership positions within the defense, space and security business and began his aerospace career with Lockheed Martin in human space flight.

"Roger Krone’s impact on Leidos and its customers will be felt for years to come. Under his leadership, Leidos has achieved tremendous growth, evolved its business strategy, and made a positive difference in the lives of countless people around the world. Now, Leidos is not only a market leader but, just as importantly, a place where employees feel a deep sense of mission and community," said Shapard. "On behalf of the Board of Directors, I extend our deepest gratitude to Roger for his nearly nine years of dedicated service. He has left an indelible mark on our company and our culture, and we are a better organization because of his leadership. We wish him all the best in his future endeavors, and we look forward to continuing to build on the foundation that he has laid for Leidos’ future success."

"Working with the extraordinary people of Leidos has been the honor of my career," said Krone. "Their dedication, innovation, and unwavering commitment to our mission have been the driving force behind our success. I want to thank them for the privilege of serving as their leader for nearly nine years, and for inspiring me with their passion, their brilliance, and their unwavering commitment to excellence. It has been a privilege to be a part of this remarkable team, and I am confident that the future of Leidos is in the best possible hands with all of them."

On February 27, 2023 InDex Pharmaceuticals Holding AB (publ) reported that the company will attend the annual congress of the European Crohn’s and Colitis Organisation (ECCO), March 1-4, 2023 in Copenhagen. ECCO is the largest forum for specialists in inflammatory bowel disease globally (Press release, InDex Pharmaceuticals, FEB 27, 2023, View Source [SID1234627731]).

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InDex Pharmaceuticals will also be present at booth #C3-17 in the exhibition hall at the Bella Center. InDex’s team members will be available on site to provide information about cobitolimod and the ongoing phase III program CONCLUDE, which is evaluating the Toll-like receptor 9 agonist cobitolimod, as a potential novel treatment for moderate to severe left-sided ulcerative colitis. In addition, InDex’s team member will take the opportunity to meet Investigators of Induction 1 study of the CONCLUDE program to discuss study progress with the coordinating Investigator Professor Raja Atreya.

"ECCO is the largest forum for specialists in inflammatory bowel disease in the world and a very significant industry and healthcare professional event," said Jenny Sundqvist, CEO of InDex Pharmaceuticals. "ECCO provides a great opportunity for the team to further interact with healthcare professionals, potential partners and relevant stakeholders to progress our lead drug candidate cobitolimod and the phase III program CONCLUDE."

For more information:
Jenny Sundqvist, CEO
Phone: +46 8 122 038 50
E-mail: [email protected]

Johan Giléus, deputy CEO and CFO
Phone: +46 8 122 038 50
E-mail: [email protected]

About the CONCLUDE program
The phase III program CONCLUDE is evaluating cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis with an inadequate response or failure to tolerate conventional therapy, biological therapy or JAK inhibitors. The program consists of two sequential induction studies and a one-year maintenance study with patients who have responded to cobitolimod as induction therapy.

Induction Study 1 of the phase III program CONCLUDE is a global randomised, double-blind, placebo-controlled, clinical phase III study designed in consultation with both the US and European regulatory authorities, the FDA and EMA respectively. The study will include approximately 440 patients, and the primary endpoint will be clinical remission at week 6, which is the same primary endpoint as used in the successful phase IIb study CONDUCT. Apart from the dosing 250 mg given at baseline and week 3, which was the highest dose and the one that showed the best efficacy in the phase IIb study, the phase III study also evaluates a higher dose, 500 mg, in an adaptive study design. Patients responding to cobitolimod in the induction study will be eligible to continue in a one-year maintenance study, where they will be treated with either cobitolimod or placebo once every three weeks. Upon a positive read-out of Induction Study 1, InDex plans to initiate Induction Study 2.

Publication
The information was submitted for publication through the agency of the contact person set out above at 12:10 CET on February 27, 2023.

This is an English translation of the Swedish press release. In case of discrepancies between the English translation and the Swedish press release, the Swedish press release shall prevail.

On February 27, 2023 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, and Break Through Cancer, a public foundation dedicated to empowering outstanding researchers and clinicians to both intercept and find cures for some of the most difficult-to-treat cancers, reported the commencement of patient enrollment in a collaboration to evaluate IMUNON’s IMNN-001 (formerly GEN-1) in combination with bevacizumab in patients with advanced ovarian cancer (Press release, IMUNON, FEB 27, 2023, View Source [SID1234627730]). The trial is now active at the University of Texas MD Anderson Cancer Center. IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in Phase 2 clinical development for the localized treatment of advanced ovarian cancer (the OVATION 2 Study).

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This new Phase 1/2 study, titled "A Phase I/II Study Evaluating the Effect of IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Minimal Residual Disease (MRD) as determined by Second Look Laparoscopy when Administered in Combination with Bevacizumab and Neoadjuvant Chemotherapy in Subjects Newly Diagnosed with Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer" is expected to enroll 50 patients with Stage III/IV advanced ovarian cancer and is being led by principal investigator Amir Jazaeri, M.D., Professor of Gynecologic Oncology and Reproductive Medicine at MD Anderson.

Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy vs. chemotherapy plus IMNN-001. The primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL) and the secondary endpoint is progression-free survival (PFS). Initial SLL data are expected within one year from the completion of enrollment and final PFS data are expected approximately three years from the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.

Tyler Jacks, Ph.D., President of Break Through Cancer, Founding Director of MIT’s Koch Institute for Integrative Cancer Research, and the David H. Koch Professor of Biology said, "Break Through Cancer is excited to support this important study. Our foundation has brought together some of the nation’s top cancer research centers to collaborate, accelerate research and clinical trials, and ultimately intercept and find cures for the deadliest cancers."

Commenting on the study, Dr. Corinne Le Goff, President and Chief Executive Officer of IMUNON, said, "The medical need for new innovative therapeutic approaches in ovarian cancer is major. The majority of patients with ovarian cancer are diagnosed with Stage III/IV disease and face low cure rates of 15% or less. The amount of data this study will generate will be a huge contribution to the treatment of ovarian cancer and we believe the combination of IMNN-001 and bevacizumab has important potential. In our animal studies, the combination clearly showed strong synergies. We are hoping that with this study we can potentially transform the current treatment landscape and provide new hope to women suffering from this deadly cancer."

"We have been very thoughtful about funding our clinical programs and are delighted that Break Through Cancer will cover approximately two-thirds of the costs of this clinical trial. IMUNON is committing to providing approximately $2.0 million to $2.5 million in IMNN-001 product costs, data and safety monitoring and project management services," Dr. Le Goff concluded.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer (EOC) is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced Stages III and IV. EOC is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, Stages III and IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stages III and 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.

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. The Company 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. It announced full enrollment in the OVATION 2 Study in September 2022 and expects to report topline data in the second half of 2023.

About Break Through Cancer

Launched in February 2021, Break Through Cancer is a public foundation designed to find new solutions to the most intractable challenges in cancer. The foundation was launched with an extraordinary challenge pledge of $250 million from Mr. and Mrs. William H. Goodwin, Jr. and their family, and the estate of William Hunter Goodwin III. This represents one of the largest gifts ever in support of cancer research. Led by Dr. Tyler Jacks, the David H. Koch Professor of Biology and Director of the Koch Institute for Integrative Cancer Research at MIT, Break Through Cancer funds and supports collaborative research teams drawn from several of the country’s top cancer centers.

Multidisciplinary research teams are selected from across five participating institutions: Dana-Farber Cancer Institute, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, MD Anderson, Memorial Sloan Kettering Cancer Center, and MIT’s Koch Institute for Integrative Cancer Research.

Break Through Cancer is focused on historically highly challenging cancer types, including pancreatic cancer, ovarian cancer, glioblastoma and acute myelogenous leukemia for its initial programs, aided by the guidance of a scientific advisory board of cancer experts from outside the participating institutions. Teams will receive substantial funding to bring new approaches and new thinking as rapidly as possible to the clinical challenges of cancer.

Disclosures

The University of Texas MD Anderson Cancer Center’s relationship with Break Through Cancer, and all research conducted at MD Anderson related to Break Through Cancer, has been identified as an institutional financial conflict of interest by MD Anderson’s Institutional Conflict of Interest Committee and therefore is managed under an Institutional Conflict of Interest Management and Monitoring Plan.