On January 24, 2022 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development reported that the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease Designation and Orphan Drug Designation for the company’s drug candidate LP-184 for the treatment of pediatric patients with ATRT (Press release, Lantern Pharma, JAN 24, 2022, View Source [SID1234606724]). LP-184 is being pursued as a potential new therapy across a range of genetically defined solid tumors, including pancreatic cancer, GBM (Glioblastoma Multiforme) and ATRT (Atypical Teratoid Rhabdoid Tumor).

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"Historical approaches to treating pediatric ATRT such as surgery, radiation, and chemotherapy have had largely unfavorable long term outcomes for children, and new options are urgently needed," said Kishor Bhatia, Ph.D., chief scientific officer of Lantern Pharma. "The gene SMARCB1 was included among several genes whose expression negatively correlated with LP-184 sensitivity in tumors. This in silico correlation was convincingly confirmed by in vitro and in vivo assessments of LP-184 in ATRT. The highest potency of LP-184 in-vivo has been seen in ATRT xenografts." Dr. Bhatia continued, "Based on both the in-silico and in-vivo observations, LP-184 has the potential to become a critical part of the armamentarium of approved treatment options specifically for these patients. Receiving Rare Pediatric Disease Designation from the FDA underscores the critical value of our growing focus on pediatric oncology indications at Lantern and represents another significant milestone for the LP-184 program."

The National Cancer Institute (NCI) classifies ATRT as Grade IV tumors, meaning they are malignant (cancerous), aggressive and fast-growing. ATRTs are very aggressive childhood malignancies of the central nervous system. The underlying genetic cause are inactivating bi-allelic mutations in SMARCB1 (also called INI1) or in SMARCA4. Nearly 90 percent of pediatric ATRTs are caused by changes in the gene known as SMARCB1.

The FDA grants rare pediatric disease designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the United States. The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. Under this program, companies are eligible to receive a priority review voucher following approval of a product with rare pediatric disease designation if the marketing application submitted for the product satisfies certain conditions, including approval prior to September 30, 2026 unless changed by legislation. If issued, a sponsor may redeem a priority review voucher for priority review of a subsequent marketing application for a different product candidate, or the priority review voucher could be sold or transferred to another sponsor.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to investigational treatments that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States. The program was developed to encourage the development of medicines for rare diseases, and benefits include tax credits and application fee waivers designed to offset some development costs, as well as eligibility for market exclusivity for seven years post approval.

LP-184 is being developed for multiple targeted oncology indications. Lantern Pharma intends to further advance LP-184 as a new, potent treatment option in genetically defined subsets of patient populations in areas of high unmet clinical need, including pancreatic cancers, GBM, and other cancers that are DNA damage repair deficient. The U.S. Food and Drug Administration (FDA) has previously granted LP-184 Orphan Drug Designation for the treatment of pancreatic cancer, and for the treatment of malignant glioma, including GBM.

On January 24, 2022 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported the publication of preclinical data evaluating the company’s lead asset NT-I7 (efineptakin alfa), a novel T cell amplifier, in mouse models of glioblastoma (GBM) (Press release, NeoImmuneTech, JAN 24, 2022, View Source [SID1234606742]). The data come from a publication titled "Long-acting recombinant human interleukin-7, NT-I7, increases cytotoxic CD8 T cells and enhances survival in mouse glioma models," in the Clinical Cancer Research journal. The paper was published in collaboration with lead author Dr. Jian Li Campian, M.D., Ph.D., of the Mayo Clinic and Principal Investigator of this study, along with additional authors from NeoImmuneTech. These data show that NT-I7, in combination with radiation therapy, significantly prolonged survival in two glioma models dependent on the NT-I7-driven increase of CD8 T cells.

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This study utilized a murine model of glioblastoma, in which one dose of NT-I7 significantly boosted lymphocyte levels in the blood, lymphoid organs and tumor and enhanced the anti-tumor response in animal. When NT-I7 was combined with radiation therapy, this translated to a significant improvement in mouse survival; the addition of temozolomide (TMZ) offered no additional survival improvement.

"The standard of care for glioblastoma patients is radiation and TMZ, a treatment regimen which causes severe prolonged lymphopenia that is associated with lower patient survival," said Dr. Campian. "NT-I7 demonstrated the ability to correct this treatment-related lymphopenia in our study, and this potential is extremely promising in the pursuit to improve outcomes for patients with glioblastoma."

In addition, data showed that NT-I7 promoted an inflamed tumor microenvironment by significantly increasing the CD8 to Treg ratio, and enhanced the anti-tumor response by increasing the infiltration of IFNγ-expressing T cells in the tumor. While chemoradiation caused a notable decrease in the number of CD4 and CD8 T cells in the lymph nodes, the addition of NT-I7 not only restored these numbers but in some cases surpassed the levels seen in untreated controls.

NT-I7 is currently under evaluation for the treatment of glioblastoma in an ongoing Phase 1/2 trial (NCT03687957).

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On January 24, 2022 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, reported that the Supervisory Board retained Greg Hamilton as Chief Executive Officer through December 31, 2025 (Press release, Epigenomics, JAN 24, 2022, View Source [SID1234606706]). Mr. Hamilton has been CEO of Epigenomics AG since mid-2016 and will continue to lead the company through the development, FDA approval and commercialization of the company’s Epi proColon "Next-Gen" Colorectal Cancer (CRC) screening test.

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Mr. Hamilton, (51), has been instrumental in working with Centers for Medicare and Medicaid Services (CMS) to establish clear reimbursement requirements for future blood-based CRC tests. Based upon the efforts of Epigenomics, CMS has issued a National Coverage Determination (NCD) for blood-based CRC screening that gives Epigenomics a clear path to develop a commercially successful next generation product. Prior to joining Epigenomics, Mr. Hamilton was Chief Executive Officer & Director of AltheaDx Inc., Chief Operating Officer and Chief Financial Officer of Enigma Diagnostics Inc., Vice President of Operations and Finance at Third Wave Technologies Inc. and Vice President of Operations at Hologic Inc. He has been responsible for multiple FDA-approved products including a Human Papillomavirus (HPV) High Risk Screening assay and the first ever cleared HPV genotyping assay. Mr. Hamilton received his MBA from the University of Chicago and his Bachelor of Science in Finance from Purdue University.

"Securing Greg’s leadership through the development, clinical trial, FDA approval and commercialization of Epi proColon’s "Next-Gen" CRC test, which has already advanced substantially since mid of last year, was a priority for the Supervisory Board," said Heino von Prondzynski, Chairman of the Supervisory Board. "His experience and strategic vision make him ideally suited to grow the company into a cancer diagnostics leader."

"I’m thrilled and honored to continue to lead Epigenomics toward our goal of becoming a leader in blood-based CRC screening," said Mr. Hamilton. "Epigenomics has always been a pioneer in liquid biopsy and now we get the chance to use all of our experience to deliver a product that will immediately receive reimbursement upon FDA approval."

On January 24, 2022 HCW Biologics Inc. (the "Company") (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, reported that the Masonic Cancer Center, University of Minnesota was cleared by the U.S. Food and Drug Administration (FDA) to proceed to evaluate the Company’s lead drug candidate, HCW9218, in a Phase 1 clinical trial in patients with advanced solid tumors with progressive disease after prior chemotherapies (Press release, HCW Biologics, JAN 24, 2022, View Source [SID1234606725]). HCW9218 is an injectable, bifunctional fusion protein complex designed to drive anti-tumor activity by activating desired immune responses to attack cancer cells while simultaneously blocking unwanted immunosuppressive activities.

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The Principal Investigator of the clinical trial is Melissa A. Geller, M.D., M.S., Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota. Dr. Geller stated, "Because the immunosuppressive tumor microenvironment limits the success of current therapies, there is a critical need for novel immune based therapies for advanced solid tumors. The estimated percentages of patients who are eligible for and who respond to cancer treatments such as checkpoint inhibitor drugs remain modest. We are excited to be able to sponsor a clinical study for treatment-resistant solid tumors using HCW9218. This immunotherapeutic might be the answer we need to augment anti-tumor activities of existing standards of care chemotherapies."

"HCW9218 is a unique combination of a TGF-ß receptor that neutralizes a highly immunosuppressive cytokine secreted by tumors, and IL-15, a potent cytokine that stimulates the natural killer and CD8+-T cell cytotoxicity. As a result, this bifunctional immunotherapeutic has the potential to drive significant anti-tumor activity," noted Jeffrey A. Miller, M.D., the Deputy Director of the Masonic Cancer Center, and co-Principal Investigator on this study. Dr. Miller continued, "HCW9218 also may define a new category of cancer treatment through modifying factors related to drug resistance and disease recurrence. We plan to conduct correlative studies to evaluate this potential in our current clinical trial."

Hing C. Wong, Ph.D., Founder and CEO of HCW Biologics, stated, "HCW Biologics is honored to have the Masonic Cancer Center as the sponsor for the second clinical trial to evaluate HCW9218 in difficult-to-treat cancers. This is an important milestone for HCW Biologics and our efforts to advance the development of potentially groundbreaking immunotherapeutic candidates for cancer and other age-related diseases. We have demonstrated that HCW9218 can augment the anti-tumor activities and lessen the side effects of chemotherapies by reducing the therapy-induced senescent cells in preclinical animal models."

On January 24, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that its Board of Directors has authorized the Company’s management to implement a stock repurchase program for up to $10 million of the Company’s common stock at any time (Press release, Greenwich LifeSciences, JAN 24, 2022, View Source [SID1234606707]).

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The term of the board authorization of the repurchase program is until March 31, 2023. The repurchase program may be suspended or discontinued at any time and will be funded using the company’s working capital.

CEO Snehal Patel commented, "The implementation of this board-approved share repurchase program provides us with another tool to deliver shareholder value. We have the ability to make opportunistic share repurchases while continuing our clinical development plans for GP2."

In addition, the Board of Directors has also extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to March 24, 2023 (30 months from date of the Company’s IPO) from March 24, 2022 (18 months from date of the Company’s IPO). During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company’s common stock unless otherwise modified by the Board of Directors.

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.