On August 29, 2023 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported a positive Type C meeting with the U.S. Food and Drug Administration ("FDA"). Eagle and the FDA agreed on a path forward to advance the clinical development of EA-114, an estrogen receptor antagonist used in the treatment of breast cancer in post-menopausal women (Press release, Eagle Pharmaceuticals, AUG 29, 2023, View Source [SID1234634742]). EA-114 has the potential to provide healthcare providers with a formulation that meaningfully optimizes the dosing regimen for all fulvestrant patients. Eagle currently anticipates filing a new drug application ("NDA") for EA-114 in 2024. If approved for all uses, EA-114 would allow physicians to provide a personalized treatment regimen to all patients, including specific sub-populations.

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Over the course of five years and multiple studies, Eagle has dosed more than 800 people with the brand formulation of fulvestrant and multiple Eagle internally developed formulations. The Company’s rigorous analysis of the data from these studies yielded significant insights which led Eagle to develop a novel formulation, EA-114, which if approved would optimize the dosing regimen of fulvestrant to allow for a more personalized treatment approach. EA-114 has the potential to improve treatment for all fulvestrant patients, including multiple subpopulations. These subpopulations collectively represent approximately half of the total patient population. EA-114 may additionally result in improved patient outcomes.

Eagle is committed to conducting the necessary clinical program to support approval of this novel formulation of fulvestrant. It is anticipated that EA-114 would be approved as a monotherapy and for use in combination with CDK4/6 inhibitors as described in the approved labeling for Faslodex. According to IQVIA, products anticipated to be co-administered with EA-114 have had sales of $7 billion in the 12 months ending June 30th, 2023, and grew by 27% over the prior 12-month period.1

Eagle anticipates filing the NDA in 2024 while pursuing a label expansion for the subpopulations in parallel.

"We are very pleased that the Eagle team’s perseverance, motivated by our desire to help breast cancer patients, has resulted in this novel formulation. We anticipate EA-114 being a very important part of a more personalized treatment regimen for post-menopausal metastatic breast cancer patients," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "Eagle is very proud that this development program has been created in-house by the company’s formulation, clinical, and regulatory teams. We believe EA-114 has the potential to become an ever-increasing part of the personalized medicine paradigm in cancer care," concluded Tarriff.

Eagle continues to advance personalized medicine in the oncology sector by working to bring critically needed novel and complementary therapies to market. If approved, this will be Eagle’s seventh internally developed NDA, highlighting the depth of Eagle’s pipeline and its research and development capabilities in the area of medical oncology.

Eagle has filed a patent application pertaining to EA-114 and anticipates pursuing a robust patent portfolio over time. The Company believes EA-114 is eligible for a unique J-code from CMS under the current regulatory framework. In addition, Eagle believes EA-114, if the label expansion for subpopulations is approved, may be eligible for a period of regulatory exclusivity of three years and a separate period of potential patent protection, including potential patents eligible for listing in the Orange Book.

Currently, fulvestrant is indicated as monotherapy first-line endocrine treatment in post-menopausal women with hormone receptor-positive metastatic breast cancer (MBC) and in combination therapy to treat hormone receptor positive, advanced breast cancer in women whose breast cancer has spread or worsened after being treated with anti-estrogen medications.

Eagle intends to provide additional updates on the progress of the EA-114 development program for the sub-populations as discussions with the FDA progress.

On August 29, 2023 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics to treat rare fibro-inflammatory diseases with high unmet need, reported that Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab, will present virtually at the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-15, 2023 (Press release, Chemomab, AUG 29, 2023, View Source [SID1234634741]).

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Investors may view the Chemomab presentation online beginning on September 11, 2023, at 7:00 AM ET via the following link: View Source

This link will remain active for 90 days. It will also be available at the investor section of the Chemomab website at View Source

Chemomab senior management will be available for virtual one-on-one meetings with investors during the conference from September 11 through September 14, 2023. For information about the conference and to register to meet with Chemomab management, visit View Source

On August 29, 2023 Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing allogeneic cell therapies and biomaterial products, reported a multi-year Research Collaboration Services Agreement with Regeneron Pharmaceuticals, Inc. (Regeneron) to support the research of Regeneron’s allogeneic cell therapy candidates (Press release, Celularity, AUG 29, 2023, View Source [SID1234634740]).

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The agreement’s initial focus is the research on a targeted allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy owned by Regeneron designed to enhance proliferation and potency against solid tumors. The research will take place at Celularity’s state-of-the-art facility located in Florham Park, N.J. Financial terms were not disclosed.

"The agreement with Regeneron announced today is an important milestone for Celularity that recognizes our expertise in the research of cellular therapies, including the engineering of CAR-T cells. We believe that this relationship paves the way for future industry collaborations leveraging our world class cell therapy facilities and capabilities," said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. "We have long admired the exceptional scientific legacy at Regeneron and welcome the opportunity to collaborate with a world leader in innovative medicines."

On August 29, 2023 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, reported that the company is scheduled to present at the Morgan Stanley 21st Annual Global Healthcare Conference on Tuesday, September 12, 2023, at 7:30 a.m. EST (Press release, Agios Pharmaceuticals, AUG 29, 2023, View Source [SID1234634739]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

On August 29, 2023 y Pharmaxis Ltd (ASX: PXS) reported publication in the prestigious journal Nature Cancer of preclinical results showing pan‐Lysyl Oxidase (pan‐LOX) inhibitor PXS‐5505 increases survival by 35% compared to chemotherapy treatment alone in the treatment of pancreatic ductal adenocarcinomas (Press release, Pharmaxis, AUG 29, 2023, View Source;utm_campaign=PXS%20Cancer%20Drug%20Shows%20Increased%20Survival%20in%20Preclinical%20Models%20of%20Aggressive%20Pancreatic%20Cancer&utm_content=PXS%20Cancer%20Drug%20Shows%20Increased%20Survival%20in%20Preclinical%20Models%20of%20Aggressive%20Pancreatic%20Cancer+CID_c1c2ee092add41ee681fc9a7144e424a&utm_source=Campaign%20Monitor&utm_term=View%20Full%20Media%20Release [SID1234634721]).

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Research in mouse models, led by a team at the Garvan Institute of Medical Research in Sydney, Australia, also showed PXS‐5505 combined with chemotherapy reduced the spread of the cancer to other organs such as the liver by 45%. Pancreatic ductal adenocarcinoma is one of the most aggressive forms of pancreatic cancer with a five‐year survival rate of less than 10%.

Associate Professor Thomas Cox, head of the Matrix & Metastasis Lab at Garvan and senior author of the study, said, "The preclinical validation of this first‐in‐class anti‐fibrotic drug marks a major milestone in the quest to overcome the significant challenges in treating pancreatic cancer and brings hope to patients and their families."

Pharmaxis Chief Executive Gary Phillips said, "We have already seen very promising early results in a phase 2 trial with patients that have the bone marrow cancer myelofibrosis. This ground‐breaking research stems from a long collaboration with the team of high calibre researchers at the Garvan Institute and provides exciting new evidence that PXS‐5505 may also have a role as a therapy to improve the effect of current chemotherapy drugs in solid tumours like pancreatic cancer and extending the life of patients."

PXS‐5505 is an anti‐fibrotic pan‐Lysyl Oxidase (pan‐LOX) inhibitor that has completed long‐term toxicity studies and Phase 1a and 1b clinical trials demonstrating a well‐tolerated drug that effectively inhibits all enzymes in the lysyl oxidase family that are involved in fibrosis. Pancreatic cancer is often diagnosed at an advanced stage, which means that chemotherapy is usually the only treatment option available. Many pancreatic cancers develop chemotherapy resistance soon after treatment starts, which contributes to the poor survival of patients. Part of this resistance is driven by tumour fibrosis forming a mesh of scar tissue within and around pancreatic tumours that in turn reduces the effectiveness of chemotherapy drugs.

"PXS‐5505 returns the tumour microenvironment to a more "normal" state by reducing fibrosis and decreasing tumour stiffness," said Dr Jessica Chitty, Senior Research Officer at Garvan and first author of the study. "This allows chemotherapy drugs to penetrate the tumours more easily, work more effectively, and destroy more cancer cells.

The Nature Cancer publication can be seen here: View Source;023‐ 00614‐y. It adds to the body of pre‐clinical evidence published from other Pharmaxis collaborations with leading scientific institutions in the last year on the role of LOX enzymes in disease including:

 Inhibition of lysyl oxidases synergizes with 5‐azacytidine to restore erythropoiesis in myelodysplastic and myeloid malignancies; Nature Communications 2023 View Source;023‐37175‐8

 Topical application of an irreversible small molecule inhibitor of lysyl oxidases ameliorates skin scarring and fibrosis, Nature Communications 2022 View Source;022‐33148‐5

 Pan‐Lysyl Oxidase Inhibitor PXS‐5505 Ameliorates Multiple‐Organ Fibrosis by Inhibiting Collagen Crosslinks in Rodent Models of Systemic Sclerosis, International Journal of Molecular Sciences 2022 View Source