Celularity Announces Multi-Year Research Collaboration Services Agreement With Regeneron

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."

Agios to Present at the Morgan Stanley Global Healthcare Conference on September 12, 2023

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.

PHARMAXIS CANCER DRUG SHOWS INCREASED SURVIVAL IN PRECLINICAL MODELS OF AGGRESSIVE PANCREATIC CANCER

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

Entry into a Material Definitive Agreement

On August 28, 2023, Biogen Inc. (the "Company") reported to have entered into a Credit Agreement with JPMorgan Chase Bank, N.A. ("JPMorgan"), as Administrative Agent, and the lenders party thereto (the "Credit Agreement") (Filing, 8-K, Biogen, AUG 28, 2023, View Source [SID1234634831]). The Credit Agreement provides for a $1.5 billion unsecured term loan facility, comprised of a $750 million 364-day tranche ("Tranche A") and a $750 million three-year tranche ("Tranche B" and collectively, the "Term Facility").

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Borrowings under the Term Facility will be available to the Company to (a) pay a portion of the consideration for the previously announced acquisition by the Company of Reata Pharmaceuticals, Inc. ("Reata") pursuant to an Agreement and Plan of Merger among the Company, River Acquisition, Inc. ("Merger Sub") and Reata (the "Merger Agreement") pursuant to which, and upon the terms and subject to the conditions set forth therein, Merger Sub will be merged with and into Reata (the "Merger"), with Reata surviving the Merger as a wholly-owned subsidiary of the Company, (b) repay indebtedness and other amounts outstanding under certain of Reata’s existing funding agreements and (c) pay fees and expenses in connection with the transactions described in the foregoing paragraphs (a) and (b).

Loans under the Credit Agreement will be denominated in dollars and will bear interest at a rate per annum equal to (i) Term SOFR, subject to a floor of 0.00% per annum, plus an applicable margin ranging from 1.250% to 1.625% based on the ratings of the Company’s non-credit enhanced, senior unsecured long-term debt, as determined by Standard & Poor’s and Moody’s (the "Debt Ratings") or (ii) at the Company’s option, a Base Rate equal to the highest of (a) the greater of the Federal Funds Rate or a composite overnight rate determined by the Federal Reserve Bank of New York (the "NYFRB") and published on the NYFRB’s website plus, in each case, 0.50%, (b) the Prime Rate and (c) Term SOFR for a one month interest period plus 1%, subject to a floor, in each case, of 0.00% per annum (the "Base Rate"), plus an applicable margin ranging from 0.250% to 0.625% based on the Company’s Debt Ratings.

In addition to paying interest on any outstanding principal under the Term Facility, the Company will pay a commitment fee in respect of the unutilized commitments thereunder ranging from 0.100% to 0.175% per annum based on the Company’s Debt Ratings.

Loans under the Credit Agreement shall be drawn in a single drawing on the closing date of the Merger (the "Funding Date"), following which any undrawn commitments under the Term Facility shall automatically terminate. The funding of the Term Facility is contingent on the satisfaction of customary conditions, including the consummation of the Merger in accordance with the terms set forth in the Merger Agreement. The Term Facility will terminate and all amounts outstanding thereunder shall become due and payable (i) in the case of Tranche A, 364 days after the Funding Date and (ii) in the case of Tranche B, 3 years after the Funding Date. Under the Term Facility, voluntary prepayments are permitted, in whole or in part, in minimum amounts without premium or penalty, other than customary breakage costs.

The Credit Agreement contains customary representations and warranties, affirmative and negative covenants and events of default that are, in each case, substantially similar to the equivalent terms of that certain Credit Agreement, dated as of January 28, 2020 (as amended, restated, amended and restated, supplemented and/or otherwise modified prior to the date hereof) among the Company, the lenders party thereto and Bank of America, N.A., as administrative agent.

The Credit Agreement also includes a financial covenant requiring the Company to maintain, as of the end of each fiscal quarter, a maximum consolidated leverage ratio of 3.5 to 1.0 (which shall be temporarily increased (a) to 4.0 to 1.0 upon the consummation of the Merger and (b) upon notice by the Company to JPMorgan as a result of other material acquisitions from time to time, subject to customary limitations, and provided that the maximum permitted consolidated leverage ratio shall not exceed 4.0 to 1.0).

Following the Company’s entry into the Credit Agreement, JPMorgan’s commitment to provide a 364-day senior unsecured bridge loan facility in an aggregate principal amount of up to $1.5 billion (as more particularly described in the Company’s Current Report on Form 8-K dated July 31, 2023) has been terminated and canceled.

A copy of the Credit Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference. The foregoing description of the Credit Agreement is a summary only and is qualified in its entirety by the terms of the Credit Agreement.

Palleon Pharmaceuticals Recognized as a Fierce Biotech “Fierce 15” Company for 2023

On August 28, 2023 Palleon Pharmaceuticals, a clinical-stage company pioneering glyco-immunology drug development to treat cancer and inflammatory diseases, reported that Fierce Biotech has recognized the company as one of its "Fierce 15" for 2023 (Press release, Palleon Pharmaceuticals, AUG 28, 2023, View Source [SID1234634733]). This annual report features the most innovative and promising biotechnology companies in the industry.

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"It is an honor to be named to the Fierce 15 and to be recognized for our work pioneering the transformational field of glyco-immunology," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "As we continue to advance our therapies in the clinic, this recognition provides validation of the strength of our team, our technologies, and our strategy to bring much-needed new therapeutic options to patients across multiple disease areas."

Palleon was co-founded by Dr. Carolyn Bertozzi, recipient of the 2022 Nobel Prize in Chemistry for the invention of bioorthogonal chemistry, a technology which enabled the company’s foundational science. In April 2023, Palleon announced Phase 1 results from the GLIMMER-01 trial to evaluate its lead candidate in oncology, E-602 as a monotherapy, demonstrating proof of mechanism, including dose dependent desialylation and dose dependent immune system activation. Additionally, E-602 was found to be well tolerated across the entire dose range evaluated with no dose limiting toxicities.

For the past 21 years, the Fierce Life Sciences team has assessed hundreds of companies for inclusion in the ‘Fierce 15’ special report. To curate this list, Fierce considers a diverse range of factors, including the robustness of technology, partnerships, venture support, and competitive positioning within the market. This special report celebrates innovation and creativity in the face of intense competition.