PharmaMar receives the first commercial milestone payment from Jazz Pharmaceuticals for US$25 million

On March 4, 2022 PharmaMar (MSE:PHM) reported the receipt of payment of $25 million (€22 million) from its U.S. partner, Jazz Pharmaceuticals, after reaching the first commercial milestone, set out in its license agreement in relation to 2021 sales (Press release, PharmaMar, MAR 4, 2022, https://pharmamar.com/en/pharmamar-receives-the-first-commercial-milestone-payment-from-jazz-pharmaceuticals-for-us25-million/ [SID1234609510]).

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After a successful launch of Zepzelca (lurbinectedin) in the United States by Jazz Pharmaceuticals, lurbinectedin is established as the treatment of choice in second-line SCLC. The sales achieved in 2021 have resulted in the first commercial milestone payment.

Lurbinectedin received accelerated approval for the second-line treatment of SCLC in June 2020 in the United States.

Following the recent $25 million payment, PharmaMar is eligible for additional regulatory milestone payments of up to $153 million and additional commercial milestone payments of up to $528 million related to achieving certain milestones in the U.S. and Canada.

CHM Partners with Be The Match Biotherapies to Advance CHM1101 (CLTX CAR T)

On March 4, 2022 Chimeric Therapeutics (ASX:CHM, "Chimeric"), a clinical-stage cell therapy company and an Australian leader in cell therapy, is pleased to announce that it has entered a strategic partnership with Be The Match BioTherapies, an organization offering supply chain solutions for companies developing and commercializing cell and gene therapies (Press release, Chimeric Therapeutics, MAR 4, 2022, View Source [SID1234609509]).

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Be The Match BioTherapies provides end-to-end services that ensure expedited collection, transport and delivery of cellular starting material and clinical drug product, which will support Chimeric’s expanded clinical development of CHM 1101 (CLTX CAR T).

CHM 1101 (CLTX CAR T) is currently being evaluated in a single-site phase 1 clinical trial to treat patients with recurrent or progressive glioblastoma. This new partnership with Be The Match BioTherapies will enable the accelerated expansion of the program to additional clinical trial sites.

To support the advancement of CHM 1101 (CLTX CAR T), Be The Match BioTherapies will draw on more than 30 years of experience in collection network, supply chain and logistics management developed by the National Marrow Donor Program (NMDP) /Be The Match. Be The Match BioTherapies plans to leverage its established relationships and resources, including its Quality System Audit Program (QSAP), to swiftly grow Chimeric’s network of apheresis centers and ensure the entire network is appropriately qualified, onboarded, trained and supervised in order to meet accelerated timelines for the trial.

"Be The Match BioTherapies is an ideal partner for us, extending the reach and resources of our experienced cell therapy team," said Jennifer Chow, CEO of Chimeric Therapeutics. "With its focused mission and the NMDP/Be The Match’s 30 plus years of experience in managing the complexity and risks of cell therapy logistics, we believe that the team at Be The Match BioTherapies is uniquely positioned to support the expansion of the CHM 1101 (CLTX CAR T) development program."

"We are proud to partner with Chimeric and support its aggressive timeline by providing optimized solutions that focus on process improvement and standardization implementation to accelerate product development and delivery", said Chris McClain, Senior Vice President, Sales and Business Development, Be The Match BioTherapies. "We have a shared commitment to advance next-generation cell therapies for waiting patients, and we intend to help them achieve their targets."

ABOUT THE AGREEMENT
Whilst the cost to Chimeric of the agreement is not considered financially material in the context of Chimeric’s annual budgeted expenditure, the nature of the agreement is considered market sensitive. The cost of the agreement is expected to be funded from existing cash reserves. There are no conditions precedent, and the agreement is effective immediately for an initial term of three years. The agreement is subject to usual industry termination provisions.

ABOUT CHLOROTOXIN CAR T
Chlorotoxin CAR T (CLTX CAR T) cell therapy is a first and best in class CAR T cell therapy that has the potential to address the high unmet medical need of patients with recurrent/ progressive glioblastoma. Research to develop the intellectual property covering this CAR T cell therapy took place at City of Hope.

CLTX CAR T cell therapy uniquely utilizes chlorotoxin (CLTX), a peptide derived from scorpion toxin, as the tumour-targeting component of the chimeric antigen receptor (CAR). CLTX and CLTX CAR T cells have been shown in preclinical models to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13.

In preclinical models, CLTX CAR T cells also demonstrated potent antitumour activity against glioblastoma while not exhibiting any off-tumour recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile.

Pepper Bio Partners with Stanford’s Felsher Lab to Identify Therapy Targets for Untreatable, MYC Addicted Lymphatic and Liver Cancers

On March 3, 2022 Pepper Bio, the world’s first transomics drug discovery company, reported a collaboration with the Dean Felsher Laboratory at Stanford University (Press release, Pepper Bio, MAR 3, 2022, View Source [SID1234638702]). Leveraging Pepper Bio’s unique platform on phosphoproteomics, the two teams aim to identify and validate novel targets for hepatocellular carcinoma and lymphoma within the year.

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Hepatocellular carcinoma, the most prevalent type of liver cancer, is diagnosed in over 35 thousand people, and lymphoma is diagnosed in over 80 thousand people each year. To treat these cancers and others, researchers need to target the broken genes that either rapidly spur or fail to suppress tumor growth. The Felsher Lab has identified one of these processes, known as oncogene addiction, in which specific tumor cells depend on a single activated oncogenic protein or pathway to maintain malignancy. When the activated pathway the cancer relies on is defeated, so is the cancer. Defeating the activated pathway is a nontrivial scientific task.

In studying oncogene addiction, Felsher’s Lab found protein phosphorylation is a critical mechanism of oncogenesis and, thus, crucial to understand for treating these highly aggressive cancers. Pepper Bio is the first and only techbio company to provide academic researchers and pharmaceutical partners with technology to identify functional, actionable insights on protein phosphorylation, known as phosphoproteomics.

"Pepper Bio’s platform is able to integrate and translate large amounts of different kinds of measurements across the omic layers into actionable insights, and provides an immense advantage in identifying disease pathways that are implicated in the proliferation of cancer," said head of the Felsher Lab and Stanford Medicine’s Associate Chief of Medical Oncology, Translational Research & Applied Medicine, Dean Felsher, MD, PhD. "As such, Pepper’s technology is highly valuable to my lab’s current research focus of surfacing insight around which phospho-proteins are linked to specific oncogenes."

By fully stacking and integrating these four layers of biological data — genomics, transcriptomics, and proteomics, and phosphoproteomics — researchers have a complete, real-time map of what happens in cells before and during disease. Pepper Bio will collaborate with the Felsher Lab and contribute to oncogene addiction and target validation research. Co-founder and Chief Science Officer Samantha Dale Strasser, PhD., will lead efforts on the startup’s side.

"As our technology teases out changes in pathway activity, notably phosphoproteomics, we can directly support the goal of finding the linchpins necessary to defeat pathways of oncogene addiction. There is a natural fit between the work the Felsher lab is doing and the transomics capabilities we have unlocked," said Dr. Strasser. "Dean is an excellent mentor, resource, and partner as we bring our technology to an application where it can advance research outcomes and improve the lives of patients and their loved ones."

Just three months after Pepper Bio launched from stealth with backing from VC firm, NFX Bio, this announcement underscores the readiness and viability of its platform for drug discovery and target validation.

To learn more about Pepper Bio, please visit: Pepper.bio

Annual Report 2021

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Puma Biotechnology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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