Champions Oncology Announces an Expanded Corporate Strategy to Include Drug Discovery and Development

On July 26, 2021 Champions Oncology, Inc. (NASDAQ:CSBR), a leading global oncology technology solutions provider that is transforming drug discovery through innovative pharmacology, biomarker, and data platforms, reported an expansion of its corporate strategy as they unveil their entry into the drug discovery and development space (Press release, Champions Oncology, JUL 26, 2021, View Source [SID1234585175]). Champions is organized as a dynamic ecosystem of business units centered around a world leading oncology research center that is based off a unique & proprietary set of data and experimental platforms. The corporate composition of the company includes three business units (1) the foundational Research Services Business, (2) the recently launched Research Software Business with its flagship product, Lumin Bioinformatics, and (3) the newly announced Discovery and Innovation Business.

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The rollout of the discovery and innovation business is the natural evolution for Champions as it continues to unlock the value contained within the rare dataset that has been amassed over the past twelve years. The tumor bank, and the dataset that has been derived, are unique for several reasons. First, unlike most other tumor models used in research, Champions’ PDX models are highly representative of tumors present within a clinical setting. Thus, the datasets established using Champions’ models provide more accurate and relevant insights. Second, the approach of using a ‘living tumor bank’ of PDX models provides for a perpetual source of tumor, enabling a continuous and deep level of characterization. Specifically, Champions’ scientists can establish multiple drug response datasets from the same tumor or re-interrogate these tumors with newly approved drugs or drug combinations. This also allows for a full characterization of the molecular nature of these tumors using multiple analytical methods. As new technologies emerge or are optimized, such as proteomic analysis, it is also possible to acquire and integrate this new data into the existing dataset. Third, by leveraging a ‘living tumor bank’ of PDX models, it is possible to manipulate these tumors and simulate important therapeutic or molecular scenarios that are otherwise unavailable in other tumor models.

To demonstrate the combined power of the Company’s proprietary dataset and the full power of the analytical tools present within the Lumin Analytic Engine, Champions has built in-house computational target discovery expertise to identify and prioritize novel therapeutic targets. This approach relies heavily on AI and machine learning algorithms. Computational approaches have emerged as a central mechanism for target discovery in recent years, but often suffer from the use of incomplete or misleading datasets. Champions’ computational approach leverages a more complete data set that is derived from tumor models with a more authentic tumor cell biology and heterogeneity. As a result, the computational teams at Champions can identify targets that are often overlooked or missed when using other datasets. The extensive pre-clinical platform available at Champions’ research facilities also allows for a quick and efficient experimental validation.

The areas of focus for Champions’ therapeutic target discovery include, amongst others, immune modulation, cell surface proteins for drug conjugates, and intracellular ligases and kinases that are required for tumor cell survival. Some of the targets that have been validated exploit the intact and complex metabolic, inflammatory and ubiquitin pathways, as well as a more representative global protein expression level, present within Champions’ tumor models. Programs that have been established around these targets leverage various therapeutic modalities, including both small and large molecule approaches. The commercial strategy for each program will vary, and can include independent development, co-development, or out-licensing.

Ronnie Morris, MD, President and CEO, said "It’s amazing to have reached the point where we see the full realization of our business model. As you know, the foundational core of the Champions business is the proprietary dataset which we have amassed over the last decade. On top of this core, we developed a set of market-leading technology-enabled platform services which fueled our becoming a fast growing & profitable company. Last year we released our software solution, Lumin Bioinformatics, which allows our customers a new way to access & search insights in our datasets. And now, we are excited to unveil discovery and innovation. The synergy of these three vibrant business units allows us to leverage our core in higher value and higher margin businesses that would accelerate our revenue and long-term profit growth."

"Drug discovery and development is the natural next step for Champions," said Michael Ritchie, PhD, MBA, Chief Commercial Officer at Champions Oncology. "We have established such a strong leadership position in delivering the highest quality of science over the years. When we coupled that with our unparalleled dataset and our newly built computational capabilities, we saw the potential to be transformative in drug development. I am amazed every day at what our drug discovery teams are delivering and look forward to seeing these programs mature towards the clinic."

Allarity Therapeutics and Lantern Pharma Enter into Agreement for Future Clinical Development of Irofulven

On July 26, 2021 Allarity Therapeutics A/S ("Allarity") and Lantern Pharma Inc. ("Lantern") reported that they have entered into an exclusive agreement under which Lantern will reacquire global rights to Irofulven ("LP-100") and assume full authority to manage and guide future clinical development and commercialization (Press release, Allarity Therapeutics, JUL 26, 2021, View Source [SID1234585174]).

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Irofulven is a well-studied small molecule that causes bulky single strand DNA adducts that cause DNA damage in cancer cells, which can only be repaired by the transcription coupled nucleotide excision repair (TC-NER) pathway. This DNA modification stalls RNA polymerase II leading to transcription and cell cycle arrest and apoptosis in certain types of cancer cells. The drug was originally developed by MGI Pharma (USA) and Eisai (Japan), through Phase 3 clinical trials. Allarity acquired global exclusive rights to the drug through a license from Lantern in 2015 and initiated a Phase 2 clinical trial in Denmark aimed to benefit late-stage, metastatic, castration-resistant prostate cancer (mCRPC) patients. Lantern plans on pursuing further development and advancement of the drug candidate immediately.

Allarity has previously developed and retrospectively validated a companion diagnostic for Irofulven, using its DRP technology, which was utilized to select and enroll mCRPC patients in its Phase 2 clinical trial at sites in Denmark. Based, in part, upon early results (unpublished) of that trial (NCT03643107) Lantern has decided to reacquire the Irofulven program and will review the potential to advance clinical development of Irofulven in both bladder and prostate cancer patients who have a key mutation in the ERCC2/3 genes (excision repair cross-complementation group 2/3 genes). The genes encode a crucial TC-NER pathway protein (helicase subunit XPB) necessary for DNA damage repair, and it is postulated that patients having tumors harboring the ERCC2/3 gene mutations, and thus lacking the crucial DNA damage repair protein, may be more responsive to treatment with Irofulven.

Under the agreement, Lantern will purchase assets and reacquire global, exclusive rights to further develop and commercialize Irofulven, and Allarity will discontinue further involvement in the Irofulven program. Allarity will provide Lantern with existing, clinical grade drug inventory, manufacturing trade secrets and know-how, and certain data from Allarity’s current Phase 2 clinical study in mCRPC, along with a developed clinical protocol for the intended ERCC2/3 study. Lantern will also receive a license to utilize, in its sole discretion, Allarity’s Irofulven DRP companion diagnostic in future clinical development and commercialization of the drug. Allarity will receive an upfront payment from Lantern, development and regulatory milestone fees, which payments together total, if all milestones (including regulatory marketing approval in the U.S. and EU) are met, up to approximately U.S. $18 million, and tiered royalties on future sales of Irofulven. Further financial terms of the agreement were not disclosed.

Steve R. Carchedi, CEO of Allarity Therapeutics, commented "We are pleased to announce this promising agreement with Lantern Pharma, in order to build on our prior efforts to explore the clinical potential of Irofulven and advance the value of this pipeline asset. Providing Irofulven to selected patients with tumors harboring the ERCC2/3 mutations and resulting DNA damage repair defect represents a novel approach to potentially increasing the therapeutic benefit of Irofulven. Our agreement with Lantern on this program enables Allarity to remain focused on its top priority programs, while at the same time leveraging Lantern’s resources, expertise, and commercial position to continue clinically advancing Irofulven."

Panna Sharma, CEO of Lantern Pharma, further commented "Irofulven has the potential to have a key position in helping extend survival in bladder and metastatic prostate cancers, and potentially other cancers that harbor mutations in ERCC2/3 and other related genes. This program is very synergistic with our other drug candidates that are also focused on DNA damage repair and the NER pathway. Most importantly Irofulven has the potential to be an important compound for several challenging cancers that are impacting patients globally. We are looking forward to advancing and expanding the Irofulven program using our data-driven and precision approach aimed at future patient benefit from this therapy."

Aurinia Pharmaceuticals to Release Second Quarter 2021 Financial Results on August 5, 2021

On July 26, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that it will release its second quarter 2021 financial results on Thursday, August 5, 2021, after the markets close (Press release, Aurinia Pharmaceuticals, JUL 26, 2021, View Source [SID1234585173]). Aurinia’s management team will also host a conference call at 4:30 p.m. EDT to discuss the Company’s financial results and to provide a general business update.

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The conference call and webcast is scheduled for August 5, 2021 at 4:30 p.m. ET. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

Athenex Announces Additional Licensing Agreements for Tirbanibulin

On July 26, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company has entered into licensing agreements and strategic partnerships with Seqirus Pty Ltd ("Seqirus"), a subsidiary of CSL Limited, and AVIR Pharma Inc. ("AVIR") for tirbanibulin (Press release, Athenex, JUL 26, 2021, View Source [SID1234585172]).

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Under the terms of the agreements, Seqirus will have an exclusive license to commercialize tirbanibulin in Australia and New Zealand, and AVIR will have an exclusive license to commercialize tirbanibulin in Canada.

The addition of these territories enhances the global coverage of the marketing and sales of Klisyri (tirbanibulin ointment) for the treatment of actinic keratosis (AK). Athenex currently has strategic partnerships for tirbanibulin in the U.S., Europe, China, Taiwan, Japan and now also Australia, New Zealand and Canada, among several other territories. In addition to upfront payments and milestone payments, the royalty/transfer prices generally range from 15% to 30% of annual sales across different territories.

"These new partnerships with Seqirus and AVIR will expand tirbanibulin access to more patients around the world," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "Tirbanibulin, or Klisyri, is approved and launched in the United States for the treatment of actinic keratosis of the face or scalp, and is a significant step forward because of its short treatment protocol, proven efficacy, and favorable safety profile. Klisyri has recently also received approval for marketing by the European Commission. The expansion of our international partnerships represents an important step in Athenex’s strategy to optimize the potential value of this important drug and create value for our stakeholders."

Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action. Athenex received approval from the U.S. Food and Drug Administration for the commercialization of tirbanibulin, under the brand name Klisyri, for the topical treatment of AK of the face or scalp. Klisyri was launched in the U.S. in February 2021, led by the Company’s partner, Almirall. In July, Almirall received European Commission approval of Klisyri (tirbanibulin) for the topical treatment of AK of the face or scalp, which followed a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in May.

"We are delighted to collaborate with Athenex to commercialize KlisyriTM in Australia and New Zealand," said Dani Dowell, Seqirus Head of Commercial Australia and New Zealand. "This is an exciting opportunity, building on Seqirus’ strong presence as a successful in-license partner in Australia and New Zealand. The addition of Klisyri will broaden our portfolio and is another example of our work to deliver innovative offerings to meet unmet patient need."

Actinic keratosis is one of the most common diagnoses in dermatology practices.[1] Australia has one of the highest prevalence of AK, with an estimated prevalence of 40-50% in the Australian Caucasian population over 40 years of age.[2] Treatment is a critical aspect in the management of the disease as it may progress to invasive skin squamous cell carcinoma.

Apellis Announces Closing of Previously Announced Exchanges of Approximately $201.1 Million in Principal Amount of Its 3.500% Convertible Senior Notes Due 2026 for Common Stock

On July 26, 2021 Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a global biopharmaceutical company and leader in targeted C3 therapies, reported the closing of its previously announced privately negotiated exchange transactions (the "Exchange Transactions") with certain holders of its 3.500% Convertible Senior Notes due 2026 (the "Notes") (Press release, Apellis Pharmaceuticals, JUL 26, 2021, View Source [SID1234585171]). In the Exchange Transactions, the holders exchanged approximately $201.1 million in aggregate principal amount of Notes and Apellis issued an aggregate of 5,992,217 shares of its common stock.

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The shares of Apellis’ common stock issued in the exchanges were not registered under the Securities Act of 1933, as amended, or the securities laws of any state or other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and such other jurisdictions.

This press release does not constitute an offer to sell or a solicitation to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.