On September 14, 2020 A team of researchers led by Mayo Clinic and the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, reported that it has identified specific potential therapeutic targets for the most aggressive and lethal form of pancreatic cancer (Press release, TGen, SEP 14, 2020, View Source [SID1234565084]).

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In what is believed to be the most comprehensive analysis of adenosquamous cancer of the pancreas (ASCP), the Mayo Clinic and TGen team identified, in preclinical models, therapeutic targets for this extremely fast-moving and deadly form of pancreatic cancer, and identified already available cancer inhibitors originally designed for other types of cancer, according to a study published today in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

"The rarity of ASCP, the scarcity of tissue samples suitable for high resolution genomic analyses, and the lack of validated preclinical models, has limited the study of this particularly deadly subtype of pancreatic cancer," said Dr. Daniel Von Hoff, Distinguished Professor and TGen’s Physician-In-Chief, considered one of the nation’s foremost authorities on pancreatic cancer, and one of the study’s authors. "We need entirely new possible approaches for our patients with ASCP."

Pancreatic ductal adenocarcinoma (PDAC) is the most common form of pancreatic cancer, which this year is projected to kill nearly 57,600 Americans, making it the nation’s third leading cause of cancer-related death, according to the American Cancer Society. Among pancreatic cancer patients, a small percentage (less than 4%) are diagnosed with ASCP, a particularly aggressive form of pancreatic cancer.

"ASCP currently has no effective therapies. Unlike PDAC, ASCP is defined by the presence of more than 30% squamous (skin-like) epithelial cells in the tumor. The normal pancreas does not contain squamous cells," said the study’s senior author, Michael Barrett, Ph.D., who holds a joint research appointment at Mayo Clinic and TGEN.

"Our study has shown that ASCPs have novel ‘hits’ (mutations and deletions) in genes that regulate tissue development and growth superimposed on the common mutational ‘landscape’ of a typical PDAC. As a consequence, cells within the tumor have the ability to revert to a stem-cell-like state that includes changes in cell types and appearance, and the activation of signaling pathways that drive the aggressive nature of ASCP,’ said Dr. Barrett.

While this activated aggressive stem-cell-like state is very resistant to current therapies for pancreatic cancer, Dr. Barrett said, the study has shown that ASCP can be targeted by drugs currently in clinical use for other cancers as well as non-cancer related conditions.

Using multiple cancer analysis methods and platforms — including: flow cytometry, copy number analysis, whole exome sequencing, variant calling and annotation, ATAC-seq, immunofluorescence, immunohistochemistry, single cell sequencing, and organoid cultures and treatments — the Mayo Clinic and TGen research team conducted what is believed to be the most in-depth analysis of ASCP tissue samples.

Researchers identified multiple mutations and genomic variants that are common to both PDAC and the more aggressive ASCP. "Of significant interest," the study says, the team also identified two potential therapeutic targets unique to ASCP genomes: FGFR signaling, including an FGFR1-ERLIN2 gene fusion, and a pancreatic cancer stem cell regulator known as RORC.

These data provide a unique description of the ASCP genomic and epigenomic landscape and identify candidate therapeutic targets for this lethal cancer, the study says.

Using organoids, which are laboratory cultures derived from samples of patient tumors, researchers tested the activity and functional significance of candidate therapeutic targets. According to the study: "Specifically, organoids carrying the FGFR1-ERLIN2 fusion show a significant response to pharmacological FGFR inhibition," providing new candidate targets for developing therapies for patients with ASCP.

In addition, the study says, "To our knowledge, this is the first study to apply DNA content sorting to the genomic analysis of ASCP," a method that purifies the cancer DNA from other cells and parts of cells, thereby eliminating any biological "noise" that might impede the precision of the analysis.

Using an interrogation tool known as ATAC-seq, researchers also identified RORC as another distinguishing feature of ASCP.

"Of significant interest will be clinical trials with FGFR and RORC inhibitors that include correlative studies of genomic and epigenomic lesions in both ASCP and PDAC," the study concludes.

Also contributing to this study — Genomic and Epigenomic Landscaping Defines New Therapeutic Targets for Adenosquamous Carcinoma of the Pancreas — were: Virginia G Piper Cancer Center at HonorHealth; University of California, San Diego School of Medicine; Salk Institute for Biological Studies; Memorial Sloan Kettering Institute; and University of Nebraska Medical Center (UNMC).

Funding for this study was provided by: the Lee Hanley Foundation; TGen’s annual stepNout pancreatic cancer fundraising; a Pancreatic Cancer Dream Team Research Grant through Stand Up to Cancer (SU2C) and Lustgarten-Cancer Research UK (CRUK); Damon Runyon Cancer Research Foundation; the National Institutes of Health (NIH); the Pancreatic Cancer Collective New Therapies Challenge; and a fellowship through the Tobacco Related Disease Research Program.

In addition, Mayo Clinic Cancer Center is supported by a Cancer Center Support Grant from the National Institute of Cancer (NCI).

The UNMC Tissue Bank Rapid Autopsy Program for Pancreas is supported by the following: Specialized Program of Research Excellence (SPORE) in Pancreatic Cancer; Pancreatic Cancer Detection Consortium; an NCI Cancer Center Support Grant; and an NCI Research Specialist.

The authors declare no conflicts of interest.

Cancer Research is a journal of AACR (Free AACR Whitepaper), which also is the Scientific Partner of SU2C. AACR (Free AACR Whitepaper) administers SU2C grants. SU2C is a division of the Entertainment Industry Foundation.

On September 14, 2020 University of Louisville reported that Cancer remains one of the most difficult and deadly challenges in human health, affecting Kentuckians at a higher rate than residents of any other state and killing more than 600,000 people each year in the U.S. alone (Press release, University of Louisville, SEP 14, 2020, View Source [SID1234565083]). In recent decades, therapies that engage the immune system to treat cancer have given hope to millions of cancer patients.

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Building on more than two decades of success in cancer research, the University of Louisville is poised to advance immunotherapy with a grant of $11.5 million from the National Institute of General Medical Sciences to establish the Center for Cancer Immunology and Immunotherapy (CCII). The new center will develop and improve strategies that use the immune response to fight cancer. The five-year grant also will allow UofL to establish the CCII as a National Institutes of Health-designated Center of Biomedical Research Excellence (CoBRE) to support young investigators and develop additional basic, translational and clinical research at the UofL Health – James Graham Brown Cancer Center.

"One of the university’s Grand Challenges is to advance the health of all people," said UofL President Neeli Bendapudi. "Through this center, our cancer researchers will grow the field of immunotherapy, saving the lives of many more patients with cancer in the future."

"Our mission is to harness the power of the immune system to eradicate cancer," said Jason Chesney, director of the Brown Cancer Center. "The University of Louisville, UofL Health and the Brown Cancer Center have been at the forefront of the clinical development of a new generation of immunotherapies that have been proven to increase the survival of cancer patients. This grant from the federal government leverages our existing strengths in cancer immunology and clinical trials to accelerate the development of new immunotherapies that will translate into lives saved across the globe."

Cancer survivor Jeff Habermel received two different immunotherapies at Brown Cancer Center in the course of treatment for three different cancers, including metastasized melanoma.

"I consider myself very fortunate to have the type of care that Dr. Chesney and Dr. (Donald) Miller and the whole staff provide at the Brown Cancer Center. We have a world-class facility right in our backyard," Habermel said. "I truly feel I am the luckiest man in the world to live in a time when we have such technologies and such amazing abilities to treat cancer in these ways."

The newest cancer treatments often are available at Brown Cancer Center through clinical trials before they are available anywhere else. One such treatment is CAR T-cell therapy, in which a patient’s own immune cells known as T cells are modified in the lab to more effectively attack cancer cells. UofL announced the creation of the Dunbar CAR T-Cell Program at UofL in October.

"Our leading-edge cancer program improves access for patients in our region, giving them the opportunity to benefit from life-saving immunotherapies through clinical trials," said Tom Miller, CEO of UofL Health. "Thousands of our cancer patients – our neighbors and family members – are alive today because of this early focus on drugs that activate immunity against cancer."

Researchers within the CCII will build on expertise and resources gained from previous research at UofL to develop better cancer immunotherapies. This will be achieved in part by enabling talented junior investigators who have not yet obtained major funding to advance their research and subsequently obtain major grant awards of their own.

"One of the major goals of the center is to cultivate the next generation of cancer scientists in immunology and immunotherapy," said Jun Yan, professor, director of the CCII and chief of the UofL Division of Immunotherapy. "Starting in year two, we will call for pilot projects that will bring in more researchers and investigators to work on immunotherapy and immunology."

The young researchers are provided funding, mentorship and access to sophisticated facilities to advance their research. Once CCII-supported researchers obtain their own funding they rotate out, allowing new investigators to come in to the program.

"It’s training a cohort of new investigators who will have their own large grants and expertise," said Paula Bates, professor of medicine and co-investigator for the CCII along with John Trent. "We are building a critical mass of well-funded researchers in the area."

Senior UofL faculty members Robert Mitchell, Nejat Egilmez, Haribabu Bodduluri, Huang-Ge Zhang and Bing Li will serve as mentors and core directors for the CCII. In the first year of the program, four junior researchers at UofL are conducting projects to improve the effectiveness of immune therapies.

Chuanlin Ding is investigating the impact of chemotherapy on anti-tumor immunity in breast cancer order to discover effective combination regimens that improve conventional chemotherapy.
Qingsheng Li is exploring a method to improve immune checkpoint inhibitor therapy for non-small cell lung cancer. Immune checkpoint inhibitors are a type of immunotherapy that blocks proteins (checkpoints) made by immune system cells, such as T cells. The checkpoints can prevent T cells from attacking cancer cells.
Corey Watson is studying immune cells to determine which of these cells are beneficial to lung cancer patient outcomes and how they may help kill tumor cells.
Kavitha Yaddanapuddi is studying immune checkpoint inhibitor resistance in lung cancer patients. This will help in developing therapies that reduce resistance and improve treatment.

Kavitha Yaddanapuddi, (left) and Chuanlin Ding use a mass cytometer to help improve the effectiveness of cancer immunotherapies.
This grant may be extended for two additional five-year phases. A previous CoBRE program for cancer research at UofL was extended through all three phases, lasting 15 years. That program significantly expanded the contingent of both junior and senior investigators at UofL, including Chesney, Trent and others whose research was funded by the previous program.

"This type of funding has been truly transformative for this cancer center," Trent said. "The research for the current generation of immunotherapeutic checkpoint inhibitors was done more than 18 years ago. This grant’s research will feed into the clinical work in time. These grants lay the groundwork for the next generation of therapies."

To extend the impact of the CCII still further, Kosair Charities has provided an additional $200,000 to facilitate the discovery and development of immunotherapy drugs for children with cancer. This gift bridges the CCII and the UofL Kosair Charities Pediatric Oncology Research Program, allowing the CCII to focus also on immuno-oncology for children.

"Kosair Charities is proud to be the first community partner to support the UofL Center for Cancer Immunology and Immunotherapy," said Kosair Charities President Keith Inman. "The UofL Kosair Charities Pediatric Cancer Research Program will allow this new center to include crucial pediatric cancer research as well as expand the scope to all people living with cancer – children and adults alike."

On September 14, 2020 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) ("Diffusion" or "the Company"), reported its management will present at the H.C. Wainwright 22nd Annual Global Investment Conference to be held virtually on September 14-16, 2020 (Press release, Diffusion Pharmaceuticals, SEP 14, 2020, View Source;Virtual-Global-Investment-Conference/default.aspx [SID1234565082]). Robert Cobuzzi, Ph.D., chief executive officer, will present a corporate overview of the Company on Tuesday, September 15th, at 3:00 p.m. Eastern time.

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A link to the live webcast of the presentation will be available online through the investor relations section of Diffusion’s website here. Following the event, a replay of the presentation will be archived on the Diffusion website for approximately 90 days.

On September 14, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient has been dosed in a phase 2 study evaluating patritumab deruxtecan (U3-1402), a HER3 directed DXd antibody drug conjugate (ADC), in patients with advanced or metastatic colorectal cancer who are resistant, refractory, or intolerant to at least two prior lines of systemic therapy (Press release, Daiichi Sankyo, SEP 14, 2020, View Source [SID1234565081]).

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Standard treatment options for patients with advanced or metastatic colorectal cancer include surgery when possible, chemotherapy with or without targeted therapy, and radiation therapy.[1],[2] However, many patients with advanced colorectal cancer will progress through multiple lines of therapy, and prognosis remains poor after failure of these therapies.[2],[3] It is estimated that up to 83 percent of patients with colorectal cancer overexpress the HER3 protein, which can be associated with an increased incidence of metastases, reduced survival and resistance to standard cancer treatment.[4],[5],[6],[7]

"The prognosis of patients with advanced or metastatic colorectal cancer remains poor, and there is a need to develop new treatment strategies, including targeting HER3," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "In this study, we are exploring whether the targeted delivery of cytotoxic chemotherapy with patritumab deruxtecan to cancer cells with varying levels of HER3 expression may be a potential treatment option for previously treated advanced or metastatic colorectal cancer."

About the Study

The multi-center, open-label, two-cohort, two-part, phase 2 study will evaluate the safety and efficacy of patritumab deruxtecan in patients with advanced or metastatic colorectal cancer who are resistant, refractory, or intolerant to at least two prior approved systemic therapies. Prior treatments must include chemotherapy (fluoropyrimidine, irinotecan and a platinum agent), an anti-EGFR agent if clinically indicated, and an anti-VEGF agent, unless contraindicated. Patients with confirmed microsatellite instability-high (MSI-H) colorectal cancer must have received treatment with an immune checkpoint inhibitor, unless contraindicated.

The first part of the study will include two cohorts of patients with varying levels of HER3 expression. One cohort will include patients with HER3 high expression (IHC 3+ or 2+), and the second cohort will include patients with HER3 low/HER3 negative expression (IHC 1+ or 0). Based on a preliminary review of the data, specifically treatment response in both cohorts, additional patients may be enrolled into a second part of the study, which will further assess treatment with patritumab deruxtecan in patients with either HER3 high expression or both HER3 high and low expression.

The primary objective of the study is to assess the antitumor activity of patritumab deruxtecan, and will evaluate objective response rate (ORR), as assessed by Blinded Independent Central Review per RECIST v1.1, as the primary endpoint. Secondary objectives of the study include the assessment of antitumor activity (evaluated by assessing duration of response (DoR), investigator-assessed ORR, disease control rate (DCR), time to response (TTR), progression-free survival (PFS) and overall survival (OS)), safety and tolerability, level of HER3 protein expression in tumor tissue and its relationship with efficacy, pharmacokinetics and immunogenicity. Secondary efficacy assessments (ORR, DOR, DCR, TTR, and PFS) will be assessed by BICR and investigator per RECIST v1.1.

The study is expected to enroll up to approximately 80 patients in the U.S., Europe and Japan.

Unmet Need in Colorectal Cancer

Colorectal cancer is the third most common cancer and the second-leading cause of cancer-related deaths worldwide.[8] In 2020, there will be an estimated 147,950 new cases of colorectal cancer diagnosed in the U.S. and an estimated 53,200 deaths.[9] Approximately 25 percent of patients have metastatic disease at diagnosis, meaning the cancer has spread to distant organs, and about 50 percent will eventually develop metastases.9,[10] Only 14 percent of patients with metastatic colorectal cancer are expected to survive five years after they are diagnosed.3

Most patients with metastatic colorectal cancer receive surgery (when possible), chemotherapy with or without targeted therapy, and radiation therapy.1,2 The introduction of EGFR targeting treatments and other targeted therapies has helped prolong overall survival in advanced colorectal cancer compared to chemotherapy.8,[11] However, many patients eventually become resistant to these targeted treatments, underscoring the need for new treatment approaches for metastatic colorectal cancer.2,4,5

About HER3

HER3 is a member of the EGFR family of tyrosine kinase receptors, which are associated with aberrant cell proliferation and survival.[12] The HER3 protein is overexpressed in as many as 83 percent of colorectal cancers, and it is associated with an increased incidence of metastases and reduced survival.4,5,6,7 Currently, no HER3 directed therapies are approved for any cancer.

About Patritumab Deruxtecan (U3-1402)

Patritumab deruxtecan (U3-1402) is one of three lead DXd antibody drug conjugates (ADC) in the oncology pipeline of Daiichi Sankyo.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Patritumab deruxtecan is comprised of a human anti-HER3 antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and help deliver chemotherapy to cancer cells that express HER3 on the surface of tumor cells.

Patritumab deruxtecan is currently being evaluated in a phase 1 study in previously treated patients with metastatic or unresectable non-small cell lung cancer (NSCLC) and a phase 1/2 study in patients with HER3 expressing metastatic breast cancer.

Patritumab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

On September 14, 2020 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in an end-to-end range of research and development technology solutions and services to improve the development and use of oncology drugs, reported its financial results for the first fiscal quarter ended July 31, 2020 (Press release, Champions Oncology, SEP 14, 2020, View Source [SID1234565080]).

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First Quarter Highlights:

•Record quarterly revenue of $9.5 million, an increase of 42% year-over-year

•Reported income from operations of $421,000, excluding stock-based compensation, depreciation and amortization

•Achieved record quarterly bookings

•Completed relocation to new lab space and expansion of capacity

Ronnie Morris, CEO of Champions, commented, "We started off our fiscal year with a record breaking revenue quarter exceeding $9.5 million. Our core PDX business, the foundation of our product offerings, continues to grow and is leading to additional end point analysis testing. Despite these uncertain times, we remained committed to our long term strategy and our business prospects remain strong."

David Miller, CFO of Champions added, "The growth in both our core products and new product offerings led to a 42% increase in year over year revenue. The record quarterly revenue combined with another quarterly bookings high, sets the trajectory for a year of continued revenue growth."

First Fiscal Quarter Financial Results

For the first quarter of fiscal 2021, revenue increased 41.7% to $9.5 million compared to $6.7 million for the first quarter of fiscal 2020. The increase in revenue was due to increased sales, both in number and size of studies, and strong demand for our services. Expansion in end point analysis testing has led to larger contracts and ex-vivo services have become a meaningful contributor to revenue. Total costs and operating expenses for the first quarter of fiscal 2021 were $9.5 million compared to $7.4 million for the first quarter of fiscal 2020, an increase of $2.2 million or 29.5%.

For the first quarter of fiscal 2021, Champions reported income from operations of $24,000, including $120,000 in stock-based compensation and $277,000 in depreciation and amortization expenses, an increase of $638,000 compared to the loss from operations of $614,000, inclusive of $131,000 in stock-based compensation and $182,000 in depreciation and amortization expenses, in the first quarter of fiscal 2020. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $421,000 for the first quarter of fiscal 2021 compared to non-GAAP loss from operations of $301,000 in the first quarter of fiscal 2020, an increase of $722,000.

Cost of oncology solutions was $5.3 million for the three-months ended July 31, 2020, an increase of $1.6 million, or 42.2% compared to $3.8 million for the three-months ended July 31, 2019. For the three- months ended July 31, 2020, gross margin was 44.1% compared to 44.3% for the three-months ended July 31, 2019. The increase in cost of oncology services for the three-month period was mainly due to an increase in compensation and outsourced lab service expenses. Excluding outsourced lab services, the overall expense increase is generally in line with expectations based on the growth in revenue, study volume, and expansion into new services. Gross margin varies based on timing differences between expense and revenue recognition and was impacted by the increase in costs on growing study volume in advance of revenue recognition. The cost of outsourced lab services magnified this effect.

Research and development expense was $1.6 million and $1.3 million for the three-months ended July 31, 2020 and July 31, 2019, respectively. The increase was due to continued investment towards developing new service capabilities, and sequencing costs associated with characterizing additional models in our TumorBank. Sales and marketing expense for the three-months ended July 31, 2020 was $1.2 million, an increase of $338,000, or 38.9%, compared to $870,000 for the three-months ended July 31, 2019. The increase was primarily due to compensation expense driven by the continued expansion of the sales force and commissions earned. General and administrative expense was flat at $1.4 million for the three-months ended July 31, 2020 and 2019.

Net cash used in operating activities was $715,000. The use of cash from operations was primarily due to ordinary course of business timing differences in working capital items for the first quarter of 2021, including an increase in accounts receivable of $263,000 and a reduction in accounts payable and accrued expenses of $813,000.

The Company ended the quarter in a strong cash position with a $6.9 million cash balance compared to $2.2 million at the end of the same period last year. The Company has no debt.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its third quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available Monday, September 14, 2020 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net income (loss) to Non-GAAP net income (loss) for an explanation of the amounts excluded to arrive at Non-GAAP net income (loss) and related Non-GAAP

Exhibit 99.1

earnings (loss) per share amounts for the three months ended July 31, 2020 and 2019. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income (loss) and Non-GAAP earnings (loss) per share are not, and should not, be viewed as a substitute for similar GAAP items. Champions defines Non-GAAP dilutive earnings (loss) per share amounts as Non-GAAP net earnings (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings (loss) and Non-GAAP diluted earnings (loss) per share may differ from similarly named measures used by other companies.