Astellas to Present Data from Expanding Oncology Portfolio During the 2021 ASCO Annual Meeting

On May 17, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that it will share new data across its oncology portfolio during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, Astellas, MAY 17, 2021, View Source [SID1234580110]). Covering three approved treatments and one investigational therapy, the 12 Astellas-sponsored abstracts underscore the company’s commitment to advancing treatment options for difficult-to-treat cancers, including bladder, prostate and gastric/gastroesophageal junction (GEJ) cancers, as well as acute myeloid leukemia (AML).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"While oncology has seen incredible advancements over the last decade, there are still many patients whose disease has few or no effective treatments. Astellas is determined to change that reality," said Andrew Krivoshik, M.D., Ph.D., Astellas Senior Vice President and Oncology Therapeutic Area Head. "Our data suggest that progress is possible, and we are committed to working with physicians, patients and others in the cancer community to change the course of hard-to-treat forms of cancer."

"The latest investigational research supported by Astellas reflects our commitment to understanding unmet needs in cancer care and our mission to turn innovative science into treatments that are truly valued by patients and healthcare professionals," said Erhan Berrak, M.D., Astellas Vice President of Medical Affairs, Oncology. "For example, research to be presented at ASCO (Free ASCO Whitepaper) includes a closer look at real-world treatment patterns in several clinical states of advanced prostate cancer, including the use of advanced treatments across racial groups – a topic closely aligned with the ASCO (Free ASCO Whitepaper) 2021 theme of equity."

Astellas will share data across its portfolio and investigational therapies, with highlights including:

Quality of life results from the Phase 3 EV-301 trial of enfortumab vedotin (EV) and an updated analysis of efficacy and safety data from EV-201 cohort 2 of EV; updated durability and long-term outcomes from the EV-103 clinical trial of EV and pembrolizumab – all in advanced types of urothelial cancer
Research on racial disparities in advanced prostate cancer treatment, as well as real-world treatment patterns for patients with advanced prostate cancer
Follow-up data from the Phase 3 ADMIRAL trial evaluating gilteritinib in patients with relapsed or refractory (resistant to treatment) AML with a FLT3 mutation
Data from the Phase 2 study of zolbetuximab plus mFOLFOX6 in claudin 18.2-positive (CLDN18.2+) locally advanced or metastatic gastric or GEJ adenocarcinoma
Astellas Presentations at ASCO (Free ASCO Whitepaper)21

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

Enfortumab vedotin in cisplatin-ineligible
patients with locally advanced or
metastatic urothelial cancer who
received prior PD-1/PD-L1 inhibitors: An
updated analysis of EV-201 Cohort 2

B. McGregor

Type: Poster

Abstract Number: 4524

Study EV-103: Update on durability
results and long-term outcome of
enfortumab vedotin + pembrolizumab in
first line locally advanced or metastatic
urothelial carcinoma (la/mUC)

T. Friedlander

Type: Poster

Abstract Number: 4528

Quality of life, functioning, and
symptoms in patients with previously
treated locally advanced or metastatic
urothelial carcinoma from EV-301: A
randomized phase 3 trial of enfortumab
vedotin vs chemotherapy

R. Mamtani

Type: Poster

Abstract Number: 4539

KEYNOTE-B15/EV-304: Randomized
phase 3 study of perioperative
enfortumab vedotin plus pembrolizumab
versus chemotherapy in cisplatin-
eligible patients with muscle-invasive
bladder cancer (MIBC)

C. Hoimes

Type: Poster

Abstract Number: TPS4587

Opioid use in locally advanced or
metastatic urothelial carcinoma patients
and matched non-cancer controls

S. Grewal

Type: Publication Only

Abstract Number: e16517

Enzalutamide

Presentation Title

Lead Author

Presentation Details

The efficacy of enzalutamide (ENZA)
plus androgen deprivation therapy
(ADT) on bone oligometastatic
hormone-sensitive prostate cancer: A
post hoc analysis of ARCHES

A. Armstrong

Type: Poster

Abstract Number: 5071

Real world first-line (1L) treatment
patterns in patients (pts) with metastatic
castration-sensitive prostate cancer
(mCSPC) in a U.S. health insurance
database

U. Swami

Type: Poster

Abstract Number: 5072

Real-world utilization of advanced
therapies and racial disparity among
patients with metastatic castration-
sensitive prostate cancer (mCSPC): A
Medicare database analysis

S. Freedland

Type: Poster
Abstract Number: 5073

Real-world treatment patterns among
patients diagnosed with metastatic
castration-sensitive prostate cancer
(mCSPC) in community oncology
settings

D. George

Type: Poster
Abstract Number: 5074

Gilteritinib

Presentation Title

Lead Author

Presentation Details

Follow-up of patients with FLT3-mutated
R/R AML in the phase 3 ADMIRAL trial

A. Perl

Type: Poster

Abstract Number: 7013

Zolbetuximab

View News Release Full Screen
Presentation Title

Lead Author

Presentation Details

Phase 2 study of zolbetuximab plus
mFOLFOX6 in claudin 18.2-positive
locally advanced or metastatic gastric or
gastroesophageal junction adenocarcinoma (G/GEJ): ILUSTRO
cohort 2

K. Lee

Type: Publication Only

Abstract Number: e16078

The ASCO (Free ASCO Whitepaper) 2021 Annual Meeting abstracts are available at the ASCO (Free ASCO Whitepaper) Meeting Library.

Enfortumab Vedotin Collaborations
Astellas and Seagen Inc. are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. In the United States, Astellas and Seagen co-promote enfortumab vedotin. In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

Astellas and Seagen entered a clinical collaboration agreement with Merck to evaluate the combination of enfortumab vedotin and Merck’s KEYTRUDA (pembrolizumab), in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Enzalutamide and the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States.

Inhibikase Therapeutics Reports First Quarter 2021 Financial Results and Highlights Recent Period Activity

On May 17, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders inside and outside of the brain, reported financial results for the first quarter ended March 31, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAY 17, 2021, View Source [SID1234580126]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key Business and Clinical Highlights

Accelerated timelines for Phase 1 Study of IkT-148009 for the treatment of PD and associated GI Disorders: In February, 2021 Inhibikase commenced patient dosing in its Phase 1 study evaluating the safety, tolerability and pharmacokinetics of IkT-148009, the Company’s novel brain penetrant Abelson tyrosine kinase (c-Abl) inhibitor with the potential to modify Parkinson’s disease and its gastrointestinal complications. In April, 2021, the Company announced that it had accelerated the timeline for completion of the study based on early data that provided the opportunity to seek regulatory approval to commence dosing of PD patients in the third quarter of 2021, much earlier than previously anticipated.
Advancing chronic toxicology studies of IkT-148009 to permit long-term dosing in patients: In January, 2021 Inhibikase initiated 3- and 6-month long-term toxicology studies of IkT-148009 in mice and 3- and 9-month long-term toxicology studies of IkT-148009 in primates as required to obtain regulatory approval for chronic administration of IkT-148009 in patients. The Company has completed 3-month toxicology studies and is presently completing its histopathology analysis in preparation for submission of the data for regulatory review early in the third quarter of 2021. The Company expects to complete 6- and 9-month toxicology studies in the fourth quarter of 2021.
Initiated clinical batch manufacturing and pill formulation of IkT-001Pro. In February, 2021, Inhibikase initiated clinical batch manufacturing and final product formulation of IkT-001Pro, the Company’s prodrug formulation of Imatinib, designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). Inhibikase expects to file an Investigational New Drug (IND) application in the third quarter of 2021, with initiation of clinical development as soon as practicable after the filing, subject to FDA acceptance of the IND.
"We are proud of the milestones we have achieved in the first quarter of 2021. The acceleration of our Phase 1 study for our lead candidate, IkT-148009 should allow us to move into evaluation of the safety, tolerability and pharmacokinetics in Parkinson’s patients early in the third quarter of 2021. Concurrently, we are advancing two long term toxicology studies in animals, which will allow for chronic administration of IKT-148009 in patients following FDA review and acceptance," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "In the third quarter of 2021, we plan to file our IND application for IKT-001Pro, which holds the potential to be a safer and better tolerated treatment for cancers such as CML, and expect to initiate clinical development as soon as practicable following the submission of the IND application. We look forward to making 2021 a success as we work to advance our early stage programs forward."

First Quarter Financial Review

Net Loss: Net loss for the quarter ended March 31, 2021, was $2.6 million, or $0.26 per share, compared to a net loss of $0.5 million, or $0.07 per share for the first quarter in 2020.

R&D Expenses: Research and development expenses were $2.4 million for the quarter ended March 31, 2021 compared to $0.3 million for the first quarter in 2020. The increase was driven by an increase in grant related research expenditures and non-grant related research. The non-grant related research was expended primarily in connection with the Company’s Phase 1 clinical trials.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2021 were $1.6 million compared to $0.5 million for the first quarter in 2020. The increase was primarily the result of increased non-cash stock compensation expense, increased directors and officer’s liability insurance related to the Company’s initial public offering in December 2020, increased legal fees, board fees, investor relations and consulting fees relating to operating as a public company registrant since December 2020, and an increase in other normal operating expenses.

Cash Position: Cash and cash equivalents were $9.6 million as of March 31, 2021.

Oncocyte Reports First Quarter 2021 Financial Results and Provides Corporate Update

On May 17, 2021 Oncocyte Corporation (NASDAQ: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reports financial results for the first quarter 2021 ended March 31, 2021, along with a corporate update (Press release, Oncocyte, MAY 17, 2021, View Source [SID1234580150]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Oncocyte’s rapid execution across our four growth engines has continued into 2021 and solidified our potential opportunity in over $10 billion in combined market TAMs. First quarter was marked by revenue above the consensus of analyst estimates, driven by DetermaRx and Pharma Services, as well as by the delivery of a compelling data set that supports the pan-cancer utility of DetermaIO, and by the completion of acquisitions that solidify our leadership in providing a single, comprehensive solution for molecular diagnostics in solid tumors," said Ron Andrews, Chief Executive Officer and President of Oncocyte. "DetermaIO has had a terrific start to 2021. With the podium presentation of our data in bladder cancer at AACR (Free AACR Whitepaper), and upcoming presentation of our renal cell carcinoma data at ASCO (Free ASCO Whitepaper), we now have validated the test in four solid tumor types. Together with our prior results in TNBC and NSCLC, the evidence is clear that DetermaIO has the potential to be a disruptive pan-cancer immunotherapy treatment selection test, and we look forward to the anticipated clinical launch of DetermaIO in the second half of the year and expect this test to be a major revenue growth opportunity for Oncocyte over the next 18 – 24 months."

Mr. Andrews continued, "Our recent acquisition of Chronix Biomedical will play an important role in our long-term growth, providing an entry into the emerging $5 billion global therapy monitoring markets with a patented, novel, blood-only/tumor naïve approach that will deliver faster information on disease progression compared to the competing tumor-informed approaches that require tissue samples. We also gain access to broader intellectual property that may enable Oncocyte to offer additional innovative blood-based tests. From an execution standpoint, we will replicate our proven DetermaIO playbook as we rapidly launch DetermaCNI for blood-based immunotherapy response monitoring for research use in pharmaceutical clinical trials in late 2021. In terms of immediate growth, our Pharma Services offerings are gaining significant traction as we have recently signed agreements with two of the largest molecular diagnostics platform companies to deliver test development and contract research services, as well as act as a priority launch site for one of their new companion diagnostic products. As I look out into the coming quarters of 2021, I envision a great year with rising revenue and at least three product launches: DetermaIO, DetermaTx for clinical use and DetermaCNI for pharma clinical research use. The efforts of our incredibly dedicated team have enabled steady progress toward our goal of developing a comprehensive array of molecular diagnostic tests for cancer. We will continue to advance our suite of technology to develop novel commercial products across the continuum of care."

First Quarter and Recent Highlights Include:

DetermaRx had continued momentum with 50% sequential quarterly growth in onboarded physicians (to 208 total), a 50% increase in onboarded accounts (to 123 hospitals total), and a total of 236 billable samples in Q1 2021, with steady sample growth month over month despite the pandemic surge in January and February
Announced agreement with MultiPlan Network, expanding access to DetermaRx to an additional 60 million covered lives at a negotiated price in line with CMS pricing
Technology transfer to Burning Rock Biotech according to our license of DetermaRx in China, the world’s largest early-stage lung cancer market, remains on-track for full onboarding and validation in Q3 with market launch in China to follow in late Q4
Closed second investment in Razor Genomics to complete acquisition with Oncocyte becoming sole shareholder of Razor, the initial developer of DetermaRx
New DetermaIO data presented at two major medical meetings, American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) 2021 and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 demonstrate the potential for pan-cancer utility for DetermaIO
AACR 2021: Oral symposium presentation of a bladder cancer study which achieved its primary endpoint, demonstrating significant correlation between DetermaIO positivity and two-year overall survival rate for patients receiving atezolizumab in metastatic bladder cancer. DetermaIO identified additional immunotherapy responsive patients missed by currently used standard of care biomarkers, PD-L1 and TMB.
ASCO 2021: Upcoming presentation at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrating utility as predictor of immunotherapy response in renal cell carcinoma, a fourth indication, further supporting the pan-cancer utility of the test
DetermaIO pilot projects secured from three biopharma companies developing novel 2nd generation immunotherapies. Projects will evaluate DetermaIO as a predictive biomarker.
Entered the rapidly growing blood-based cancer monitoring market with the acquisition of Chronix Biomedical Inc. The acquisition gives Oncocyte proprietary capabilities for blood-based immune therapy monitoring with the CNI monitor test and transplant rejection testing.
Chronix Biomedical’s ongoing and completed studies of the CNI Monitor test in lung, head and neck, ovarian and pancreatic cancer have now recruited over 700 patients to date. Completed studies demonstrate broad potential utility of this blood only test, including predicting the presence of disease post-surgery (MRD) and recurrence in ovarian cancer, and predicting response to cancer treatment, including but not limited to immunotherapy treatment.
Medicare Coverage Determination for molecular testing in solid organ allograft rejection, which exclusively cites multiple publications from Chronix Biomedical, Inc. This coverage policy for transplant rejection monitoring establishes a simplified and accelerated pathway for Medicare coverage of Chronix’s solid organ transplant rejection monitoring test that Oncocyte now owns.
Initiated project with top 20 pharma company utilizing Oncocyte’s proprietary blood-based cell-cycle test for monitoring resistance in an ongoing Phase 3 trial
Corporate

Strengthened balance sheet with $69 million raised in offerings of common stock
Transitioned listing to Nasdaq Global Market
Oncocyte Revenues for Q1 were $1.12 million, above the consensus estimate, driven by DetermaRx growth and Pharma Services projects
Completed relocation to new Irvine clinical facility
First Quarter 2021 Financial Results

At March 31, 2021, Oncocyte had cash, cash equivalents and marketable securities of $59.8 million. In January and February 2021, Oncocyte raised an aggregate of $69 million in net proceeds from a direct placement and a public offering, as well as shares sold from its at-the-market (ATM) program. In February 2021, Oncocyte completed the acquisition of the remaining equity interests in Razor Genomics and paid the $10 million cash portion to the selling shareholders, so Oncocyte now owns all of the outstanding common stock of Razor and will consolidate Razor as of that date.

Consolidated revenues for the first quarter of 2021 were approximately $1.12 million, a 123% increase from the fourth quarter of 2020, as revenues from both sources increased over the fourth quarter of 2020. Since inception, Oncocyte generated revenues for the first time in the first quarter of 2020, therefore comparison of current quarter consolidated revenues to the first quarter of 2020 is not meaningful. During the three months ended March 31, 2021, Oncocyte commenced recognizing Medicare Advantage covered tests on an accrual basis, rather than on a cash basis, after accumulating additional history of cash receipts and other factors considered by management that it believes entitles Oncocyte to get reimbursed for Medicare Advantage covered DetermaRx tests at the Medicare rate. Accordingly, DetermaRx tests performed for both Medicare covered patients and Medicare Advantage covered patients are being recognized when the tests are performed, on an accrual basis, at the Medicare rate, rather than on a cash basis. Oncocyte will continue to recognize revenues from commercial and other payors on a cash basis until it has reimbursement contracts with those payors, at which point Oncocyte will recognize all DetermaRx revenues on an accrual basis.

Cost of revenues for the first quarter 2021 was approximately $1.0 million, which included $307,000 in non-cash amortization expenses from the Razor Genomics asset acquired in February. The cost of our Razor asset amortization, which is a non-cash amortization expense over the remaining life of the Razor patent, will be included in cost of revenues each quarter. Cost of revenues also include testing services we perform for our pharma customers.

Research and development expenses for the first quarter of 2021 were $3.4 million as compared to $2.2 million for the same period in 2020, an increase of $1.2 million, primarily due to increased investment in DetermaIO, personnel and related expenses.

General and administrative expenses for the first quarter of 2021 were $4.8 million, as compared to $4.6 million for the same period in 2020, an increase of $0.2 million.

Sales and marketing expenses for the three months ended March 31, 2021, were $2.3 million, as compared to $1.5 million for the same period in 2020. The increase during the respective period was primarily due to personnel and related expenses for ramp up in sales and marketing activities for the commercialization efforts of DetermaRx as well as market development investments in preparation for the launch of new products later this year.

Operating losses, as reported, for the first quarter of 2021 were $11.4 million, an increase of $3.0 million from $8.4 million as compared to the first quarter of 2020. Operating losses, on an adjusted basis, were $8.6 million, an increase of $1.2 million from $7.4 million as compared to the first quarter of 2020.

Oncocyte has provided a reconciliation between GAAP and non-GAAP operating losses in the financial tables, included with this earnings release, which it believes is helpful in understanding its ongoing operations.

For the first quarter ended March 31, 2021, Oncocyte reported a net loss of $3.9 million, or ($0.05) per share, as compared to $7.7 million, or ($0.13) per share, for the first quarter ended March 31, 2020.

Cash used in operations was approximately $9.8 million for the first quarter of 2021. The first quarter of each year is generally our largest cash burn quarter due to annual merit and bonus payments.

Conference Call Information

The Company will host a conference call today, May 17, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments. The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13719464. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here View Source The webcast replay will be available on the Oncocyte website for 90 days following the completion of the call.

Dana-Farber Cancer Institute Announces $2 Billion Fundraising Campaign to Defy Cancer

On May 17, 2021 Dana-Farber Cancer Institute reported the most ambitious fundraising campaign in its history, and the largest campaign ever in New England focused entirely on cancer (Press release, Dana-Farber Cancer Institute, MAY 17, 2021, View Source [SID1234580166]). The Dana-Farber Campaign is a multi-year fundraising effort to raise $2 billion to accelerate the Institute’s strategic priorities by supporting revolutionary science, extraordinary care, and exceptional expertise.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

More than 1,000 people joined Dana-Farber for a special one-hour virtual event on Monday night to kick off the campaign and embraced the Institute’s vision to prevent, treat, and Defy Cancer. The event featured Journalist and Author Tom Brokaw; Dana-Farber Cancer Institute President and CEO Laurie H. Glimcher, MD; Chairman of the Dana-Farber Board of Trustees and Co-chairman and Managing Director of Bain Capital Josh Bekenstein; and Chair of The Dana-Farber Campaign, Institute Trustee, and Founding Partner and Managing Director of Charlesbank Capital Partners Michael Eisenson; along with inspiring patient stories, and special guests including musician Andy Grammer, actress Amy Poehler, actor Pierce Brosnan, and more.

This campaign comes at a crucial time, when scientific progress in oncology is advancing dramatically, yet the need for innovations in research and care to help more cancer patients is still great, according to Glimcher.

"We have made groundbreaking discoveries in cancer, and today, thanks to the support from a generous community of donors, we know more about this terrible disease than ever before," said Glimcher. "While discoveries and new therapies are increasing at a rapid pace, many cancers remain difficult to diagnose early and hard to treat. Cancers are striking younger people more frequently, and many barriers to equitable care still exist. The Dana-Farber Campaign will marshal the resources necessary to support our strategic initiatives and to Defy Cancer."

From chemotherapy discovered by Sidney Farber, MD, to targeted drugs for immunotherapies, to the 2019 Nobel Prize winning research of William Kaelin, MD, and throughout its seven-decade history, Dana-Farber discoveries have changed the lives of patients everywhere. Starting with scientific breakthroughs against childhood leukemia at the Institute’s founding in 1947, and many times since, Dana-Farber has advanced the standard of cancer care.

"Cancer isn’t one disease. It is many different diseases and different for each patient. But just as cancer continues to change, Dana-Farber needs resources to continue to evolve, advance, adapt, and accelerate our efforts if we are to ultimately defeat cancer for everyone – forever," said Bekenstein.

The Dana-Farber Campaign is a multi-year fundraising effort to increase philanthropic support to accelerate success against cancer focusing on three pillars: revolutionary science, extraordinary care, and exceptional expertise:

Revolutionary Science: Science at Dana-Farber is rapidly transforming what is known about how cancer develops and how to treat it. While Institute findings have led to new therapies and helped many people, some cancers still elude early detection and treatment. Gifts to The Dana-Farber Campaign will support crucial research areas including cancer prevention and early detection; data science, including artificial intelligence and machine learning; precision immunotherapy; and more.
Extraordinary Care: Dana-Farber’s integrated approach to care is a unique model, and its standards and protocols have been adopted around the world. Most Dana-Farber clinicians also conduct research, providing patients with ready access to more than 1,000 therapeutic and non-therapeutic trials and speeding the pathway "from bench to bedside" and back again. Campaign funds will spark innovations in research-based care, expand access to the high-quality care Dana-Farber is known for by reaching more patients and families in underserved populations, help address cancer disparities, and more.
Exceptional Expertise: Dana-Farber is committed to providing its expert scientists and clinicians with the resources they need to provide world-class care and pursue innovative research. Gifts to the Campaign will enable Dana-Farber to continue attracting and retaining the best talent, allow scientists to explore new ideas that could lead to the next cure, and provide clinicians more time with their patients.
Dana-Farber and the Jimmy Fund have always relied on generous donors and grassroots fundraisers to make huge strides against cancer, giving more "Jimmys" a hopeful future. Every step walked or race run; each mile on a bike or swing of the club; every donation to honor a loved one; every dollar makes a powerful difference because it is not a single act—it is part of a movement and an entire community coming together to fund cancer research and care at Dana-Farber.

"The Dana-Farber Campaign is ambitious and important. Each gift will make a difference in the lives of pediatric and adult patients around the world," said Michael Eisenson. "Together, we can make monumental strides to Defy Cancer."

Working closely with Eisenson is Vice Chair of The Dana-Farber Campaign, Monica Chandra, an Institute Trustee and Managing Partner of 3EDGE Asset Management.

The Dana-Farber Campaign began its quiet phase in October 2017 and the Institute has received commitments for approximately 60 percent of the goal to date.

Last week, Judith B. Hale, her son, Robert T. Hale, Jr., and his wife, Karen Hale, pledged a $50 million gift to support The Dana-Farber Campaign by enabling a wide range of ambitious work in two main areas of pancreatic cancer research: early detection and prevention, and precision medicine and biology. The gift will launch teams of scientists to leverage health system data to identify those at highest risk for pancreatic cancer, detect it earlier through new imaging approaches and blood tests, and develop new treatments for pre-invasive and early invasive pancreatic cancers.

The campaign is anticipated to close in September 2024.

Cue Biopharma Reports First Quarter 2021 Results, Recent Updates of CUE-101 Phase 1 Dose Escalation Study, Platform Progress and Business Highlights

On May 17, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, reported a business and clinical progress update for the first quarter 2021 (Press release, Cue Biopharma, MAY 17, 2021, View Source [SID1234608279]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the first quarter of 2021 and early second quarter, we continued to make significant progress advancing the Phase 1a/1b monotherapy trial of CUE-101 and continued development of our expanding pipeline and technology platforms, as well as enhancing our capital resources," said Daniel Passeri, chief executive officer of Cue Biopharma. "Importantly, we recently reported a confirmed partial response (PR) in a patient from our ongoing Phase 1 monotherapy dose escalation trial of CUE-101 and look forward to providing further details as well as describing the development implications for CUE-101 and potential of the CUE-100 series and Immuno-STAT platform, during the quarterly update call."

Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We finished the first quarter of 2021 in a solid financial position which was further strengthened by the deployment of our at-the-market (ATM) common stock facility in April that enabled us to boost our cash position by an additional $10.4 million giving us operational runway into the fourth quarter of 2022."

Recent News & Business Updates

Reported PR in one patient and stable disease (SD) in five patients, confirmed by RECIST criteria, providing evidence of single-agent clinical activity of CUE-101 in the ongoing Phase 1 monotherapy dose escalation trial in late stage second-line and beyond patients with HPV+ recurrent/metastatic head and neck cancer, as well as evidence of both tumor-specific CD8+ T cell expansion and dose-dependent increases in NK cells.
Extended cash runway with sales in April of an aggregate of $10.4 million shares of our common stock pursuant to our ATM equity offering sales agreement with Stifel. As of April 30, 2021, we sold a cumulative total of 2,099,700 shares of common stock for aggregate net proceeds of $32.7M, net of commissions paid, under the sales agreement.
Initiated Phase 1 dose escalation clinical trial of CUE-101 in combination with Merck’s KEYTRUDA, an anti-PD-1 biologic agent, as first-line therapy in patients with advanced HPV16+ head and neck cancer.
Appointed renowned experts Abul K. Abbas, M.D., distinguished professor in pathology and former chair of the department of pathology at the University of California, San Francisco (UCSF) and Michael Kalos, Ph.D., managing director of Next Pillar Consulting, LLC and former executive vice president and head of research and development at ArsenalBio, to our Scientific Advisory Board (SAB).
First-Quarter 2021 Financial Results

The Company reported collaboration revenue of approximately $1.6 million and $0.9 million for the three months ended March 31, 2021 and 2020, respectively.

Research and development expenses were $9.8 million and $9.9 million for the three months ended March 31, 2021 and 2020, respectively. The decrease in research and development expenses of $0.9 million was primarily due to a decrease in laboratory and drug substance manufacturing costs as the clinical supply for our lead drug candidate, CUE-101, was produced during 2020, as well as a reduction in clinical and travel related expenses.

General and administrative expenses were $4.3 million and $4.0 million for the three months ended March 31, 2021 and 2020, respectively. The increase in general and administrative expense of $0.3 million was primarily due to an increase in stock-based compensation expense and legal fees incurred in the first quarter of 2021 as compared to the same period in 2020.