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.

On May 17, 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, led by its Orascovery platform, reported that investigators from Texas Children’s Cancer Center and the Center for Cell and Gene Therapy at Baylor College of Medicine presented new clinical data from the ongoing GINAKIT2 phase 1 study of Athenex’s cell therapy candidate KUR-501 targeting GD2 in neuroblastoma at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting on Friday, May 14, at 11 am ET (Press release, Athenex, MAY 17, 2021, View Source [SID1234580111]).

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!

Observed responses to date in 11 evaluable, heavily pretreated patients with neuroblastoma, include one complete response (CR) and one partial response (PR). Four additional patients have exhibited stable disease (SD). The durations of response for the CR and PR were approximately 5 and 3 months, respectively. No patients experienced grade 2 or higher toxicities related to the GD2-CAR NKTs. Post-treatment tumor biopsies showed GD2-CAR NKTs homing to metastatic lesions at all dose levels. The CAR-NKT AUC normalized to disease burden (AUC/Curie score using MIBG scan quantified tumor burden) appears to be associated with response to therapy.

"The results of the ongoing phase I study further validate the clinical activity of CAR-NKT cells," said Dr. Kurt Gunter, Chief Medical Officer of Athenex Cell Therapy. "The data thus far demonstrate clinical responses and tumor homing with an attractive safety profile. We are grateful to the patients and families for their participation in these studies and to the scientists and physicians at Texas Children’s Cancer Center and Baylor College of Medicine for their scientific leadership."

Dr. Andras Heczey, from Baylor College of Medicine, presented updated data from the GINAKIT2 study of autologous CAR-NKT cells. The title of the presentation is "Natural Killer T Cells Expressing a GD2-CAR and IL-15 Are Safe and Can Induce Complete Remission in Children with Relapsed Neuroblastoma – A First-in-Human, Phase 1 Trial". Dr. Heczey is the principal investigator for this study. The abstract and his work were selected for presentation at this year’s Clinical Trials Spotlight Symposium.

"We are encouraged by the reassuring safety profile, expansion/persistence/tumor trafficking parameters and by the evidence of clinical activity with autologous, engineered CAR-NKT cell therapy at relatively low doses," said Dr. Heczey, Associate Professor of Pediatrics – Oncology at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center. "We look forward to advancing the program into additional dose levels and treating additional patients."

About KUR-501

KUR-501 is an autologous product in which NKT cells are engineered with a CAR targeting GD2, which is expressed on almost all neuroblastoma tumors, as well as other malignancies. KUR-501 is being tested in the phase 1 GINAKIT2 clinical study (NCT03294954) in patients with R/R high risk neuroblastoma. The single-arm study will evaluate six dose levels of KUR-501 with patients receiving pre-dose lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine.

Neuroblastoma is a pediatric cancer and patients with R/R high risk neuroblastoma have a poor prognosis and a significant unmet medical need. The KUR-501 development program is also designed to provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target.

The GINAKIT2 study is supported by Athenex, Inc., which acquired Kuur Therapeutics in May 2021, and Alex’s Lemonade Stand Foundation, is conducted by Athenex’s collaborator, BCM, and is currently recruiting patients.

On May 17, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the first quarter of 2021 ended March 31, 2021 and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, MAY 17, 2021, View Source [SID1234580151]).

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!

"The last few months were marked by significant accomplishments. We leveraged existing and new alliances to materially bolster our balance sheet with $46 million in capital through recent upfront and milestone payments, focused equity stakes by partners AstraZeneca and Seagen, and ongoing funding support by our partners for several assets, ensuring that we are well positioned to execute on our strategic plans into 2023. These partnerships are helping us advance several therapeutic programs and further validate our Anticalin platform. We are pleased that dosing of asthmatic patients with PRS-060/AZD1402 has begun in the previously announced phase 2a study, and we expect to report data from this study next year. The phase 1 data we presented at AACR (Free AACR Whitepaper) last month for cinrebafusp alfa, our 4-1BB/HER2 bispecific, support entry into a phase 2 study this summer in HER2-high and HER2-low gastric cancer, where we are setting a high bar to govern development beyond the initial cohort in each study arm. The preclinical data we presented at AACR (Free AACR Whitepaper) with our co-development partner, Servier, for PRS-344/S095012, a 4-1BB/PD-L1 bispecific, provide a compelling rationale for clinical development, which will begin later this year. Expanding our roster of 4-1BB-based bispecifics advancing towards clinical development, we also recently announced an immuno-oncology collaboration with Boston Pharmaceuticals to advance PRS-342, a 4-1BB/GPC3 bispecific, into the clinic," said Stephen S. Yoder, President and Chief Executive Officer of Pieris.

PRS-060/AZD1402 and AstraZeneca Collaboration: Dosing has begun in the first part of the global phase 2a study of PRS-060/AZD1402, an inhaled IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Pieris and AstraZeneca expect to announce data from the phase 2a study next year. Upon completion of the study, which is being sponsored and funded by AstraZeneca, Pieris will have options to co-develop and, subsequently, co-commercialize PRS-060/AZD1402 in the United States. Pieris and AstraZeneca continue to advance each of the four programs in the collaboration beyond PRS-060/AZD1402.
Cinrebafusp Alfa (PRS-343): Pieris is preparing a two-arm phase 2 study for cinrebafusp alfa, a 4-1BB/HER2 bispecific for the treatment of HER2-expressing solid tumors, in gastric cancer that will begin this summer and will set a high bar for clinical benefit, durability of response, and safety to determine further development beyond the planned initial 20 patients in each study arm. Pieris presented updated data for this program in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. In clinical trials to date, cinrebafusp alfa has shown an acceptable safety profile at all doses tested with no dose-limiting toxicities. Single-agent activity has been most pronounced on a Q2W regimen, which includes one confirmed complete response and four confirmed partial responses, and which will be the basis for phase 2 development. The bispecific also showed a clear dose response and a 4-1BB-driven mechanism of action based on clinical benefit and pharmacodynamic correlates. Additionally, clinical activity was observed in patients with "cold" tumors, as well as those with HER2-low expressing tumors. Supported by these data, the first arm of the announced phase 2 study will be in combination with ramucirumab and paclitaxel in HER2-high gastric cancer, while the second arm will be in combination with tucatinib in HER2-low gastric cancer. Collaboration partners Lilly and Seagen will supply ramucirumab and tucatinib, respectively, under previously announced drug supply agreements.
PRS-344/S095012 and Servier Collaboration: Pieris and Servier presented preclinical data for PRS-344/S095012, a 4-1BB/PD-L1 bispecific, as part of a poster session at the AACR (Free AACR Whitepaper) Annual Meeting 2021. PRS-344/S095012 induced a dose-dependent anti-tumor response and significantly extended survival in an anti-PD-L1-resistant mouse model. The data also demonstrated PRS-344/S095012 to be superior to the combination of individual PD-L1- and 4-1BB- targeting molecules. PRS-344/S095012 is expected to enter phase 1 development later this year. Pieris holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales for this program. As part of our multi-program immuno-oncology collaboration, Servier is also responsible for further development of PRS-352, an undisclosed bispecific.
PRS-342/BOS-342 and Boston Pharmaceuticals Collaboration: Pieris entered into an exclusive product license agreement wherein Boston Pharmaceuticals will develop PRS-342, a 4-1BB/GPC3 immuno-oncology Anticalin-antibody bispecific fusion protein in the IND-enabling phase. Under the terms of the agreement, Boston Pharmaceuticals exclusively licensed worldwide rights to PRS-342. Pieris will receive an upfront payment of $10 million and is further entitled to receive up to approximately $353 million in development, regulatory, and sales-based milestone payments, and tiered royalties. Pieris will also contribute an undisclosed amount and input for manufacturing activities to support IND-readiness.
Preclinical Respiratory Pipeline: Pieris continues to advance several proprietary early-stage respiratory programs and expects to share data and rationale for advancement of one of its lead innovative proprietary programs this year.
First Quarter Financial Update:

Cash Position – Cash and cash equivalents totaled $66.8 million for the quarter ended March 31, 2021, compared to a cash and cash equivalents balance of $70.4 million for the quarter ended December 31, 2020. The increase was due to $13 million received from Seagen in March 2021 offset by operating cash needs. The quarter end cash balance excludes both $23 million received from AstraZeneca in April and $10 million to be received from Boston Pharmaceuticals.

R&D Expense – R&D expenses were $16.6 million for the quarter ended March 31, 2021, compared to $12.8 million for the quarter ended March 31, 2020. The increase reflects higher spending on preclinical activities for our proprietary respiratory program and manufacturing costs for our immuno-oncology programs, while maintaining flat spending on other non-project related R&D costs.

G&A Expense – G&A expenses were $4.1 million for the quarter ended March 31, 2021, compared to $4.4 million for the quarter ended March 31, 2020. The decrease reflects more one-time costs incurred in 2020 related to the move to a new R&D facility in Hallbergmoos, Germany, partially offset by higher consulting expenses in the first quarter of 2021.

Net Loss – Net loss was $4.2 million or $(0.07) per share for the quarter ended March 31, 2021, compared to a net loss of $3.6 million or $(0.07) per share for the quarter ended March 31, 2020.

First Quarter Financial Update Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Monday, May 17, 2021, to discuss the first quarter of 2021 financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.

On May 17, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes, reported the close of its US$125 million Series C financing round (Press release, Hummingbird Bioscience, MAY 17, 2021, View Source [SID1234580169]). The financing was led by Novo Holdings, with significant participation from new investors including Frazier Healthcare Partners, Octagon Capital, EDBI, AMGEN Ventures, DROIA Ventures, Morningside Ventures, Pureos Bioventures, Polaris Partners, Affinity Asset Advisors, Ally Bridge Group and Altrium Capital Management. Existing investors including SK Inc, Heritas Capital, and Mirae Asset Venture Capital also joined the round.

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!

"We are delighted to have the support and confidence of leading global healthcare investors to advance the development of our unique pipeline of precision therapies against important, yet hard-to-drug targets. We have made tremendous progress since closing our Series B in 2019 and this financing reflects strong support for our platform, people, and development strategy," said Piers Ingram, Chief Executive Officer and co-founder, Hummingbird Bioscience. "With our world-class team of researchers and proprietary technologies, Hummingbird is at the cutting-edge of scientific discovery. These new funds give us further resources to invest in our early stage pipeline, as well as supporting the clinical development of our two lead programs that we believe can deliver very meaningful benefit for patients."

Proceeds from the financing will be used to advance the clinical development of Hummingbird’s lead assets including HMBD-001, a best-in-class HER3 antibody for NRG1-fusion and HER3-driven tumors, and HMBD-002, a first-in-class anti-VISTA neutralizing antibody for advanced solid tumors. The funds will also be used to expand the capabilities of Hummingbird’s proprietary Rational Antibody Discovery platform and progress the development of its next-generation pipeline of precision therapeutics including HMBD-009, a BCMA-TACI dual-specific T cell engager.

"We are delighted to lead this financing in Hummingbird and pleased to have attracted a syndicate of sophisticated investors to enable the acceleration of the company’s clinical development activities. We believe that Hummingbird’s novel data-driven, systems biology approach brings new precision to the field of antibody drug discovery and development, and we are proud to support the team in realizing their vision," said Kenneth Harrison, Partner, Novo Ventures.

Kenneth Harrison along with Dan Estes, General Partner, Frazier Healthcare Partners, and Kiel Kim, Vice President, SK Inc., will join Hummingbird’s board of directors.

"Hummingbird is at an exciting point, on the cusp of starting clinical studies for both HMBD-001 and HMBD-002. I look forward to working with the Hummingbird team in developing and building out its portfolio of drug candidates that have transformative potential for patients with cancer and autoimmune diseases," said Dan Estes.

Kiel Kim said: "There is significant potential for novel antibody-based therapeutics and through Hummingbird’s Rational Antibody Discovery platform, we can now discover high value antibodies for challenging targets. We look forward to continuing our partnership with Hummingbird to solve complex challenges in antibody development, and deliver highly differentiated therapies to patients in need."

On May 17, 2021 Landos Biopharma, Inc (NASDAQ: LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, and LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, reported an exclusive collaboration and license agreement for the development and commercialization of omilancor and NX-13 in Greater China (mainland China, Hong Kong, Taiwan and Macau) and select Asian markets (Press release, LianBio, MAY 17, 2021, View Source [SID1234580242]). Omilancor is a novel, oral, gut-restricted LANCL2 agonist in development for the treatment of ulcerative colitis (UC), Crohn’s disease (CD) and Eosinophilic Esophagitis (EoE). NX-13 is a novel, oral, gut-restricted NLRX1 targeting compound in development for the treatment of UC and CD.

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!

"We are excited to collaborate with LianBio to strategically integrate their clinical and operational expertise in major Asian markets as we expand into global development programs with our innovative autoimmune disease pipeline," said Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. "Our lead product candidates, omilancor and NX-13, are designed to have critical advantages over current therapies, including the capacity to target key and novel pathways specifically linked to immune function. The opportunity to capitalize upon LianBio’s resources in Asian markets will enable us to leverage the full value of our assets globally and bring our potentially more effective and better tolerated first-in-class oral therapeutics to patients with UC and CD in Greater China and select Asian markets."

Under the terms of the collaboration, LianBio will receive exclusive rights to develop and commercialize omilancor and NX-13 in Greater China, South Korea, Singapore, Thailand, Vietnam, Myanmar, Cambodia, Indonesia, and the Philippines. Landos will receive an upfront cash payment of $18 million and is eligible to receive development and commercial milestone payments of up to $200 million. Landos is also eligible to receive tiered low double-digit royalties based on net sales of omilancor and NX-13 in the licensed territories. LianBio will participate in future global Phase 3 trials of omilancor and NX-13 by enrolling a meaningful number of patients in these studies. LianBio will fund development and commercialization expenses in the collaboration territory, and Landos will continue to fund all development and commercialization expenses in all other geographies.

"We believe Landos’ differentiated approach to the discovery and development of first-in-class oral therapeutics to target novel immunometabolic pathways has the potential to transform the treatment paradigm for CD, UC and other autoimmune diseases," said Konstantin Poukalov, Managing Director, Perceptive Advisors and Executive Chairman, LianBio. "With inflammatory bowel disease incidence projected to significantly increase throughout Asia over the coming decade, we look forward to partnering with Landos to address the current and future needs of IBD patients."