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AffyImmune Therapeutics’ AIC100 Granted Fast Track Designation for Treating Thyroid Cancer

On May 17, 2021 AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers, reported that the US Food and Drug Administration (FDA) granted Fast Track designation to its lead compound, AIC100, for the treatment of anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer (Press release, AffyImmune Therapeutics, MAY 17, 2021, View Source [SID1234580172]). The company previously received Orphan Drug designation for AIC100.

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The FDA’s Fast Track designation is designed to facilitate development and expedite review of drug candidates to treat serious conditions and address an unmet medical need. Receipt of Fast Track designation provides grounds for more frequent interaction with the FDA throughout the drug development process for more rapid advancement, earlier approval and access for patients.

"We are pleased to have received Fast Track designation for our first-in-human CAR T cell product currently being tested in patients with refractory thyroid cancer," remarked Eric von Hofe, President and COO of AffyImmune. "It highlights the unmet need in treating refractory solid tumors and points to the potential of AIC100 to address that need. We look forward to a close relationship with the FDA to expedite development and future approvals."

In connection with the approval, AffyImmune has made available its expanded access policy for AIC100 at View Source

Nuvation Bio Reports First Quarter 2021 Financial Results and Provides Business Update

On May 17, 2021 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported its financial results for the first quarter ended March 31, 2021, and provided a business update (Press release, Nuvation Bio, MAY 17, 2021, View Source [SID1234580171]).

"Nuvation Bio continues to make meaningful progress on advancing our deep pipeline of therapies for difficult-to-treat cancers and remains on track to submit five additional Investigational New Drug (IND) applications by 2026," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "We also continue to enroll and dose patients in our Phase 1/2 study of NUV-422, our lead cyclin-dependent kinase (CDK) 2/4/6 inhibitor, in high-grade gliomas and expect top-line data from the Phase 1 portion of this study in 2022. Our strong cash, cash equivalents and marketable securities of $824.7 million at the end of the first quarter provides us sufficient resources to continue to execute on our robust clinical development plan and grow our pipeline of novel and mechanistically distinct cancer treatments."

Recent Business Highlights

Enrollment ongoing in Phase 1/2 study of NUV-422. Nuvation Bio continues to enroll and dose patients in the Phase 1/2 study of its lead investigational compound, NUV-422, a CDK 2/4/6 inhibitor, in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM). The Phase 1 dose escalation portion of the study is designed to evaluate safety and tolerability, as well as to determine a recommended Phase 2 dose based on the tolerability profile and pharmacokinetic properties of NUV-422. The Phase 2 dose expansion portion of the study is expected to initially focus on patients with high-grade gliomas and is designed to evaluate overall response rate, duration of response and survival. Data from the Phase 1 portion of this study is expected in 2022.
First Quarter 2021 Financial Results

As of March 31, 2021, Nuvation Bio had cash, cash equivalents, and marketable securities of $824.7 million.

For the three months ended March 31, 2021, research and development expenses were $15.9 million, compared to $7.3 million for the three months ended March 31, 2020. The increase of $8.6 million was due to an increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial. Also, the current period includes approximately $3.7 million related to the issuance of common stock as consideration for the purchase of in-process research and development.

For the three months ended March 31, 2021, general and administrative expenses were $4.6 million, compared to $1.9 million for the three months ended March 31, 2020. The increase of $2.7 million was due to increased personnel-related costs driven by an increase in headcount, as well as increases in professional fees, insurance costs and tax expense.

For the three months ended March 31, 2021, Nuvation Bio reported a net loss of $20.4 million, or $(0.12) per share. This compares to a net loss of $8.7 million, or $(0.10) per share, for the comparable period in 2020.

Restatement of Panacea Financial Statements

Nuvation Bio also announced that, as reported in a Current Report on Form 8-K filed with the SEC on May 14, 2021, as a result of guidance provided by the SEC on April 12, 2021 regarding the accounting for warrants issued by special purpose acquisition companies (SPACs), it is restating the previously issued 2020 consolidated financial statements of Panacea Acquisition Corp. (Panacea). Panacea combined with Nuvation Bio Inc. (Legacy Nuvation Bio) and changed its name to Nuvation Bio Inc. on February 10, 2021 (the Merger).

The restatement pertains to the accounting treatment for Panacea’s public and private placement warrants that were outstanding on December 31, 2020, as well as the forward purchase agreement (the "FPA") with certain anchor investors, which provided for the potential future issuance of securities, including additional warrants. Consistent with market practice among SPACs, Panacea had been accounting for the warrants and the FPA as equity under a fixed accounting model. However, in light of the recent SEC guidance, we are restating Panacea’s historical financial statements for the year ended December 31, 2020 such that the warrants and the FPA are accounted for as liabilities and marked-to-market each reporting period. In general, under the mark-to-market accounting model, we measure the fair value of the liability-classified warrants and the FPA at the end of each reporting period and recognize any changes in their fair value in our operating results. As of December 31, 2020, Panacea had 4,954,167 warrants outstanding and subject to reclassification. Upon completion of the Merger, an additional 833,333 warrants were issued pursuant to the FPA.

The change in accounting treatment does not impact the historical financial statements of Legacy Nuvation Bio, which became the historical financial statements of the combined company upon completion of the Merger. In addition, Nuvation Bio currently expects that the reclassification of the warrants will have no impact on the liquidity or cash or cash equivalents in the historical financial statements of Panacea.

GT Biopharma Reports First Quarter 2021 Results

On May 17, 2021 GT Biopharma, Inc. ("GT Biopharma" or the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager (TriKE) protein biologic technology platform reported financial results for the first quarter ended March 31, 2021 and provided a general business update (Press release, GT Biopharma, MAY 17, 2021, View Source [SID1234580170]).

"In the first quarter of 2021, and in the weeks since, we were very pleased to report exciting and encouraging data from our ongoing Phase I/II clinical trial of GTB-3550 in MDS and AML," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "Both from efficacy and safety perspectives, our GTB-3350 TriKE program appears to be delivering the TriKE’s unique therapeutic potential which has been well tolerated in all of our patients. Our differentiated approach stimulating NK cell activity, reinforces our rationale to proceed with additional programs in solid tumor and hematologic cancers. In addition, with our $28.7M financing completed and a key strategic manufacturing partnership in place, we are well equipped and positioned to capitalize on the potential we are already seeing from these innovative new therapies. We again thank the patients and their families for their contribution, as we advance towards the prospect of an off-the-shelf monotherapy cancer therapeutic that can be therapeutically effective without supplemental engineered NK cells or the need for any combination drugs."

Clinical Highlights

Updated Interim Results from First-in-Human GTB-3550 TriKE Phase I/II Clinical Trial for the Treatment of High-Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML): In March and April 2021, GT Biopharma announced updated interim results from the Phase I dose-escalation portion of the Phase I/II expansion clinical trial of GTB-3550 TriKE from 9 patients with MDS and AML. Results demonstrated up to 63.7% reduction in bone marrow blast levels, restoration of endogenous NK cell function, proliferation and immune surveillance. All patients treated displayed no signs of any grade of cytokine release syndrome (CRS) across all dose cohorts. GTB-3550 TriKE is currently being administered to patients at doses significantly higher than the reported maximum tolerated dose (MTD) for continuous infusion of recombinant human interleukin-15 (IL-15).
Enrollment in Phase I Portion of GTB-3550 TriKE Phase I/II Clinical Trial in MDS and AML Continues: In April 2021, GT Biopharma announced the enrollment of patient 10 in its GTB-3550 TriKE Phase I/II Clinical Trial in high-risk MDS and AML patients. The patient was dosed at 100mcg/kg/day.
Additional New Findings Supporting GTB-3550 TriKE Monotherapy: In April 2021, GT Biopharma announced additional interim results demonstrating that GTB-3550 TriKE monotherapy is able to rescue the patient’s otherwise exhausted/inhibited/non-functional endogenous NK cell population, and target direct killing of the patient’s AML and MDS cancer cells without the need for the co-administration addition of supplemental progenitor-derived or autologous/allogenic engineered NK cells.
Announced Preliminary Phase II Clinical Trial Design: In May 2021, GT Biopharma announced updates to the Phase 2 design of the ongoing Phase I/II clinical trial of GTB-3550 TriKE monotherapy. The Phase II portion intends to enroll patients with CD33 expression ≥50% in independent cohorts (higher-risk MDS and AML); treat patients with two cycles of GTB-3550 therapy with a rest period between cycles as opposed to the single-cycle used during Phase 1; enroll patients with fewer prior treatment lines; and, (evaluate the potential use of minimal residual disease (MRD) based endpoints that may allow for accelerated approval.
Corporate Highlights

Closed $28.7 Million Public Offering and Successful Nasdaq Listing: In February 2021, GT Biopharma announced the closing of an underwritten public offering extending GT Biopharma’s cash runway through 2022. The Company also retired over $32 million in debt and consolidated capital structure to 28,637,000 shares issued and outstanding.
Strengthened Leadership Team with Key Appointments: In April 2021, GT Biopharma announced the appointment of Gregory Berk, M.D., as Chief Medical Officer and the transition of Jeffrey S. Miller, M.D., from Consulting Chief Medical Officer to Consulting Chief Scientific Officer. Additionally, in January 2021, GT Biopharma announced the appointments of Michael Breen and Rajesh Shrotriya, M.D., as independent directors to the Company’s Board of Directors.
Expanded GMP Manufacturing Agreement with Cytovance Biologics: In February 2021, GT Biopharma announced that it signed an expanded GMP manufacturing agreement with Cytovance Biologics for the manufacturing of all TriKE product candidates.
First Quarter 2021 Financial Results:

Cash Position: As of March 31, 2021, cash, cash equivalents and investments were $27.6 million, compared to $5.3 million as of December 31, 2020. The increase in cash, cash equivalents and investments was primarily due to the completed public offering of 4,945,000 shares of common stock for net proceeds of $24,679,000 after deducting underwriting discounts, commissions and other direct offering expenses. As of May 14th, current cash position of $35,000,000.
Research and Development Expenses: Research and development expenses were $1.6 million for the first quarter of 2021, compared to $.3 million for the same period in 2020. The increase in research and development expenses for the first quarter 2021 was primarily due to the issuance of 189,753 shares of common stock as payment of a fee valued at $1,355,000. We anticipate our direct clinical costs to increase in the remainder of 2021 upon the continuation of a phase one/two clinical trial of our most advanced TriKE product candidate, GTB-3550.
General Administrative Expenses: General administrative expenses were $27.3 million for first quarter 2021, compared to $.7 million for the same period in 2020. The increase in selling, general and administrative expenses is primarily attributable the increase in stock-based compensation. In the period ended March 31, 2021 we incurred $21,535,000 of stock-based compensation, we incurred no such expenses during 2020.
Net Loss: Net loss was $29.7million for the first quarter of 2021, resulting in basic and diluted net loss per share of $1.83. Net loss was $1.7 million for the same period in 2020, resulting in basic and diluted net loss per share of $0.41.
About GTB-3550 TriKE

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

Hummingbird Bioscience Raises US$125 Million in Series C Financing

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.

"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."

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.

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.