On March 15, 2021 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP), reported in collaboration with Pfizer Inc., ten projects have been chosen to receive funding to support innovative approaches to improve the processes related to appropriate biosimilar adoption in oncology (Press release, NCCN, MAR 15, 2021, View Source [SID1234576675]).

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The selected organizations and research projects are:

American Society of Clinical Oncology, Inc., ASCO (Free ASCO Whitepaper)’s PracticeNET Learning Network
Analysis of Biosimilar Utilization and Perspectives within ASCO (Free ASCO Whitepaper)’s PracticeNET Learning Network
Baptist Memorial Hospital Tipton
Adoption of Biosimilars in Oncology
Cancer Support Community
Frankly Speaking About Cancer: Biosimilars – Researching Oncology Patient and Caregiver Perceptions
Cedars-Sinai Medical Center
Optimize Systemic Platform to Assure Quality, Value and Evidence-Based Decision Making on Biosimilar Products Use in Oncology Patients
City of Hope Medical Foundation
Challenges to Biosimilar Adoption in Community Oncology Due to Diverse Payer Preferences for Different Biosimilar
Houston Methodist
Impact of Discordant Preferred Drug Status between Hospitals and Payers for Chemotherapeutic Biosimilars
Roswell Park Comprehensive Cancer Center
Identifying Best Practices in Biosimilar Implementation
University of Illinois at Chicago
Developing a Human-Centered Information Packet to Increase Trastuzumab Biosimilars Uptake
The University of Texas at Austin
Biosimilar Optimization in Community Oncology Practice
UT Southwestern Medical Center
Developing a Clinical Decision Support Tool for Biosimilar Use in Oncology
"This research highlights NCCN’s commitment to exploring new avenues for increasing the availability of affordable, effective treatment options in oncology," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "These projects will help us to determine best practices for using biosimilars—when safe and appropriate—and how to educate providers and patients about them."

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology. For more information, visit NCCN.org/ORP.

On March 15, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided recent business highlights.

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"2020 was a transformative year for Shattuck, and as we look ahead to 2021, we are excited to reveal the unique biology unlocked by the Agonist Redirected Checkpoint (ARC) technology in patients with cancer," said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. "We look forward to the Phase 1 data releases in the second half of this year for SL-172154 in patients with ovarian cancer and for SL-279252 in patients with advanced solid tumors. In addition, we are on-track to file an Investigational New Drug application in 2021 and to announce the lead candidate from our Gamma Delta T Cell Engager (GADLEN) platform. This is an exciting time for Shattuck and all of our stakeholders, and we believe that we are poised for years of clinical progress and expansion."

Fourth Quarter 2020 Recent Business Highlights and Other Recent Developments

Continued Enrollment of Phase 1 Clinical Trial of SL-172154 in Ovarian Cancer: Shattuck continues to enroll patients in its Phase 1 clinical trial for its lead wholly owned asset SL-172154, a CD47/SIRPα inhibitor and CD40 agonist, and the second clinical program to advance from its proprietary ARC platform. The Phase 1 trial is an open label, multi-center dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 in patients with ovarian cancer. Initial Phase 1 dose-escalation data from the trial are expected in the second half of 2021.
Initiated Enrollment of Phase 1 Clinical Trial of SL-172154 in Head and Neck or Skin Squamous Cell Carcinoma: Shattuck also initiated a Phase 1 clinical trial for its lead wholly owned asset SL-172154, administered intratumorally. The Phase 1 trial will evaluate the safety, tolerability, and anti-tumor effects of SL-172154 in patients with squamous cell carcinoma of the head and neck or skin. Initial Phase 1 dose-escalation data from the trial are expected in the first half of 2022.
Continued Enrollment of Phase 1 Clinical Trial of SL-279252: Shattuck continues to enroll patients in its Phase 1 clinical trial evaluating SL-279252, a PD-1/PD-L1 inhibitor and OX40 receptor agonist. The Phase 1 trial is an open label, multi-center, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamics effects of SL-279252 in patients with advanced solid tumors or lymphomas. SL-279252 is currently being developed in collaboration with Takeda Pharmaceuticals. Phase 1 dose-escalation data from the trial are expected in the second half of 2021.
Presented Preclinical Development of SL-9258: Preclinical data for SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, was released at the TIGIT Therapies Summit in October 2020. These data provided preclinical evidence for anti-tumor activity of the murine equivalent of SL-9258 in PD-1 resistant tumors and increased tumor rejection in comparison to TIGIT blocking antibodies.
Presented Preclinical Introduction of GADLEN Platform: Preclinical proof of concept data on Shattuck’s proprietary GADLEN platform was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting in November 2020. GADLEN compounds were shown to stimulate proliferation and activation of gamma delta T cells in vivo and to target those expanded cells to a selected tumor antigen.
Completed Initial Public Offering (IPO): In October 2020, Shattuck completed an upsized IPO of common stock at $17.00 per share, raising gross proceeds of approximately $232.3 million and extending its cash runway through 2024.
Upcoming Events

In April 2021, Shattuck will present an update on preclinical development of an in vivo model of checkpoint acquired resistance and updated information on its GADLEN platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
Shattuck will attend the following investor conferences. Details of the presentations and webcasts will be announced prior to the events.
○ 31st Annual Oppenheimer Healthcare Conference, March 16-18
○ 20th Annual Needham Healthcare Conference, April 12-15
○ 7th Annual Truist Securities Life Sciences Summit, May 4-5
Fourth Quarter and Full Year 2020 Financial Results

Cash Position: As of December 31, 2020, cash and cash equivalents and short-term investments were $335.4 million, as compared to $39.1 million as of December 31, 2019. Net cash provided by financing activities for the year ended December 31, 2020 was $330.9 million, primarily comprised of approximately $117.0 million in net proceeds from Shattuck’s Series B and B-1 financings and $213.5 million in net proceeds from Shattuck’s IPO, completed in October 2020, partially offset by cash used in operating and investing activities.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter ended December 31, 2020 were $9.8 million, as compared to $8.8 million for the fourth quarter ended December 31, 2019. R&D expenses for the year ended December 31, 2020 were $37.5 million, as compared to $29.2 million for the year ended December 31, 2019.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter ended December 31, 2020 were $3.6 million, as compared to $1.7 million for the fourth quarter ended December 31, 2019. General and administrative expenses for the year ended December 31, 2020 were $9.4 million, as compared to $5.7 million for the year ended December 31, 2019.
Net Loss: Net loss was $12.0 million for the fourth quarter ended December 31, 2020, or $0.31 per basic and diluted share, as compared to a net loss of $7.4 million for the fourth quarter ended December 31, 2019, or $0.97 per basic and diluted share. Net loss for the year ended December 31, 2020 was $36.6 million, or $2.36 per basic and diluted share, as compared to $24.0 million, or $3.17 per basic and diluted share, for the year ended December 31, 2019.
2021 Financial Guidance

Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations through 2024, which is beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding that may be received or business development or additional clinical development activities that may be undertaken. (Press release, Shattuck Labs, MAR 15, 2021, View Source [SID1234576694])

On March 15, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported financial results for the fourth quarter and full year 2020 (Press release, Agenus, MAR 15, 2021, View Source [SID1234576640]).

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"2020 was a pivotal year for Agenus, marking the beginning of our transition to a commercial company with the initiation of our rolling BLA filing for balstilimab monotherapy. We also reported positive data on multiple programs," said Garo Armen, PhD, Chief Executive Officer of Agenus. "We expect 2021 to be even more impactful, with the expected completion of our balstilimab monotherapy BLA filing in the first half. This filing, followed by an anticipated commercialization, will provide a solid foundation to support the development of our next-generation pipeline. Our best-in-class pipeline reveals true differentiation potential, notably our next-generation anti-CTLA-4 AGEN1181 and our anti-TIGIT bispecific AGEN1777."

Balstilimab (anti-PD-1): BLA completion expected in first half of 2021

Balstilimab accelerated approval in second line cervical cancer expected to be a significant milestone in the transition to a commercial company and a key inflection point for Agenus’ combinations strategy both with its own pipeline agents and with partnered products

Balstilimab shows differentiation from commercial PD-1s and achieves response rates of 19% in PD-L1 positive tumors with 14% in all tumors (PD-L1 positive and negative) and a median duration of response of 15.4 months in a Phase 2 trial. Data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 and in an Oncogene editorial

Balstilimab + zalifrelimab Phase 2 trial in second line cervical cancer achieves response rates of 27% in PD-L1 positive tumors with 22% in all tumors (PD-L1 positive and negative) with a median duration of response not yet reached; data presented at ESMO (Free ESMO Whitepaper) 2020. Responses continue to improve as data matures

Discussions with the FDA regarding accelerated BLA filing for balstilimab plus zalifrelimab ongoing; additional guidance and updated response rate data to be provided upon FDA acceptance of balstilimab monotherapy BLA
AGEN1181: Clinical data points to superior next-generation anti-CTLA-4 agent

As of our February 9th report, six confirmed objective clinical responses were achieved in Phase 1/2 trial of AGEN1181 out of 46 evaluable patients: 1 confirmed response among 24 treated with monotherapy, and 5 confirmed responses among 22 treated with AGEN1181 in combination with balstilimab

New clinical data to be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021

Optimized Fc-enhanced design differentiates AGEN1181 as a more active next-generation anti-CTLA-4

Responses seen in patients who do not generally respond to first-generation anti-CTLA-4 due to a genetic polymorphism, thus potentially expanding benefit to 3x more patients

Further, responses seen in cold tumor settings (microsatellite stable) and in indications that are generally not responsive to immunotherapy, including colorectal, endometrial, and ovarian

No complement-mediated toxicities typically seen with first-generation anti-CTLA-4 agents

First anti-CTLA-4 to demonstrate clinical depletion of Tregs, immunosuppressive T cells whose depletion can allow for an improved antitumor immune response

Phase 2 trial in colorectal cancer initiated; registrational trials targeted to commence in 2021 with focus on indications enabling a rapid path to BLA filing
AGEN1777 (Anti-TIGIT bispecific): Best-in-class potential; slated for IND filing in 2Q 2021

Superior antibody candidate for bispecific targeting and Fc enhancement, designed for best-in-class performance

Optimized antibody designed to improve upon limited monotherapy activity of other anti-TIGITs

Potential to broaden clinical benefit to additional 40% of patients versus other TIGIT antibodies by expanding benefit to patients with a genetic polymorphism

Bispecific design enables dual blockade of tumor growth, cutting off a potential cancer escape mechanism to TIGIT blocking

IND planned for the second quarter of 2021; Phase 1 study to commence in the third quarter
iNKTs – Intelligent cell therapy: Trial underway in patients with COVID-19; cancer trials to commence in 1H 2021

Preliminary Phase 1 data suggest iNKTs can be dosed with no safety concerns and may demonstrate early signals of activity. Trial expansion is underway

Dose escalation expected to be completed in the first half of 2021 for initiation into a Phase 2 trial

Dosing in Phase 1 study to treat hematologic cancers and solid tumors expected to commence in the first half of 2021
Partnered program MK-4830: Phase 2 initiated; milestone received

MK-4830 (antibody targeting ILT4 licensed to Merck) advanced into Phase 2 in patients with PD-L1 positive advanced non-small cell lung cancer

$10M milestone payment received; Agenus is eligible for up to an additional $85M in potential milestone payments plus royalties. Agenus retains 90% of all milestones from Merck and 67% of future royalties under its Royalty Purchase Agreement with XOMA LLC

MK-4830 positive Phase 1 data presented at ESMO (Free ESMO Whitepaper) 2020
Enhancing talent density to drive key initiatives

Dr. Steven O’Day, pioneer in I-O and anti-CTLA-4 therapy, joins as Chief Medical Officer to drive clinical trial development especially for AGEN1181

Andy Hurley, a seasoned commercial executive, joins as Chief Commercial Officer to head Agenus’ efforts as it prepares for anticipated balstilimab commercialization

Marc Wiles, an expert in new product approvals, joins as Vice President of Regulatory Affairs

Jason Paragas, leader in AI and pandemic surveillance, joins as Divisional Vice President of Strategic Initiatives
Agenus initiatives in adjuvants, biomarker platforms, and predictive AI

First QS-21 milestone payment of $15.1M based on SHINGRIX sales received from Healthcare Royalty Partners; process for large-scale production of renewable raw source of QS-21 advancing to GMP scale-up

Proprietary VISION platform, along with artificial intelligence, designed to allow for discovery of novel biomarkers and design of optimal treatment protocols for patients

Updates on AGEN2373, our anti-CD137 antibody, and AGEN1223, our novel bispecific, will be presented at future scientific and medical conferences
Strategic partnerships expand potential of Agenus molecules

Betta Pharmaceuticals licensing agreement for balstilimab and zalifrelimab in Greater China; Agenus received $35M in cash and equity and is eligible for up to $100M in milestones plus royalties

Rottapharm Biotech access program for balstilimab in combination with CR6086, a potent and selective prostaglandin EP4 receptor antagonist, in patients with advanced metastatic colorectal cancer

Nelum Pharmaceuticals clinical collaboration for zalifrelimab in combination with NLM-001, Nelum’s small molecule hedgehog inhibitor, and chemotherapy for first-line advanced pancreatic cancer
Fourth Quarter and Full Year 2020 Financial Results

For the year ended December 31, 2020, we recognized revenue of $88 million which includes revenue related to the upfront license fee from our transaction with Betta plus non-cash royalties and milestones earned. For the year ended 2019 we recorded revenue of $150 million which included revenue related to the upfront license fee from our transaction with Gilead and milestones earned, in addition to non-cash royalties earned.

Net loss for the fourth quarter was $38 million or $0.20 per share compared to a net loss for the same period in 2019 of $31 million, or $0.22 per share. Net loss for the year ended 2020 was $183 million or $1.05 per share compared to a net loss for the year ended 2019 of $112 million or $0.80 per share.

Fiscal year end 2020 cash balance was $100 million as compared to $62 million at fiscal year end 2019.

Conference Call

Dial-in numbers: (833) 614-1394 (US) or (914) 987-7115 (International); Conference ID: 2339028.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

On March 15, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that the Company will present at the Oppenheimer 31st Annual Healthcare Conference, a virtual event, on Thursday, March 18, 2021 at 9:20 AM (EDT) (Press release, Cyclacel, MAR 15, 2021, View Source [SID1234576658]). Spiro Rombotis, President & Chief Executive Officer, will provide an overview of the Company and progress in key programs. Cyclacel will host one-on-one meetings with investors during the event.

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A live webcast of the presentation will be available through the Company’s website: www.cyclacel.com. The webcast will be archived for 90 days.

On March 15, 2021 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that its President and Chief Executive Officer, Peter L. Hoang, will present at the upcoming Virtual Oppenheimer 31st Annual Healthcare Conference on Wednesday, March 17, 2021 at 3:10 p.m. ET (Press release, Marker Therapeutics, MAR 15, 2021, View Source [SID1234576676]).

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A live webcast of the presentation will be accessible from the Investors section of the company’s website at markertherapeutics.com and will be available for replay following the event.