On March 1, 2022 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering the discovery and development of immuno-neurology therapeutics, reported management will participate in a panel discussion at the Cowen Annual Health Care Conference on Tuesday, March 8, 2022, at 2:10 p.m. ET (Press release, Alector, MAR 1, 2022, View Source [SID1234609319]).

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A live webcast of the panel will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 30 days following the event.

On March 1, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported that Shawn M. Leland, PharmD, RPh, Elevation Oncology’s Founder and Chief Executive Officer, will participate in the following investor conferences in March (Press release, Elevation Oncology, MAR 1, 2022, View Source [SID1234609311]):

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Cowen 42nd Annual Health Care Conference
Date: Tuesday, March 8
Panel Title: Tumor Agnostic Development
Panel Time: 12:50 p.m. ET

Oppenheimer 32nd Annual Healthcare Conference
Date: Wednesday, March 16
Presentation Time: 12:40 p.m. ET

A live webcast and replay of these events will be available on the Events page of the Company’s Investor Relations website at View Source

On March 1, 2022 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported that company management will participate in a panel discussion and one-on-one investor meetings at Cowen’s 42nd Annual Healthcare Conference taking place virtually March 7-9, 2022 (Press release, Cardiff Oncology, MAR 1, 2022, View Source [SID1234609310]).

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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

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Details on the panel can be found below.

A replay of the panel discussion will be available by visiting the "Events" section of the Cardiff Oncology website and will be archived for 30 days after the conference’s conclusion.

On March 1, 2022 Bold Therapeutics, a clinical-stage biopharmaceutical company, reported that they have successfully completed the Phase 1b (dose-escalation) portion of its seamless adaptive oncology trial of BOLD-100 in combination with FOLFOX in the treatment of advanced gastrointestinal cancers (colorectal, pancreatic, gastric and bile duct) (Press release, Bold Therapeutics, MAR 1, 2022, View Source [SID1234609309]).

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Bold Therapeutics Successfully Completes Phase 1b Trial and Advances into Global Phase 2 Trial of BOLD-100 in the Treatment of Advanced GI Cancers
Bold Therapeutics Successfully Completes Phase 1b Trial and Advances into Global Phase 2 Trial of BOLD-100 in the Treatment of Advanced GI Cancers
BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest. Collectively, these effects result in cell death in both sensitive and resistant solid and liquid cancers and in combination with a wide range of existing anti-cancer therapies. The FDA previously granted BOLD-100 Orphan Drug Designations (ODDs) in both Gastric and Pancreatic cancers, and Bold Therapeutics anticipates leveraging clinical data from the Phase 1b portion of its trial for one or more Breakthrough Therapy Designations (BTDs) in 2022.

The Phase 1b data – which Bold Therapeutics anticipates presenting at an upcoming cancer conference – indicate that (1) BOLD-100 can be safely combined with FOLFOX chemotherapy at a dose of 625 mg / m2 (the highest dose level tested), with no new Grade 3 or 4 treatment-emergent adverse events; and (2) patients can safely remain on treatment for an extended number of treatment cycles. Based on this strong safety and tolerability profile, the Study Steering Committee unanimously endorsed proceeding immediately into the Phase 2 (dose-expansion) portion of the study.

"Completing our Phase 1b trial with a strong safety profile for BOLD-100 is a significant achievement for Bold Therapeutics – and while it is too early to say anything definitive, preliminary efficacy data is undoubtedly encouraging," said Jim Pankovich, EVP, Clinical Development. "Despite substantial headwinds from the ongoing COVID-19 pandemic, we were nevertheless able to successfully enroll and treat patients at our six clinical sites in Canada, and I wish to recognize the patients for their contribution to this study as well as the persistent and resilient efforts of our investigators."

The Phase 2 (dose-expansion) portion of the seamless adaptive trial of BOLD-100 will enroll 80 additional patients at 13 investigational sites worldwide: 6 sites in Canada; 2 sites in the U.S.; and 5 sites in South Korea. Interim and complete Phase 2 data is expected by year-end 2022 and late 2023, respectively.

"As BOLD-100 advances into Phase 2, Bold Therapeutics crosses another significant value inflection point," stated Glenn Walthall, Chairman of the Board of Bold Therapeutics. "As Bold Therapeutics’ largest institutional investor, we are encouraged with the results that we’ve seen thus far and optimistic that BOLD-100 may significantly improve outcomes in these difficult-to-treat cancers that are often refractory to conventional treatment options. Consistent with preclinical observations, a number of patients in the study who had previously failed on FOLFOX alone suddenly responded when BOLD-100 was added to the treatment regimen – a result that can only be described as remarkable."

Bold Therapeutics executed a regional option agreement with an undisclosed biopharmaceutical company in South Korea in 2020 and is actively seeking development partners in other territories. Bold Therapeutics is also seeking investors for a data-driven institutional Series B round to be closed later in 2022, likely concurrent with interim Phase 2 results.

"I am exceptionally proud of the agile and industrious Bold Therapeutics team without whom this success would not be possible," added E. Russell McAllister, CEO of Bold Therapeutics. "Through innovative programs like NRC-IRAP, the Canadian government has provided Bold Therapeutics with substantial support in advancing our scientific understanding of BOLD-100 that not only allowed us to advance in the treatment of gastrointestinal cancer indications, but also opened up promising areas for future development. As a result, they share this win with us. The strong results from this Phase 1b trial and the overall accumulation of data on BOLD-100 continue to excite support for the development of this innovative therapeutic for patients with a wide range of advanced cancers."

On March 1, 2022 Dragonfly Therapeutics, Inc. ("Dragonfly") reported the achievement of a Phase 1 clinical development milestone for the DF6002/BMS-9896415 IL-12 program (Press release, Dragonfly Therapeutics, MAR 1, 2022, View Source [SID1234609308]). DF6002/BMS-9896415 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

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Dragonfly received investigational new drug approval for DF6002 from the U.S. Food and Drug Administration in May 2020, and its Phase 1/2 clinical trial for patients with advanced solid tumors began in July 2020. Bristol Myers Squibb (NYSE:BMY) signed an exclusive worldwide license agreement with Dragonfly Therapeutics for its IL-12 investigational immunotherapy program, including its extended half-life cytokine DF6002, in August 2020. Bristol Myers Squibb intends to advance the research and development of DF6002 in oncology and hematology.

Bristol Myers Squibb is responsible for the development and any subsequent commercialization of DF6002/BMS-9896415 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. Dragonfly is eligible to receive additional performance-based development, regulatory and commercial milestone payments. Dragonfly will receive up to 24% royalties on worldwide net sales.

"We are very encouraged by the progress being made on the DF6002/BMS-9896415 program and with Bristol Myers Squibb, whose broad range of oncology agents will help to accelerate the development of DF6002, the most advanced cytokine in Dragonfly’s pipeline," said Bill Haney, Co-founder and CEO of Dragonfly Therapeutics. "We remain confident that the talent, experience and commitment to science-driven innovation of the Bristol Myers Squibb team will enable DF6002/BMS-9896415 to discover novel, life-saving solutions for patients."

"We are pleased to see results in the clinic bearing out the original hypothesis that DF6002/BMS-9896415 offers a remarkably differentiated profile from other cytokine programs," said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Executive Vice President, Research & Early Development, Bristol Myers Squibb. "We look forward to our continued work with Dragonfly to further guide the program’s clinical data at this pivotal point in its development, as we continue to deliver on our commitment to serve more patients with cancer."

About DF6002
DF6002, an extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines developed by Dragonfly to address the high unmet need in patients with advanced cancer.

The Phase 1/2 clinical trial for DF6002/BMS-986415 is a first-in-human open-label, dose-escalation study with a consecutive parallel-group efficacy expansion study, designed to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of DF6002 as monotherapy and in combination with nivolumab. Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04423029).