On June 2, 2022 NuCana plc (NASDAQ: NCNA) reported that financial results for the first quarter ended March 31, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, JUN 2, 2022, View Source [SID1234615424]).

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As of March 31, 2022, NuCana had cash and cash equivalents of £52.6 million compared to £60.3 million as of December 31, 2021. NuCana continues to advance its various clinical programs and reported a net loss of £8.4 million for the quarter ended March 31, 2022, as compared to a net loss of £9.8 million for the quarter ended March 31, 2021. Basic and diluted loss per share was £0.16 for the quarter ended March 31, 2022, as compared to £0.19 per share for quarter ended March 31, 2021.

"We are excited about the optimized development plan we recently announced for NUC-3373 in colorectal cancer and have initiated the randomized Phase 2 study, NuTide:323, in second-line patients", said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We are also pleased to have initiated the NuTide:303 Phase 1b/2 study of NUC-3373 in combination with other agents, including PD-1 inhibitors, for the treatment of patients with solid tumors. In addition, we have enrolled the first patients into the Phase 2 part of the NuTide:701 study of NUC-7738. We look forward to providing numerous data updates throughout 2022 for both NUC-3373 and NUC-7738."

Mr. Griffith continued: "Positive data that we have previously announced for NUC-3373 and NUC-7738 have demonstrated our ProTides’ potential to provide cancer patients with more efficacious and safer treatment options. These data continue to demonstrate our ProTides’ encouraging anti-cancer activity and favorable safety profiles and pharmacokinetic properties."

Mr. Griffith concluded: "We have an anticipated cash runway which we expect will extend into 2025 and through many key milestones for both NUC-3373 and NUC-7738. We look forward to progressing towards our goal of significantly improving treatment options for patients with cancer."

Anticipated 2022 Milestones

NUC-3373 (a ProTide transformation of 5-FU)

In 2022, NuCana expects to:

Commence enrollment in the randomized, controlled Phase 2 (NuTide:323) study of NUC-3373 in combination with other agents for the second-line treatment of patients with colorectal cancer;
Commence enrollment in the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents, including PD-1 inhibitors, in patients with solid tumors to identify additional indications for development;
Expand the Phase 1b/2 (NuTide:302) study of NUC-3373 in second-line colorectal cancer patients, and evaluate NUC-3373-based regimens in combination with bevacizumab;
Announce data from the Phase 1b/2 (NuTide:302) study of NUC-3373 combined with leucovorin, irinotecan and bevacizumab in patients with colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents in patients with solid tumors to identify additional indications for development.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2022, NuCana expects to:

Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 in patients with solid tumors.

On June 2, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported that it will participate in a "Fireside Chat" presentation at the Jefferies Healthcare Conference, to take place June 8-10, 2022, in New York, NY (Press release, Ayala Pharmaceuticals, JUN 2, 2022, View Source [SID1234615442]). The company will also be available for one-on-one meetings with institutional investors at the conference.

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Details on the presentation can be found below:

A webcast of the presentation will be available on the "Events and Presentations" section of the Ayala Pharmaceuticals website.

On June 2, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported a broad strategic collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies (Press release, Grail Bio, JUN 2, 2022, View Source [SID1234615458]). The collaboration will initially focus on developing companion diagnostic tests to identify patients with high-risk, early-stage disease, with plans to embark on numerous studies across multiple indications over the next several years. The parties are additionally planning to use GRAIL’s technology to enable recruitment of patients with early-stage cancer for AstraZeneca’s clinical studies.

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"GRAIL has developed a novel approach to detect cancer signals in blood, regardless of whether or not the patient has clinical symptoms. We are excited to embark on this work with AstraZeneca to transform cancer outcomes through a broad, strategic collaboration," said Sir Harpal Kumar, President, Biopharma Business and Europe at GRAIL. "Through our collaboration, we hope to provide critical information to improve the identification of patients who may be eligible for clinical trials and change clinical paradigms for the treatment of early-stage cancers."

Across the projects within this collaboration, GRAIL will use its methylation platform to perform testing for patients enrolled in AstraZeneca’s clinical trials. GRAIL will seek regulatory approval in key markets for the liquid biopsy companion diagnostics.

Susan Galbraith, Executive Vice President of Oncology R&D, AstraZeneca, said: "Identifying and treating cancer early is at the heart of this strategic collaboration. Combining GRAIL’s innovative blood-based methylation profiling platform with AstraZeneca’s leadership in Oncology, we hope to accelerate the adoption of circulating tumor DNA across clinical trials and make our cancer medicines available at an earlier stage of disease when there is greater potential to transform patient outcomes, and even cure."

GRAIL is developing its proprietary methylation platform for use in multiple post-diagnostic settings to identify patients at high risk of future cancer recurrence, detect the presence or absence of residual disease, and to inform treatment decisions, including identifying patients with cancer who may be eligible for neoadjuvant or adjuvant therapy. GRAIL’s technology platform is designed to optimize circulating tumor DNA testing to enable detection of early stage disease and minimal residual disease (MRD).

On June 2, 2022 ProfoundBio, a biotech company focusing on the development of novel targeted therapies, reported the closing of a $70 million Series A+ financing round led by Sequoia China (Press release, ProfoundBio, JUN 2, 2022, View Source [SID1234615476]). Current investors Lilly Asia Venture, Oriza, Chang’an Capital, LYFE Capital, and K2VC also participated in this round of financing. ProfoundBio has raised a total of more than $138 million in the past two years. Following the closing, Lynn Yang from Sequoia China will be joining the company’s Board of Directors.

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ProfoundBio will use the proceeds to advance PRO1184 and PRO1160 into Phase 1 clinical trials. PRO1184 is a folate receptor alpha (FRα)-directed ADC for potential treatment of multiple solid tumors and PRO1160 is a CD70-directed ADC for both hematological and solid tumor indications. Preclinical studies suggest that both compounds may achieve favorable benefit to risk profiles in the clinic. Additionally, the company will continue to accelerate multiple early-stage programs to preclinical and CMC development, strengthen and expand innovative ADC technologies, and establish vertically integrated development capabilities to streamline discovery to clinical trials.

"This financing, especially in the context of this challenging economic environment, represents the confidence our new and all our current investors have in our capabilities, pipeline, and ADC technology." said Baiteng Zhao, PhD, co-founder, CEO, and Chair of the Board of ProfoundBio. "We made tremendous advancements as we continue to execute on our plan to bring novel therapeutics to patients with cancer. We will soon submit an IND for PRO1184, already initiated IND-enabling activities for PRO1160, and continue to expand our pipeline. In addition, we established multiple novel ADC technology platforms as presented at the 2022 AACR (Free AACR Whitepaper) annual meeting. Finally, and of equal importance, our team continues to strengthen with numerous key people identifying with and wanting to be a part of our vision."

Lynn Yang, Partner at Sequoia China, said, Sequoia China invests in founders who are truly capable of pushing the envelope of ground-breaking technologies. We invested in the ProfoundBio Series A financing and led the following A+ financing. ProfoundBio is a leading company in ADC research and development, and they deeply understand the balance between an ADC’s effectiveness and safety. With proprietary underlying technologies, ProfoundBio has developed a pipeline of products that are expected to be highly competitive in the market. The company’s products will enter into the clinical stage and potentially provide better care for patients in need.

On June 2, 2022 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported that members of its management team will present in a fireside chat at the Jefferies Healthcare Conference being held at the Marriott Marquis in New York, NY on Thursday, June 9, 2022 at 9:30 AM ET (Press release, Replimune, JUN 2, 2022, View Source [SID1234615409]).

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