On November 16, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported it will report its financial results for the third quarter of 2022 on November 23, 2022 before market open and subsequently host a webcast presentation at 4 p.m. CET / 10 a.m. ET (Press release, Nykode Therapeutics, NOV 16, 2022, View Source [SID1234624158]). A live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website: View Source

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On November 16, 2022, Phio Pharmaceuticals Corp. (the "Company") reported that entered into a Subscription and Investment Representation Agreement (the "Subscription Agreement") with Robert J. Bitterman, its interim Executive Chairman, who is an accredited investor (the "Purchaser"), pursuant to which the Company agreed to issue and sell one (1) share of the Company’s Series D Preferred Stock, par value $0.0001 per share (the "Preferred Stock"), to the Purchaser for $1,750 in cash (Filing, 8-K, Phio Pharmaceuticals, NOV 16, 2022, View Source [SID1234624157]). The sale closed on November 16, 2022. Additional information regarding the rights, preferences, privileges and restrictions applicable to the Preferred Stock is set forth under Item 5.03 of this Current Report on Form 8-K and is incorporated herein by reference.

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The Subscription Agreement contains customary representations and warranties and certain indemnification rights and obligations of the parties.

The foregoing summary of the Subscription Agreement does not purport to be complete and is subject to, and qualified in its entirety by, such document, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On November 16, 2022 NuCana plc (NASDAQ: NCNA) reported that financial results for the third quarter ended September 30, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, NOV 16, 2022, View Source [SID1234624156]).

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As of September 30, 2022, NuCana had cash and cash equivalents of £50.8 million compared to £46.5 million as of June 30, 2022 and £60.3 million at December 31, 2021. NuCana continues to advance its various clinical programs and reported a net loss of £4.5 million for the quarter ended September 30, 2022, as compared to a net loss of £8.0 million for the quarter ended September 30, 2021. Basic and diluted loss per share was £0.09 for the quarter ended September 30, 2022, as compared to £0.15 per share for the quarter ended September 30, 2021.

"This year we have focused on advancing our transformative ProTides through the clinic and evaluating additional indications and combinations to expand our development program," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Based on NUC-3373’s promising efficacy and favorable safety profile, we initiated two clinical studies: NuTide:323, a randomized Phase 2 trial of NUC-3373 in combination with irinotecan (NUFIRI) and bevacizumab for the second-line treatment of patients with colorectal cancer; and NuTide:303 a Phase 1b/2 study of NUC-3373 in combination with either pembrolizumab in patients with solid tumors or in combination with docetaxel in patients with non-small cell lung cancer (NSCLC). Furthermore, we entered the Phase 2 part of the NuTide:701 study which is investigating NUC-7738 as a monotherapy and in combination with pembrolizumab in patients with solid tumors."

Mr. Griffith continued: "We recently presented data at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting that showed the promising anti-tumor activity and favorable safety profiles of both NUC-3373 and NUC-7738. We presented encouraging data for NUC-3373 in combination with irinotecan (NUFIRI) or oxaliplatin (NUFOX) from the NuTide:302 Phase 1b/2 study in patients with advanced colorectal cancer. We also presented positive data on NUC-7738 in patients with solid tumors, including melanoma, from the Phase 1 part of the Phase 1/2 NuTide:701 study. At the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Annual Meeting in October, we presented data demonstrating that NUC-3373 is a more potent inhibitor of thymidylate synthase than pemetrexed in both adenocarcinoma and squamous subtypes of NSCLC. In addition, we presented data that demonstrate NUC-3373’s ability to increase the immunogenic cell death of lung cancer cells in combination with pembrolizumab."

Mr. Griffith concluded: "We are pleased with the progress we have made this year with NUC-3373 and NUC-7738. Based on these positive data updates, we have expanded our development programs and are rapidly advancing them as we progress towards our goal of providing more effective and safer treatment options for patients with cancer. With a cash runway that is expected to fund operations into 2025, we look forward to achieving numerous value-driving catalysts in the near future."

Anticipated Milestones: Q4 2022 and H1 2023

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

In Q4 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 either pembrolizumab in patients with various solid tumors or in combination with docetaxel in patients with non-small cell lung cancer (NSCLC) to identify additional indications for development; and
Expand the Phase 1b/2 (NuTide:302) study of NUC-3373 in colorectal cancer patients, and evaluate NUC-3373-based regimens in combination with bevacizumab in second-line patients with colorectal cancer.
In the first half of 2023, NuCana expects to:

Announce data from the Phase 1b/2 (NuTide:302) study of NUC-3373 combined with leucovorin, bevacizumab and either irinotecan or oxaliplatin in second-line patients with colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with either pembrolizumab in patients with various solid tumors or docetaxel in patients with non-small cell lung cancer (NSCLC) to identify additional indications for development.
• NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In Q4 2022, NuCana expects to:

Commence enrollment in the Phase 2 part of the NuTide:701 study of NUC-7738 in combination with the PD-1 inhibitor pembrolizumab, in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study in patients with solid tumors treated with NUC-7738 monotherapy.
In the first half of 2023, 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 in patients with solid tumors treated with NUC-7738 monotherapy and NUC-7738 in combination with pembrolizumab.

On November 16, 2022 Eli Lilly and Company (NYSE: LLY) reported that it will attend the fifth annual Evercore ISI HealthCONx Conference on Wednesday, Nov. 30, 2022. Jacob Van Naarden, Lilly executive vice president and CEO of Loxo@Lilly, and David Hyman, M.D., chief medical officer, Loxo@Lilly, will participate in a fireside chat at 12:10 p.m., Eastern time (Press release, Eli Lilly, NOV 16, 2022, https://investor.lilly.com/news-releases/news-release-details/lilly-participate-evercore-isi-healthconx-conference [SID1234624154]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On November 16, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers, reported that the first patient has been dosed in Part B of RINGSIDE, the Phase 3 randomized segment of the trial evaluating AL102 in desmoid tumors (Press release, Ayala Pharmaceuticals, NOV 16, 2022, View Source [SID1234624152]). AL102 is a potent, selective, oral gamma-secretase inhibitor (GSI).

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"We are pleased to begin enrollment in the Phase 3 segment of RINGSIDE, which is a significant milestone in our AL102 development program," said Roni Mamluk, Ph.D., President and Chief Executive Officer of Ayala. "The emerging data from Phase 2 / Part A have been very promising and we have selected a dose of 1.2mg once-daily for the randomized portion. If approved, AL102 has the potential to improve the lives of people living with desmoid tumors."

The Phase 3 segment of RINGSIDE is a double-blind, multi-center trial enrolling up to 156 patients with progressive disease, randomized between AL102 1.2mg dosed once daily or placebo. The primary endpoint is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures.

Positive interim data from Part A, the Phase 2 segment of RINGSIDE were presented at ESMO (Free ESMO Whitepaper) in September 2022. Data showed efficacy across all cohorts, with early responses that deepened over time. The first confirmed partial response (PR) was achieved at week 16 and 3 additional unconfirmed PRs over the follow-up period. AL102 was well tolerated with no dose-limiting toxicities and no Grade 4/5 adverse events. Longer-term data from Phase 2 / Part A of RINGSIDE are expected in mid-2023.

AL102 received Fast Track designation from the U.S. FDA granted in September 2022 for the treatment of progressing desmoid tumors.

For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Desmoid Tumors
Desmoid tumors also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

About the RINGSIDE study

The RINGSIDE pivotal Phase 2/3 study is a randomized global multi-center trial. The Phase 2 segment of the study evaluated the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in patients with desmoid tumors. It enrolled 42 patients and evaluated 3 doses of AL102. Patients who participated in the Phase 2 segment of the study are eligible to enroll into an open-label extension study at the selected dose of 1.2 mg daily, and long-term efficacy and safety will be monitored.

The Phase 3 segment of the study has been initiated. This is a double-blind, placebo-controlled segment enrolling up to 156 patients with progressive disease that compares AL102 at 1.2 mg once daily to placebo. The primary endpoint for the Phase 3 segment is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), duration of response (DOR), tumor volume reduction, and patient-reported Quality of Life (QOL) measures. For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).