On June 24, 2024 Nerviano Medical Sciences S.r.l. ("NMS" and "the Company"), a part of NMS Group S.p.A. (NMS Group) and Nerviano Medical Sciences, Inc., a wholly owned subsidiary of NMS Group, focused on the discovery and development of oncology drugs and the largest oncological R&D company in Italy, reported that the United States Food and Drug Administration (FDA) has cleared the protocol for investigational new drug (IND) application for NMS-812, a first-in-class orally bioavailable and highly potent small molecule dual inhibitor of PERK/GCN2 (Press release, Nerviano Medical Sciences, JUN 24, 2024, https://www.nervianoms.com/nerviano-medical-sciences-announces-fda-protocol-clearance-of-new-ind-application-for-nms-812-a-first-in-class-dual-inhibitor-of-perk-gcn2-brian-sherer-phd-appointed-to-lead-and-accelerate-the-dev/ [SID1234644505]).

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NMS-812 has very strong scientific rational in the multiple myeloma indication by modulating the unfolded protein response via PERK in the integrated stress response (ISR) pathway since this is a high protein production setting. In addition, NMS-812 inhibits GCN2, another ISR component, affecting mainly amino acid deprivation stress, to augment cell death. Together the double inhibition likely overcomes resistance. The first in human (FIH) study showed excellent pharmacokinetic profile allowing daily oral dosing and likely permissive safety for further development. The multiple myeloma indication was deprioritized because it would require significant resources due to multiple treatment lines, but NMS is fully committed to continuing in partnership with other companies interested in the multiple myeloma space.

NMS-812’s ability to inhibit two key components, PERK and GCN2, of the ISR, may offer superiorapoptosis in other cancer settings such as AML. In addition, NMS-812 modulates the immune response via direct and indirect mechanisms which may contribute to anti-cancer activity.

Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy. According to American Cancer Society, in 2024, an estimated 20,800 new cases of leukemia will be diagnosed in the US and 11,220 people will die from the disease.

NMS expects to initiate enrollment of patients with relapsed/refractory AML including patients with TP53 mutations in the Phase I PERKA-812-003 trial in the second half of 2024.

NMS today also announces the discontinuation of the FIH clinical trial with NMS-812 in the setting of relapsed/refractory multiple myeloma (NCT05027594) due to strategic reasons.

"Acute Myeloid Leukemia (AML) remains an aggressive hematological malignancy with tremendous unmet medical need especially in the p53 mutant patient population. Based on preclinical data and unique dual Integrated Stress Response mechanism, NMS-812 may represent a novel strategy for AML through the unfolded protein response and amino acid deprivation stressors , with potential for synergies with other drugs and potential to overcome drug resistance." said Lisa Mahnke, MD, Ph.D., Chief Medical Officer at NMS. "We are thrilled to have Brian to join the NMS team to lead the development."

Brian has had leadership roles with Exelixis, EMD Serono, and AstraZeneca over a 25 year career. He has been instrumental in the discovery and early development of more than 10 small molecule clinical candidates.

In addition to PERK/GCN2, Brian will also lead NMS’ MPS1 asset, leveraging his extensive expertise.

"Both PERK/GCN2 and MPS1 assets hold potential as first-in-class drugs for subsets of cancers with high unmet medical needs. Our teams have made remarkable progress in developing these novel assets, and we are excited about the future under Brian’s leadership." said Lisa Mahnke.

On June 24, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and Co-founder, will participate in a fireside chat during the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference on Tuesday, June 25, 2024 at 2:30 p.m. ET (Press release, In8bio, JUN 24, 2024, View Source [SID1234644504]).

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A live webcast and replay will be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

On June 24, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in advanced development of its non-viral DNA-mediated immunotherapy, reported database lock for its Phase 2 OVATION 2 Study evaluating the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer (Press release, IMUNON, JUN 24, 2024, View Source [SID1234644503]). Median Overall Survival (OS) and Progression Free Survival (PFS) have been reached and all patients in the open-label study have achieved treatment observation duration of 16 months, as required per protocol to evaluate efficacy. The independent statisticians have received the raw trial data and will follow the statistical analysis plan as they analyze the data from the trial. IMUNON expects to report topline results including hazard ratios before the end of July 2024.

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OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy (NACT) in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. Patients were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. Patients randomized to the IMNN-001 treatment arm received up to 17 doses of 100 mg/m2, in addition to NACT. Full enrollment of 110 patients was reached in September 2022.

The OVATION 2 Study is meant to inform the design of the intended Phase 3 trial and was not powered for statistical significance. Per the Statistical Analysis Plan (SAP), the primary efficacy analysis will be based on the Intent to Treat (ITT) population. The primary efficacy endpoint is PFS, with secondary endpoints including OS, Objective Response Rate, Chemotherapy Response Score and Surgical Response.

Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON, said, "Reaching data lock for the OVATION 2 Study is a significant achievement for our team and a step forward in our mission to bring an innovative treatment to patients battling ovarian cancer. With the last patient enrolled in September 2022, the analyses generated using the ITT population, an industry gold standard, will now have sufficient data maturity to analyze both PFS and OS endpoints with a good level of confidence. We are hopeful that IMNN-001 will offer improved outcomes and a much-needed alternative to those affected by this deadly disease."

Sebastien Hazard, M.D., Ph.D., chief medical officer of IMUNON, added, "Given the maturity of our data, OS will be important in the readout of the trial and in planning the Phase 3 trial. As the definitive endpoint, OS has been observed across all tumor types as most reflective of the long-term benefit of immunotherapies. We look forward to the trial readout and sharing learnings from the trial with the patient and medical community."

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75% in Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On June 24, 2024 Illumina, Inc. (NASDAQ: ILMN) reported the successful completion of the spin-off of GRAIL (Press release, Illumina, JUN 24, 2024, View Source [SID1234644502]). This milestone follows the company’s previously announced plans to divest GRAIL, and GRAIL is now a public and independent company. GRAIL will begin regular way trading on Nasdaq on Tuesday, June 25 under the ticker symbol "GRAL." Illumina will continue to trade on Nasdaq under the ticker symbol "ILMN."

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"With the completion of the spin-off of GRAIL, we have achieved our goal of divesting GRAIL in a manner that allows its breakthrough technology to continue benefiting patients," said Jacob Thaysen, CEO of Illumina. "Illumina will maintain a minority share of 14.5% in the company. GRAIL plays a critical role in the fight against cancer, and while the company is no longer part of Illumina, we remain confident in its future and will continue to support GRAIL with our sequencing technology, end-to-end workflows, and suite of services."

Later this week, Illumina will file an 8-K/A providing historical unaudited pro forma financial information and will provide supplemental non-GAAP information on its investor relations website at View Source

Illumina also announced it will issue results and host its earnings call for the second quarter of 2024 following the close of market on Tuesday, August 6, 2024. Illumina will also host a virtual Strategy Update on Tuesday, August 13, 2024, beginning at 8:00 am Pacific Time (11:00 am Eastern Time) and running for approximately two hours. Additional details for these events will be announced in the coming weeks and provided on Illumina’s investor relations website, View Source Replays of these events will be posted on Illumina’s investor relations website after each event and for at least 30 days following.

"As we turn the page, we are excited to share our plan to accelerate topline growth, achieve operational excellence, deliver for our customers, and maximize value for shareholders in our upcoming strategy update," said Thaysen. "Illumina is prepared to lead the next era of innovation in next generation sequencing by continuing to focus on strengthening our business and catalyzing the industry with an even greater focus on our customers’ priorities."

Financing Information

As previously disclosed, on June 17, 2024, Illumina entered into a 364-day delayed draw credit agreement that provided for a senior unsecured term loan credit facility in an aggregate principal amount of up to $750 million. The credit facility was drawn in full on June 20, 2024, and the proceeds, together with cash from Illumina’s balance sheet, were used to fund cash to the balance sheet of GRAIL in connection with Illumina’s divestment of GRAIL. The current borrowing rate under the credit facility is approximately 6.70%.

Distribution Details

The separation was achieved through the distribution of 85.5% of the outstanding shares of GRAIL to holders of Illumina common stock at 12:01 a.m. ET on June 24, 2024 (the "Distribution Date"). In addition to retaining their shares of Illumina common stock, Illumina shareholders received one share of GRAIL common stock for every six shares of Illumina stock held as of close of business on the record date of June 13, 2024. Illumina retained 14.5% of the outstanding shares of GRAIL common stock.

On Tuesday, June 25, 2024, the first trading day following the Distribution Date, GRAIL will begin trading "regular way" on Nasdaq under the ticker symbol "GRAL." There will no longer be two markets in Illumina common stock and Illumina will continue to trade on Nasdaq under the ticker symbol "ILMN."

Fractional shares of GRAIL common stock were not distributed to Illumina shareholders and are instead being aggregated and sold in the open market. The net proceeds will be distributed pro rata, in cash, to Illumina shareholders who would otherwise have received a fractional share of GRAIL common stock.

For U.S. federal income tax purposes, Illumina’s U.S. shareholders (other than those subject to special rules) generally should not recognize a gain or loss as a result of the distribution of GRAIL shares, except with respect to cash received in lieu of fractional shares. Illumina shareholders are urged to consult with their tax advisors with respect to the U.S. federal, state, and local or foreign tax consequences, as applicable, of the spin-off.

For more information about the distribution, please contact the distribution agent, Computershare Trust Company, N.A., at 150 Royall Street, Canton, MA 02021 or at the telephone number 877-373-6374.

On June 24, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that it will host a R&D update in Shanghai, China, and via webcast on Tuesday, July 9, 2024 (Press release, Hutchison China MediTech, JUN 24, 2024, View Source [SID1234644501]) (Press release, Hutchison China MediTech, JUN 24, 2024, View Source [SID1234644501]).

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During the event, the senior management team will share insights into the Company’s R&D strategy and vision. Additionally, the team will provide updates on certain programs within HUTCHMED’s extensive and innovative pipeline. This will include updates on the Phase III ESLIM‑01 and Phase II/III ESLIM‑02 studies of our Syk inhibitor sovleplenib in immune thrombocytopenia ("ITP") and warm antibody autoimmune hemolytic anemia, ("wAIHA") respectively; the surufatinib Phase II/III study for metastatic pancreatic ductal adenocarcinoma ("PDAC"); and the Phase III RAPHAEL study of our IDH1/2 inhibitor HMPL-306 in acute myeloid leukemia ("AML").

The in-person event will take place from 3:00 p.m. to 5:00 p.m. HKT in Chinese (Putonghua) in Shanghai. A live webcast will be held simultaneously. Attendance for the in-person event is by invitation only.

An English language webcast will take place from 8:30 p.m. HKT / 8:30 a.m. EDT / 1:30 p.m. BST on Tuesday, July 9, for approximately two hours.

Both webcasts will be live and can be accessed via www.hutch-med.com/event. Investors interested in listening to a webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days.