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BIOGEN TO REPORT SECOND QUARTER 2023 FINANCIAL RESULTS JULY 25, 2023

On July 10, 2023 Biogen Inc. (Nasdaq:BIIB) reported that it will present second quarter 2023 financial results Tuesday, July 25, 2023, before the financial markets open (Press release, Biogen, JUL 10, 2023, View Source [SID1234633178]).

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Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available for at least 90 days following the presentation.

Starton Therapeutics Contracts Global Clinical Research Organization to Conduct STAR-LLD Phase 1b Clinical Trial in Multiple Myeloma

On July 10, 2023 Starton Therapeutics Inc. ("Starton" or "the Company"), a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, reported to have entered into a definitive agreement to conduct its Phase 1b trial in multiple myeloma with a global Clinical Research Organization (CRO) (Press release, Starton Therapeutics, JUL 10, 2023, View Source [SID1234633150]).

This pilot, open-label study will evaluate patients treated with continuously delivered lenalidomide for safety and tolerability, immune biomarkers, and signals of efficacy. Transplant-ineligible multiple myeloma patients who are to receive lenalidomide/dexamethasone/bortezomib in their second- or greater-line of therapy, meet all other eligibility criteria and provide informed consent are eligible for the study. The study is expected to accrue patients in the United States in two centers over a period of 10 months and will provide readouts in the tolerability of the regimen, as well as the impact of continuous delivery on immune function by measuring biomarkers of T-cell, NK-cell, and B-cell upregulation, along with cytokine profiles induced by lenalidomide. It is also expected to provide signals of efficacy in assessing response rates, duration of response, progression-free survival, and changes in minimal residual disease.

"With our recently announced FDA authorization to proceed with the Phase 1b clinical trial of STAR-LLD in multiple myeloma, we are pleased to announce a CRO partner as we actively prepare to initiate this study," said Pedro Lichtinger, chairman and CEO of Starton Therapeutics. "STAR-LLD has the potential to bring much-needed innovation to the treatment of multiple myeloma, which under current therapeutic options presents deteriorating quality of life for patients. We are eager to evaluate the potential of STAR-LLD in this trial as a critical step towards delivering on our pipeline of transformative therapies using our continuous delivery technology."

Starton has signed an agreement for a business combination with Healthwell Acquisition Corp. I (Nasdaq: HWEL) ("Healthwell"). Please see "Additional Information and Where to Find It" below for additional information related to the proposed business combination.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide in development to expand and replace the standard of care for the most common blood cancers, multiple myeloma and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide and shrank by 80% with STAR-LLD. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg/day continuous LLD and 20% of animals in this cohort were tumor free after 100 days vs. 0% ORR with active control with daily pulsatile once daily dosing. In addition, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid demonstrated the drug is well tolerated and is >91% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid. These data support the safety of the planned Phase 1 dose of 400 mcg/hr (9.6 mg a day) versus a standard 25 mg a day dose of Revlimid.

First Patient Enrolled in Phase 1/2 “ELUCIDATE” Trial Assessing GTAEXS617 in Advanced Solid Tumours

On July 10, 2023 Exscientia plc (Nasdaq: EXAI) reported that it has enrolled the first patient in its Phase 1/2 "ELUCIDATE" (GTAEXS617-001) study evaluating GTAEXS617 (‘617), Exscientia’s precision-designed CDK7 inhibitor, for the treatment of advanced solid tumours (Press release, Exscientia, JUL 10, 2023, View Source [SID1234633149]). The clinical trial will evaluate the safety, efficacy and pharmacokinetics of ‘617 across multiple ascending doses in patients with advanced solid tumours including head and neck cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast carcinoma and ovarian cancer. ‘617 is a novel CDK7 inhibitor that has been designed by Exscientia in collaboration with GT Apeiron for high potency, selectivity, oral bioavailability and safety.

"We are excited to begin the clinical evaluation of another AI-designed molecule at Exscientia," said Dr. Michael Krams, Chief Quantitative Medicine Officer at Exscientia. "‘617 was created to solve critical design challenges not met by traditional drug discovery methods with a focus on on-target potency, selectivity and safety. Combined with our unique ability to gather data from primary patient samples to predict response, we believe our ‘617 programme exemplifies the power of the various ways in which we create value through our precision medicine platform. We look forward to enrolling additional patients into the ELUCIDATE trial and anticipate that ‘617, if approved, could meaningfully improve treatment outcomes for patients."

As in Exscientia’s IGNITE trial evaluating its A2AR antagonist, EXS21546, the company used simulation guided clinical trial design to determine the operating characteristics of the two stages of the trial. The dose escalation (Phase 1) portion of the study will characterise the safety profile of ‘617 and establish the recommended Phase 2 dose (RP2D) both as monotherapy and in combination with selected standard of care regimens. The dose expansion (Phase 2) portion of the study will evaluate the preliminary anti-tumour activity of ‘617 as monotherapy and in combination with standard of care.

Exscientia previously highlighted novel ex vivo patient sample response data at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium in October 2022 identifying and confirming CDK7-specific pharmacodynamic biomarkers in cancer and immune cells and identifying high and low responder groups from patient samples across the indications tested ex vivo. Leveraging this translational data has the potential to eventually predict ‘617 treatment response among individual patients, therefore increasing the chances of treatment success. Alongside the evaluation of ‘617 in the ELUCIDATE trial programme, Exscientia and GT Apeiron will also generate data, including clinical endpoints, peripheral and tumour multi-omics, and correlate data and response to previously collected ex vivo results to further support the value of Exscientia’s precision medicine platform.

About the Phase 1/2 ELUCIDATE trial

The ELUCIDATE trial is a multicentre, open-label, two-stage clinical trial to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of ‘617 administered orally as monotherapy and in combination with standard of care therapies. The company is enrolling patients with solid tumours who have advanced, recurrent or metastatic disease and have failed standard of care.

Both the monotherapy and combination therapy dose escalation portion of the trial will enrol patients across up to seven dose levels, depending on how many dose levels are needed to define the RP2D. The dose expansion phase of the trial will commence upon identification of the RP2D. The primary efficacy endpoint of the expansion phase is objective response rate (ORR).

CDK7 inhibition combines cell cycle disruption with transcription inhibition, making it an attractive target to overcome common resistance pathways in CDK4/6 inhibition, which only targets the cell cycle. ‘617 has the potential to overcome significant safety and efficacy limitations of existing treatments due to its differentiated reversibility and potentially reduced gastrointestinal (GI) toxicity.

MAIA Biotechnology Reports Updates on Preliminary Survival Data for THIO-101 Phase 2 Trial for Advanced Non-Small Cell Lung Cancer

On July 10, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported updates on preliminary survival data in the Part A safety lead-in of its ongoing THIO-101 phase 2 trial, evaluating THIO in sequential combination with cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, JUL 10, 2023, View Source [SID1234633148]).

The first 2 patients enrolled in the study continue to be alive, approximately 12.2 and 11.5 months respectively, from treatment initiation. Both patients have advanced Stage IV metastatic disease and failed 2 prior lines of therapy, including one line with an immune checkpoint inhibitor (CPI), and platinum-based chemotherapy. Following the conclusion of study treatment, they have remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy. No new safety analysis was conducted.

"We are excited by the observed continued progression free survival of the first 2 patients following treatment discontinuation, and these results align with our hypothesis that THIO, followed by an immune CPI, can re-sensitize tumors to the CPI and stimulate a potent and long-lasting anti-cancer immune response. This is particularly encouraging given that patients with advanced NSCLC who failed two or more therapy regimens in real-world scenarios have an expected survival of only 3 to 4 months. With therapy, third-line patients generally survive about 6 months; without therapy, survival is only weeks," said Vlad Vitoc, MAIA’s Chief Executive Officer.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in sequential combination with Regeneron’s anti-PD1 therapy, Libtayo (cemiplimab), allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

Verastem Oncology Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On July 10, 2023 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the grant of stock options to purchase 28,917 shares of its common stock to five new employees (Press release, Verastem, JUL 10, 2023, View Source [SID1234633145]). The awards were granted pursuant to the Nasdaq inducement grant exception as an inducement material to the employees’ acceptance of employment with Verastem Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price equal to $7.75 per share, the closing price of Verastem Oncology’s common stock as reported by Nasdaq on July 3, 2023. The stock options that were granted to the five new employees will vest at a rate of twenty-five percent (25%) on the one-year anniversary of the employees’ date of hire, with the remaining shares vesting quarterly over the next three (3) years in equal quarterly amounts, provided the employees continue to serve as an employee of or other service provider to Verastem Oncology on each such vesting date.