On July 10, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that  the Compensation Committee of Crinetics’ Board of Directors granted non-qualified stock option awards to purchase an aggregate of 323,600 shares of its common stock to 10 new non-executive employees under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") (Press release, Crinetics Pharmaceuticals, JUL 10, 2023, View Source [SID1234633133]). The stock options were granted as inducements material to the employees entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4).

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The 2021 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Crinetics, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Crinetics, pursuant to Nasdaq Listing Rule 5635(c)(4).

The options have an exercise price of $19.75 per share, which is equal to the closing price of Crinetics’ common stock on The Nasdaq Global Select Market on July 10, 2023. The shares subject to the stock options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter, subject to each employee’s continued employment with Crinetics on such vesting dates. The options are subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of a stock option agreement covering the grant.

On July 10, 2023 Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity"), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming drug candidate, reported further design features of its Phase 2 MARIO-8 study in SCCHN (Press release, Infinity Pharmaceuticals, JUL 10, 2023, View Source [SID1234633127]).

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The adaptive design of the MARIO-8 study is intended to optimize the dose of the oral drug candidate, eganelisib, in combination with the standard dose of pembrolizumab, in 40-70 patients in Part A of the study. The dose optimization phase of the study will evaluate two dose regimens of eganelisib; a 30mg regimen, dosed daily for two out of every three weeks, and a 20mg regimen, with continuous daily dosing. The company has received FDA feedback and, pending final FDA review and subject to the successful close of the company’s proposed merger with MEI Pharma, Inc. ("MEI"), preliminary safety and efficacy data to inform the dose selection are expected in the second half of 2024.

The selected eganelisib dose, in combination with pembrolizumab, will be further evaluated in Part B of the study in approximately 100 additional patients, with the primary endpoint of overall survival and secondary endpoints of progression free survival and safety.

"Our ability to optimize the eganelisib dose in MARIO-8 is a very attractive component of this study, furthering our objective of bringing eganelisib to patients with squamous cell cancer of the head and neck. These patients are in urgent need of better therapies and the data generated to date with eganelisib in combination with a checkpoint inhibitor in patients with SCCHN are encouraging," said Robert Ilaria, MD, Infinity’s Chief Medical Officer. "We are pleased to have received the FDA’s feedback and to have made great progress toward study initiation."

To view presentations on eganelisib, the treatment landscape in SCCHN, the data generated to date with eganelisib in patients with SCCHN from the MARIO-1 study, and the MARIO-8 study design by Infinity Chief Medical Officer Robert Ilaria and Dr. Ezra Cohen, the principal SCCHN investigator in the MARIO-1 study, please view the webcast on Infinity’s website which can be located at www.infi.com under the Investor/Media tab in the Events and Presentations folder titled "MEI Pharma and Infinity Merger and Clinical Program Update June 19, 2023".

Update on Proposed Transformative Merger with MEI

Infinity is pleased to report that a second leading independent proxy advisory firm, Glass, Lewis & Co ("Glass Lewis") has joined Institutional Shareholder Services Inc. ("ISS") in recommending that stockholders of Infinity and MEI vote FOR the merger between the two companies. The combined company is expected to have an attractive combined clinical pipeline, strong balance sheet, and multiple potential value creation opportunities for stockholders.

Infinity stockholders are reminded to vote their proxies today FOR the proposals described in the joint proxy statement and prospectus, prior to the Infinity virtual special meeting of stockholders on July 14, 2023, at 10 a.m. Eastern Time.

It is very important that Infinity stockholders vote, as not voting has the same effect as voting against the proposed merger.

Infinity Stockholders who have questions about voting their proxy are encouraged to contact Morrow Sodali LLC who are assisting us, at 1-800-662-5200 or [email protected].

On July 10, 2023 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported findings from a Phase 1 study showing that allogeneic cytokine-induced memory-like (CIML) natural killer (NK) cells used in combination with ImmunityBio’s IL-15 superagonist N-803 may induce tumor regression associated with persistent CIML NK cell expansion in advanced head-and-neck cancer patients (Press release, ImmunityBio, JUL 10, 2023, View Source [SID1234633125]). The results indicate the potential for a new treatment approach for the disease in advanced cases that currently have extremely poor prognoses.

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The data from the proof-of-concept study were presented by Glenn J. Hanna, M.D., Medical Oncologist with Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the American Head and Neck Society (AHNS) joint conference in Montreal, July 7-8, 2023.

Patients with recurrent incurable or metastatic (R/M) head and neck cancers (HNCs) that do not respond to platinum chemotherapy and immunotherapy have poor survival rates. Cellular therapies have emerged as treatments with potential activity in solid tumors.

"It was exciting to observe some tumor regression among heavily pre-treated patients with advanced head-and-neck cancer using a live cell therapy approach," said Dr. Hanna. "I am hopeful that future studies can build on this work to further evaluate NK and other immune cell therapies for these cancers."

This study (NCT04290546) sponsored by Dana-Farber Cancer Institute investigated allogeneic CIML NK cell infusion followed by N-803 after lead-in CTLA-4 inhibition (ipilimumab) plus lymphodepleting (LD) chemotherapy in advanced HNC. The study showed that tumor regression was associated with expansion of the NK cell type with cytolytic activity, CD56dimCD16+ NK cells, that target and kill tumor cells.

This phase 1 single-center trial enrolled 10 patients with R/M HNC (n=7 HNSCC, n=3 salivary cancer) regardless of human papillomavirus (HPV) status who had prior platinum chemotherapy and immunotherapy. Patients in cohort 1 received LD fludarabine (25 mg/m2) and cyclophosphamide (60 mg/m2/kg) on days -6 to -2 prior to haploidentical CIML NK cell infusion on day 0 (5-10 x 106 viable cells/kg=dose level 0) followed by N-803 (15 mcg/kg subcutaneously) starting on day +1 every 21-days for 4-doses. Patients in cohort 2 received the same regimen with a dose of lead-in ipilimumab on day -7. A total of 6 patients were treated in cohort 1 and 4 patients in cohort 2.

The primary objective was safety and maximum tolerated dose of CIML NK cells. The secondary objective was objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and phenotypic expansion and function of adoptively transferred NK cells.

"It is encouraging that allogeneic CIML NK cells supported by N-803 may induce tumor regression in advanced head-and-neck cancer patients," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "These results may have potential implications for many of the estimated 68,000 men and women in the United States who are diagnosed with head-and-neck cancers annually, and it is an ongoing pursuit of ImmunityBio’s technology platform to orchestrate T and NK cells to fight cancer."

On July 10, 2023 ibioPharma presented its corporate presentation (Presentation, iBioPharma, JUL 10, 2023, View Source [SID1234633124]).

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On July 10, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that it has initiated a Phase I study in China of HMPL-415, an investigational novel selective allosteric inhibitor targeting Src homology-2 domain-containing protein tyrosine phosphatase-2 ("SHP2") (Press release, Hutchison China MediTech, JUL 10, 2023, View Source [SID1234633123]). The first patient received their first dose on July 6, 2023.

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The clinical trial is a multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-415 as a single agent in patients with advanced malignant solid tumors. This study is expected to enroll up to approximately 80 patients, including patients as part of the dose escalation stage, and further patients at the determined recommended Ph II dose (RP2D). The leading principal investigators are Dr. Tianshu Liu of Zhongshan Hospital Fudan University and Dr. Nong Yang of Hunan Cancer Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT05886374.

About HMPL-415

HMPL-415 is a novel, highly potent and selective allosteric inhibitor targeting SHP2. SHP2 is a non-receptor protein tyrosine phosphatase ubiquitously expressed mainly in the cytoplasm of several tissues. SHP2 modulates diverse cell signaling events that control metabolism, cell growth, differentiation, cell migration, transcription and oncogenic transformation. It interacts with diverse molecules in the cell, and regulates key signaling events including RAS/ERK, PI3K/AKT, JAK/STAT and PD-1 pathways downstream of several receptor tyrosine kinases (RTKs) upon stimulation by growth factors and cytokines. Dysregulation of SHP2 expression or activity causes many developmental diseases, and hematological and solid tumors.1

HUTCHMED currently retains all rights to HMPL-415 worldwide.