On July 10, 2023 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that zedenoleucel, its multi-tumor-associated antigen (multiTAA)-specific T cell product candidate, MT-401, was granted Orphan Drug Designation by the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) for the treatment of patients with acute myeloid leukemia (AML) (Press release, Marker Therapeutics, JUL 10, 2023, View Source [SID1234633137]).

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AML is a life-threatening and chronically debilitating disease that is rapidly progressive and fatal if untreated. Relapse rates after initial treatment are high, and the next step for eligible patients is an allogeneic hematopoietic stem cell transplant (HSCT). Unfortunately, AML relapse after HSCT is frequent and outcomes are dismal. Patients who relapse after HSCT have an estimated median survival of less than one year (Estey and Döhner, Lancet, 2006), highlighting the urgent need for new therapies.

MT-401 utilizes a novel non-genetically modified approach that recognizes multiple antigens expressed on tumor cells, thereby designed to minimize tumor escape. MT-401 is currently being studied in a Phase 2 clinical trial for the treatment of relapsed AML following allogeneic HSCT, and was designed to specifically target four different antigens that are upregulated in AML but have limited expression on normal cells.

In the European Union, orphan drug designation is granted to drugs intended for the treatment of life-threatening or chronically debilitating conditions affecting no more than five in 10,000 individuals in the European Union. Orphan drug designation by the EMA provides crucial support to expedite the development and market readiness of necessary drugs for such rare diseases. This designation will help Marker Therapeutics continue to develop MT-401 to fill a significant void in the treatment of AML and provides Marker Therapeutics with a range of potential benefits, including ten years of market exclusivity following approval, reduced regulatory fees, and invaluable scientific advice from the EMA during the drug development phase.

"The orphan drug designation for MT-401 by the EMA is a significant regulatory milestone," said Nadia Agopyan, Ph.D., RAC, Senior Vice President, Regulatory Affairs of Marker Therapeutics. "It acknowledges not just the potential therapeutic impact of MT-401, but also the urgent need to deliver innovative treatment options to patients living with AML. In 2020, MT-401 was also granted orphan designation by the U.S. Food and Drug Administration for the treatment of patients with AML. We are deeply committed to working with regulatory authorities to expedite the drug development and approval process."

"We are extremely proud to have been granted Orphan Drug Designation by the EMA for MT-401," said Juan F. Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "In our Phase 2 clinical trial of patients with post-transplant AML, we have observed promising results from patients with measurable residual disease, suggesting that the unique and differentiated targeting technology of MT-401 can be a potential treatment for patients with AML before relapse."

"This is an important milestone for Marker and a significant step forward in our mission to improve the lives of patients with AML, especially of those with relapsed AML where no therapeutic options have been approved. Our team at Marker is committed to accelerating the development of MT-401 and believes that this designation brings us one step closer to offering a new, potentially life-altering therapy for relapsed AML patients after stem cell transplant," concluded Dr. Vera.

About multiTAA-specific T cells

The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Clinical trials that enrolled more than 180 patients with various hematological malignancies and solid tumors showed that autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses, and consistent epitope spreading. The latter is typically not observed with other T cell therapies and enables the potential contribution to a lasting anti-tumor effect. Unlike other cell therapies which require hospitalization and close monitoring, multiTAA-specific T cells are designed to be administered in an outpatient setting.

On July 10, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported positive regulatory and clinical updates related to its registrational single-arm Phase 2 IOV-LUN-202 trial in post-anti-PD-1 NSCLC (Press release, Iovance Biotherapeutics, JUL 10, 2023, View Source [SID1234633135]).

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NSCLC Regulatory and Clinical Update:

At a Type B Pre-Phase 3 meeting held between Iovance and the U.S. Food and Drug Administration (FDA), the FDA provided positive regulatory feedback that the design of the IOV-LUN-202 trial may be acceptable for accelerated approval of LN-145 TIL therapy for patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable or metastatic) NSCLC without EGFR, ROS or ALK genomic mutations and had received at least one line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations. Based on this FDA feedback, Iovance completed a preliminary analysis of the IOV-LUN-202 trial. This recent data cut1 included 23 NSCLC patients treated with LN-145. An ORR of 26.1% by RECIST v1.1 (n=6, one complete response and five partial responses) was observed, with a disease control rate of 82.6%. While still early on study, the median duration of response (DOR) was not reached. The DOR ranged from 1.4+ months to 9.7+ months. Treatment-emergent adverse events were consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2. Based on the regulatory discussions, Iovance plans to enroll a total of approximately 120 patients into the registrational IOV-LUN-202 trial. Enrollment is expected to be complete during the second half of 2024. As previously announced, Iovance is also preparing to meet with the FDA this year to discuss a randomized confirmatory trial of LN-145 in frontline advanced NSCLC patients. This confirmatory trial in frontline advanced NSCLC is expected to be well underway at the time of a potential approval in advanced post-anti-PD-1 NSCLC.

Lifileucel BLA Submission on Track in Advanced Melanoma:
The FDA’s Priority Review of Iovance’s Biologics License Application (BLA) for lifileucel in advanced melanoma remains on track and continues to progress well. The Prescription Drug User Fee Act target action date for the BLA is November 25, 2023.

Data cut date of July 6, 2023.

On July 10, 2023 Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that the underwriters of its previously announced initial public offering have fully exercised their option to purchase an additional 585,000 shares of its common public stock at the IPO offering price of $5.00 per share, less underwriting discounts and commissions (Press release, Intensity Therapeutics, JUL 10, 2023, View Source [SID1234633134]).

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The total net proceeds to Intensity from the offering, including proceeds from the exercise of the underwriter’s over-allotment option, after deducting the underwriting discounts, commissions and transaction expenses, were approximately $18.9 million.

The Benchmark Company and Freedom Capital Markets acted as the joint book-running managers for the offering.

The securities described above were offered by the Company pursuant to a registration statement on Form S-1 (Registration No. 333-260565) that was previously filed with the U.S. Securities and Exchange (the "SEC") and declared effective on June 29, 2023. This offering was made only by means of a prospectus forming part of the effective registration statement. Copies of the final prospectus can be obtained through the SEC’s website at www.sec.gov or from: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th floor, New York, NY 10155 at 212-312-6700 or by email at [email protected] and Freedom Capital Markets, 40 Wall Street, 58th Floor, New York, NY 10005, via email at [email protected] and via telephone at (800) 786-1469.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.

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].