On June 12, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, reported details on its novel allogeneic blood-derived NK cell therapy ("SNK02") commercial manufacturing and cryopreservation process by Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, entitled, "Protecting Patients by Removing Need for Lymphodepletion to Better Preserve Immune Function" (Press release, NKGEN Biotech, JUN 12, 2024, View Source [SID1234644281]). Dr. Song also provided an update on the Company’s initial Phase 1 results using SNK02 to treat patients with advanced refractory solid tumors.

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Dr. Song’s presentation explored the potential benefits of eliminating pre-treatment lymphodepletion in patients undergoing SNK02 therapy, aiming to safeguard immune function and aid in recovery. Avoiding lymphodepletion before administering cancer treatment can provide many benefits including reduced toxicity, preservation of immune function and potentially enhancing treatment efficacy. The presentation also included a discussion on the results from the Company’s Phase 1 SNK02 clinical study in solid tumors previously disclosed in a publication at the 2024 American Society for Clinical Oncology annual meeting. Moreover, unpublished Phase 1 SNK02 data were also presented.

The Phase 1 clinical trial administered SNK02 intravenously ("IV") weekly for a total of 8 weeks with a starting dose of 6 x 109 SNK02 cells in patients with advanced refractory solid tumors, without lymphodepletion. The primary endpoint was safety based on adverse events, vitals, laboratory tests and physical exams. Tolerability and maximum tolerated dose were also evaluated. SNK02 was found to be well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion.

Dr. Song commented during the presentation, "As most of the focus of NK cell therapy has been for liquid tumors with lymphodepletion, we have always believed that lymphodepletion could be detrimental to patients with solid tumors especially those being treated with immune checkpoint inhibitors, monoclonal antibodies or bispecific therapies where a robust immune response is essential. We therefore set out to develop a commercial scale manufacturing and cryopreservation process which could yield greater than 100,00 doses of SNK02 (cryopreserved enhanced activated allogeneic NK cells) with the idea that large doses could be delivered without lymphodepletion to potentially overcome any host versus graft reaction. We are pleased to show that, despite developing autoantibodies to sustained repeated dosing of our allogeneic product, SNK02 was safe and treatment appeared to stop the progression of several heavily pretreated solid tumors as a monotherapy. We are excited to further explore the efficacy of SNK02 in combination with immune checkpoint inhibitors and antibodies against solid tumors."

Presentation Highlights:

In the Phase 1 SNK02 clinical trial, 6 patients, with advanced refractory solid tumors and an average of 4 prior lines of therapy, were enrolled. The median age was 64 years old (range, 44–71), and 4 were male.
The cancer subtypes included 2 colorectal cancers, 1 leiomyosarcoma, 1 angiosarcoma, 1 endometrial adenocarcinoma, and 1 undifferentiated pleomorphic sarcoma
Four of six patients completed 8 cycles of SNK02. The best objective response of stable disease (tumor stopped growing) was demonstrated in 100% of patients that completed the 8 cycles.
One patient received 18 consecutive weekly doses and another patient received 12 consecutive weekly doses.
Out of the 36 doses administered through Cycle 8, there were 17 Grade 1, 3 Grade 2, and 1 Grade 3 adverse events ("AEs") related to investigational product ("IP"). The Grade 3 AE of increased fatigue resolved after 1 day with no intervention required.
There was 1 death on study, which was deemed unrelated to the IP.
Auto-antibodies appeared to develop around Cycle 5 and appeared to correlate with AEs.
There did not appear to be any correlation with KIR mismatch or HLA subtyping with AEs or tumor response.
SNK02 was well-tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion. SNK02 will continue to be studied as a monotherapy and in potential combination treatment regimens with monoclonal antibodies and immune checkpoint inhibitors.
A copy of the presentation is available on the Scientific Publications page of the Company’s website at View Source Previously disclosed Phase 1 data on the positive effects of SNK02 on advanced solid tumors, which may not be included in this conference presentation, can also be found on the Scientific Publications page.

About SNK02

SNK02 is a novel cell-based, donor-derived ex vivo expanded allogeneic NK cell immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK02 for the treatment of a broad range of cancers.

On June 12, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported that it will present at the Virtual Investor Pitch Conference on June 18, 2024 at 3:00 PM ET (Press release, Moleculin, JUN 12, 2024, View Source [SID1234644280]).

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As part of the event, Walter Klemp, Chairman and Chief Executive Officer of Moleculin, will provide an "elevator pitch" and outline the Company’s upcoming milestones. Additionally, investors and interested parties will have the opportunity to submit questions live during the event. Participating companies will answer as many questions as possible in the time allowed.

A live video webcast of the event will be available on the Events page under the Investors section of the Company’s website (moleculin.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On June 12, 2024 Day One Biopharmaceuticals presented its corporate presentation (Presentation, Day One, JUN 12, 2024, View Source [SID1234644279]).

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On June 11, 2024 Moleculent AB, a company pioneering technology to study the communication between cells in human tissue, reported the closing of its oversubscribed $26 million Series A financing (Press release, Moleculent, JUN 11, 2024, View Source [SID1234644273]). The round was led by ARCH Venture Partners (ARCH) and co-led by Eir Ventures with participation from the company’s existing investors. ARCH’s Patrick Weiss has been appointed Chairman. Sean Kendall from ARCH, together with Magnus Persson from Eir Ventures, have also joined the company’s Board of Directors.

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Moleculent’s functional biology platform detects cell-cell interactions and profiles their communication directly within their tissue environment. This novel approach allows scientists to see how healthy cells function and how diseased cells differ at a complex, networked level. A complete picture of the cell-cell communication in a tumor, for example, offers a practical understanding of the signaling pathways and molecular mechanisms involved in drug response. Studying cell-cell interactions between many different receptors and ligands, in a tissue context, represents a paradigm shift in understanding biological systems by enabling scientists to see a more comprehensive picture and to decode the cell-cell conversations and disease pathways.

"Analysis of DNA, as well as RNA and protein expression inform us about the building blocks of a cell but do not directly measure how cells are working together. Understanding cell-cell communication networks in tissues has the potential to bring us into a new era of understanding functional biology and human disorders," said Olle Ericsson, PhD, co-founder and Chief Executive Officer of Moleculent. "The Moleculent platform has been designed to allow scientists to uncover radical new insights into the cellular level of human biology and pathology. We are very happy to partner with ARCH Venture Partners and Eir Ventures to bring this enabling platform to the scientific community."

Moleculent is led by a team of industry veterans with expertise in developing and globally commercializing life science tools at leading companies including Halo Genomics (acquired by Agilent), Vanadis Diagnostics (acquired by Perkin Elmer), and Spatial Transcriptomics (acquired by 10x Genomics).

"Spatial mapping technologies transformed our understanding of cellular neighborhoods, and the next frontier is to measure the critical communications between networks of individual cells. Moleculent will enable scientists to decipher this communication to better understand functional human biology," said Weiss. "I am honored to chair the Moleculent Board and look forward to working with this exceptional team of experienced entrepreneurs and technology developers to change how we understand and diagnose disease in the coming decade."

On June 11, 2024 Incyte Corporation (Nasdaq: INCY) ("Incyte" or the "Company") reported the preliminary results of its modified "Dutch auction" tender offer to purchase up to $1.672 billion in value of shares of its common stock, which expired at 12:00 midnight, at the end of the day, New York City time, on June 10, 2024 (Press release, Incyte, JUN 11, 2024, View Source [SID1234644271]).

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Based on the preliminary count by Computershare Trust Company, N.A., the depositary for the tender offer, a total of approximately 29.8 million shares of Incyte’s common stock were properly tendered and not properly withdrawn at or below the purchase price of $60.00 per share, including approximately 14.8 million shares that were tendered through notice of guaranteed delivery. Incyte has been informed by the depositary that the preliminary proration factor for the shares to be purchased by Incyte pursuant to the tender offer is approximately 93.4 percent.

In accordance with the terms and conditions of the tender offer and based on the preliminary count by the depositary, the Company expects to purchase approximately 27.9 million shares of its common stock through the tender offer at a purchase price of $60.00 per share, for a total cost of approximately $1.672 billion, excluding fees and expenses relating to the tender offer. These shares represent approximately 12.4 percent of the Company’s total outstanding shares of common stock as of June 7, 2024.

As previously announced, on May 12, 2024, Incyte entered into a separate stock purchase agreement with Julian C. Baker (a member of Incyte’s Board of Directors), Felix J. Baker, and entities affiliated with Julian C. and Felix J. Baker, including funds advised by Baker Bros. Advisors LP (collectively, the "Baker Entities"), under which the Baker Entities agreed not to tender or sell any shares in the tender offer and instead agreed to sell to the Company, following completion of the tender offer, a pro rata number of shares at the same price per share as will be paid by the Company in the tender offer, such that the Baker Entities’ aggregate percentage ownership in the Company will be substantially the same as prior to the tender offer. As such, the Company expects to repurchase a total of approximately 33.3 million shares of its common stock through the tender offer and the stock purchase agreement at a price of $60.00 per share, for a total cost of approximately $2.0 billion, excluding fees and expenses. These shares represent approximately 14.8 percent of the Company’s total outstanding shares of common stock as of June 7, 2024.

The number of shares expected to be purchased in the tender offer and under the stock purchase agreement and the purchase price per share are preliminary and subject to change. The preliminary information contained in this press release is subject to confirmation by the depositary and is based on the assumption that all shares tendered through notice of guaranteed delivery will be delivered within the required one business day period. The final number of shares to be purchased in the tender offer and the final purchase price per share will be announced following the expiration of the guaranteed delivery period and the completion by the depositary of the confirmation process. Payment for the shares accepted for purchase pursuant to the tender offer, and the return of all other shares tendered and not purchased, will occur promptly following the completion of the confirmation process. The Company expects to fund the purchase of shares in the tender offer and pursuant to the stock purchase agreement with the Baker Entities, together with all related fees and expenses, with cash on hand.

The dealer manager for the tender offer is Goldman Sachs & Co. LLC. D.F. King & Co., Inc. is serving as information agent for the tender offer. Stockholders who have questions or would like additional information about the tender offer may contact D.F. King & Co., Inc. toll-free at (866) 864-4943.