On January 21, 2023 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported preclinical data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, in combination with cetuximab (Ctx), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place January 19-21, 2023, in San Francisco, California (Press release, Wugen, JAN 21, 2023, View Source [SID1234626433]).

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"Our best-in-class memory NK cell platform is uniquely designed to have broad applications across solid and liquid tumors," said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen."WU-NK-101 has a unique CIML phenotype with enhanced metabolic fitness/flexibility and decreased susceptibility to immunosuppression—key properties that in combination with these data, build our conviction in the development trajectory for WU-NK-101 as a novel treatment for solid tumor cancers. We plan to initiate a first-in-human study of WU-NK-101 in combination with cetuximab for CRC in addition to SCCHN later this year."

Today’s presentation highlighted the following:

WU-NK-101 potency against colorectal cancer (CRC) cells was further enhanced when combined with Ctx in vitro and in vivo, confirming an antibody-dependent cellular cytotoxicity (ADCC) mechanism of action. WU-NK-101 in combination with Ctx showed improved CRC cell killing compared to WU-NK-101 and Ctx monotherapy.

WU-NK-101 showed robust homing to the TME, which was further improved when combined with monoclonal antibodies (mAbs). Intra-tumor penetration and persistence was also increased when combined with mAb in in vivo models.

WU-NK-101 displayed enhanced metabolic fitness/flexibility and maintained cytotoxicity within adverse, immunosuppressive tumor microenvironment (TME)-aligned media as compared to conventional NK (cNK) and T-cells. WU-NK-101 cells maintained cytotoxicity in a 3D TME model with native cellular components from primary CRC samples.

A Phase 1b clinical trial of WU-NK-101 in combination with Ctx for advanced and/or metastatic CRC and advanced and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) is in development.

The details of Wugen’s presentation at ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium are as follows:

Title: WU-NK-101, an Enhanced Memory Natural Killer (NK) Cell Therapy, with Cetuximab (Ctx) for the Treatment of Advanced Colorectal Cancer (CRC).
Abstract Number: 170
Session Name: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: Saturday, January 21, 2023 from 9:30 a.m. – 10:55 a.m. ET
Location: On Demand | Level 1, West Hall
Presenting Author: John Muth, Wugen

Additional meeting information can be found at View Source

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

About Wugen

On January 20, 2023 ImmuneOnco Biomedical Technology (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") reported that the first domestic SIRPαFc fusion protein drug targeting human CD47 (project number: IMM01) combined with PD-1 monoclonal antibody against relapsed and refractory classical Hodgkin’s lymphoma (R/RcHL) completed the first subject’s enrollment and administration of the Phase II clinical trial (Press release, ImmuneOnco Biopharma, JAN 20, 2023, View Source [SID1234655676]).

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The performance of IMM01 in the clinical phase I study of a single drug is encouraging. At a lower dose level, some patients with advanced lymphoma (including relapsed and refractory cHL) have good clinical efficacy and good safety. sex. Based on the molecular design characteristics of IMM01, IMM01 does not bind to human red blood cells in vitro at all, avoiding the "antigen sink effect". The molecule is only about half of the antibody, and has good tissue permeability and bioavailability. At the same time, in the preclinical in vivo drug efficacy test, IMM01 was used in combination with targeted drugs and immunotherapy drugs, showing strong tumor suppressive activity against solid tumors, and has the potential of combination therapy.

Dr. Tian Wenzhi, Founder and Chairman of ImmuneOnco, said, "I am very pleased to see that the phase II clinical trial of our IMM01 project combined with PD-1 monoclonal antibody for relapsed and refractory classical Hodgkin’s lymphoma (R/RcHL) has completed the first patient enrollment and administration. Preclinical studies have shown that The combination of IMM01 and PD-1 monoclonal antibody has a strong synergistic effect. In the patients enrolled in the combination, it showed good safety and tolerability, and it was observed in patients with non-small cell lung cancer resistant to previous PD1 therapy Preliminary positive efficacy response. We have reason to believe that in further clinical studies, IMM01 combined with PD-1 monoclonal antibody will show outstanding clinical efficacy and good safety, which is very hopeful to bring good news to the majority of cancer patients. It is our company’s mission to develop first-class new medicines, and we will unswervingly pursue this dream."

On January 20, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME) (Paris:ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that pursuant to the liquidity contract entrusted to Invest Securities by TME Pharma N.V. the assets outlined below appeared on the liquidity account (Press release, TME Pharma, JAN 20, 2023, View Source [SID1234626438]). During the reporting period the company changed its name from NOXXON Pharma to TME Pharma (July 15, 2022), and effected a share consolidation such that every 100 shares with a nominal value of 1 eurocent each were consolidated and converted into 1 new share with a nominal value of 1 euro (July 27, 2022). Both processes are being reflected in this half-yearly report.

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The following assets appeared on the liquidity account as of December 31, 2022:

• Number of shares: 13,992

• Cash balance of the liquidity account: €11,622.12

For the period July 28, 2022 – December 31, 2022:

• Total number of shares bought: 81,080

representing an amount of: €217,453.70

representing total transactions of: 1,222

• Total number of shares sold: 67,779

representing an amount of: €185,844.42

representing total transactions of: 1,519

The company made an additional payment of €15,000.00 on November 23, 2022, into the liquidity account in order to improve the balance and maintain the liquidity contract. For more detailed information for the period of July 28, 2022 – December 31, 2022, please see annex A of this press release.

The following assets appeared on the liquidity account as of July 27, 2022:

• Number of shares: 691 (equating to 69,192 before the share consolidation)

• Cash balance of the liquidity account: €28,231.41

For the period July 01, 2022 – July 27, 2022:

• Total number of shares bought: 47,517

representing an amount of: €2,173.69

representing total transactions of: 33

• Total number of shares sold: 64,518

representing an amount of: €3,260.45

representing total transactions of: 42

As a reminder, as of June 30, 2022, the following assets appeared on the liquidity account:

• Number of shares: 86,193

• Cash balance of the liquidity account: €27,144.62

For more detailed information for the period of July 01, 2022 – July 27, 2022, please see annex B of this press release.

On January 20, 2023 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that we have completed the closing of our previously announced definitive agreement with Akeso Inc. (HKEX Code: 9926.HK, "Akeso") to in-license its breakthrough bispecific antibody, ivonescimab (Press release, Summit Therapeutics, JAN 20, 2023, View Source [SID1234626436]). Ivonescimab, known as AK112 in China and Australia, and as SMT112 in the United States, Canada, Europe, and Japan, is a novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.

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Summit is initiating development activities for SMT112 and will do so first in non-small cell lung cancer (NSCLC) indications.

The definitive partnership calls for Summit to receive the rights to develop and commercialize ivonescimab (SMT112) in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world, including China.

In exchange for these rights, Summit committed to an upfront payment of $500 million to be paid in two installments. The first installment worth $300 million has been paid in conjunction with the closing of the transaction. Of the $300 million paid to Akeso by Summit, Akeso opted, in accordance with the definitive agreement, to convert approximately $25.1 million of the payment into 10 million shares of Summit common stock; the remaining $274.9 million was paid by Summit to Akeso in cash. The second installment of $200 million will become due on March 5, 2023 and will be paid by Summit in cash.

Going forward, Akeso will be eligible to receive regulatory and commercial milestones of up to an additional $4.5 billion. In addition, Akeso will receive low double-digit royalties on net sales in the Summit territories.

In conjunction with the closing of the deal, Dr. Michelle Xia, Co-Founder, Chairwoman, and CEO of Akeso, has been appointed to the board of directors of Summit.

Update on $500 Million Rights Offering

We continue to plan for our previously announced rights offering, which will be available to all holders of record of the Company’s common stock, par value $0.01 (the "Common Stock") as of the close of the market on the record date. The record date will be no earlier than February 2, 2023 (the "Record Date").

The Company intends to distribute to all holders of Common Stock as of the Record Date non-transferable subscription rights to purchase shares of Common Stock at a price per share equal to the lesser of (i) $1.05, or (ii) the volume weighted-average price of the Common Stock for the five consecutive trading days through and including the expiration date of the offering. Assuming that the rights offering is fully subscribed, the Company will receive gross proceeds of up to $500 million, less expenses related to the rights offering.

We will provide additional information as we approach the final record date.

Summit has filed a registration statement (including a prospectus) on Form S-3 with the Securities and Exchange Commission (the "SEC") on December 21, 2022, which has not yet become effective. The registration statement covers, among other things, the rights offering to which this communication relates. Such securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. Before you invest, you should read the final prospectus in that registration statement, together with any prospectus supplement, that we will file prior to commencing any rights offering, and the documents incorporated by reference in the prospectus (or any prospectus supplement), as well as the other documents Summit has filed with the SEC for more complete information about Summit and the rights offering. You may get these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The rights offering will be made pursuant to an effective registration statement on Form S-3 containing the detailed terms of the rights offering to be filed with the SEC. Any offer will be made only by means of a prospectus forming part of the registration statement.

Summit Therapeutics’ Mission Statement

To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, and successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate.

We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders.

On January 20, 2023 Universal Diagnostics (Universal DX), a bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, reported the results of an international, observational cohort study which evaluated the effectiveness of utilizing a combination of cell-free DNA (cfDNA) methylation, fragmentation and machine learning to detect early-stage colorectal cancer (CRC) (Press release, Universal Diagnostics, JAN 20, 2023, View Source [SID1234626435]).

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This is the latest in a series of findings from Universal DX; today’s news demonstrates the use of methylation and fragmentation characteristics of cancer-related cfDNA regions, combined with a machine-learning algorithm is highly accurate for early-stage (I-II) CRCs (92% sensitivity at 94% specificity). These results were achieved on a prospectively collected patient sample set from four different populations: the U.S., Spain, Germany, and Ukraine.

Universal DX has previously shown that non-invasive blood testing can be used to detect CRC and pre-cancerous advanced adenomas (AA) through both analysis of cell-free circulating tumor DNA (ctDNA) methylation, fragmentation and microbiome patterns with single targeted sequencing analysis and combining it with advanced computational biology and machine learning algorithms. In 2022, the company extended early-stage colorectal cancer detection to prognostics and stratification; the ability to do so could lead to better outcomes and improved survival rates.

"This study further validates and reinforces the work we are doing to develop tests that detect cancer in its earliest stages," said Christian Hense, COO at Universal DX. "With a completely new sample set, we have again demonstrated highly-accurate early-stage CRC detection, further verifying the robustness of our technology and use of biomarkers to find traces of cancer in a person’s blood. At Universal DX, we believe early detection is one of the most powerful tools for improving survival rates, and are encouraged to see these promising results once again."

Study results:

Prediction model that utilized a panel of methylation and fragmentation scores originating from cfDNA biomarkers that belong to relevant cancer development and progression-related pathways correctly classified 92% (87/95) of CRC patients.
Sensitivity per cancer stage ranged from 91% (21/23) for stage I, 92% (23/25) for stage II, 91% (30/33) for stage III and 93% (13/14) for stage IV.
Fragmentation signals contributed most to early-stage cancers (I-II), while methylation signals were more significant for late stage (III-IV) detection.
Specificity of the model was 94% (199/204), with 97% (28/29) NAA (non-advanced adenoma), 93% (116/125) BEN (benign colonoscopy findings of diverticulosis/diverticulitis, hemmorhoids, hyperplastic/inflammatory polyps) and 94% (47/50) cNEG (colonoscopy negative) patients correctly identified.
Lesion location, gender, age and country of origin were not significantly correlated to prediction outcome.
Universal DX leverages proprietary, state-of-the-art computational biology tools combined with a targeted next generation sequencing assay platform that allows for simultaneous detection of methylation, fragmentation and microbiome signals for highly-sensitive cancer signal scoring of cell-free DNA regions linked to cancer of interest.

Hense continued: "Colorectal cancer is the third most common cancer diagnosed in the U.S.; in 2023, The American Cancer Society estimates there will be more than 150,000 new diagnoses of colon and rectal cancer. This demonstrates the need to not only prioritize screening, but find tools that help us detect cancer in its earliest forms, when there are more treatment options available and survival rates are higher."

Universal DX will present its findings live at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in San Francisco, CA on January 21st as poster #201 titled "Use of methylation and fragmentation signals in the detection of early-stage colorectal cancer."

In addition to today’s results, the company will be presenting findings from additional studies in the upcoming months.