TME Pharma: Half-yearly Report on the Liquidity Contract With Invest Securities

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.

Summit Therapeutics Closes Deal with Akeso Inc. to In-License Breakthrough Innovative Bispecific Antibody

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.

New Data from Universal DX Demonstrates Effective Detection of Early-stage Colorectal Cancer Using Combination of Methylation, Fragmentation and Machine Learning

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.

Genexine Receives Fast Track Designation from Korean Health Authority (MFDS) for its promising DNA vaccine for advanced cervical cancer

On January 20, 2023 Genexine (KOSDAQ: 095700), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported it received Fast Track Designation (FTD) from the Korean Ministry of Food and Drug Safety (MFDS) for GX-188E (tirvalimogene teraplasmid), its first-in-class proprietary therapeutic DNA vaccine (Press release, Genexine, JAN 20, 2023, View Source [SID1234626434]).

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Following an evaluation of the full set of Phase 2 data from the recently completed clinical trial in advanced cervical cancer, Korea’s Health Authority (MFDS) concluded that GX-188E met the criteria for fast-track designation. Under MFDS regulations, FTD is given to a drug that is intended to treat a serious condition and the nonclinical or clinical data demonstrate the potential to address an unmet medical need. Having such a designation can mean that a drug can move more quickly through the development and regulatory process in an expedited manner.

"We are grateful to the Korean Health Authority for their careful evaluation and recognition that GX-188E has the potential to be a key life-saving drug for the treatment of advanced cervical cancer," said Neil Warma, Genexine’s President and CEO. "We are committed to the cancer patients in which this therapy could be effective and appreciate that FTD could help to possibly speed our time to market to deliver the drug to patients more rapidly. We are in the process of designing the optimal Phase 3 study with GX-188E and expect to initiate that study this year."

Genexine recently reported Phase 2 trial data which evaluated the efficacy and safety of the combination of GX-188E and KEYTRUDA (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy, in a total of 65 patients (safety population) with HPV 16- and/or HPV 18- positive recurrent or metastatic advanced cervical cancer. The final efficacy analysis evaluated in 60 patients (efficacy evaluable population) showed an Objective Response Rate (ORR) of 35% (21 of 60 patients) indicating that of the 60 patients with advanced cervical cancer, 21 patients saw either over 30% reduction in tumor size or complete remission.

BriSTAR Immunotech To Present its Novel Cell Therapy for Acute Myeloid Leukemia at the AACR Special Conference on AML and MDS

On January 20, 2023 BriSTAR Immunotech, a clinical-stage cell therapy company, reported it will showcase its T-cell receptors (TCR) and antigen receptor (STAR)-T cell therapy technology platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) special conference on acute myeloid leukemia and myelodysplastic syndrome, taking place January 23-25, 2023, in Austin, Texas (Press release, Bristar Immunotech, JAN 20, 2023, View Source [SID1234626425]).

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"The data shows that our LILRB4 STAR-T cell therapy exhibits potent anti-tumor activity against AML in preclinical models," said Dr. James Pan, CEO at BriSTAR Immunotech. "These findings support our strategy to maximize the potential of our unique STAR-T technology platform."

Presentation Details:

Abstract title: Development of LILRB4 biparatopic synthetic T-cell receptor and antigen receptor (STAR)-T cells for the treatment of acute myeloid leukemia (AML)
Presenter: Dr. James Pan
Date / Time: Tuesday, January 24, 2023 7:15 – 9:30 p.m. CST
The complete abstract will be available here. An electronic copy of the poster is available upon request EMAIL: [email protected].

About LILRB4 STAR-T

BriSTAR Immunotech has developed LILRB4 STAR-T cell therapy for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML). This novel cell therapy drug candidate was developed using BriSTAR’s STAR-T platform to introduce the biparatopic STAR gene targeting LILRB4 into autologous T cells with a lentiviral gene transduction approach. This next generation T cell therapy uses two novel nano-antibodies that bind to different epitopes and fused to the alpha and beta chains of the STAR structure, respectively. This gives LILRB4 START-T better antigen engagement and increased cytotoxicity against this highly aggressive AML. In December 2022, the LILRB4 STAR-T program received Orphan Drug Designation from the U.S. FDA.

About Acute Myeloid Leukemia (AML)

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML occurs when a bone marrow cell suddenly develops genetic abnormalities. It is highly heterogeneous with limited therapeutic options and poor prognosis. AML is the most common acute leukemia in adults, with an incidence of over 20 000 cases per year in the United States alone, and China ranked among the top three in the world in terms of the number of AML cases and deaths, with 13,200 and 7,100 cases, respectively. For patients with relapse/refractory AML, there is no treatment that significantly extends the survival period of 5-9 months.

About STAR-T Platform

BriSTAR Immunotech’s synthetic TCR and antigen receptor (STAR)-T cell therapy technology platform is highly effective at building a product pipeline for both hematological and solid tumors. STAR-T has the characteristics of natural T cells, such as sensitive target engagement and strong tumor infiltration and offers a natural framework for engineering dual-targeting T cell products.

In September 2022, an investigational new drug (IND) application for CD19/CD20 STAR-T cell injection (research code: HXYT-001) was granted by Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), for the treatment of recurrent/refractory non-Hodgkin lymphoma (B-NHL). In addition, the STAR-T exploratory clinical studies have been initiated for several types of solid tumors.