On June 30, 2024 SCG Cell Therapy Pte Ltd (SCG), a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, reported that U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate Phase 1/2 clinical trial for SCG142, a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy for patients with HPV-associated solid tumors (Press release, SCG Cell Therapy, JUN 30, 2024, View Source;hpv-specific-tcr-t-cell-therapy-for-patients-with-hpv-associated-solid-tumors-302186559.html [SID1234644617]).

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"This FDA IND approval of another TCR T cell therapy candidate generated from our proprietary GianTCRTM platform is an important milestone for SCG. It marks the advancement of our TCR-based therapeutic program to treat unmet needs in different major cancer indications", said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "We are ready to commence multi-center Phase 1/2 clinical trials, assessing the potential benefits for patients via our proprietary TCR T technology."

SCG142 is a high-avidity fully natural HPV-specific TCR armoured with a TGFβRII-41BB chimeric switch receptor. In May 2024, SCG presented preclinical data of SCG142 at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting. The data indicates SCG142 had exhibited high polyfunctional avidity. It recognized both HPV-16 and HPV-52 genotypes, with a favourable safety profile with no alloreactivity or off-target toxicity. In addition, SCG142 demonstrated dual CD8 and CD4 TCR T cell proliferation and tumor inhibition in both in vitro and in vivo models, indicating CD8 co-receptor independent T cell functionality, as well as promoting long-term persistence of memory T cells.

"SCG142 is a novel and differentiated HPV-specific TCR T cell therapy. By armoring the TCR T cells with the chimeric switch receptor, it overcomes the hostile tumor microenvironment and converts inhibitory effects into a co-stimulatory signal. This process is essential for effective immunotherapy treatment of solid tumors. With this unique next-generation design, SCG142 represents a groundbreaking innovation that translates from our in-house discovery platforms into clinics", said Dr. Ke Zhang, Chief Scientific Officer of SCG Cell Therapy.

On June 28, 2024 Sumitomo Dainippon Pharma reported its Consolidated Financial Statements for Years ended March 31, 2024 and 2023 (Press release, Sumitomo Dainippon Pharma, JUN 28, 2024, View Source [SID1234644827]).

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On June 28, 2024, Incyte Corporation (the "Company") and its subsidiary, Incyte Holdings Corporation ("Incyte Holdings"), reported to have entered into Amendment No. 2 ("Amendment No. 2") to the Revolving Credit and Guaranty Agreement dated as of August 21, 2021 among the Company, as borrower, Incyte Holdings, as a guarantor, the lenders from time to time party thereto, J.P. Morgan Chase Bank, N.A. as administrative agent, and the other financial institutions party thereto (such Revolving Credit and Guaranty Agreement, as amended by Amendment No. 1 thereto, the "Existing Credit Agreement" and, as amended by Amendment No. 2, the "Amended Credit Agreement") (Filing, 8-K, Incyte, JUN 28, 2024, View Source [SID1234644663]).

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Amendment No. 2 extended the maturity date of the revolving credit facility under the Existing Credit Agreement from August 18, 2024 to June 28, 2027.

A copy of Amendment No. 2, which will include a full copy of the Amended Credit Agreement, will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.

On June 28, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported that Defence’s Accum-002TM ("AccuTOX") has different mode of actions: AccuTOX is working as a tumor killing molecule and as an immune booster (Press release, Defence Therapeutics, JUN 28, 2024, View Source;utm_medium=rss&utm_campaign=defences-accutox-boosts-and-synergizes-with-immune-checkpoint-inhibitors [SID1234644649]). AccuTOX mode of action synergizes with the activity of Immune Checkpoint Inhibitors ("ICI") and the immune system itself.

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Immune Checkpoint Inhibitors produces promising therapeutic effects in treatments of solid tumors. However, their overall response rate is still very low for a few patients suffering of solid tumors. For example, melanoma patient is one population group having the best response with only 20% of patients having a complete or partial response to ICI treatment. To explain the intrinsic resistant of those majority of patients to the ICI treatment, the scientific community discovered that those tumors have a cold tumor environment which block the patient immune system to recognize and attack the cancer cells. This cold environment is translated in part by a low level of immune infiltrating cell inside the tumor and by decreasing the potential of the immune system to recognize tumor as a non healthy tissue and to promote the attack and destruction of tumor cells.

The scientific and medical community is seeking solutions to this intrinsic resistance by transforming this cold tumor into hot tumor by using combination treatments with ICI. This transformation into hot tumor will increase tumor vulnerability to ICI treatment and to the immune system attacks. Defence Therapeutics team have discovered that the mode of action of AccuTOX exploits this tumor vulnerability by inducing immune system recruitment and increasing the tumor recognition by the immune system, which synergized with ICI mode of actions. Surprisingly and compared to competitors, AccuTOX induces the recruitment and/or the activation of different immune cells and transforms the cold tumor into very hot tumor which is easily recognized and attacked by the immune cells. These immune cells are responsible of tumor regression in context of ICI and other immunotherapy treatments. In other words, AccuTOX acts as an intelligent spotlight having specialized lens and biometric recognition software (facial and fingerprint recognition) for the immune system to recognize, focus, track and attack cancer tumors inside the body. AccuTOX has shown that it induces the death of cancer cells on its own mode of action and, more importantly, AccuTOX has the potential to transform a cold tumor into a hot tumor which the immune system will recognize, attack, and destroy.

AcccuTOX has the potential to treat more efficiently the patient who already has a positive response to ICI treatment and, in fact, AccuTOX can increase the patient population eligible to ICI treatment which shall increase the market of each existing ICI. The Company believes that AccuTOX is a strong candidate to enhance and boost the therapeutic value of the ICI and is open to potential partnerships and collaborations in that regard.

Defence’s scientific team has shown in many in vivo preclinical studies that AccuTOX significantly increases the efficacy of several ICI (anti-PD1, anti-CD47, anti-LAG3 and anti-CTLA4) when combined with AccuTOX, by at least a factor of 10 folds, to treat different cancer indications. The PD1/PDL1 (which is the ICI used in most of Defence’s AccuTOX in vivo preclinical studies) market is projected to grow from USD 36.4 Billion in 2023 to USD 139.7 Billion by 2032, exhibiting a CAGR of 18.3% during the forecast period of 2023-2032.

On June 28, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported results of the second exercise of Warrants Z and an update on the outstanding number of ordinary shares and Warrants Z as of the settlement date taking place today (Press release, TME Pharma, JUN 28, 2024, View Source [SID1234644618]). The exercise of 513,472 Warrants Z has resulted in the issuance of 641,840 new shares for gross proceeds of €128,368, an amount similar to that generated in the first exercise period.

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In the second Warrant Z exercise period, from May 27 to June 21, 2024, holders were entitled for every 4 Warrants Z held to subscribe for 5 new shares at €0.20 per share. Following this exercise, 2,812,632 outstanding Warrants Z remain with the potential to raise an additional €703,158 if exercised in full before the end of the final exercise period on June 20, 2025.

The following numbers of TME Pharma securities are thus issued and outstanding:

ALTME ordinary shares (ISIN: NL0015000YE1): 42,183,371
Warrants Z (ISIN: NL0015001SR3): 2,812,632
The third Warrant Z exercise period will run from August 26 to September 20, 2024, with settlement on September 27, 2024. Warrants Z may be exercised through June 20, 2025, with one period of exercise per quarter (six periods of exercise in total; see "Warrant Terms and Conditions" on the TME Rights Issue page for more details). Warrants Z that have not been exercised by the end of the last exercise period will become null and void.

Additional Information

The characteristics, terms and conditions and dilution resulting from the transaction are summarized in the press releases published on November 24, 2023, November 28, 2023, and February 23, 2024, and in the dedicated Rights Issue page on the TME Pharma website.

Dilution

The table below summarizes the dilution from the new ordinary shares issued today, and the maximum additional dilutive potential for an investor who did NOT participate in the transaction should all potential Warrants Z be exercised. Shareholders who participated fully in the transaction will not be diluted by this transaction.

Description

Shares to be issued

Total shares outstanding

Dilution (cumulative)

Shareholder starting with 1% on June 27, 2024, would then hold

Outstanding shares on June 27, 2024

–

41,541,531

–

1%

Shares Issued on June 28, 2024, from exercise of 513,472 Warrants Z

641,840

42,183,371

1.52%

0.98%

Exercise of outstanding Warrant Z (latest on June 20, 2025)

3,515,790

45,699,161

9.10%

0.91%