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 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a TIL cell therapy, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor (Press release, Iovance Biotherapeutics, JUN 28, 2024, View Source [SID1234644594]). If approved, lifileucel will be the first and only approved therapy in this treatment setting in all European Union (EU) member states.

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Raj K. Puri, M.D., Ph.D., Executive Vice President, Regulatory Strategy and Translational Medicine, stated, "This EU regulatory submission is the first step toward expanding lifileucel into global markets with a high prevalence of advanced melanoma. The unmet need and strength of the clinical data will support approval of lifileucel as the first and only approved therapy for advanced melanoma patients in the EU who have progressed following standard of care therapies. Following the accelerated approval in the U.S., our global expansion strategy can more than double the number of patients with significant unmet need who may access lifileucel."

The MAA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. If the MAA for lifileucel is validated, which is anticipated in the third quarter of 2024, the Committee for Medicinal Products for Human Use (CHMP) is expected to issue a scientific opinion for the European Commission to adopt in 2025. Additional marketing submissions for lifileucel are on track in Canada and the United Kingdom during the second half of 2024 and in Australia in 2025. Each year, more than 20,000 people die from advanced melanoma in the U.S., EU, United Kingdom, Canada, and Australia.1

1. World Health Organization International Agency for Research on Cancer (IARC) GLOBOCAN 2022.

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 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy (Press release, Regeneron, JUN 28, 2024, View Source [SID1234644595]). The European Commission is expected to announce a final decision in the coming months.

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FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). While FL is a slow-growing subtype, it is an incurable disease, and most patients will relapse after initial treatment. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment (e.g., relapsing or refractory to treatment). It is estimated that approximately 120,000 FL cases and 163,000 DLBCL cases are diagnosed annually worldwide. In Europe, it is estimated that approximately 15,000 FL cases and 31,000 DLBCL cases are diagnosed each year.

The positive CHMP opinion is supported by results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab in adults with R/R FL or R/R DLBCL. In a pooled safety population, the most common serious adverse reactions were cytokine release syndrome, pneumonia, COVID-19 and pyrexia.

The EMA previously granted odronextamab Orphan Designation for both FL and DLBCL. Odronextamab is currently under clinical development and has not been approved by any regulatory authority.

Regeneron continues to evaluate the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. This includes the registrational ELM-1 and ELM-2 studies, the Phase 3 OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs, as well as early-stage trials with chemotherapy-free combinations.

About the Odronextamab Clinical Trial Program
Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy, including a cohort of patients who had progressed after CAR-T therapy.

ELM-2 is an ongoing, open-label, multicenter Phase 2 trial investigating odronextamab across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-NHL. The primary endpoint is objective response rate according to the Lugano Classification as assessed by independent review committee, and secondary endpoints include complete response, progression-free survival, overall survival and duration of response.

In addition to the Phase 3 OLYMPIA development program, Regeneron is investigating odronextamab in combination with a costimulatory bispecific antibody, REGN5837 (CD22xCD28), and Regeneron’s PD-1 inhibitor cemiplimab for R/R aggressive B-NHL through the ATHENA-1 and CLIO-1 studies, respectively. For more information, visit the Regeneron clinical trials website, or contact [email protected] or +1 844-734-6643.

On June 28, 2024 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology, reported the preliminary results of its rights offering, which expired at 5:00 p.m., Eastern Time, on June 26, 2024 (the "Expiration Date") (Press release, Pulse Biosciences, JUN 28, 2024, View Source [SID1234644616]).

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In accordance with the pricing structure described in the prospectus supplement relating to the rights offering, the final subscription price for the units offered (the "Units") is $10.00 per Unit. Each Unit consisted of one share of the Company’s common stock, par value $0.001 per share, and two warrants, each being a warrant to purchase one-half of one share of common stock. Each warrant will be exercisable for $11.00 per whole share, which equals 110% of the subscription price for the Units. Warrants are exercisable immediately and will expire on the fifth anniversary of the completion of the rights offering. Half of the warrants issued in the rights offering are redeemable by the Company if the Company’s stock trading price exceeds $16.50 for twenty consecutive trading days and the other half of the warrants issued in the rights offering are redeemable by the Company if its stock trading price exceeds $22.00 for twenty consecutive trading days.

Based on a preliminary tabulation by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent"), as of the Expiration Date, the Company received basic subscriptions and over-subscriptions in excess of $83 million, equal to approximately 138% of the $60 million limit in the rights offering, and subscriptions from over 800 accounts, including those of the Company’s Executive Chairman, Robert Duggan. Available Units will therefore be allocated proportionately among those rights holders who exercised their over-subscription right based on the number of Units each rights holder subscribed for under its basic subscription rights, in accordance with the procedures described in the prospectus relating to the rights offering, as amended, and the remaining oversubscription amounts will be returned by the Subscription Agent to the investors. The common stock and warrants comprising the Units will separate upon the closing of the rights offering and will be issued individually. The Company expects the Subscription Agent to distribute such shares and warrants, as well as the sale proceeds, as soon as practical upon the closing of the rights offering.

The Company expects to receive aggregate gross proceeds from the rights offering of $60 million, excluding additional proceeds of up to $66 million from the exercise of warrants issued in the rights offering (if any such exercises occur). The results of the rights offering are preliminary and subject to change pending finalization of subscription procedures by the Subscription Agent.

The rights offering was made pursuant to the Company’s registration statement on Form S-3, as modified by the post-effective amendment filed with the Securities and Exchange Commission ("SEC") on May 28, 2024, which was deemed effective by the SEC on May 31, 2024, including the prospectus contained therein, as further modified by the prospectus filed pursuant to Rule 424(b)(2) of the Securities Act of 1933, which contains the detailed terms of the rights offering and was filed with the SEC on June 4, 2024. Copies of the foregoing documents may be obtained at the SEC’s website at www.SEC.gov. Subscription rights that were not exercised by 5:00 p.m., Eastern Time, on June 26, 2024, have expired.