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 Genmab A/S (Nasdaq: GMAB) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab (TEPKINLY), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy (Press release, Genmab, JUN 28, 2024, View Source [SID1234644593]). The final European Commission decision on this indication for epcoritamab is anticipated later this year.

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"Many people living with follicular lymphoma that has either relapsed or is refractory to existing therapies experience significant treatment challenges with poor prognosis," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "This positive opinion recognizes the unmet need in the European Union for patients whose follicular lymphoma is considered difficult-to-treat and that epcoritamab may represent a new therapeutic option."

The CHMP opinion is supported by overall and complete response data from the Phase 1/2 EPCORE NHL-1 clinical trial in 128 patients with R/R FL treated with epcoritamab after two or more lines of systemic therapy. The study included patients who were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent, patients who were refractory to last prior treatment, and patients whose disease progressed within two years of first systemic therapy. In the trial, the most common (≥10%) adverse reactions were CRS, injection site reactions, pyrexia, neutropenia, anemia, thrombocytopenia, diarrhea, nausea, headache, upper respiratory tract infection, pneumonia, and rash.

An additional cohort of 86 patients evaluated an optimized step-up dosing (SUD) schedule to reduce the incidence and severity of cytokine release syndrome (CRS), which is an associated side effect from immune-engaging cancer treatments. Hospitalization was not mandatory in the optimization cohort. The incidence of CRS was 49% (42 of 86 patients; 9% were grade 2) and there were no grade 3 or higher CRS events in the optimization cohort. The EPCORE NHL-1 results, including results from the optimization cohort, were recently published in the Lancet Haematology. Additionally, data from the optimization cohort were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, selected to be a part of Best of ASCO (Free ASCO Whitepaper) (July 19-20, Boston, MA), and were presented at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Congress.

"Each year, thousands of people in Europe are diagnosed with follicular lymphoma and it’s an upsetting reality that many of them will experience relapse and refractory disease," said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. "Patients deserve new treatment options, and this positive opinion is the first step to bringing epcoritamab to more patients who need it."

About the EPCORE NHL-1 Trial
EPCORE NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a dose escalation part; an expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. In the expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The expansion part generated pivotal data from patients with FL and DLBCL. The optimization part evaluated additional CRS mitigation strategies during cycle 1. The primary endpoint of the expansion part was overall response rate (ORR) as assessed by an Independent Review Committee (IRC). Secondary efficacy endpoints included duration of response, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints. The primary endpoint of the optimization part was the rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab.

About Follicular Lymphoma (FL)
FL is typically an indolent (or slow-growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes.i Although FL is an indolent lymphoma, it is considered incurable with conventional therapy and patients who achieve remission also often experience relapse.iii,iv,ii Generally, with each relapse, the remission and time to next treatment is shorter.iii,iv

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.v

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

On June 28, 2024 Waypoint Bio (aka "Waypoint"), a biotechnology company pioneering novel cell therapies for solid tumors using in vivo spatial pooled screening technology, reported $14.5 million in seed funding led by Hummingbird Ventures with participation from other institutional investors, including Recode Ventures and pre-seed lead Fifty Years (Press release, Waypoint Bio, JUN 28, 2024, View Source [SID1234644605]).

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The FDA recently approved the first ever cell therapy for solid tumors, yet innovation in this area has been slow given the challenges of the solid tumor microenvironment and difficulty testing therapies in relevant model systems at-scale. Waypoint’s platform – which uniquely combines spatial biology with pooled screening for the purpose of drug discovery – can conduct initial screens of cell therapy designs in vivo and simultaneously measure hundreds of phenotypes at the single cell level, helping illuminate which designs work and why. This novel approach enables the simultaneous measurement of how many cell therapy candidates can navigate multiple aspects of the solid tumor microenvironment, helping guide the engineering of cell therapy designs for the treatment of historically intractable diseases, such as pancreatic cancer.

"Pooled screening is an incredibly powerful technology for drug discovery, but it’s historically been limited to measuring simple cell phenotypes, such as growth or drug resistance. This limits the technology’s value in more complex diseases where interactions between cells and their environment are key, including T cell interactions with solid tumors in cancers," said Xinchen Wang, PhD, Co-founder and CEO. "Our platform turbocharges traditional pooled screening by leveraging spatial biology to generate complex, multivariate and spatial readouts for every perturbation, helping us quickly generate novel drug candidates with a greater probability of clinical success."

"We built our platform so that we could start our discovery process directly in mouse models, skipping the in vitro step while still testing cell therapy designs at high-throughput and lower cost," said David Phizicky, PhD, Co-founder and Chief Scientific Officer. "This scale of in vivo testing allows us to screen many more innovative cell therapy designs with higher potential for clinical translatability. Using spatial biology, we’re able to read out not only which assets show efficacy in vivo, but also why these assets succeed or fail, and which assets match the phenotypes observed from patient samples. This level of detail presents a potential leap forward in cell therapy design."

Waypoint will use its seed financing toward first designing CAR T-cell therapies with superior efficacy against the tumor microenvironment, and later, Treg therapies for autoimmune diseases.

"We’re thrilled to partner with Xinchen and Dave and lead Waypoint Bio’s seed funding, which will accelerate Waypoint’s plans to develop solid tumor cell therapy designs using spatial biology at scale," said Pablo Lubroth, Investor, Hummingbird Ventures. "Waypoint Bio’s founders are part of an extremely unique subset of scientists that understand the wet lab and computational biology equally well, evidenced by how they combine an in vivo spatial pooled screening platform to generate interpretations of disease that open the door for many new therapies for underserved patients."

Waypoint Bio was co-founded by Xinchen Wang and David Phizicky, MIT alum with complementary wet and dry lab backgrounds and a shared vision for leveraging AI, automation and spatial biology to build a next-generation platform for drug discovery that could impact our treatment of intractable disease. They are joined by a team of 11 researchers, scientists and engineers, and a diverse, expert Scientific Advisory Board, comprised of:

Melina Claussnitzer, PhD, Broad Institute of Harvard & MIT
Robbie Majzner, MD, Dana-Farber Cancer Institute
Yvonne Chen, PhD, UCLA
Shantanu Singh, PhD, Broad Institute
Ron Lennox, D.Phil. MBA, Biotech entrepreneur and investor
To learn more about Waypoint Bio, including partnering and career opportunities, please visit waypointbio.com.

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.