On May 25, 2022 Chimeric Therapeutics Ltd (ASX:CHM) reported that it has exercised its exclusive option for the CORE-NK platform from Case Western Reserve University (CWRU) (Press release, Chimeric Therapeutics, MAY 25, 2022, View Source [SID1234614976]).

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The move will allow the clinical-stage cell therapy company to proceed with negotiations for an exclusive licence.

Chimeric has had six months to exercise this option, provided it met certain milestones in accordance with an agreed development plan.

The Clinically validated, Off the shelf, Robust, Enhanced Natural Killer (CORE-NK) cell platform technology provides an excellent foundation for accelerated development of multiple next generation NK and CAR-NK products.

In March 2022, Chimeric delivered positive final results from a Phase 1 trial of the platform conducted in blood cancers and solid tumours.

Read: Chimeric Therapeutics concludes safety trial for blood and solid tumour cancer treatment; one patient in remission

Chimeric expects to use the CORE-NK platform while leveraging its existing portfolio of CARs to pursue new clinical trials in blood cancers and solid tumours beginning in 2023.

On May 24, 2022 Daewoong Pharmaceutical (CEO Seung-ho Jeon and Chang-jae Lee) reported that it has been newly selected as an operator of TIPS (Television, Private Investment-led Technology Startup Support), a technology startup investment program hosted by the Ministry of SMEs and Startups (hereinafter referred to as the MSS) (Press release, Daewoong Pharmaceutical, MAY 24, 2022, View Source [SID1234647377]).

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TIPS is a program that utilizes the operator’s private (angel) investment and incubation capabilities to discover and invest in promising startups, and then supports them with matching funds such as government technology development, startup commercialization, and overseas marketing. When the operator selects a startup and recommends it to the Ministry of SMEs and Startups, it provides support for technology development (R&D), startup commercialization, etc. after a separate evaluation.

Daewoong Pharmaceutical registered as a specialized accelerator in the pharmaceutical and biotechnology field with the Ministry of SMEs and Startups in 2020 and has successfully discovered and invested in two prospective startups and two early-stage investment companies through its startup investment competition program, Innobear Startup School.

Daewoong Pharmaceutical applied for the recruitment of a new TIPS operator in March to promote a company building that helps start-up companies in the bio sector with promising technologies prepare for startups and foster early-stage companies, and to create an environment where Daewoong Pharmaceutical and start-ups can grow together. As a result, it was officially selected this month. Daewoong Pharmaceutical is the only company selected as a specialized operator for bio and healthcare.

Daewoong Pharmaceutical will recruit and select startups with potential in the field of bio-fusion R&D that encompasses synthetic new drugs, cell gene and antibody treatments, new modalities, innovative technologies that can become next-generation game changers, artificial intelligence and various IT technologies, and support them with angel investment, incubation, mentoring, and bio-specialized acceleration programs.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "Daewoong Pharmaceutical will become the optimal customized partner that can grow together with startups based on its 30+ years of research and clinical development capabilities, global blockbuster launch and technology export experience, global business and production infrastructure, and early-stage investment and accelerator experience."

Meanwhile, Daewoong Pharmaceutical has been actively pursuing open collaboration with promising startups prior to selecting the TIPS operator. In the field of cell and gene therapy, it is jointly developing anticancer immune cell therapy with Alloplex and target protein degradation (TPD) platform new drugs with Pin Therapeutics. In the field of innovative new drugs and DDS, it is jointly developing immune anticancer drugs with NEX-I and continuing long-term collaboration with Nurron for the development of brain disease treatments (Parkinson’s disease).

On May 24, 2023 Hervolution, an early-stage biotechnologycompany developing effective immunotherapies targeting the Human Endogenous Retroviruses (HERVs), reported that it has raised EUR 6M of Seed funding from private investors with the participation of the European Innovation Council (EIC) Fund (Press release, Hervolution Therapeutics, MAY 24, 2022, View Source [SID1234637206]). The financing will enable Hervolution to advance its lead drug candidate, IPT001, a first-in-class immunotherapy against solid tumors, into clinical development.

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Incubated at the BioInnovation Institute (BII) and seeded by the Novo Nordisk Foundation, Hervolution was established to develop immunotherapies designed to overcome the limitations of cancer vaccines. Hervolution is targeting the human endogenous retroviruses (HERVs) to treat cancer. HERVS are well recognized as tumor specific antigens, but until now, have been undruggable. Hervolution is targeting HERV tumor antigens with a powerful technology that stimulates both arms of the immune system, the humoral and the cellular response. The Company delivers the immunogen by using Adenoviral and RNA vectors.

Hervolution has generated robust pre-clinical, proof-of-concept data that demonstrate therapeutic potential for multiple oncology indications including pancreatic, ovarian, breast and prostate cancer. It plans to enter First-In-Human (FIH) trials in 2024.

To support its growth, Hervolution has appointed Dr Hamina Patel, MD, as Chief Medical Officer, and Dr Sven Rohmann, MD, PhD, MBA as Chairman of the Board of Directors.

Jordi Naval, Chief Executive Officer of Hervolution said: "Hervolution is shifting the paradigm in cancer immunotherapy and is at an exciting phase of growth. Our aim is tounlock the full potential of immunotherapy in cancer. We believe Hervolution can solve the limitations of current cancer vaccines, as our pre-clinical data has shown that our immunotherapy induces higher tumor control, survival rate and tumor efficacy, compared toother competing approaches. I am very pleased to welcome Sven and Hamina to Hervolution. Their expertise and track record of success will be invaluable as we accelerate the development of our lead candidate into clinical development."

Hermann Hauser, the EIC Fund Board member commented: "The EIC Fund has established itself as a strong force in EU deep-tech investments. This unique form of financing via EIC combining grants and equity – is proving itself highly attractive to Europe’s most promising start-ups."

Dr Sven Rohmann, newly appointed Chairman added: "I am thrilled to have joined the Board of Directors of Hervolution at this time of company expansion. The Company is working on cutting-edge technology at the forefront of cancer immunotherapies and I look forward to taking this technology into clinics."

Dr Patel has over 20 years of experience in the pharmaceutical industry with proven track record of leadership roles in clinical development, oncology and global commercialization, having previously held positions as Director of Drug Development, Oncology, at Johnson and Johnson, where she helped build a broad and differentiated portfolio of indications for the cancer drug VELCADE. Dr Rohmann is experienced in General Management and leadership and has a track record in raising funds for SMEs and public companies. He has extensive international experience in M&A, business and corporate development, clinical development, strategic marketing and portfolio management in small- and large-scale Venture Capital Financing at Merck, Novartis and MPM Bio IV NVS Strategic Fund.

The Seed round of EUR 6M includes private investors and a convertible loan from EICF. Hervolution is planning to raise an additional Series A to finance the pivot from preclinical to clinical development.

For further information, please contact:
Optimum Strategic Communications
Hollie Vile, Hana Malik, Eleanor Cooper
Tel: +44 20 3922 0891
Email: [email protected]

On May 24, 2022 / ENB Therapeutics, Inc., a clinical stage biotechnology company pioneering a new and differentiated class of therapeutics targeting the endothelin B receptor (ETBR) inhibitor, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, ENB-003, for the treatment of pancreatic cancer (Press release, ENB Therapeutics, MAY 24, 2022, View Source [SID1234634068]). This is the second Orphan Drug Designation award for ENB-003, which has also been granted Orphan Drug Designation for melanoma.

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"Immune checkpoint therapies have significantly improved the survival of patients with certain cancers; however, there remain a significant percentage of patients that exhibit no response to these therapies," said Sumayah Jamal, MD-PhD, President, Co-founder and CSO of ENB Therapeutics. "This is especially true for pancreatic cancer patients, where only about 3% of tumors are responsive to the leading anti-PD-1 therapy KEYTRUDA (pembrolizumab). We believe that combining our ETRB inhibitor, ENB-003, with pembrolizumab, has the potential to overcome this resistance, and provide much needed additional treatment options for patients in a broader range of pancreatic tumors."

"Our Phase 1/2 trial will exclude patients with pancreatic tumors that have the molecular alterations known as high microsatellite instability (MSI-H) or defective DNA mismatch repair (dMMR). Thus, we are targeting truly pembrolizumab resistant patients to evaluate the potential for a ENB-003 + pembrolizumab combination as a potential treatment for this population with clear and significant unmet need," said Dr. Jamal.

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. This designation acts as a stimulus for the development of drugs for rare diseases through several incentives, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and the potential for seven years of post-approval marketing exclusivity after FDA approval.

About ENB-003

ENB-003 is a selective endothelin B receptor (ETBR) inhibitor that, in preclinical studies, enhanced the efficacy of immunotherapies such as anti-PD-1, anti-CTLA-4 and CAR T across multiple cancer types in preclinical studies. In an ongoing multi-center Phase 1/2 clinical trial, early efficacy signals suggest that ENB-003 overcomes resistance to the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in heavily pre-treated drug resistant cancer patients. The Phase 2 portion of the ENB-003 + pembrolizumab combination study is expected to start in the first quarter of 2023. The trial will enroll melanoma patients with innate resistance to anti-PD-1 based immunotherapies, platinum refractory and platinum resistant ovarian cancer patients, as well pancreatic cancer patients that have failed standard of care.

On May 24, 2022 PeLeMed reported that it will present the preclinical study results of the FLT3/RET dual inhibitor candidate ‘PLM-102’ at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 (ASCO 2022) (Press release, PeLeMed, MAY 24, 2022, View Source [SID1234615603]).

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PLM-102, a target anticancer drug candidate of Pelemed, targets even FLT3-resistant mutations (D835Y, F691L) that develop resistance after treatment with existing drugs such as ‘Xospata, gilteritinib’, an FLT3 inhibitor for the treatment of acute myeloid leukemia (AML). do. Pelemed is aiming to submit an IND to the Korean and US Food and Drug Administration (FDA) next year.

At this ASCO (Free ASCO Whitepaper), Pelemed will present △in vitro biochemical, cellular △ in vitro efficacy, △mode of action, etc. of PLM-102 along with the existing drug Zosphata. .

Specifically, PLM-102 showed an excellent Kd value for binding even at a lower dose compared to the FLT3/AXL inhibitor Zosphata in the binding affinity test. The Kd value of PLM-102 was 0.019 nM (vs 1.4 nM) for normal FLT3 and 0.01 to 1.1 nM (vs 0.16 to 19 nM) for TKD mutant, which showed a lower Kd value than that of Zosphata.

Pelemed’s PLM-102 resulted in effective cell growth inhibition at a lower dose than Zosphata in acute myeloid leukemia cell lines (MV4-11, MOLM-13, MOLM-14) and Ba/F3 cell lines with FLT3 mutations. showed

A tumor mouse model administered with a dose of 5 mg/kg or more of PLM-102 showed complete remission with tumor growth inhibition when administered orally once a day. In addition, Pelemed explained that the anticancer effect was also confirmed in drug-resistant double mutation models (ITD/F691L, ITD/D835Y) administered with PLM-102.

Pelemed confirmed the RET inhibitory effect of PLM-102 and the decomposition effect of RET and FLT3 proteins. This proteolysis phenomenon did not appear in Zosphata and another approved RET inhibitor, Roche’s ‘Gavreto, pralsetinib’, indicating a differentiated mechanism of RLM-102, the company explained.

Acute myeloid leukemia (AML) is a type of blood cancer in which tumor cells appear in the blood or bone marrow. FLT3 mutations are observed in about 30% of acute myeloid leukemia patients. It is known that 50% of patients with acute myeloid leukemia who have achieved complete remission with high-intensity chemotherapy experience recurrence, and patients with FLT3 mutations are known to have a higher risk of recurrence and a lower survival rate than those who do not.

An official from Pelemed said, "PLM-102, which has a differentiated mechanism, is under non-clinical research this year.