On June 8, 2022 C&Cure (CEO Min Jeong-jun and Park Joong-gon), which develops a bacterial anticancer drug platform and radioactive pharmaceuticals, reported the company has completed Series B bridge investment (Press release, CNCure, JUN 8, 2022, View Source [SID1234649033]).

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It has been one year since it was selected for Series A investment (KRW 6.5 billion) and investment-linked Ministry of Trade, Industry and Energy project (support amount KRW 2.5 billion) in February last year.

According to C&Cure on the 8th, existing institutional investors DT&Investment and ID Ventures made follow-up investments in the Series B bridge investment, and Hana Ventures participated as a new institutional investor.

Including the 2019 seed round (KRW 2.3 billion), the total amount raised up to this stage amounts to KRW 13 billion.

Kang Hoon-mo, an executive director at Hana Ventures who led this investment, said, "The investment point is the high research capabilities of C-level executives with world-class global competitiveness."

The funds raised will be used for the development of a bacterial anticancer drug currently underway in the United States (under contract with a US CDMO) and for the development of a radiopharmaceutical drug (in the first clinical trial underway with the Ministry of Food and Drug Safety).

The company plans to apply for an additional clinical trial of a radiopharmaceutical for the early diagnosis of malignant melanoma in the second half of this year.

C&Cure is a company established in 2019 by professors at Chonnam National University College of Medicine, and is conducting a national research project with a total budget of 8 billion won hosted by the Ministry of Trade, Industry and Energy and the Ministry of Science and ICT.

Professor Min (Department of Nuclear Medicine, photo), Professor Hong Young-jin (Microbiology), and Professor Kim Dong-yeon (College of Pharmacy, Gyeongsang National University) who are co-representatives are leading the research and development.

On June 8, 2022 BioVaxys Technology Corp. (CSE: BIOV; FRA: 5LB; OTCQB: BVAXF) ("BioVaxys" or "Company"), reported that its Lyon, France-based bioproduction partner, BioElpida ("BioElpida"), has completed the creation of multiple OVCAR-3 cell banks as the next step in the GMP manufacturing process development for BVX-0918, BioVaxys’ vaccine for treatment of platinum-resistant ovarian cancer (Press release, BioVaxys Technology, JUN 8, 2022, View Source [SID1234615747]).

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The OVCAR-3 cell line is mandatory for creating the identity assays that will have to be performed on every batch of ovarian cancer vaccine. This assay is required by regulatory bodies in the EU and United States. The cell line is derived from a human ovarian adenocarcinoma, established from a patient refractory to cisplatin, a chemotherapeutic agent used in late-stage ovarian cancer. Patients whose tumors are innately cisplatin-resistant at the time of initial treatment generally have poor prognosis, which is the patient population target for BVX-0918.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated that "Completion of OVCAR-3 cell banks is another step towards our ability to produce GMP yields of BVX-0918, and brings us closer to our Phase I study in the EU planned for later this year."

BioVaxys recently entered collaborations with Hospices Civils de Lyon in France and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients. Tumor samples from both hospitals are being used to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU. Tumor samples from HCL will also be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production.

BioVaxys’ vaccine platform is based on the established immunological concept that modifying surface proteins—whether they are viral or tumor—with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors.

A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results.

On June 8, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Robert M. Davis, chief executive officer and president, and Dean Y. Li, president, Merck Research Laboratories, will participate in a fireside chat at the live 2022 Goldman Sachs 43rd Annual Global Healthcare Conference (Press release, Merck & Co, JUN 8, 2022, View Source [SID1234615764]).

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The conversation will take place Monday, June 13, 2022, at 3:20pm PT // 6:20pm ET. Investors, analysts, members of the media and the general public are invited to listen at View Source

On CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that Geert Kersten, Chief Executive Officer, reported to present at the LD Micro Invitational XII Conference today, June 8, 2022 at 4:30 p.m. EDT (Press release, Cel-Sci, JUN 8, 2022, View Source [SID1234615780]). The Conference is taking place in-person at the Four Seasons in Westlake Village, CA from June 7 – 9, 2022.

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The presentation will be broadcast live at View Source or on the Investor Relations section of CEL-SCI’s website at cel-sci.com/new-investor-information/.

On June 8, 2022 Chimeric Therapeutics Ltd (ASX:CHM) reported that it has formally submitted a pre-Investigational New Drug (IND) meeting request to the US Food and Drug Administration (FDA) for its cancer drug CHM 2101, a novel third-generation CDH17 CAR T cell therapy from the University of Pennsylvania (Press release, Chimeric Therapeutics, JUN 8, 2022, View Source [SID1234615796]).

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The pre-IND meeting request marks a major milestone for the development of CHM 2101 as it is the first formal meeting with the FDA on the development path to IND submission.

What’s more, the pre-IND meeting will provide Chimeric with the opportunity to discuss its IND plans with the FDA to gain feedback and insight prior to IND submission.

Looking ahead, the next step will be the submission of the CHM 2101 IND, enabling Chimeric to initiate the phase 1 clinical trial.

"First critical step"
Chimeric CEO and managing director Jennifer Chow said: "We are very excited to be taking this first critical step on the path to IND submission for CHM 2101,"

"We believe that CHM 2101 offers great promise for patients with gastrointestinal cancers and are very eager to move this asset to the clinic."

About CHM 2101
CHM 2101 (CDH17 CAR T) is a novel, third-generation CDH17 CAR T invented at the world-renowned cell therapy centre, University of Pennsylvania.

Preclinical evidence for CHM 2101 was published in March 2022 in Nature Cancer.

CHM 2101 (CDH17 CAR T) is in preclinical development with a planned phase 1 clinical trial in neuroendocrine tumours, colorectal, gastroesophageal and gastric cancer.