Chimeric takes Initial Regulatory Step towards IND for CHM 2101

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.

Alkermes to Participate in the Goldman Sachs Healthcare Conference

On June 8, 2022 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Wednesday, June 15, 2022 at 2:40 p.m. PT (5:40 p.m. ET/10:40 p.m. BST) (Press release, Alkermes, JUN 8, 2022, View Source [SID1234615795]). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Ariceum Therapeutics Launches with EUR 25M Series A to Advance Lead Asset, Satoreotide, for the Treatment of Low- and High-Grade Neuroendocrine Cancers

On June 8, 2022 Ariceum Therapeutics (Ariceum), a private biotech company developing a radiopharmaceutical product for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, reported the successful completion of an oversubscribed EUR 25 million Series A financing round (Press release, Ariceum Therapeutics, JUN 8, 2022, View Source;and-high-grade-neuroendocrine-cancers-301563216.html [SID1234615794]). Ariceum was co-founded by EQT Life Sciences (formerly LSP) and HealthCap who also co-led the financing that was joined by Pureos Bioventures. Ipsen transferred assets, and all corresponding rights into the Company in late 2021.

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The proceeds from the financing will enable Ariceum to further develop its lead asset and proprietary peptide derivative, satoreotide. Satoreotide is a radiopharmaceutical drug and an antagonist of the somatostatin type 2 (SST2) receptor which is overexpressed in many cancers, including certain hard-to-treat cancers such as small cell lung cancer (SCLC), high-grade neuroendocrine tumours (NETs) and neuroblastoma, an aggressive, rare type of cancer that occurs mainly in young children. Satoreotide will be used as a ‘theranostic’ for both the diagnosis and treatment of tumours expressing the SST2 receptor. Satoreotide is in early clinical development and, as of today, has been administered to more than 100 patients including more than 150 therapeutic administrations.

Ariceum is led by a highly experienced management team with a strong track record and expertise in clinical trials, systemic targeted radiation therapy and radiopharmaceutical development, as well as launching and commercialising diagnostic and therapeutic products in a variety of indications worldwide.

In conjunction with the financing, Karin Kleinhans of EQT Life Sciences, Per Samuelsson of HealthCap and Martin Münchbach of Pureos Bioventures will join Ariceum’s board of directors together with Eduardo Bravo, CEO of EBAC, who has been elected as chairman of the board.

Founded in 2021, Ariceum is headquartered in Berlin, with operations in Germany and activities currently across Europe, North America and Australia.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "We are very pleased to attract this outstanding syndicate of venture capital and corporate investors which validates our approach to developing our lead radiopharmaceutical product, satoreotide. I am excited to lead an exceptional team as we continue to build our platform and advance satoreotide for systemic targeted radiation therapy (STRT) to visualize and treat neuroendocrine tumors and certain other more aggressive cancers."

Karin Kleinhans, PhD, Partner at EQT Life Sciences, stated: "We founded Ariceum with the aim to build a European leader in targeted radiopharmaceuticals. We are delighted to support the Company in the development of its innovative technology to create more effective treatments for patients suffering from hard-to-treat cancers which are currently not adequately addressed by existing therapies, in addition to neuroendocrine cancers expressing the receptor."

Per Samuelsson, Partner at HealthCap, stated: "We are proud to have been involved with the Company since its early days and are very impressed with the progress achieved to date. We believe Ariceum’s innovative theranostic approach to diagnose and treat different types of cancers is world-leading and we look forward to supporting the Company through the next stages of growth."

Martin Münchbach, PhD, Managing Partner at Pureos Bioventures, added: "We are honoured to join this round with HealthCap and EQT Life Sciences and believe it will be a tremendous joint effort to bring Ariceum to the next level. Ariceum understands the power of radiopharmaceuticals which will enable the Company to develop better targeted drugs to eradicate cancer more effectively with less side-effects."

IDEAYA Biosciences to Present at the 2022 Jefferies Global Healthcare Conference

On June 8, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation at the 2022 Jefferies Global Healthcare Conference (Press release, Ideaya Biosciences, JUN 8, 2022, View Source [SID1234615793]).

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2022 Jefferies Global Healthcare Conference
Wednesday, June 8 at 11:00am ET

Fireside chat with Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences, hosted by
Maury Raycroft, Ph.D. Equity Research Analyst, Biotechnology

A live audio webcast of the event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

Harbour BioMed Announces IND Approval for B7H4x4-1BB Bispecific Antibody

On June 8, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that China National Medical Products Administration (NMPA) had approved the investigational new drug (IND) application to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in China (Press release, Harbour BioMed, JUN 8, 2022, View Source [SID1234615792]). This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with solid tumors. It has successfully completed the dosing of first patient in the phase I trial of HBM7008 in Australia on 25 May 2022.

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HBM7008 is generated from HBM’s unique and innovative HBICE platform. It is a first-in-class bispecific antibody targeting B7H4 and 4-1BB. The bispecific antibody can engage and activate T cells by 4-1BB only in B7H4 positive tumor microenvironment. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial, and non-small cell lung cancers. With its crosslinking-dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study, including completed response observed in the mouse tumor model.

"4-1BB is one of the most promising anti-tumor immune targets, providing new solutions for cancer treatment. As the first-in-class bispecific antibody targeting B7H4 and 4-1BB, HBM7008 is expected to lead the development of next-generation immunotherapeutics. Based on preclinical study data, we are highly confident in B7H4x4-1BB bispecific antibody. We will efficiently promote this clinical study to provide a novel, effective and safe treatment for patients, so that more cancer patients can benefit from the innovative therapeutic." said Dr. Humphrey Gardner, CMO of Harbour BioMed.

About HBM7008

HBM7008 is a bispecific antibody targeting Tumor-Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition, and potentially may also translate to better safety due to its strict dependency of TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutic in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.