On April 7, 2021 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV) reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) for the Phase I/IIa clinical study of the immuno-modulatory anti-TNFR2 antibody BI-1808 (Press release, BioInvent, APR 7, 2021, View Source [SID1234577707]).

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"FDA approval of the Phase I/IIa study of BI-1808 is another important milestone for BioInvent as we continue to broaden our exciting pipeline of anti-cancer antibodies. TNFR2 is increasingly attracting interest as revealed by the recent deals in the field. The development of BI-1808 is supported by an impressive set of preclinical data and is one of three BioInvent lead candidates in clinical development," said Martin Welschof, CEO of BioInvent.

The Phase I/IIa study will evaluate the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent, and in combination with the anti-PD-1 therapy Keytruda in patients with ovarian cancer, non-small cell lung cancer and CTCL. It is planned to be carried out in the U.S., Denmark, Hungary, the United Kingdom and Russia and is already enrolling patients.

The anti-TNFR2 antibody BI-1808 is a first-in-class drug candidate and is part of BioInvent’s tumor-associated regulatory T cells (Treg)-targeting program. This has emerged from the F.I.R.S.T platform technology that simultaneously identifies new targets and high-quality antibodies, generating promising new drug candidates to target the tumor microenvironment (TME). TNFR2 is particularly upregulated on Tregs of the TME and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapies.

On April 7, 2021 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, reported the closing of its previously announced initial public offering in the United States of 9,750,000 American Depositary Shares ("ADSs") representing 9,750,000 ordinary shares, at an initial public offering price of $18.00 per ADS (Press release, UCLB, APR 7, 2021, View Source [SID1234577692]). The gross proceeds to Achilles from the offering were approximately $175.5 million. All ADSs sold in the offering were offered by Achilles.

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J.P. Morgan, BofA Securities and Piper Sandler acted as joint book-running managers for the offering. Chardan, Oppenheimer & Co, and Kempen & Co acted as co-managers.

A registration statement relating to these securities became effective on March 30, 2021. The securities referred to in this announcement were offered only by means of a prospectus. Copies of the preliminary prospectus relating to and describing the terms of the proposed IPO can be obtained from the following sources:

J.P. Morgan Securities LLC, Attention Equity Syndicate Desk, 383 Madison Avenue, New York, New York 10179, or via email: [email protected];
BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, or via email: [email protected]; or
Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or via email: [email protected].

On April 7, 2021 Bridge Biotherapeutics, a research and development company for innovative new drugs, reported that the first phase of clinical trials for BBT-176, a candidate for the next-generation lung cancer target anticancer drug, began in earnest, and that it was administered to patients participating in the clinical trial on the 2nd (Press release, Bridge Biotherapeutics, APR 7, 2021, View Source;pn=6&sn=1&idx=64 [SID1234577708]).

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BBT-176 is a novel epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) targeting the C797S specific EGFR mutation. The C797S mutation is known as an acquired resistance mutation that appears after treatment with tagriso (ingredient name: osimertinib) in Non-small Cell Lung Cancer (NSCLC). Bridge Biotherapeutics has secured data related to the tumor suppression effect of brain metastasis, including the tumor suppression effect against the C797S positive triple mutation in animal models, through the preclinical development previously advanced.

This clinical trial, which is first initiated by three domestic institutions, targets patients with locally advanced or metastatic non-small cell lung cancer with an EGFR mutation. ) We plan to closely grasp patient group data by mutation by applying procedures, etc.

BBT-176 In the first phase of clinical phase 1/2, the Dose Escalation Study evaluates the safety and tolerability of the drug to be tested to determine the recommended phase 2 dose. Next, in the Dose Expansion Study, which is expected to enter Korea and the United States within this year, ▲ Objective Response Rate (ORR), ▲ Objective Response Rate (ORR) according to version 1.1 of the Solid Tumor Response Assessment (RECIST) ; Duration of Response) and ▲ Progress-free Survival (PFS). The clinical trial is planned to be conducted on about 90 patients.

Bridge Biotherapeutics CEO Jeong-gyu Lee said, "I think it is meaningful to be the first to start the clinical trial of BBT-176, a new anticancer drug candidate targeting C797S mutant non-small cell lung cancer, in Korea, which has no treatment options worldwide." Based on the development strategy, the entire development team will do their best to conduct the clinical trials with full accuracy and speed based on the development strategy. I will add it."

More detailed information related to the BBT-176 clinical trial, which was launched this time , can be found in the Clinical Trial Information menu in the Korea Food and Drug Administration’s Integrated Drug Information System website .

On the other hand, Bridge Biotherapeutics, which started to discover its own candidates this year, started to discover and develop new candidates for non-small cell lung cancer drugs that can effectively meet various unmet medical demands, including C797S double mutation.

On April 7, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that Chief Executive Officer, Gil Beyen, will participate in the following conferences in the month of April and engage in select one-on-one investor meetings alongside members of the senior management (Press release, ERYtech Pharma, APR 7, 2021, View Source [SID1234577740]).

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SMALLCAP EVENT- CF&B Communication – April 14-15, 2021

Gil Beyen, Chief Executive Officer, will participate in one-on-one meetings from 8am to 1pm ET (02:00pm to 07:00pm CEST). For more information about the CF&B Communication’s SMALLCAP EVENT, please refer to the CF&B website: View Source

Kempen & Co. Life Sciences Conference – 2021 Thematic Virtual Series – April 28, 2021

Gil Beyen, Chief Executive Officer, Iman El-Hariry, Chief Medical Officer, and Eric Soyer Chief Financial Offier will participate in one-on-one meetings, small group meetings and showcase sessions from 8am to 2pm ET (02:00pm to 08:00pm CEST). For more information about the Kempen & Co Life Sciences Conference Series, please refer to the Kempen conference website: View Source

If you are interested in arranging a one-on-one meeting, please contact your conference representative or contact Corey Davis at LifeSciAdvisors.

On April 7, 2021 NovalGen Ltd ("NovalGen"), a biopharmaceutical company developing breakthrough cancer therapies, reported that its Clinical Trial Application ("CTA") has been accepted by the UK Medicines and Healthcare products Regulatory Agency ("MHRA"), and that University College London Hospital ("UCLH") has been activated as NovalGen’s first UK clinical site (Press release, UCLB, APR 7, 2021, View Source [SID1234577693]). The Company is now ready to conduct a Phase 1/2 first in human study evaluating the safety and efficacy of its lead product, NVG-111. The study will include patients with both Chronic Lymphocytic Leukemia ("CLL") & Mantle Cell Lymphoma ("MCL"), and the Company expects to dose the first patient in Q2 2021. NVG-111 is a first-in-class bispecific antibody T-cell engager which simultaneously binds CD3 on T-cells and Receptor Tyrosine Kinase Like Orphan Receptor 1 ("ROR1") on tumour cells.

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"Approval to start our first clinical study represents an important validation of our approach and is a significant milestone for NovalGen only 2 years following the company’s formation" said Professor Amit Nathwani, CEO of NovalGen. "We are developing bispecific therapies that can safely harness the immune system to treat both hematological malignancies and solid tumours, and we are excited to imminently bring our first antibody forward to patients with CLL and MCL in this study."

NVG-111 redirects endogenous T-cells to sites of tumours and, upon engagement with the ROR1 antigen on cancer cells, promotes the formation of immunological synapses, selectively killing the tumour independently of major histocompatibility complex, costimulatory molecules and antigen presentation. It is designed to be highly effective in the killing of cancer cells without affecting healthy immune cells or tissues and may potentially target cancer-initiating stem cells, a subpopulation of cancer cells that are resistant to standard cancer therapies. In preclinical studies, NVG-111 showed efficacy in a range of hard-to-treat blood cancers as well as solid tumours. The initial clinical focus with NVG-111 is in previously treated CLL and MCL patients to establish the drug’s safety and efficacy profile, followed by clinical expansion to target other ROR1-expressing cancers. The Company’s proprietary ROR1 and CD3-targeting bispecific molecule has been engineered for optimal tumour targeting and T-cell activation, respectively, for the efficient killing of cancer cells without excessive release of cytokines.