On June 5, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 10:00 a.m. EDT (Press release, Merck & Co, JUN 5, 2024, View Source [SID1234644126]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

On June 5, 2024 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported expansion of its therapeutic pipeline and multiple updates to its Research and Development programs.

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"At Inhibikase we have let fundamental scientific discoveries drive identification of new product candidates that could transform the lives of patients. We first began clinical development of our product candidates in 2021. In 2025, we anticipate having multiple late-stage ready assets across our therapeutic pipeline," commented Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "The 201 Trial in untreated Parkinson’s disease has reached 94% enrollment and we anticipate enrolling the last patient in mid-June. In parallel, we are seeking grant funding for the 202 trial in Multiple System Atrophy through The National Institute of Neurological Diseases and Stroke (NINDS). Finally, following our pre-IND meeting with the U.S. Food and Drug Administration (FDA) in April, 2024, we have made the decision to redirect our efforts with IkT-001Pro into cardiopulmonary disease, opening a new therapeutic area for the Company. Taken together, we believe we are on track to advance our clinical assets into late-stage trials in the coming year."

Upcoming Milestones and Strategic Updates:

Complete The 201 Trial in untreated Parkinson’s disease. The Company anticipates that the last patient will complete the 12-week treatment period before the close of the third quarter of 2024. The Company expects to report biomarker and outcome data to support the Company’s pursuit of an End of Phase 2 and Phase 3 protocol discussion with the FDA by the end of 2024.

Expansion into cardiopulmonary disease. Following the Company’s pre-IND meeting with the FDA, the Company will submit its IND application to the FDA for IkT-001Pro as a treatment for Pulmonary Arterial Hypertension (PAH) early in the third quarter of 2024, opening a new therapeutic area for the Company. The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that 001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication. If approved, IkT-001Pro could be a branded product with all the value drivers of a novel treatment for indication of high unmet need. The IND for 001Pro in PAH represents the seventh the Company has filed since 2019.

Scaling manufacturing of IkT-001Pro. Following the Company’s pre-NDA meeting with the FDA in January, 2024, the Company is scaling its process development efforts for IkT-001Pro to support late-stage clinical development and NDA batch requirements. These activities include development of new dosage forms to differentiate 001Pro tablets from generic imatinib mesylate in alignment with FDA feedback.

Seeking support for the 202 Trial in Multiple System Atrophy through the Other Transaction Authority of NINDS. The National Institute of Neurological Diseases and Stroke (NINDS) is initiating a new funding mechanism for clinical development in neuroscience beginning June, 2024. Through this new program, termed the Other Transaction Authority (OTA), the Company is seeking to support its Phase 2 ‘202 Trial’ in MSA trial using a dedicated U.S. trial network set-up by the Institute.
Discontinuing antiviral development for Progressive Multifocal Leukoencephalopathy (PML): As part of the Company’s strategy to focus on late-stage clinical assets in neurodegeneration, cancer and cardiopulmonary disease, Inhibikase will discontinue development of treatments for PML.

On June 5, 2024 ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, reported its Final Results for the twelve months ended 31 December 2023 (the "Period") (Press release, ImmuPharma, JUN 5, 2024, View Source [SID1234644124]).

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Key Highlights (including post Period review)

Financials

Loss for the Period of £2.9m (2022: £3.8m)
Research and development expenses of £2.0m (2022: £2.0m)
Administrative expenses of £1.0m (2022: £0.8m)
Share based expense of £0.14m (2022: £0.16m)
Cash balance of £0.2m at 31 December 2023 (31 December 2022: £0.7m)
Lanstead derivative financial asset of £0.6m (2022: £0.3m)
Basic and diluted loss per share of 0.81p ( 2022: 1.26p)
Incanthera financial asset: shares of £0.6m (2022: £0.7m) – warrants of £1 (2022: £1k)
Fundraising in September 2023, comprising gross proceeds of £130,683 in addition to £1.35 million being raised in a Subscription and Direct Subscription
Portfolio

SLE/Lupus

A Phase 3 dose-range study of P140, rather than a Phase 2/3 adaptive study, is the preferred design.
Importantly, the direct Phase 3 route is faster to filing for approval whilst also incorporating the FDA’s request for demonstration of a dose-ranging in the pivotal program
The international SLE Phase 3 dose-range study design and protocol is substantially different from the previous Phase 3 clinical trial completed by ImmuPharma in 2018
Dosing will be significantly higher and subcutaneous injection, once a month, will be administered with a highly convenient and patient friendly autoinjector. The doses are safe and well tolerated.
Two planned interim analyses during the study will allow early detection of the effectiveness of P140
Simbec-Orion appointed as the Contract Research Organisation ("CRO")
CIDP

In May 2023, ImmuPharma received positive guidance from FDA following the PIND meeting that confirms the route for a Phase 2/3 adaptive clinical study of P140 in CIDP
This will be the first pivotal stage study of P140 in patients with CIDP: a rare neurological disease with high medical need
An IND application is now close to submission to the FDA, incorporating all guidance points
An application for Orphan Drug status for CIDP will be also submitted in parallel
Simbec-Orion, has been appointed as the CRO for this program
P140 technology platform

Recent further insights into P140’s mechanism of action ("MOA") confirms its position as the only non-immunosuppressing molecule in clinical development in the industry
The favourable impact of P140 on immune system homeostasis also support P140 as a new potential standard of care not only for SLE sufferers, but for patients suffering from a multitude of autoimmune diseases that are caused by the same underlying malfunction
In April 2024, the Company announced that it has initiated a new intellectual property strategy to significantly enhance the patent life and commercial value for its P140 technology platform
Anti-infectives | Bio-AMB

After multiple in vivo studies assessing the Pharmacokinetic/Pharmacodynamic ("PK/PD") and safety profile of BioAMB, the dose-effect relationship has now been assessed in Part 1 of a new dose-range pharmacodynamic study in an aspergillosis rat model. Part 1 has now been completed – no toxicity related to BioAMB was observed at the active dose
Part 2 of the study will further evaluate the safety of BioAMB at the active dose and confirm the advantage of BioAMB over the other forms of AMB
Cancer

In March 2023 a collaboration with Orano SA on ImmuPharma’s peptide technology was established
Partnering

Active discussions are ongoing with new potential corporate partners across the P140 platform and anti-infective programs.
Corporate

In August 2023, the Board was strengthened with two NED appointments: Dr Laurence Reilly & Dr Sébastien Goudreau
Incanthera

On 3 June 2024 the Company sold its investment in shares in Incanthera plc. All of the 9,904,319 shares held at the year end were sold at 15p per share realising gross proceeds of £1.4 million. ImmuPharma continues to hold 7,272,740 warrants in Incanthera plc.
Commenting on the statement and outlook Tim McCarthy, CEO and Chairman, said:

"As a Board, we remain focused on the development of our two key late stage clinical assets, P140 (SLE) and P140 (CIDP), and on securing additional partnering deals for each. .We have made significant scientific progress over the last year, including further refinement of the protocol for the P140 (SLE) study and new insights into the MOA of P140, and as a result, we have a high level of confidence of the success of the new study.

We look forward to providing further updates on the progress of this study, together with progress on P140 (CIDP) and our earlier stage programs throughout 2024.

We will also continue to concentrate on further commercial and partnering opportunities. In conjunction with the above objectives, we continue to take prudent measures on managing our cost base.

In closing, we would like to thank our shareholders for their support as well as our staff, corporate and scientific advisers and our partners including CNRS and Avion."

On June 5, 2024 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, reported that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY) (Press release, I-Mab Biopharma, JUN 5, 2024, View Source [SID1234644123]). The collaboration will evaluate the combination of givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody jointly developed by I-Mab and ABL Bio (KOSDAQ: 298380), with Bristol Myers Squibb’s immune checkpoint inhibitor, nivolumab, and chemotherapy (FOLFOX or CAPOX), as a potential first-line treatment for patients with advanced Claudin 18.2-positive gastric and esophageal cancers.

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Under the terms of the agreement, the study will be a multi-national Phase 1 study conducted by I-Mab. Bristol Myers Squibb will supply nivolumab. Nivolumab is an immune checkpoint inhibitor that is designed to block the PD-L1 protein on cancer cells from binding to PD-1, enhancing T-cell function and resulting in improved anti-tumor responses.

"We are pleased to enter into this clinical collaboration agreement with Bristol Myers Squibb as we embark on the next stage of givastomig’s development to explore the significant promise of this bispecific antibody in a triple-therapy regimen," said Raj Kannan, CEO of I-Mab. "The study builds on the encouraging single-agent activity and safety we have observed with givastomig as presented at ESMO (Free ESMO Whitepaper) 2023. We remain optimistic that givastomig in combination with nivolumab and chemotherapy will drive potent anti-tumor activity in specific tumors, and we look forward to accelerating progress in the clinic."

About Givastomig

Givastomig, also known as TJ-CD4B/ABL111 or TJ033721, is a bispecific antibody designed to bind to Claudin 18.2 (CLDN18.2) as a tumor engager and 4-1BB as a conditional T-Cell activator. Givastomig uniquely binds to tumor cells expressing various levels of CLDN18.2, including gastric cancer and pancreatic cancer cells, and conditionally activates intra-tumoral T-cells at the tumor site through 4-1BB. Givastomig appears to effectively maintain a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both CLDN18.2 antibody and 4-1BB antibody while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Developed through a collaboration between I-Mab and ABL Bio, a clinical-stage biotechnology company in South Korea, givastomig is currently being investigated in a Phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.

On June 5, 2024 Genmab A/S (Nasdaq: GMAB) reported that its Chief Financial Officer Anthony Pagano and Chief Operating Officer Anthony Mancini will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, Florida 9:20 AM EDT (3:20 PM CEST) on June 10, 2024 (Press release, Genmab, JUN 5, 2024, View Source [SID1234644122]). A webcast of the fireside chat will be available on Genmab’s website at View Source

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