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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On June 5, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported an update on the status of its oncological lead drug candidate, Namodenoson in the treatment of advanced liver cancer (Press release, Can-Fite BioPharma, JUN 5, 2024, View Source [SID1234644121]). The Phase 3 pivotal study, now has 31 recruiting medical centers in Europe, Israel and the US. Namodenoson has Orphan Drug status with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency, as well as Fast Track Status with the FDA. A compassionate use program has also been ongoing in Israel and Romania.

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In the former Phase 2 study, conducted in patients with advanced liver cancer, Namodenoson prolonged survival, patients had good quality of life, and in two patients, clearance of peritoneal carcinomas have been reported. In addition, one patient had a long term complete response of more than 7 years.

Liver cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. The market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.

The current double blind, placebo-controlled trial, known as LIVERATION, will enroll 450 patients diagnosed with advanced liver cancer (hepato-cellular carcinoma) and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will be randomized to oral treatment with either 25 mg of Namodenoson or a matching placebo, in a ratio of 2:1 given twice daily as a second- or third-line treatment. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On June 5, 2024 Bio-Path Holdings, Inc. (NASDAQ:BPTH) ("Bio-Path" or the "Company"), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it has closed its previously announced private placement for the issuance and sale of an aggregate of 1,809,955 shares of its common stock (or common stock equivalents in lieu thereof), series A warrants to purchase up to 1,809,955 shares of common stock and short-term series B warrants to purchase up to 1,809,955 shares of common stock at a purchase price of $2.21 per share of common stock (or per common stock equivalent in lieu thereof) and accompanying warrants priced at-the-market under Nasdaq rules (Press release, Bio-Path Holdings, JUN 5, 2024, View Source [SID1234644119]). The series A warrants and short-term series B warrants have an exercise price of $2.00 per share and are exercisable immediately upon issuance. The series A warrants expire five years from the date of issuance and the short-term series B warrants expire twenty-four months from the date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering were approximately $4.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the securities described above, including the shares of common stock underlying the warrants, may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement, the Company has agreed to file a resale registration statement covering the securities described above.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.