Bio-Path Holdings Expands Global Patent Portfolio

On April 15, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the receipt of newly issued patents in Mexico, Australia and Japan, and updated investors on the extent of its global intellectual property portfolio (Press release, Bio-Path Holdings, APR 15, 2024, View Source [SID1234642065]).

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Bio-Path has expanded its intellectual property portfolio by filing patent applications that are applicable to its technology and business strategy. Bio-Path’s patent portfolio currently includes five issued patents in the U.S. and 54 issued patents in foreign jurisdictions, providing protection in 21 countries.

"We continue our efforts to build protection around our platform as it safeguards our technology, is a deterrent to would-be competitors and creates value around our core competencies," said Peter Nielsen, Chief Executive Officer of Bio-Path. "These efforts are designed to protect our investments and advance our clinical programs to bring new medicines to patients suffering with cancer."

Bio-Path’s composition of matter patents are intended to protect encroachment from third parties on its proprietary products. This technology is solely owned by Bio-Path. These composition patents, including composition and methods of use patents covering the DNAbilize technology, should allow the Company to apply its core technology to new protein targets and receive an additional 20 years of patent exclusivity. On this basis, Bio-Path has one additional patent application allowed in the U.S. and five additional patent applications allowed in foreign jurisdictions, for a total of six additional patent grants expected this year. Further, the Company has five pending patent applications in the U.S. and 46 pending patent applications in key foreign jurisdictions across six families of applications, for a total of 51 pending applications.

Newly issued patents have been granted in Mexico, Australia, and Japan. Instituto Mexicano de la Propriedad Industrial (IMPI) has issued MX 409482 titled, "P-ethoxy nucleic acids for IGF-1R inhibition." In addition, IP Australia issued three new patents: AU 2018255352 titled, "P-ethoxy nucleic acids for STAT3 inhibition;" AU 2018255353 titled, "P-ethoxy nucleic acids for IGF-1R inhibition;" and AU 2018254468 titled, "P-ethoxy nucleic acids for BCL2 inhibition." Finally, the Japanese Patent Office has issued JP 7441002 titled, "P-ethoxy nucleic acids for liposomal formulation."

Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

On April 15, 2024 Aileron Therapeutics, Inc. ("Aileron", the "Company", "we", "our" or "us") (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update (Press release, Aileron Therapeutics, APR 15, 2024, View Source [SID1234642064]).

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"We ended the year in a solid position after the successful completion of our merger with Lung Therapeutics, which provided a focused pipeline of promising clinical-stage candidates for life-threatening lung conditions, coupled with a strengthened balance sheet from the successful closure of a $18.4 million financing," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "We anticipate 2024 as a pivotal year of execution as we continue to progress our lead product candidate, LTI-03. We expect to report topline results from the ongoing Phase 1b study of LTI-03 in the third quarter of this year. LTI-03 and its potential dual mechanism of action on both epithelial cells and fibroblasts is gaining support from the medical community, and we look forward to building upon encouraging preclinical data that LTI-03 has the potential to protect healthy lung epithelial cells and to reduce pro-fibrotic signaling."

Recent Business Highlights and Upcoming Milestones

Corporate Updates

In October 2023, Aileron acquired Lung Therapeutics, Inc. ("Lung"), shifting the Company’s disease focus to advance a pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis diseases. The Company’s lead clinical programs include LTI-03 for idiopathic pulmonary fibrosis (IPF) and LTI-01 for loculated pleural effusion (LPE).

Immediately following the closing of Aileron’s acquisition of Lung ("Lung Acquisition"), the Company entered into a definitive agreement for the sale of shares of its Series X non-voting convertible preferred stock and warrants to purchase shares of Aileron common stock in a private placement to a group of accredited investors led by Bios Partners, the majority stockholder of Lung prior to the Lung Acquisition, and including Nantahala Capital, as well as additional undisclosed investors. The private placement resulted in gross proceeds to Aileron of approximately $18 million before deducting placement agent fees and other offering expenses.

In March 2024, the Company announced the appointment of Brian Windsor, Ph.D., as President and Chief Executive Officer and to the Board of Directors. Dr. Windsor previously served as Aileron’s Chief Operating Officer and President, and Chief Executive Officer and director of Lung.
Pipeline

In February 2024, Aileron hosted a pulmonary care expert panel to discuss the potential implications of LTI-03 for IPF, featuring pulmonary care experts Fernando J. Martinez, M.D., M.S., Chief of the Pulmonary and Critical Care Medicine Division at Weill Cornell Medicine; Tejaswini Kulkarni, M.D., M.P.H., Associate Professor of Pulmonology, Allergy and Critical Care Medicine and Director of the Interstitial Lung Disease Program at University of Alabama at Birmingham Medicine; and Andreas Günther, M.D., Senior Physician of Pulmonology and Intensive Care Medicine and Chief Physician of Pulmonology and Internal Intensive Care Medicine at Agaplesion Evang. Central Hesse Hospital and Professor of Interstitial and Rare Lung Diseases at Justus Liebig University. A replay of the event can be accessed at View Source

LTI-03: a novel Caveolin-1-related (Cav1) peptide with a dual mechanism targeting both alveolar epithelial cell survival as well as inhibition of profibrotic signaling
LTI-03 is currently in a randomized, double-blind, placebo-controlled Phase 1b clinical trial in IPF patients. Aileron expects to report topline results from this trial in the third quarter of 2024.
LTI-01: a PAI-1 resistant plasmin activated proenzyme for loculated pleural effusions
LTI-01 has been evaluated in Phase 1b and Phase 2a clinical trials in patients with infected, non-draining LPEs and is ready for Phase 2b. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.
Fourth Quarter and Full Year 2023 Financial Results

Cash Position: Cash, cash equivalents, and investments on December 31, 2023, were $17.3 million, compared to $21.2 million on December 31, 2022. Based on its current operating plan, the Company expects its existing cash, cash equivalents, and investments will fund operations into the fourth quarter of 2024.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended December 31, 2023, were $2.0 million, compared to $2.4 million for the quarter ended December 31, 2022. R&D expenses decreased primarily due to the termination of R&D activities related to ALRN-6924. R&D expenses for the full-year 2023 were $4.0 million, compared to $18.0 million for the prior year.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended December 31, 2023, were $5.3 million compared to $2.3 million for the quarter ended December 31, 2022. G&A expenses increased due to the integration and operating activities of Lung. G&A expenses for the full-year 2023 were $11.4 million, compared to $9.7 million for the prior year.

Net Loss: Net loss for the quarter ended December 31, 2023, was $7.3 million, compared to $4.5 million for the quarter ended December 31, 2022. The basic and diluted net loss per share for the quarter ended December 31, 2023 was $1.54 compared to $1.00 for the quarter ended December 31, 2022. The basic and diluted net loss per share for the full-year 2023 was $3.42 compared to $6.02 for the full-year 2022.

Innate Pharma Announces Advancement of Sanofi-developed NK Cell Engager SAR443579 / IPH6101 Progressing to Phase 2 for Blood Cancer Patients

On April 15, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the first patient was dosed in the Phase 2 dose expansion part of the Sanofi-sponsored clinical trial of SAR443579 / IPH6101 (NCT05086315), evaluating SAR443579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia and high-risk myelodysplasia (Press release, Innate Pharma, APR 15, 2024, View Source [SID1234642045]).

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SAR443579 is an investigational trifunctional anti-CD123 NKp46xCD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi. SAR443579 received FDA Fast Track Designation for the treatment of acute myeloid leukemia. Efficacy and safety results from the dose-escalation part of the trial were shared in a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2023 Annual Meeting in San Diego, California.

"The progression of SAR443579 to the Phase 2 expansion part of the clinical trial in blood cancers is another step in bringing this innovative NK cell engager to patients," said Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma. "SAR443579 has shown promising clinical efficacy in the dose escalation of the Phase 1/2 in R/R AML patients, and we look forward to the dose expansion part of the study."

Under the terms of the 2016 research collaboration with Sanofi, the progression to the dose expansion part of the trial has triggered a milestone payment from Sanofi to Innate of €4m.

"Our goal is to continue to develop the best and most impactful treatments for patients with cancer," said Peter Adamson, Global Development Head, Oncology, Sanofi."We are encouraged by our progress in this study for patients with AML, and look forward to sharing results in the future as data continues to emerge."

More information about the Phase 1/2 trial can be found on clinicaltrials.gov.

About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.

This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About the Innate-Sanofi research collaboration and licensing agreements

The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes SAR443579/IPH6101 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and SAR445514/IPH6401 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

As part of the license agreement entered in December 2022, Sanofi licensed IPH62 and IPH67 and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales.

Bile Tract Cancer expansion study opens following clearance of Imugene’s MAST trial high dose cohort

On April 15, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that enrolment has opened for its expansion study in bile tract cancer (cholangiocarcinoma) patients, having completed the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its cancer-killing virus CF33-hNIS (VAXINIA) (Press release, Imugene, APR 15, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/d90ab1d4-f16c-5d92-40f9-240afd491d30/Bile_Tract_Cancer_Study_Opens_after_MAST_High_Dose_Clearance.pdf [SID1234642044]).

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Imugene Managing Director & CEO Leslie Chong said: "As a team we’re particularly eager to begin the cholangiocarcinoma expansion study, given the meaningful difference we’ve seen VAXINIA make for patients with gastrointestinal cancers, including one patient with cholangiocarcinoma who achieved a complete response and another who achieved stable disease. It’s timely for enrolment to open as we present our VAXINIA technology to the 2024 Cholangiocarcinoma Foundation Annual Conference later this week."

The expansion of the MAST (Metastatic Advanced Solid Tumours) Phase 1 trial is planned for 10 patients with bile tract cancers, after early positive responses were observed in gastrointestinal cancers, particularly in cholangiocarcinoma.

Cholangiocarcinoma is a rare disease in which malignant cancer cells form in the bile ducts. It is difficult to treat and generally responds poorly to immunotherapy drugs.

One patient with cholangiocarcinoma who had failed three prior lines of therapy received a mid-dose of IT-administered monotherapy VAXINIA achieved a complete response, meaning the disappearance of all signs of cancer in response to treatment, with no known recurrence in more than 430 days. A second patient with cholangiocarcinoma, who has also progressed on prior drug therapies, achieved stable disease for more than four months upon receiving IV-administered VAXINIA.

In November 2023, the FDA granted the VAXINIA MAST clinical program Fast Track Designation for the treatment of bile duct cancer (cholangiocarcinoma), which allows Imugene closer cooperation with the FDA to expedite the program and potential approval process. This designation followed the promising data detailing Phase 1 efficacy and tolerability.

On Friday 12 April 2024, the Cohort Review Committee cleared the fifth cohort in the IT arm of the monotherapy dose escalation portion of the MAST trial, with no safety signals seen to date. In addition to the patients dosed in the monotherapy dose escalation portion of the trial, enrolment is ongoing for the VAXINIA and pembrolizumab combination portion of the trial, with 16 patients dosed to date.

The multicenter, Phase 1, MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. With no safety signals identified to date, the trial has since progressed through the monotherapy dose escalation cohorts as well as the combination study, whereby VAXINIA is administered with well-known checkpoint inhibitor pembrolizumab. CF33 oncolytic virus, developed by City of Hope, has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.

Illumina’s planned divestment of GRAIL approved by the European Commission

On April 12, 2024 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported it has received approval of its divestment plan for GRAIL from the European Commission (EC) (Press release, Illumina, APR 12, 2024, View Source [SID1234642040]).

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While this does not mean the method of divestment has been finalized, the company is pleased to reach an agreement with the EC on specific divestment options as it represents an important milestone in the process. Illumina continues to explore divesting GRAIL through either a trade sale or a capital markets transaction, each of which are contemplated by the plan approved today. In the event of a capital markets transaction, Illumina must capitalize GRAIL with two-and-a-half years of funding, which is estimated at approximately $1 billion based on GRAIL’s long-range plan.

Illumina looks forward to working with the EC on approval of final terms consistent with the divestment plan. As previously stated, Illumina has a goal of finalizing those terms by the end of the second quarter of 2024.