On March 5, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported safety and initial efficacy data from the first ever 90mg dosing of eftilagimod alpha (efti) in combination with weekly paclitaxel in patients from the safety lead-in (N=6) of the AIPAC-003 Phase II/III trial (Press release, Immutep, MAR 5, 2024, View Source [SID1234640856]).

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Updated safety data from patients with HR-positive/HER2-negative/low metastatic breast cancer (MBC) treated with this innovative immuno-oncology (IO)-chemotherapy combination reveal no treatment-emergent serious adverse events. Additionally, all treatment-emergent adverse events during the safety observation period to date have been of mild severity.

Initial efficacy reports show these six MBC patients, who exhausted all endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, exhibited encouraging results achieving a 50% overall response rate, including one complete response and two partial responses, and a 100% disease control rate overall with the remaining three patients having stable disease as best response.

Acknowledging the early nature of these results, efti with paclitaxel historically has shown a dose-dependent effect in MBC and has in some cases also led to stable disease patients becoming partial responders after six months. The biologically active 30mg efti dose, previously the highest dose of efti ever tested, has demonstrated a stronger immune response and greater efficacy than lower dosing levels (1mg, 6mg) in multiple clinical trials.

The ongoing randomized Phase II portion of the trial, which will include up to 58 evaluable patients, is focused on whether 90mg efti dosing is safe and more efficacious than 30mg dosing. This portion of the trial has enrolled 23 patients to date. Importantly, the determination of the optimal biological dose in AIPAC-003 is directly tied to the FDA’s Project Optimus initiative and is relevant for the entire efti program.

Further updates from AIPAC-003 will be provided in CY2024. For more information on the trial, please visit clinicaltrials.gov (NCT05747794).

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-y and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On March 5, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported the pricing on March 5, 2024 of an underwritten public offering of 8,620,690 shares of its common stock at a public offering price of $29.00 per share, before deducting underwriting discounts and commissions (Press release, BridgeBio, MAR 5, 2024, View Source [SID1234640849]). In addition, BridgeBio has granted the underwriters a 30-day option to purchase up to an additional 1,293,103 shares of its common stock on the same terms and conditions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $250.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares in the offering to be sold by BridgeBio.

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J.P. Morgan, Cantor and Mizuho are acting as joint book-running managers for the offering. Raymond James is acting as lead manager. The offering is expected to close on or about March 8, 2024, subject to the satisfaction of customary closing conditions.

The shares of common stock are being offered by BridgeBio pursuant to an effective shelf registration statement on Form S-3ASR (File No. 333-271650) that was previously filed with the U.S. Securities and Exchange Commission (SEC) on May 4, 2023 and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on March 4, 2024. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (866) 803-9204, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected]; Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, New York 10020, by telephone at 1-212-205-7602 or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

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

On March 5, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), a leader in AI-driven cancer drug discovery and development, reported that it will be presenting at a virtual conference being hosted by HCW. The conference will be on Thursday, March 7th, and is a virtual event (Press release, Lantern Pharma, MAR 5, 2024, View Source [SID1234640842]).

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Lantern Pharma’s CEO, Mr. Panna Sharma, will be discussing and presenting via a fireside chat format at The 1st Annual Artificial Intelligence Based Drug Discovery & Development Virtual Conference at approximately 2 pm Eastern / 11 am Pacific. While addressing AI in drug discovery, Mr. Sharma will talk about how RADR, Lantern’s proprietary AI platform, is transforming the cost, pace, and timeline of oncology drug development.

Earlier this week, Lantern Pharma announced that RADR has surpassed 60 billion data points and will reach 100 billion data points during 2024, making innovation in developing cancer therapies potentially more precise, durable, and personalized.

Investors, companies and industry professionals are encouraged to register for the event in advance at this link or contact their HCW representative for more information.

About RADR

RADR is Lantern Pharma’s proprietary integrated AI platform for large-scale biomarker and drug-tumor interaction data analytics that leverages machine learning. It is used to provide mechanistic insights about drug-tumor interactions, predict the potential response of cancer types and subtypes to existing drugs and drug candidates, and uncover patient groups that may respond to potential therapies being developed by Lantern Pharma and its collaborators.

RADR uses an ensemble-based approach to apply its library of algorithms to statistical, correlative, and inferential problems in drug-tumor interactions. This allows the platform to rapidly analyze large amounts of complex data and predict how both patients and tumors will respond to therapeutic combinations. RADR also evolves as new datasets are added, which improves and sharpens the insights generated from the algorithms.

RADR’s highly scalable machine-learning methods are designed to guide drug development and yield new biological insights, while also having the potential to increase response rates and improve outcomes in clinical trials. The robustness and growing number of datasets powering RADR is anticipated to continue to improve machine-learning results, accelerate automation of other features and aid oncology drug development for Lantern and its partners with an ultimate focus on benefitting cancer patients.

On March 5, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND)1 application for NOX-A12, TME Pharma’s CXCL12 inhibitor, for use in the treatment of aggressive adult brain cancer, glioblastoma (Press release, TME Pharma, MAR 5, 2024, View Source [SID1234640841]).

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With the IND now open at the FDA, TME Pharma plans to proceed with the continued clinical development of NOX-A12 in a Phase 2 randomized controlled study in approximately 100 newly diagnosed, chemotherapy-resistant glioblastoma patients having residual measurable tumor remaining after surgery. The study is expected to be initiated later this year, starting first in Europe, once the necessary resources and preparations are in place. Sufficient NOX-A12 clinical grade material has already been manufactured to initiate the study.

"Receiving approval of the FDA for the design of our Phase 2 clinical trial in glioblastoma provides a clear roadmap to potential industrial partners and investors on the next steps in clinical development. The discussions with the FDA have been constructive and have allowed us to design a robust Phase 2 that should provide us with solid evidence of the highly differentiated profile of NOX-A12 in combination with bevacizumab in newly diagnosed, chemotherapy-resistant glioblastoma patients. The open IND will also allow us to expand our clinical development into the US, where we expect to generate significant interest in the medical community," said Aram Mangasarian, CEO of TME Pharma. "We also expect to receive the FDA’s decision regarding Fast-Track Designation for NOX-A12 in glioblastoma in the next few weeks, which can further strengthen our regulatory position in the US and should help us in the search for industrial and financial partners who can assist TME Pharma in bringing NOX-A12 to patients in the quickest way possible."

The study will address questions of dosing and contribution of components – NOX-A12 and bevacizumab – to overall efficacy of the combination therapy and will allow TME Pharma to optimize late phase development by testing multiple doses of NOX-A12 with bevacizumab in a patient population that is also randomized to standard of care. Together with the IND submission TME Pharma has also submitted a Fast-Track Designation2 request to the FDA to secure an expedited regulatory pathway for NOX-A12 in glioblastoma and the company expects to receive the FDA’s decision before the end of March 2024.

Based on discussions with the FDA last year and further interaction during the IND application process, the FDA-approved study design includes five arms, with 20 patients per arm:

Arm 1: NOX-A12 – 200mg/week + radiotherapy and bevacizumab
Arm 2: NOX-A12 – 400mg/week + radiotherapy and bevacizumab
Arm 3: NOX-A12 – 600mg/week + radiotherapy and bevacizumab
Arm 4: NOX-A12 – 600mg/week + radiotherapy
Arm 5: Standard of Care control (temozolomide + radiotherapy)
TME Pharma’s regulatory interactions were supported by recent survival data from the GLORIA Phase 1/2 study in which NOX-A12 demonstrated an unprecedented median Overall Survival (mOS) of 19.9 months in combination with bevacizumab and radiotherapy in glioblastoma patients with measurable chemotherapy-resistant residual tumors after surgery. This survival rate compares very favorably to a matched standard of care reference cohort, which achieved an mOS of approx. 10 months, and exceeds what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy.

On March 5, 2024 Ankyra Therapeutics, a clinical stage biotechnology company pioneering anchored immunotherapies to treat cancer, reported the first patient dosed in the dose escalation cohort in a Phase 1 clinical study evaluating ANK-101, a tumor-directed, anchored immune medicine for solid tumors (Press release, Ankyra Therapeutics, MAR 5, 2024, View Source [SID1234640840]).

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"The first patient dosed in the Phase 1 monotherapy study of ANK-101 marks a significant milestone in our mission to provide a potential treatment to patients with minimal unwanted side effects," said Howard L. Kaufman, M.D., President and Chief Executive Officer of Ankyra Therapeutics. "This is not only a critical step in the development of our first-in-class asset, ANK-101, but also in our ultimate commitment to bring other biologically active agents as anchored immunotherapies to those who need them most."

ANK-101, an interleukin-12 (IL-12) cytokine anchored to aluminum hydroxide, is locally delivered and retained in the tumor microenvironment for several weeks where it mediates recruitment and activation of effector immune cells. ANK-101 is currently under investigation in patients with advanced solid tumors who have failed standard of care treatments. In multiple preclinical models, ANK-101 demonstrated increased immune cell infiltration into tumors without systemic toxicity.

The dose escalation cohort portion of the study will assess the safety of ANK-101 and determine the recommended dose for expansion in people with cutaneous, subcutaneous, soft tissue, or nodal malignancies, with an additional 10 participants ultimately dosed at the recommended dose for expansion (RDE). The study will secondarily evaluate the PK, immunogenicity, and preliminary clinical activity of the medicine.

"These data will provide a roadmap for advancing ANK-101 through clinical development and for identifying appropriate clinical indications for future trials," said Joe Elassal, M.D., MBA, Chief Medical Officer of Ankyra Therapeutics. "We believe this approach will enable patients to receive effective immunotherapy while potentially mitigating significant side effects during treatment."

"ANK-101 capitalizes on a novel delivery mechanism, and this anchored immune medicine approach to oncology represents potential for positive impact across indications," said Jong Chul Park M.D., assistant professor at Harvard Medical School and attending physician at Mass General Cancer Center, an investigator of the Phase 1 dose escalation trial. "Patient wellbeing throughout the treatment journey is paramount, and I look forward to our ongoing work together."

About ANK-101
ANK-101 is an anchored drug complex composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks but does not diffuse into the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with recruitment and retention of CD8+ T cells, NK cells and M1 macrophages activating innate and adaptive anti-tumor immunity. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The Phase 1 first-in-human, open-label clinical trial of ANK-101 as a monotherapy (NCT:06171750) consists of a dose escalation portion that will evaluate the safety and tolerability of ANK-101, followed by dose expansion cohorts.