On August 1, 2022 Avalo Therapeutics, Inc. (Nasdaq: AVTX) and Apollo Therapeutics Group Limited reported that they have entered into a worldwide, exclusive license agreement granting rights to Apollo to research, develop, manufacture and commercialize AVTX-007 (camoteskimab), Avalo’s anti-IL-18 monoclonal antibody product (Press release, Avalo Therapeutics, AUG 1, 2022, View Source [SID1234617206]). Under the terms of the agreement, Apollo will assume responsibility for the future development of AVTX-007, including the ongoing clinical trial. Apollo will lead future clinical development in its selected therapeutic indications.

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"This transaction is critically important to Avalo. It extends our cash runway and allows us to increase our focus on our lead molecule, AVTX-002, and our ongoing phase 2 PEAK trial evaluating AVTX-002 for the treatment of non-eosinophilic asthma," said Garry A. Neil, MD, President and Chief Executive Officer of Avalo Therapeutics. "Furthermore, we are excited to transition camoteskimab to a capable and well-funded partner in Apollo Therapeutics whom we expect will progress the development of this promising asset to the potential benefit of patients and our collective financial interests."

"We are pleased to have entered into this agreement with Avalo and look forward to building upon the work done to date with camoteskimab," said Richard Mason, MD, chief executive of Apollo. "With our university partners we have built translational leadership in three core areas of biological focus – immunology, cell signaling, and cell stress responses and metabolism – and the addition of this Phase 2 ready antibody for an important inflammasome target substantially accelerates the growth of our pipeline in this area of immunology, where we are advancing additional preclinical programs. We seek further opportunities to acquire clinical assets in our areas of biological and therapeutic focus."

Pursuant to the license agreement, Avalo will receive within 5 days of execution of the agreement $5 million of upfront fee and an additional approximately $10 million as consideration for transfer activities. Apollo will also pay Avalo up to $74 million of milestones, as well as a royalty payment of a low single digit percentage of annual net sales.

The AVTX-007 program was originally licensed to Avalo by MedImmune Limited, a subsidiary of AstraZeneca plc, and such license was transferred to Apollo as part of the transaction.

About AVTX-007 (camoteskimab)
Camoteskimab is a high affinity, fully human monoclonal antibody targeting the proinflammatory cytokine IL-18.

On August 1, 2022 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the closing of its initial public offering of 2,000,000 shares of the Company’s common stock at a public offering price of $5.00 per share (Press release, MAIA Biotechnology, AUG 1, 2022, View Source [SID1234617222]). The gross proceeds from the initial public offering were $10,000,000 prior to deducting underwriting discounts, commissions, and other offering expenses. The Company has granted the underwriters a 45-day option to purchase up to an additional 300,000 shares of common stock at the initial public offering price less discounts and commissions, to cover over-allotments.

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The shares of common stock began trading on the NYSE American on July 28, 2022 under the ticker symbol "MAIA."

ThinkEquity acted as sole book-running manager for the offering.

The Company intends to use the net proceeds from the initial public offering to fund the first part of the Phase 2 trials of the Company’s product candidate THIO, pre-clinical development of second-generation of telomere targeting compounds and other research and development activities, as well as for working capital and other general corporate purposes.

The Registration Statement on Form S-1 (File No. 333-264225) relating to the shares of common stock being sold in this offering has been filed with the U.S. Securities and Exchange Commission (the "SEC") and became effective on July 27, 2022. A final prospectus related to the proposed offering has been filed and is available on the SEC’s website at View Source The offering is being made only by means of a prospectus. Electronic copies of the final prospectus may be obtained, when available, from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004, by telephone at (877) 436-3673 and by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 August 1, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3-related immunotherapy treatments for cancer and autoimmune disease, reported that new interim data from 2nd line NSCLC patients (Part B) in the Phase II TACTI-002 trial (Press release, Immutep, AUG 1, 2022, View Source [SID1234617244]). The data was presented as part of the electronic poster presentation at the IASLC 2022 World Conference on Lung Cancer (WCLC 2022) being held in Vienna, Austria and is also available on the Company’s website.

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This part of TACTI-002 (Part B), evaluates Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") in combination with MSD’s KEYTRUDA (pembrolizumab) in a total of 36 patients with 2nd line PD-X refractory metastatic NSCLC who were not pre-selected for their PD-L1 status. The data cut-off date is 1 July 2022.

In this 2nd line setting, patients were treated with pembrolizumab, which is an anti-PD-1 therapy, in combination with efti despite having confirmed disease progression on PD-X based therapy in the 1st line setting.3 This was to evaluate whether efti with its unique mechanism of action in combination with pembrolizumab might provide a benefit for these patients that would otherwise move on to chemotherapy in 2nd line. Typically this standard of care 2nd line chemotherapy would be just single agent taxane chemotherapy, as the majority of patients received platinum based doublet chemotherapy plus PD-X therapy in the 1st line setting.

Thus, the enrolled patients were advanced in their disease with limited treatment options.

Immutep CSO and CMO, Dr Frederic Triebel, said: "It is encouraging to see efti in combination with pembrolizumab continues to report promising antitumour and safety results in 2nd line NSCLC. In particular, efti in combination with pembrolizumab is demonstrating sustained survival compared with standard of care chemotherapy regimens, and favourable safety and tolerability. Of course, for patients with such advanced disease, having a chemo-free alternative could mean a very real difference to their quality of life."

"Furthermore, these results provide promising insights into how efti may provide a meaningful patient benefit in other PD-X refractory indications in the future," he said.

TACTI-002 Investigator, Dr Martin Forster of the UCL Cancer Institute and University College London Hospital NHS Foundation, London, UK, said: "The TACTI-002 trial is showing 36.5% of patients have survived for at least 18 months when receiving efti in combination with pembrolizumab. The median overall survival is 9.7 months which is a meaningful survival benefit, plus disease control and durability have also continued favourably as the trial has advanced. All these results support further clinical investigation of efti in combination with pembrolizumab in PD-X resistant NSCLC patients."

Condition of Patients
All enrolled patients had confirmed progressive disease on or after standard of care 1st line therapy with PD-X monotherapy (33%) or a combination of PD-X therapy and platinum-based doublet chemotherapy (67%). These patients are therefore resistant to PD-X based therapy and are referred to as "PD-X refractory". Per standard clinical practice, they would otherwise usually go on to single agent chemotherapy if they received combination PD-X therapy and platinum based doublet chemotherapy in 1st line or, alternatively, go on to doublet chemotherapy if they received PD-X monotherapy in 1st line. A vast majority (75%) of enrolled patients had a PD-L1 tumour proportion score (TPS) of < 50%.

Accordingly, the enrolled patients represent a challenging to treat patient population with limited current treatment options.

Key Findings – data cut-off 1 July 2022

Median OS of 9.7 months for those who received chemo-free therapy of efti in combination with pembrolizumab, which is comparable with current standard of care chemotherapy options in this 2nd line setting4
Favourable sustained survival with 36.5% of patients alive at 18 months5
36.1% (13/36) Disease Control Rate (DCR) and disease control (progression free) in 25% of patients at 6 months
Durable responses of 10+ months in 5.6% (2/36) of patients, with both patients continuing in the trial for over 11 months and 24+ months
Table 1 – TACTI-002 Interim Results for Part B of TACTI-002

Tumour Response Part B
2nd line NSCLC6
Response as per iRECIST Stage 1 & 2
N (%)
Total N=36
Complete Response (CR) 0 (0)
Partial Response (PR) 2 (5.6)
Stable Disease (SD) 11 (30.6)
Progressive Disease (PD) 22 (61.1)
Not Evaluable 1 (2.8)
Overall Response Rate (ITT) 2/36 (5.6)
Disease Control Rate (ITT) 13/36 (36.1)
Overall Response Rate (evaluable patients) 2/35 (5.7)
Disease Control Rate (evaluable patients) 13/35 (37.1)
Safety
Efti in combination with pembrolizumab continues to be safe and well-tolerated, with no new safety signals. Efti’s good safety profile to date compares favourably to standard of care chemotherapy options.

Conclusion
Efti in combination with pembrolizumab is continuing to demonstrate encouraging early signs of antitumour activity in 2nd line confirmed PD-X refractory, NSCLC patients.

About the TACTI-002 Trial
TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Rahway, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of eftilagimod alpha (efti) with MSD’s KEYTRUDA (pembrolizumab) in patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in study centres across Australia, Europe, and the US.

Patients participate in one of the following:

• Part A – first line non-small cell lung cancer (NSCLC), PD-X naïve – given the promising results of the first two stages of Part A, an expansion stage with 74 additional patients was commenced in November 2020 to assist with trial design in subsequent late-stage settings
• Part B – second line NSCLC, PD-X refractory
• Part C – second line head and neck squamous cell carcinoma (HNSCC), PD-X naïve

TACTI-002 is an all-comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC and HNSCC.

More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier: NCT03625323).

On August 1, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported a reminder to shareholders that the record date of its proposed rights offering is Wednesday, August 3, 2022 ("Record Date") (Press release, Navidea Biopharmaceuticals, AUG 1, 2022, View Source [SID1234617174]). To be a shareholder of record on the Record Date, ownership of Navidea stock must occur by market close on Monday, August 1, 2022 to account for settlement. Holders of certain of our outstanding warrants, Series D preferred stock and Series F preferred stock are also entitled to participate in the rights offering.

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The subscription rights will be non-transferable and may only be exercised during the anticipated subscription period of August 4, 2022 through 5:00 PM ET on August 17, 2022, unless extended by Navidea.

The expected calendar for the rights offering is as follows:

August 1, 2022: Ownership Day — in order to be considered a stockholder of record on August 3, shares should be acquired by this date.
August 3, 2022: Record Date
August 4, 2022: Distribution Date; Subscription Period Begins
August 17, 2022: Subscription Period Ends 5:00 PM ET (unless extended at Navidea’s sole discretion)
Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other stockholders, on a pro rata basis and subject to ownership limitations.

Navidea has engaged Maxim Group LLC as dealer-manager for the proposed rights offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses, when available, may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

A registration statement (Registration No. 333-262691) relating to these securities has been filed with the Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. The rights offering, which is expected to commence following the effectiveness of the registration statement, is being made only by means of a written prospectus. A preliminary prospectus relating to and describing the proposed terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at View Source Copies of the preliminary and final prospectuses for the rights offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will 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 registration or qualification under the securities laws of any such state or jurisdiction.

On August 1, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported the publication of a manuscript titled "Tilmanocept as a novel tracer for lymphatic mapping and sentinel lymph node biopsy in melanoma and oral cancer," based on work performed at the Crown Princess Mary Cancer Centre ("CPMCC") at the University of Sydney, in Sydney, Australia (Press release, Navidea Biopharmaceuticals, AUG 1, 2022, View Source [SID1234617191]). The research, appearing in the ANZ Journal of Surgery (PMID: 35848587), was led by Principal Investigator Dr. Muzib Abdul-Razak, MBBS, FRACS, FRCSE, MCh., of the Faculty of Medicine, Department of Surgical Oncology and Head and Neck Surgery in the CPMCC at the University of Sydney.

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Sentinel lymph node biopsy ("SLNB") is widely accepted as an important clinical step in staging cutaneous melanoma ("CM") and is also a validated procedure to stage the neck in oral cavity squamous cell carcinoma ("OCSCC"). Despite this widespread acceptance, several different radiocolloids and dyes have been used, resulting in a non-standardized method of localizing and retrieving sentinel lymph nodes. Tc99m tilmanocept (approved as "Lymphoseek" in the US, EU, and the United Kingdom; "Lymphoaim" in India) was developed to overcome limitations of radiocolloids (lack of specific binding sites in the lymph nodes, for example, resulting in higher than desired false negative rates in some studies) and acts by selectively targeting and binding CD206 receptors on the surface of macrophages and dendritic cells. The use of Tc99m tilmanocept as a radiopharmaceutical for SLNB in CM and OCSCC has not been studied in Australia to date. This prospective study had as its aim the investigation of Tc99m tilmanocept use to evaluate its application, suitability, and reliability in an Australian setting.

A total of thirty-five patients were included in this study (N=26 with CM; N=9 with OCSCC). Lymphoscintigraphy with Tc99m tilmanocept identified at least 1 SLN (sensitivity of 100%) in all patients. There was a 100% intraoperative retrieval rate of SLNs in all patients, with positive nodes found in 20% of patients. Tc99m tilmanocept also demonstrated high tissue specificity (100%), with lymph nodal tissue confirmed histologically, with no false positives.

This is the first study to evaluate the use of Tc99m tilmanocept in the Australian setting, adding to a growing list of studies worldwide, and further supports that Tc99m tilmanocept is a reliable radiotracer for assessing the nodal status in patients with CM and OCSCC.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted to see the continued exploration of the utility of Lymphoseek for sentinel node biopsy in solid tumors. This study provides further support that Lymphoseek can provide high sensitivity and specificity for detection of sentinel nodes and supports our continued expansion of Lymphoseek outside of North America."

Dr. Abdul-Razak said, "This first-of-its-kind study in the Australian setting provides additional evidence that Tc99m tilmanocept based lymphoscintigraphy is both a feasible and an accurate method for assessing nodal status in patients with CM and OCSCC. Furthermore, our study adds to the growing body of literature supporting its use for these indications."