On December 13, 2024 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches to precision T cell activation, reported that Chief Executive Officer, Zhen Su, M.D., MBA, presented a clinical update highlighting the STARt-001 trial at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2024 taking place in Geneva, Switzerland (Press release, Marengo Therapeutics, DEC 13, 2024, View Source [SID1234649110]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The oral presentation highlighted findings from the Phase 1 clinical study of invikafusp alfa (STAR0602), Marengo’s first-in-class Vβ6/10 selective dual T cell agonist as monotherapy in patients with PD-1-resistant cancers. The results, previously showcased during a late-breaking plenary session at the SITC (Free SITC Whitepaper) Annual Meeting, demonstrated initial anti-tumor activity and a favorable safety profile in heavily pre-treated, biomarker-enriched patients who are resistant to prior PD-1 therapy.

"We are honored to share this exciting clinical advancement with the global oncology community at ESMO (Free ESMO Whitepaper) IO," said Dr. Su. "The insights gained from the STARt-001 trial underscore the potential of invikafusp alfa to address the unmet needs of patients with PD-1-resistant tumors. They also validate the precision immunology approach underlying our STAR platform, which drives the design of Marengo’s selective dual T cell agonist antibodies. We look forward to advancing invikafusp alfa into a Phase 2 study in the near term."

Oral presentation details:

Title: Reinvigorating T cell repertoire in vivo: Igniting the TIL Compartment
Session Title: Special Session: Boosting cancer cell immunity
Presentation Date and Time: Friday, December 13, 2024, 10:45 AM – 11:00 PM CET
Presenter: Zhen Su, M.D., MBA, Chief Executive Officer at Marengo

On December 13, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") reported that it has closed the first tranche (the "First Tranche") of its previously announced non-brokered private placement (the "Private Placement") with the issuance of 2,200,000 units (the "Units") of the Company at a price of $0.05 per Unit for aggregate gross proceeds of $110,000 (Press release, BioVaxys Technology, DEC 13, 2024, View Source [SID1234649111]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Each Unit consist of one (1) common share in the capital of the Company (each, a "Share") and one (1) whole Share purchase warrant (each, a "Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until December 13, 2026, being the date that is 24 months from the date of issue.

The Company intends to use the net proceeds of the First Tranche for working capital. No finder’s fees were paid in connection with the First Tranche. All securities issued pursuant to the First Tranche are subject to a statutory hold period expiring April 14, 2025, being the date that is four months and one day from the date of issuance in accordance with applicable securities legislation

In addition, the Company announces that it has entered into a debt settlement agreement with an arm’s-length consultant of the Company to settle an aggregate of $500,000 in debt owed to the consultant by issuing 5,000,000 Shares at a deemed price of $0.10 per Share (the "Debt Settlement"). The board of directors of the Company has determined that it is in the best interests of the Company to settle the outstanding debt through the issuance of Shares in order to preserve the Company’s cash for working capital purposes.

All securities proposed to be issued pursuant to the Debt Settlement will be subject to a statutory hold period of four months from the date of issuance in accordance with applicable securities legislation. Closing of the Debt Settlement is conditional upon a number of conditions, including receipt of all applicable corporate and regulatory approvals, including the acceptance of the Canadian Securities Exchange.

This news release does not constitute an offer to sell or a solicitation of an offer to buy of any securities in the United States. The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities laws or pursuant to available exemptions therefrom.

On December 13, 2024 BrightPath Bio (Tokyo Stock Exchange Growth 4594, "BrightPath"), a pioneer in iPS cell-derived Natural Killer T ("NKT") cell therapy, and Cellistic, a leader in advanced iPS cell therapy manufacturing, reported a process development and manufacturing agreement to advance BrightPath’s novel allogeneic CAR-T cell therapy platform, utilizing iPSC-derived NKT cells for clinical trials (Press release, BrightPath Biotherapeutics, DEC 13, 2024, View Source [SID1234649112]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The strategic collaboration includes the use of Cellistic’s innovative 3D bioreactor-based manufacturing platform, Echo, to enable GMP-compliant, clinical-scale manufacturing of iPSC-derived BCMA-targeting CAR-NKT cells for Phase 1 multiple myeloma trial; establishing BrightPath as a first mover in this emerging field.

"The use of NKT cells as effectors in allogeneic CAR-T therapy represents a promising strategy, offering not only direct cytotoxicity but also indirect anti-tumor activity through the priming of host CD8+ T cells—a mechanism expected to evade host immune rejection and to enhance the durability of clinical responses. However, achieving clinical-scale manufacturing of such a rare subset of T cells while preserving their original functionality has conventionally been a significant challenge. Induced pluripotent stem (iPS) cell technology has overcome this barrier, making large-scale production feasible," stated Ken Nagai, CEO of BrightPath.

"While we have established a robust 2D culture-based manufacturing process, we have recognized the importance of anticipating the full scalability potential of the iPS cells from commercial perspective at an early stage. To address this need, we are committed to implement more scalable manufacturing solutions. Cellistic is well-positioned to meet this critical requirement with their unique 3D platform and extensive experiences in iPSC differentiation and scale-up of a variety of cell types," Ken Nagai further noted. "We are delighted to partner with Cellistic, which has the most experience in culturing iPS cells using 3D bioreactors. This collaboration with Cellistic allows us to leverage their state-of-the-art development and manufacturing capabilities to accelerate the development of our BCMA CAR-NKT product."

"We are excited to partner with BrightPath in the development of their revolutionary iPSC derived cell therapy," said Gustavo Mahler, CEO of Cellistic. "Our Echo manufacturing platform is designed to meet the unique challenges of cell therapy production, ensuring scalability, quality, and regulatory compliance. Together, we can advance the therapeutic potential of BCMA CAR-NKT cells and help BrightPath to bring innovative solutions to patients in need."

The agreement marks a significant step forward in the industry’s pursuit of innovative and effective cell therapies, with both companies committed to advancing healthcare solutions that improve patient outcomes.

On December 12, 2024 Alessa Therapeutics, Inc., a clinical-stage drug development company pioneering an innovative and proprietary localized drug delivery technology for the early interception of cancer and other diseases, reported the closing of a $15M seed financing led by Mission BioCapital joined by Johnson & Johnson (through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc. (JJDC)., and a representative of JJDC will join the Board of Directors at Alessa Therapeutics Inc (Press release, Alessa Therapeutics, DEC 12, 2024, View Source [SID1234649066]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are appreciative of the support provided by this syndicate of leading life science industry investors," said Pamela Munster, M.D., Founder & Chief Executive Officer of Alessa. "Alessa is well positioned to advance our pipeline and leverage our platform of tissue-targeted drug delivery for the treatment of prostate cancer and other solid organ diseases. This funding enables us to pursue our mission and bring new medicines to patients who desperately need more effective treatments."

Alessa will use the funds to advance development of its lead program, Enolen, a novel enzalutamide-eluting seed implant for the treatment of localized prostate cancer. Alessa recently announced the start of a first-in-human trial with Enolen in collaboration with the NCI, and the company anticipates initial data to read out next year. Alessa’s Enolen program builds on the company’s successful proof of concept for the approach with Biolen, which were presented at the 39th Annual EAU Congress (EAU24, April 2024) in Paris, France and at the AUA Annual Meeting (May 2024) in San Antonio, TX.

Prostate cancer is the most common cancer among men in the United States. According to the American Cancer Society, an estimated 299,010 men will be diagnosed with prostate cancer in 2024 in the United States alone. Patients with low-risk prostate cancer face difficult treatment decisions today between potentially invasive surgical and ablative procedures or active surveillance. While many efficacious therapeutics have been developed for regional and metastatic disease, to date, they have failed to move forward to patients with localized low-risk disease given their adverse-event profiles. Alessa’s proprietary localized drug-delivering implants are designed for sustained release of an anti-androgen selectively to the prostate thus limiting systemic side effects despite providing therapeutic concentrations in the prostate.

On December 12, 2024 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported the presentation of clinical, translational, and preclinical data from its adenosine A2A receptor (A2AR) antagonist program, inupadenant, including interim data from the dose escalation portion of A2A-005, the Phase 2 trial assessing inupadenant and platinum-doublet chemotherapy in post-immunotherapy metastatic non-small cell lung cancer (NSCLC) patients, at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2024 (Press release, iTeos Therapeutics, DEC 12, 2024, View Source [SID1234649083]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We believe our presentations at ESMO (Free ESMO Whitepaper) IO on the adenosine pathway demonstrate the strong efforts our research and discovery team have put into understanding this immunosuppressive mechanism," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "While the initial signal for inupadenant’s RP2D in the A2A-005 trial compared to chemotherapy alone is encouraging and supports its differentiated, insurmountable profile, we as well as our scientific and clinical advisory boards believe it does not meet sufficient level of clinical activity to warrant further investment. We remain committed to focusing our resources on developing differentiated, first- or best-in-class therapies and look forward to providing updates on our pipeline in 2025."

Mini Oral Sessions
Title: Inupadenant Combined with Chemotherapy in Patients with Non-Squamous NSCLC Progressing On or After Immune Checkpoint Inhibitor Therapy: Results from Dose-Finding Part of the A2A-005 Trial
Summary: As of the October 29, 2024 data cutoff, the topline data from the dose escalation portion of A2A-005 presented at the ESMO (Free ESMO Whitepaper) IO Congress were based on 36 patients eligible for safety and efficacy evaluation. Patients received inupadenant at 40mg, 60mg, or 80mg twice daily (BID) in combination with carboplatin/pemetrexed. All patients had a minimum follow-up of 6 months. Patient baseline characteristics were balanced across arms, with a slight imbalance of more patients with brain metastases in the 40mg and 80mg cohorts and ECOG status 0 favoring the 80mg cohort.

The primary endpoint of the safety of inupadenant in combination with carboplatin/pemetrexed was observed to be manageable and tolerable, with no dose dependent toxicities.
The secondary endpoint of ORR was 63.9% across all patients (53.3% at 40mg, 66.7% at 60mg, and 73.3% at 80mg).
The secondary endpoint of mPFS was 7.7 months across all patients (5.6 months at 40mg and 6.6 months at 60mg; mPFS remains unreached at 80mg).
The exploratory biomarker of CXCL13, a B-cell chemokine and lymphoid structure marker associated with clinical activity, was observed to be restored by inupadenant after depletion by chemotherapy, with quicker restoration kinetics in patients with PFS greater than 6 months.
As of the data cutoff, 8 patients remained on treatment (1 at 40mg, 1 at 60mg, and 6 at 80mg). The median follow-up was 9.7 months (10.6 months at 40mg, 13.1 months at 60mg, and 8.2 months at 80mg).

Response Measure Inupadenant 40mg + carboplatin / pemetrexed BID Inupadenant 60mg + carboplatin / pemetrexed BID Inupadenant 80mg + carboplatin / pemetrexed BID Overall
(N=15) (N=6) (N=15) (N=36)
ORR, % 53.3% 66.7% 73.3% 63.9%
n
(95% CI) n=8
(26.6–78.7) n=6
(22.3–95.7) n=15
(44.9–92.2) n=36
(46.2–79.2)
Complete response, n (%) 0 0 2 (13.3%) 2 (5.6%)
Partial response, n (%) 8 (53.3%) 4 (66.7%) 9 (60.0%) 21 (58.3%)
Stable disease, n (%) 7 (46.7%) 1 (16.7%) 3 (20.0%) 11 (30.6%)
Progressive disease, n (%) 0 0 1 (6.7%) 1 (2.8%)
Not evaluable/no assessment, n (%) 0 1 (16.7%) 0 1 (2.8%)
mPFS, months 5.6 6.6 NC 7.7
Event n (%)
(95% CI) 13 (86.7%)
(4.1-8.3) 5 (83.3%)
(0.4-NC) 6 (40.0%)
(4.9-NC) 24 (66.7%)
(5.1-11.0)
Landmark 6-Month PFS % 46.7%
(21.2-68.7) 50.0%
(11.1-80.4) 64.6%
(34.7-83.5) 54.5%
(36.8-69.1)
CI, confidence interval; NC, not calculable

Title: The A2AR Antagonist Inupadenant Promotes Humoral Responses in Patients
Summary: Based on monotherapy clinical and translational data, inupadenant demonstrated modulation of humoral responses in patient blood and tumor tissue, supporting our previous finding that expression of antibody-secreting cells (ASCs) in tumor tissue is associated with non-progression in patient disease. Furthermore, CXCL13 expression, a protein involved in immune cell recruitment, activation, and adaptive immune response regulation, increased in patients treated with inupadenant and more rapidly and extensively in non-progressors compared to progressors. These findings confirm inupadenant plays a key role in B cell maturation restoration and may play a substantial role in delaying progression in end-stage patients.

Poster Sessions
Title: The A2AR Antagonist Inupadenant Promotes Humoral Responses in Preclinical Models
Summary: In preclinical models, inupadenant counteracted the A2AR-mediated inhibition of B cell maturation into ASCs and immunoglobulin production in both in vitro and ex vivo systems by modulating B cells at the level of the germinal center (GC). These findings suggest that inupadenant restores or even enhances B cell maturation towards ASCs and GC reactions in both secondary lymphoid organs as well as the tumor in the presence of A2AR signaling. Furthermore, this process is essential for producing high-affinity antibodies and potentially for sustained anti-tumor immunity.

Title: A Novel Tumor Adenosine Signature to Guide Indication Selection for Adenosine Pathway inhibitor
Summary: Based on the spatial quantification of adenosine in human tumors, we developed the first adenosine gene signature, demonstrating its potential for indication selection. This new signature, derived from 249 differentially expressed genes (DEGs) associated with metabolism and immune activation, showed high predictive power across tumor types. Furthermore, the adenosine signature was higher in tumors compared to healthy tissue and exhibited variable expression and prognostic value across tumor subtypes. These findings suggest that the adenosine signature represents a powerful tool for prioritizing tumor types which may benefit most from adenosine-targeting therapies and for understanding the mechanisms of adenosine-mediated immunosuppression.