On January 4, 2024 Integral Molecular, a leading biotech company specializing in antibody discovery against undruggable protein targets, reported that it has entered into an antibody license agreement with Seismic Therapeutic (Press release, Integral Molecular, JAN 4, 2024, View Source [SID1234638976]). Under the terms of the agreement, Integral Molecular will provide an exclusive license to Seismic Therapeutic for a collection of fully humanized, highly specific, preclinical antibodies to add to their platform, library, and pipeline of molecules in the immunology space. Seismic Therapeutic will assume full responsibility for all research, development, and commercialization activities related to these antibodies.

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The antibodies licensed by Seismic Therapeutic were identified using Integral Molecular’s MPS Antibody Discovery platform. This platform is built upon the company’s 20+ years of experience in working with the most challenging protein targets and ability to deliver preclinical lead candidate molecules. Unique aspects of this platform include the use of advanced immunization strategies including combinations of RNA, DNA and protein boosting via Lipoparticles, and evolutionarily divergent host animals (chickens) capable of generating diverse panels of antibodies against highly conserved targets.

"We are thrilled that Seismic chose Integral Molecular as a partner for their antibody discovery efforts," said Ross Chambers, PhD, VP of Antibody Discovery at Integral Molecular. "Using chickens as immunization hosts was important for Seismic’s project, as conventional approaches like mouse immunization would not have produced the diverse antibodies needed for their program. We wish Seismic Therapeutic much success as they continue to develop these antibodies."

On January 4, 2024 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class cancer therapeutics, reported that Chief Executive Officer Dr. Usman "Oz" Azam, M.D., will participate in a corporate presentation at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024 at 8:30am PT / 11:30am ET (Press release, Inspirna, JAN 4, 2024, View Source [SID1234638975]).

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On January 4, 2024 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class cancer therapeutics, reported a licensing agreement with Merck KGaA, Darmstadt, Germany, for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, currently in development for RAS mutated (RASm) second-line (2L) advanced or metastatic colorectal cancer (mCRC) and SLC6a8 targeting follow-on compounds (Press release, Inspirna, JAN 4, 2024, View Source [SID1234638974]).

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"We are excited to partner with Merck KGaA, Darmstadt, Germany, a leader in the oncology field with global drug development and commercial expertise in colorectal cancer specifically, to help bring our novel therapies to more patients in need," said Dr. Usman "Oz" Azam, M.D., Chief Executive Officer of Inspirna. "The data to date validates our belief in ompenaclid as a potential first-in-class therapy for advanced colorectal cancer and underscores the power of our proprietary target discovery platform RNA-DRIVEr. We look forward to working closely with Merck KGaA, Darmstadt, Germany, as we continue to evaluate ompenaclid in a Phase 2 randomized controlled trial."

"Over the past decade, the treatment paradigm for patients with RAS-mutated CRC, accounting for approximately 45% of second-line population, has not seen major innovation," said Victoria Zazulina, M.D., Head, Development Unit, Oncology for the Healthcare business of Merck KGaA, Darmstadt, Germany. "With our expertise in the treatment of CRC, and based on the encouraging early data for ompenaclid, this agreement with Inspirna offers the opportunity to advance a potential new first-in-class therapy that may improve outcomes for patients."

Under the terms of the license agreement, Merck KGaA, Darmstadt, Germany will receive an exclusive license to ompenaclid outside of the United States and an option to co-develop and co-promote ompenaclid in the US. Furthermore, the parties agreed to collaborate on Inspirna’s SLC6A8 follow-on compounds for which Inspirna will retain US co-development and co-commercialization rights. Inspirna will receive an upfront payment of $45 million. Upon the achievement of certain development and sales milestones for ompenaclid, Inspirna is eligible to receive milestone payments with tiered royalty rates in the low teens on net sales outside of the US. Inspirna is eligible to also receive development, regulatory and sales milestone payments for each follow-on compound targeting SLC6A8 along with up to double-digit royalties on net sales outside of the US.

Inspirna most recently presented clinical data from the Phase 1b/2 study of ompenaclid in combination with FOLFIRI and bevacizumab at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2023. Results as of the September 18, 2023 data cutoff showed encouraging efficacy and safety data, including a median progression-free survival of 10.2 months and median overall survival of 19.1 months across all 41 patients with 2L RASm mCRC. Of the 30 evaluable patients for response, the objective response rate was 37%, with 11 partial responses. Ompenaclid was well-tolerated, with no dose-limiting toxicities observed in the dose-escalation cohort and combination safety profile comparable to FOLFIRI plus bevacizumab backbone treatment.

Inspirna has initiated a Phase 2 double-blind randomized controlled trial in 2L RAS mutant advanced or metastatic mCRC comparing ompenaclid versus placebo plus FOLFIRI and bevacizumab.

On January 4, 2024 IN8bio, Inc. (NASDAQ: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported recent business updates and provided pipeline goals for 2024 (Press release, In8bio, JAN 4, 2024, https://investors.in8bio.com/news-releases/news-release-details/in8bio-highlights-recent-company-accomplishments-and-outlines [SID1234638973]).

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"2023 was a year marked by strong execution for IN8bio. We delivered on several clinical milestones, reporting positive data updates across our pipeline of innovative gamma-delta T cell therapies at many prestigious medical meetings, and secured the financing to extend our runway into 2025," said William Ho, CEO and co-founder of IN8bio. "We continue to be excited by the data from the Phase 1 trial of INB-100, which showed that all evaluable patients remained in durable complete remission, with six patients remaining relapse free beyond one year. Importantly, we are excited that we are seeing in vivo expansion and persistence of allogeneic gamma-delta T cells, now out to 365 days. This persistence clearly differentiates our results from the data presented on other allogeneic cellular therapies to date and we believe this data underscores the far-reaching potential of gamma-delta T cells to help provide durable relapse-free periods in patients with hematologic malignancies undergoing haploidentical stem cell transplantation. We believe we are well positioned to execute on our clinical programs and are poised for many exciting updates in 2024."

Recent Company Updates

Announced positive clinical update demonstrating continued durable complete remissions in 100% of evaluable patients (n=10) in the Phase 1 trial of INB-100 in leukemia patients undergoing haploidentical stem cell transplantation. The data was presented at the ASH (Free ASH Whitepaper) Annual Meeting in December.
Presented data demonstrating INB-200’s extended progression-free survival in glioblastoma multiforme (GBM) patients and potential for INB-400 to treat GBM at the SNO Annual Meeting.
Initiated enrollment for the Phase 2 trial of INB-400 in GBM (NCT05664243).
Announced a private placement totaling up to $46.9 million in gross proceeds. The initial closing of $14.4 million is expected to support operational execution and extended the Company’s cash runway into 2025 with the potential for up to $32.5 million in additional capital at increasing valuations.
Appointed internationally recognized immuno-oncology expert Dr. Corinne Epperly, M.D., M.P.H., to IN8bio’s Board of Directors.
Anticipated 2024 Pipeline Goals

INB-100: Enroll an additional 10 patients in an expansion cohort at the recommended Phase 2 dose (RP2D) and report Phase 1 long-term follow-up results at multiple medical meetings throughout 2024; potentially submit IND for Phase 3 randomized control trial in 2024.
INB-200: Report Phase 1 long-term follow up results at multiple medical meetings in 2024.
INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform targeting CD33 and CD123 at American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024.
INB-400: Dose first patient and treat up to 15 patients at multiple sites across the United States in the Phase 2 trial in newly diagnosed GBM; potentially submit IND for allogeneic Phase 1b in relapsed GBM in 2024.

On January 4, 2024 Halia Therapeutics, a clinical-stage biopharmaceutical company, is pioneering a novel class of small molecule medications designed to combat inflammation, reported that its leadership team will attend the 42nd JP Morgan Healthcare Conference (January 8 – 11) and present at Biotech Showcase 2024 (January 8–10) in San Francisco (Press release, Halia Therapeutics, JAN 4, 2024, View Source [SID1234638972]).

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Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities.

At the Showcase, Halia Therapeutics will discuss its lead product, HT-6184, which inhibits chronic inflammation associated with multiple diseases. A Phase II clinical trial to evaluate HT-6184 was recently initiated to treat patients with lower-risk myelodysplastic syndromes. This year, registered attendees can view Halia’s presentation live and access a recorded version currently available.

Presentation details at Biotech Showcase:

Category Listing: Inflammation, Oncology, Neurology

Speaker: Margit Janat-Amsbury, M.D., Ph.D., Chief Medical Officer of Halia Therapeutics

Date: January 9, 2024

Time: 10:15 a.m. PT

Location: Hilton San Francisco Union Square, 333 O’Farrell St, San Francisco, CA 94102 (Franciscan-B)