On October 31, 2023 Outpace Bio, a cell therapy company that is solving the major barriers to curing solid tumors with AI-powered protein design, reported it will present the latest advancements to its OutSmartTM platform during a poster presentation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held from November 1-5, 2023 in San Diego, CA (Press release, Outpace Bio, OCT 31, 2023, View Source [SID1234637782]).

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!

Overcoming major barriers to efficacy & safety in solid tumors with OutSmartTM

Cancer cells produce signaling proteins that turn off the immune response, creating a suppressive tumor microenvironment (TME) that allows cancer to grow and spread. Pro-inflammatory cytokines could overcome this barrier to effective cancer immunotherapies but pose a significant safety risk to patients when delivered systemically given their potency.

The forthcoming data showcase the most recent advancements in Outpace’s groundbreaking OutSmartTM platform technology, which enables exquisite regulation of cytokine signaling within the TME to surmount this significant hurdle to the success of engineered cell therapy for solid tumors. OutSmartTM cytokines orchestrate a productive immune response at the tumor through highly localized activity that stimulates both the engineered cell therapy as well as endogenous immune cells.

New data on context-dependent, localized IL-12 activity designed leveraging OutSmartTM technology

The presentation highlights an innovative tumor-restricted IL-12 (trIL-12) technology that delivers potent IL-12 stimulation at the tumor site while avoiding systemic exposure. IL-12 is an immune-stimulatory cytokine that can induce potent anti-tumor activity, but systemic delivery of IL-12 has been shown to cause severe toxicity in patients.

trIL-12 was designed leveraging Outpace’s OutSmartTM technology to rapidly auto-inactivate IL-12 after inducible secretion from engineered T cells with the aim of achieving safe, local delivery of IL-12 activity. trIL-12 is being advanced under a collaboration between Lyell Immunopharma and Outpace with the goal of improving efficacy for T-cell therapies while maintaining a favorable safety profile.

"With the latest application of our OutSmartTM technology, we believe that we have successfully unlocked the therapeutic potential of IL-12, a goal that the scientific community has pursued for quite some time," remarked Dr. Scott Boyken, PhD, Chief Technology Officer. "The highly localized and conditionally controlled activity of trIL-12 is unattainable through traditional small molecule drugs or protein-based therapeutics. Our work underscores the immense therapeutic potential of cell therapies powered by protein design, and we will continue to harness our protein design expertise to address the urgent needs of patients with limited treatment options."

Poster Presentation Details

Title: Protein design and inducible expression allow context-dependent, localized IL-12 activity to enhance solid tumor T cell therapies
Session Date/Time: Friday, November 3, 2023 (12-1:30 pm, 5:10-6:40 pm)
Abstract Number: 1047 (link to full abstract)
Presenting Author: Dr. Scott Boyken, PhD, Chief Technology Officer at Outpace Bio

On October 31, 2023 Daiichi Sankyo reported its Consolidated Financial Results for the First Six Months of the Year Ending March 31, 2024 (Press release, Daiichi Sankyo, OCT 31, 2023, View Source [SID1234637729]).

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!

On November 7, 2023 Triumvira Immunologics presented its corporate presentation (Press release, Triumvira Immunologics, OCT 31, 2023, View Source [SID1234637165]).

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!

On October 31, 2023 (the "Fourth Amendment Effective Date"), Akebia Therapeutics, Inc. (the "Company"), BioPharma Credit PLC (the "Collateral Agent"), BPCR Limited Partnership (as a "Lender") and BioPharma Credit Investments V (Master) LP (as a "Lender") reported to have entered into the Fourth Amendment to Loan Agreement (the "Fourth Amendment"), which amends certain provisions of the Loan Agreement, dated November 11, 2019, as amended by the First Amendment and Waiver, dated February 18, 2022, the Second Amendment and Waiver, dated July 15, 2022 and the Third Amendment dated June 30, 2023, between the parties (as amended, the "Loan Agreement") (Filing, 8-K, Akebia, OCT 31, 2023, View Source [SID1234636723]). As of October 31, 2023, there was $35.0 million of principal outstanding under the Term Loans (as defined in the Loan Agreement).

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 Fourth Amendment extends the maturity date of each Term Loan from November 11, 2024 to March 31, 2025 (the "New Maturity Date"). The Fourth Amendment also delays the payment of additional principal of each Term Loan until October 31, 2024, at which time the Company will make monthly payments of principal; provided that, if certain pre-specified events occur, the Company will (a) make payments of principal of such Term Loans commencing on the Payment Date (as defined in the Loan Agreement) immediately following the occurrence of such event and continuing on a quarterly basis on each Payment Date thereafter through the New Maturity Date and (b) repay, on a specified date on or after July 1, 2024, all unpaid principal that would have been due and payable during the period commencing on the Payment Date immediately following the Fourth Amendment Effective Date and ending on the Payment Date immediately following such date (including all accrued and unpaid interest thereon, if any), as if the Company had been required to make equal quarterly payments of principal of such Term Loans commencing on the Payment Date immediately following the Fourth Amendment Effective Date.

The Term Loans bear interest through maturity at a variable rate based upon the three-month Secured Overnight Financing Rate ("SOFR") rate, plus a SOFR adjustment of 0.3%, plus 7.50%. Prior to the Fourth Amendment, the three-month SOFR rate was subject to a 3.35% cap (the "SOFR Cap"). The Fourth Amendment removed the SOFR Cap as of the Fourth Amendment Effective Date. The SOFR rate as of the Fourth Amendment Effective Date was 5.35%.

The foregoing description of the Fourth Amendment does not purport to be complete, and is qualified in its entirety by reference to the Fourth Amendment, a copy of which the Company expects to file with its Annual Report on Form 10-K for the year ending December 31, 2023.

As previously disclosed, on May 22, 2023, CohBar, Inc., a Delaware corporation ("CohBar"), Morphogenesis, Inc., a Delaware corporation ("Morphogenesis"), and Chimera MergeCo, Inc., a Delaware corporation and wholly owned subsidiary of CohBar ("Merger Sub"), reported to have entered into an Agreement and Plan of Merger (as amended by the First Amendment thereto dated as of August 28, 2023, the "Merger Agreement"), which provided that, among other things, and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Merger Sub would merge with and into Morphogenesis, with Morphogenesis surviving as a wholly owned subsidiary of CohBar (the "Merger") (Filing, 8-K, CohBar, OCT 31, 2023, View Source [SID1234636628]). The Merger Agreement is filed as Annex A to CohBar’s definitive proxy statement/prospectus filed with the Securities and Exchange Commission on September 12, 2023 (the "Proxy Statement/Prospectus"). The material terms of the Merger Agreement were described in the section titled "The Merger Agreement" of the Proxy Statement/Prospectus and are incorporated by reference herein.

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!

In connection with the Merger Agreement, CohBar filed an initial listing application for the common stock of the combined company to be listed on The Nasdaq Capital Market ("Nasdaq"). It is a condition of the closing of the Merger under the Merger Agreement that the initial listing application with Nasdaq shall have been approved by Nasdaq. On October 30, 2023, CohBar and Morphogenesis received oral guidance from Nasdaq on the initial listing application indicating that the structure proposed by the parties would not receive approval. As a result, CohBar and Morphogenesis proceeded to discuss the oral guidance from Nasdaq over the course of October 30 and 31, 2023. As of October 31, 2023, CohBar had not received approval of the initial listing application from Nasdaq.

On October 31, 2023, the board of directors of CohBar, in consultation with management and after careful consideration, determined that there was not a viable path forward to consummate the Merger primarily due to the oral guidance received from Nasdaq. On November 1, 2023, CohBar received a termination notice from Morphogenesis pursuant to Section 8.1(b) of the Merger Agreement, effective November 1, 2023, and the Merger Agreement was terminated in accordance with its terms. Section 8.1(b) of the Merger Agreement provides that the Merger Agreement may be terminated by CohBar or Morphogenesis if the Merger has not been consummated by October 31, 2023.

CohBar intends to commence the process of liquidating and dissolving itself in accordance with its organizational documents and applicable law. As of September 30, 2023, CohBar had cash, cash equivalents and investments of approximately $9.1 million (unaudited) and accrued liabilities of approximately $1.5 million (unaudited). Due to anticipated but as yet unquantifiable expenses associated with the liquidation and dissolution process, an estimate of the amounts expected to be available to return to CohBar’s public stockholders, if any, cannot be provided at this time.