On January 25, 2024 Genialis, the RNA-biomarker company, and Debiopharm, a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, reported to have reached an agreement to define and discover biomarkers within the DNA Damage Repair (DDR) biology space to predict the clinical benefit of one or more drugs in Debiopharm’s pipeline (Press release, Debiopharm, JAN 25, 2024, View Source [SID1234639473]). The initial phase kicked off this month, deploying Genialis’ biology-first, machine learning-enabled ResponderIDTM framework to develop predictive biomarkers for DDR-directed therapies.

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"Debiopharm continues to lead the oncology field in adopting artificial intelligence solutions at various stages across our preclinical and clinical development programs. Genialis’ expertise and cutting-edge technologies are an ideal fit to help us make the smartest translational decisions and advance our drugs to reach the right patients," said Bertrand Ducrey, CEO of Debiopharm.

Many cancers exhibit deficiencies in one or more DNA damage response pathways. Various classes of approved and investigational drugs aim to exploit known sensitivities; however, the heterogeneous biology of DNA damage response means that one drug only fits some, and combinations may prove essential. Biomarkers will help select patients whose cancer biologies are best suited to treatment with the right drug targeting the active disease mechanism.

"DNA damage response is among the most exciting biological domains of cancer drug development today and an area in which Debiopharm is working on several exciting molecules," said Carolina Haefliger, Head of Translational Medicine at Debiopharm. "Genialis’ biology-first approach allows us to collaborate in a truly scalable way, incorporating novel AI-based solutions in our programs."

Using biomarkers increases the odds of advancing an oncology clinical asset to the next trial phase by 5-12 fold[1]. However, post-approval, many of the best drugs achieve clinical benefit in only 30-40 percent of patients, and even those existing targeted therapies considered successful and supported by a biomarker can benefit from further refinement of patient tailoring strategies.

"Genialis’ RNA biomarkers have proved especially well-suited to support the development of new drugs targeting complex biological systems," said Mark Uhlik, Vice President of Biomarker Discovery at Genialis. "Debiopharm is working on some really promising molecules, and Genialis’ biomarkers will help ensure these drugs have the best possible chance of clinical success."

Genialis is based in Boston, Mass., and will attend PMWC in Santa Clara, Calif., from January 23-25, 2024. To request a meeting or for more information on ResponderID, please email [email protected] or visit www.genialis.com

Debiopharm is headquartered in Lausanne, Switzerland, and will be presenting at the 7th Annual DDR Inhibition Conference in Boston from January 29-30, 2024.

About DNA-Damage Repair (DDR)
When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells use their hyperactive DDR response to divide and grow uncontrollably, which promotes cancer expansion. Inhibition of DDR, particularly in combination with other anticancer agents, induces an overall arrest in the uncontrollable cancer cell cycle. This ultimately activates a self-destruction program in cancer cells. DDR inhibitors are currently being tested in preclinical and clinical studies.

On January 25, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of best-in-class IL-2 therapeutics, reported dosing of the first patient in the initial Phase 2 expansion cohorts of its Phase 1/2 clinical trial evaluating AU-007 for treatment of unresectable locally advanced or metastatic cancers (Press release, Aulos Bioscience, JAN 25, 2024, View Source [SID1234639471]). AU-007 is a human IgG1 monoclonal antibody designed to harness the power of interleukin-2 (IL-2) to eradicate solid tumors, and the first AI-designed human monoclonal antibody to be tested in a clinical trial. Phase 1 data demonstrate that AU-007 is currently the only IL-2 agent that can reduce regulatory T cells (Tregs), which suppress the immune system.

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"Dosing of the first patient in the Phase 2 portion of our AU-007 Phase 1/2 study marks a significant milestone as we advance development of this promising, novel IL-2 therapeutic for the treatment of solid tumor cancers," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "AU-007 was created to solve pressing safety and efficacy challenges associated with IL-2 therapeutics, and we are encouraged by ongoing new Phase 1 data that indicate clinical activity in several heavily pre-treated patients whose tumors progressed through checkpoint inhibitors. We are grateful to the participating patients and investigators in this clinical trial, and look forward to enrolling additional patients and presenting clinical data from the Phase 2 expansion cohorts later this year."

Aulos’ Phase 1/2 clinical trial is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. The initial Phase 2 expansion cohorts focus on melanoma and renal cell carcinoma (RCC), with AU-007 administered every two weeks in combination with a single loading dose of low-dose, subcutaneous Proleukin (aldesleukin; recombinant human IL-2), or with AU-007 and low-dose, subcutaneous Proleukin, both administered every two weeks.

Created by Biolojic Design, AU-007’s unique computational design allows it to bind precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Phase 1 dose escalation cohort data presented at two separate medical meetings last fall demonstrate that when AU-007 is administered to patients as monotherapy or in combination with low doses of Proleukin, the number of immunosuppressive Tregs decreases and the numbers of Teffs and NK cells increase. Additionally, data indicate that AU-007 is well tolerated and tumor shrinkage was observed in patients with melanoma, bladder, kidney, head and neck, and lung cancers.

To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On January 25, 2024 Aim Immunotech presented its corporate presentation (Presentation, AIM ImmunoTech, JAN 25, 2024, View Source [SID1234639470]).

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On January 24, 2024, Kura Oncology, Inc. (the "Company") reported to have entered into a securities purchase agreement (the "Securities Purchase Agreement") with certain institutional accredited investors named therein (the "Purchasers"), pursuant to which the Company agreed to issue and sell to the Purchasers in a private placement (the "Private Placement") (i) an aggregate of 1,376,813 shares (the "Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), at a purchase price of $17.25 per share, and (ii), in lieu of shares of Common Stock to certain Purchasers, pre-funded warrants (the "Pre-Funded Warrants") to purchase up to an aggregate of 7,318,886 shares of Common Stock (the "Warrant Shares") at a purchase price of $17.2499 per Pre-Funded Warrant (representing the $17.25 per Share purchase price less the exercise price of $0.0001 per Warrant Share) (Filing, Kura Oncology, JAN 24, 2024, View Source [SID1234639627]). The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire.

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Leerink Partners LLC acted as the sole placement agent for the Private Placement.

The Private Placement closed on January 26, 2024. The Company received aggregate gross proceeds from the Private Placement of approximately $150.0 million, before deducting estimated offering expenses payable by the Company.

The Pre-Funded Warrants issued in the Private Placement provide that the holder of the Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded Warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that the holder may increase or decrease the Beneficial Ownership Limitation by giving 61 days’ notice to the Company, but not to any percentage in excess of 19.99%.

The foregoing descriptions of the Securities Purchase Agreement and the Pre-Funded Warrants do not purport to be complete and are qualified in their entirety by reference to such agreements, copies of which are filed as Exhibits 10.1 and 4.1 hereto, respectively, and incorporated by reference herein.

Registration Rights Agreement

On January 26, 2024, the Company entered into a registration rights agreement (the "Registration Rights Agreement") with the Purchasers, pursuant to which the Company agreed to register for resale the Shares and the Warrant Shares held by the Purchasers (the "Registrable Securities"). Under the Registration Rights Agreement, the Company has agreed to file a registration statement covering the resale of the Registrable Securities by no later than February 23, 2024 (the "Filing Deadline"). The Company has agreed to use reasonable efforts to cause such registration statement to become effective as soon as practicable, but in any event no later than the 30th calendar day following the filing of the registration statement (or, in the event of a "limited" or a "full review" by the U.S. Securities and Exchange Commission (the "SEC"), the 45th or 60th day, respectively, following such filing date). The Company also agreed to use reasonable efforts to keep such registration statement effective until the date the Shares and Warrant Shares covered by such registration statement have been sold or may be resold pursuant to Rule 144 without restriction. The Company has agreed to be responsible for all fees and expenses incurred in connection with the registration of the Registrable Securities.

In the event (i) the registration statement has not been filed by the Filing Deadline, (ii) the registration statement has not been declared effective prior to the earlier of (A) three business days after the date which the Company is notified by the SEC that the registration statement will not be reviewed by the SEC staff or is not subject to further comment by the SEC staff, or (B) 30 days following the Filing Deadline (or, in the event of "limited review" or "full review" by the SEC, 45 or 60 days, respectively, following the Filing Deadline) or (iii) after the registration statement has been declared effective by the SEC, sales cannot be made pursuant to the registration statement for any reason including by reason of a stop order or the Company’s failure to update such registration statement, subject to certain limited exceptions, then the Company has agreed to make pro rata payments to the Purchasers as

liquidated damages in an amount equal to 1% of the aggregate amount invested by the Purchasers in the Registrable Securities per 30-day period or pro rata for any portion thereof for each such month during which such event continues, subject to certain caps set forth in the Registration Rights Agreement.

The Company has granted the Purchasers customary indemnification rights in connection with the registration statement. The Purchasers have also granted the Company customary indemnification rights in connection with the registration statement.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the Registration Rights Agreement, a copy of which is filed as Exhibit 10.2 hereto and incorporated by reference herein.

On January 24, 2024 Synnovation Therapeutics, a precision medicine company developing small molecule therapies optimized to achieve best-in-class pharmacology against highly validated disease targets, reported to have launched with a $102 million Series A (Press release, Synnovation Therapeutics, JAN 24, 2024, View Source [SID1234639467]). The financing was led by Third Rock Ventures with participation from Nextech, Lilly Asia Ventures, Sirona Capital and Cormorant Asset Management. Synnovation was founded by a world-class medicinal chemistry team with a track record of developing best-in-class therapeutics. Proceeds will fund the advancement of the company’s clinical and preclinical pipeline, including SNV1521 and SNV4818, as well as additional programs.

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Synnovation’s pipeline is built around highly validated precision oncologic targets where greater potency, selectivity and optimized pharmaceutical properties have the potential to address liabilities in existing standards of care, and meaningfully improve patient outcomes. The company’s lead program, SNV1521, is a potentially best-in-class, potent, highly selective and CNS penetrant PARP1 inhibitor. PARP1 isoform selective inhibition is emerging as one of the most exciting new approaches to combat solid tumors, offering the potential to create new and well-tolerated therapeutic approaches that attack genetic and pharmacologic vulnerabilities of cancer. The company is initiating a Phase I study and anticipates dosing its first patient in the coming weeks. Synnovation’s second program targets oncogenic PI3K-alpha, leveraging multiple distinct mutant-selective approaches. The company’s first development candidate, SNV4818, is a potent, and potentially best-in-class mutant selective PI3K-alpha inhibitor. SNV4818 is differentiated from competitor molecules by virtue of its excellent selectivity for H1047X and moderate selectivity over relevant E545/542X mutants.

Synnovation was founded by a world-class medicinal chemistry team with drug discovery expertise and a track record of developing best-in-class therapeutics. While at Incyte, the management team worked together for more than a decade and contributed to the discovery of five approved drugs including Jakafi (ruxolitinib), Olumiant (baricitinib), Pemazyre (pemigatinib), Tabrecta (capmatinib), and Opzelura (topical ruxolitinib). These novel medicines have become important treatments for many diseases, including myelofibrosis and polycythemia vera, graft-vs-host disease, rheumatoid arthritis, cholangiocarcinoma, non-small-cell lung cancer, atopic dermatitis, and vitiligo.

"At Synnovation, we have assembled a top-notch team dedicated to fostering a multidisciplinary and collaborative approach as advocated by my mentor Dr. Ralph F. Hirschman, who ardently believed that the collaboration between creative chemists and outstanding biologists could lead to remarkable discoveries," said Wenqing Yao, Ph.D., chief executive officer of Synnovation. "Our goal is to develop best-in-class therapies, ultimately aiming to enhance the lives of patients. We look forward to advancing in the clinic with SNV1521, a novel PARP1 selective inhibitor, as we continue to grow our potential best-in-class pipeline of agents."

"Synnovation was founded by one of the most accomplished medicinal chemistry teams in biopharma," said Reid Huber, Ph.D., board member at Synnovation and partner at Third Rock Ventures. "This highly experienced leadership team has a rich history of successful drug discovery and development, and a passion to build further on this success. We are excited to be a part of this company and look forward to what this stellar team will accomplish as it takes its decades of experience and applies them to an entirely new set of R&D challenges."

Synnovation Leadership

Wenqing Yao, Ph.D., Founder and CEO, was most recently EVP and Head of Discovery Chemistry at Incyte, where he spent 19 years. While at Incyte, Dr. Yao led a chemistry team which discovered more than 30 clinical compounds and five approved drugs including Jakafi, Olumiant, Pemazyre, Tabrecta, and Opzelura. Dr. Yao joined Incyte in early 2002 as one of the founding scientists and contributed to the establishment of Incyte’s world-class small molecule drug discovery group.
Liangxing Wu, Ph.D., Co-Founder and SVP Drug Discovery, was most recently Executive Director, Medicinal Chemistry at Incyte, where he spent nearly 10 years working in drug discovery and contributed to the discovery of multiple clinical compounds and FDA approved drug Pemazyre.
Phillip Liu, Ph.D., SVP Head of Biology, has more than 20 years of experience in biotech and pharma including 17 years at Incyte, where he led a cell and molecular biology group that supported Incyte’s discovery pipeline and collaborated closely with Dr.s. Yao and Wu on FGFR and PD-L1 small molecule programs. He was most recently Executive Director, Oncology, Kymera Therapeutics.
Kevin O’Hayer, M.D., Ph.D., SVP Head of Clinical Development is an Medical Oncology physician-scientist who most recently led the Oral PD-L1 program as VP, GPH at Incyte. Dr. O’Hayer also developed clinical programs with multiple JAK inhibitors in inflammatory conditions and COVID-19.
The Board of Directors at Synnovation includes Ting Feng, Ph.D., Sirona Capital; Reid Huber, Ph.D., Third Rock Ventures; Judith Li, Lilly Asia Ventures (observer); Jigar Raythatha, Third Rock Ventures; Thilo Schroeder, Ph.D., Nextech; Liangxing Wu, Ph.D., Synnovation; and Wenqing Yao, Ph.D., Synnovation.