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.

On January 24, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that the World Intellectual Property Organization (WIPO) has published MAIA’s global Patent Cooperation Treaty (PCT) application titled "Dinucleotides and Their Use in Treating Cancer (Press release, MAIA Biotechnology, JAN 24, 2024, View Source [SID1234639466])." These compounds are key next-generation telomere-targeting agents, an important extension of MAIA’s innovative cancer treatment platform.

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The international patent application covers potential cancer therapies using dinucleotide compounds that target telomeres in cancer cells, and methods for using the dinucleotide compounds to treat cancers alone or before administration with checkpoint inhibitors (CPIs). The new dinucleotides disclosed in the patent application are telomere-targeting molecules, such as THIO fragments or other THIO analogues.

The PCT system streamlines the process for obtaining patent protection globally. Under the PCT, applicants can seek patent protection in a large number of countries.

"This new IP would expand the value of our telomere-targeting compounds as first-in-class cancer treatments in regions around the world and provide patent coverage through 2043," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "Previous preclinical studies of several of our second-generation telomere-targeting agents have shown highly significant anti-cancer efficacy in multiple in vivo and in vitro models. Importantly, this new coverage would further cement our robust and transformational cancer treatment franchise."

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On January 24, 2024 Ferring Pharmaceuticals reported that it is presenting the methodology for the ADSTILADRIN in BLadder cancEr (ABLE-41) Real World Evidence (RWE) study at the 20th Annual American Society of Clinical Oncologists Genitourinary Cancers Symposium (ASCO GU) (Press release, Ferring Pharmaceuticals, JAN 24, 2024, View Source [SID1234639465]). ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness, overall experiences, patterns of use, and safety of ADSTILADRIN (nadofaragene firadenovec-vncg) in a U.S. real-world setting.

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"ABLE-41: Nadofaragene firadenovec-vncg early utilization and outcomes in a real-world setting in the United States."

ADSTILADRIN is the first and only intravesical gene therapy approved by the U.S. Food and Drug Administration (FDA) in adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).

"Many NMIBC patients who initially respond to BCG therapy experience disease recurrence or progression, so developing a local, effective, bladder-preserving treatment option like ADSTILADRIN has long been needed," said Kristen Litchfield, DHSc, Vice President, Medical Affairs, Uro-Oncology, Ferring Pharmaceuticals, U.S. "In our pivotal Phase 3 trial, ADSTILADRIN demonstrated long-term efficacy and tolerability starting from the first dose. With this new post-marketing study, we are looking to build an additional body of evidence in the real-world setting."

ABLE-41 is a non-interventional study following NMIBC patients aged 18 years or older who are being treated with ADSTILADRIN in a clinical setting and had not previously received this therapy in a clinical trial. In September 2023, Ferring announced the first patient enrolled in ABLE-41. Eligible patients include those who were prescribed and scheduled to receive treatment, per their physician’s discretion, or patients who received their first instillation (per physician discretion) after September 5, 2023, but before the site was activated in the trial. The primary objective is to assess whether patients achieve a complete response (CR) at three months and/or at any time within a year of their first instillation.

"ABLE-41 is a unique real-world registry that will provide important evidence on what patients and physicians can expect from intravesical gene therapy in a clinical setting," said Siamek Daneshmand, M.D., who is affiliated with USC/Norris Comprehensive Cancer Center and the University of Southern California, and a lead ABLE-41 investigator. "I am thrilled to be part of this ongoing research and among the first uro-oncologists to be treating patients with ADSTILADRIN in a clinical setting. This is an innovative therapy that is already changing how we manage NMIBC patients who no longer respond to standard BCG therapy, providing an alternative to radical cystectomy, or bladder removal surgery."

Participants in ABLE-41 will be followed for 24 months, or until study discontinuation or withdrawal. Key secondary outcomes include the following: treatment patterns of use; duration of CR; recurrence-free survival, cystectomy-free survival, progression-free survival, overall survival, and bladder cancer–specific mortality; patient, caregiver, and physician experiences; adjunctive use of molecular markers; and safety. Patient experiences will be assessed with a commonly used quality of life questionnaire (EuroQol 5 Dimension 5 Level), measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Caregiver experiences will be measured with the Work Productivity and Activity Impairment questionnaire, adapted for caregiving, which assesses the impact of health problems on paid and unpaid work.

Final results from this prospective, multi-institutional study are expected at the end of 2026. Learn more at www.clinicaltrials.gov/study/NCT06026332.

Poster Presentation Info:

Trials in Progress Poster Session B: Urothelial Carcinoma
"ABLE-41: Nadofaragene firadenovec-vncg early utilization and outcomes in a real-world setting in the United States."
Abstract #TPS705, Friday, Jan. 26 at 5:45 – 6:45 p.m. PST
Presenters: Neal Shore, Sia Daneshmand, Kristen Litchfield, Amy Guo, Kristian Juul, Sandra Guedes, Dalila Delattre, and Yair Lotan

About ADSTILADRIN
ADSTILADRIN (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high quantities of interferon alfa-2b protein, a naturally-occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.

ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-grade, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849).1

About Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC is a form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.2 Bladder cancer is the sixth most common cancer in the U.S., and it is estimated that there were approximately 81,180 new cases of bladder cancer in the U.S. in 2022,3 75% of which present as NMIBC.4 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard of care. However, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.3 Current treatment options for BCG-unresponsive patients are very limited, and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).5

INDICATION
ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.

WARNINGS AND PRECAUTIONS:

Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.
DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration.

USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.

ADVERSE REACTIONS: The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

Please click to see the full Prescribing Information.

On January 24, 2024 Astrin Biosciences, a leader in AI-empowered 3D holographic technology for cancer cell detection, reported a comprehensive research collaboration with Memorial Sloan Kettering Cancer Center (MSK) (Press release, Memorial Sloan-Kettering Cancer Center, JAN 24, 2024, View Source [SID1234639463]). This collaboration will leverage the combined strengths of both organizations, with the goal of transforming biomarker development and its role in cancer research and treatment.

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The collaboration sets the stage for an integrated approach, enabling researchers from Astrin and MSK to work together on a wide range of projects across the spectrum of cancer care. The collaboration is fueled by a shared commitment to eradicate the global scourge of cancer.

Astrin’s Founder and CEO, Jayant Parthasarathy, PhD, expressed his gratitude and optimism, "We are deeply honored to collaborate with MSK. Their trust in our platform is a testament to our technology’s potential. Together, we have a remarkable opportunity to make a significant impact on the lives of those affected by cancer."

"This collaboration holds immense promise for advancing our understanding of cancer, from early detection to addressing the challenges of treatment resistance and disease complexity," said Howard I. Scher, MD, FASCO, Head of MSK’s Biomarker Program and a world-renowned expert in cancer diagnostics.

The collaboration promises to accelerate the development of innovative cancer diagnostics and treatments. It underscores the commitment of both Astrin Biosciences and MSK to lead the charge in the global fight against cancer.

For more information about this collaboration, please contact: [email protected]