On December 8, 2023 Novartis reported results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali (ribociclib) treatment completion by 78.3% of patients (Press release, Novartis, DEC 8, 2023, View Source [SID1234638330]). Results reinforce the benefit seen at the earlier interim analysis, with a 25.1% (HR=0.749; 95% CI: 0.628, 0.892; p=0.0006) reduction in risk of disease recurrence in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with adjuvant Kisqali plus a non-steroidal aromatase inhibitor as standard endocrine therapy (ET) compared to ET alone1,2. Late-breaking data from this analysis will be presented today at the 2023 San Antonio Breast Cancer Symposium (SABCS) Annual Meeting.

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Kisqali iDFS benefit across pre-specified subgroups1:

Subgroup 3-year iDFS rate, % HR (95% Cl)
ITT population Kisqali + ET: 90.7 0.749
ET alone: 87.6 (0.628, 0.892)
AJCC Stage II Kisqali + ET: 94.2 0.700
ET alone: 92.6 (0.496, 0.986)
AJCC Stage III Kisqali + ET: 88.1 0.755
ET alone: 83.8 (0.616, 0.926)
Node-negative (N0) Kisqali + AI: 93.2 0.723
ET alone: 90.6 (0.412, 1.268)
"As clinicians, we know that patients diagnosed with HR+/HER2- early breast cancer remain at risk of recurrence for decades, despite adjuvant endocrine therapy. Moreover, the real risk observed in this analysis in patients treated with endocrine therapy alone, including those with node-negative disease, highlights the need for effective and tolerable treatment options that can help keep patients cancer-free in the short and long term," said Gabriel N. Hortobagyi, MD, FACP, Professor of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center. "The updated NATALEE results reinforce the potential of ribociclib to help address these needs for the broader at-risk population with no added disruptions to patients’ quality of life compared to endocrine therapy alone."

Kisqali data across all secondary efficacy endpoints was also consistent, including distant disease-free survival (DDFS) (25.1% risk reduction) and recurrence-free survival (RFS) (27.3% risk reduction). With fewer than 4% of events in both treatment arms (3.3% in the Kisqali-ET arm and 3.4% in the ET only arm), overall survival (OS) results will continue to evolve in the longer term1,2.

The safety profile of Kisqali at the 400 mg dose remained consistent with previously reported results, with generally low-grade adverse events (AEs), other than laboratory abnormalities. AEs of special interest (grade 3 or higher) were neutropenia (44.3%), liver-related AEs (e.g., elevated transaminases) (8.6%), and QT interval prolongation (1.0%)1,2. No new safety signals were identified1,2.

"The final iDFS analysis of NATALEE represents a significant milestone, building upon the robust evidence supporting Kisqali as a potential new adjuvant treatment for a broad, clinically common and identifiable population of patients with stage II and III HR+/HER2- early breast cancer," said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. "We are seeking approval for Kisqali in early breast cancer from health authorities worldwide, aspiring to more than double the number of at-risk patients who could potentially benefit from CDK4/6 inhibitor treatment in this setting."

Novartis submitted NATALEE data to the European Medicines Agency and plans to finalize submission to the U.S. Food and Drug Administration by end of year.

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali (ribociclib) with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO2. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable2. The primary endpoint of NATALEE is iDFS as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria2. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial2.

Results previously announced at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2023 showed Kisqali plus ET, compared to ET alone, lowered the risk of cancer recurrence by 25.2% (HR=0.748; 95% CI: 0.618, 0.906; p=0.0014), along with consistent clinically meaningful iDFS benefit across key pre-specified subgroups2.

NATALEE explored a lower starting dose (400 mg) of Kisqali than the dose approved for treatment in metastatic breast cancer (MBC) (600 mg) with the goal to minimize disruptions to patient quality of life without compromising efficacy. Compared to the 600 mg dose, the safety profile of Kisqali at 400 mg was observed to have lower rates of symptomatic AEs and less need for dose modifications when administered up to three years2. AEs of special interest (grade 3 or higher) are neutropenia (44.3%), liver-related AEs (e.g., elevated transaminases) (8.6%), and QT interval prolongation (1.0%)1,2.

About Early Breast Cancer
More than 90% of patients diagnosed with breast cancer have EBC16. Despite adjuvant ET, approximately one-third of those diagnosed with stage II and more than half of those diagnosed with stage III HR+/HER2- EBC experience cancer recurrence17,18. The risk of recurrence continues over decades with more than half of breast cancer recurrences occurring five or more years after diagnosis17,19. For many of these patients, there are currently no targeted therapeutic options outside of the standard chemotherapy and ET20.

About Kisqali (ribociclib)
Kisqali has consistently demonstrated OS benefit while preserving or improving quality of life across three Phase III trials in MBC4-15. Updates to the NCCN Guidelines for breast cancer, released in January 2023, recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an aromatase inhibitor (AI)21. Additionally, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer22. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line23.

Kisqali has been approved in 99 countries worldwide, including by the United States Food and Drug Administration (FDA) and the European Commission. In the U.S., Kisqali is approved for the treatment of adult patients with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men. In the EU, Kisqali is approved for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist20.

Novartis is committed to continuing to study Kisqali in breast cancer. Novartis is collaborating with SOLTI, which is leading the HARMONIA study to test whether Kisqali changes tumor biology to enable a better response to ET compared to Ibrance* (palbociclib) for patients with HR+/HER2-, HER2-enriched subtype24 MBC, and with the Akershus University Hospital in Norway on the NEOLETRIB trial, a neoadjuvant Phase II trial studying the effects of Kisqali in HR+/HER2- EBC to discover the potentially unique underlying mechanism of action25.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.com

On December 8, 2023 NightHawk Biosciences, Inc., a Delaware corporation (the "Company"), reported to have entered into a Sales Agreement (the "Sales Agreement") with A.G.P./Alliance Global Partners (the "Sales Agent" or "A.G.P.") providing for the sale by the Company of its shares of common stock, par value $0.0002 per share (the "Common Stock"), from time to time, through or to A.G.P., as sales agent or principal, with certain limitations on the amount of Common Stock that may be offered and sold by the Company as set forth in the Sales Agreement (the "Offering") (Filing, 8-K, NightHawk Biosciences, DEC 8, 2023, View Source [SID1234638328]). Prior to entering into the Sales Agreement with A.G.P., the Company terminated the 2020 ATM Sales Agreement (as defined below) that it previously entered into with B. Riley Securities, Inc. and Cantor Fitzgerald & Co.

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Offers and sales of shares of Common Stock by the Company, if any, under the Sales Agreement, will be made through a prospectus supplement, dated December 8, 2023 and an accompanying base prospectus, dated December 22, 2020, contained therein (the "ATM Prospectus Supplement"), which prospectus forms a part of the Company’s shelf registration statement on Form S-3, as amended (File 333-251255), initially filed by the Company with the U.S. Securities and Exchange Commission (the "SEC") on December 10, 2020 (the "Registration Statement") and declared effective by the SEC on December 22, 2020. The aggregate market value of the shares of Common Stock eligible for sale under the ATM Prospectus Supplement will be subject to the limitations of General Instruction I.B.6 of Form S-3, to the extent required under such instruction.

Pursuant to the Sales Agreement, the Company will set the parameters for the sale of shares of Common Stock, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, the Sales Agent may sell the shares by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on the NYSE American or on any other existing trading market for the Common Stock. In addition, with the Company’s prior written approval, the Sales Agent may also sell shares by any other method permitted by law, including in privately negotiated transactions.

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Sales Agent will use its commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of the NYSE American, to sell shares of Common Stock from time to time based upon the Company’s instructions. The Company has no obligation to sell any shares of Common Stock under the Sales Agreement and may at any time suspend solicitation and offers under the Sales Agreement. The Sales Agent is not obligated to purchase any shares of Common Stock on a principal basis pursuant to the Sales Agreement.

The Sales Agreement provides that the Company will pay the Sales Agent commissions for its services in acting as agent in the sale of shares of Common Stock pursuant to the Sales Agreement. The Sales Agent will be entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the Sales Agreement. The Company has agreed to provide the Sales Agent and certain affiliates of the Sales Agent with customary indemnification and contribution rights, including for liabilities under the Securities Act. The Company also will reimburse the Sales Agent for certain specified expenses in connection with entering into the Sales Agreement up to $50,000, and certain specified expenses on an annual basis not to exceed $10,000. The Sales Agreement contains customary representations and warranties and conditions to the placements of shares of Common Stock pursuant thereto, obligations to sell shares under the Sales Agreement are subject to satisfaction of certain conditions, including the effectiveness of the Registration Statement and other customary closing conditions.

The Sales Agreement will terminate upon the earlier of (i) the sale of all shares of Common Stock subject to the Sales Agreement; (ii) termination of the Sales Agreement as permitted therein, including by the Company to the Sales Agent upon one (1) day’s prior written notice and by the Sales Agent to the Company upon five (5) days’ prior written notice, in each instance without liability of any party; and (iii) termination by the Sales Agents upon written notice to the Company at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

A copy of the legal opinion of Blank Rome LLP regarding the legality of the shares of Common Stock that may be issued pursuant to the ATM Prospectus Supplement is attached to this Current Report on Form 8-K as Exhibit 5.1.

On December 8, 2023 Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, and The Leukemia & Lymphoma Society (LLS), the largest private funder of blood cancer research, reported a clinical collaboration to evaluate Kura’s menin inhibitor, ziftomenib, in combination with chemotherapy in pediatric patients with relapsed/refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutant acute leukemia (Press release, Kura Oncology, DEC 8, 2023, View Source [SID1234638327]).

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"We are honored to be designated for the PedAL initiative, marking Kura’s continued development of ziftomenib for the treatment of acute leukemias," said Mollie Leoni, M.D., Executive Vice President, Clinical Development. "Kura remains committed to developing new treatment options across the continuum of care, including for pediatric patients with acute leukemias where poor outcomes and significant unmet medical need remain. We are proud to collaborate with an exceptional organization such as LLS, which recognizes the importance of expanding patient populations beyond adults to provide effective therapies to infants and children with blood cancers."

In partnership with the PedAL Initiative, LLS will serve as the coordinating sponsor in North America and the Princess Máxima Center for Pediatric Oncology in Utrecht, the Netherlands, will serve as the coordinating sponsor in Europe. PedAL is a pioneering global master clinical trial for Pediatric Acute Leukemia, founded and led by LLS, which aims to advance more effective, safer treatments with fewer long-term side effects, for children with blood cancer.

"We developed PedAL as part of LLS’s Dare to Dream Project to fundamentally change how children with acute leukemia are treated and to provide a clinical trial framework that would help innovative companies like Kura accelerate research into precision treatments for pediatric patients," said Gwen Nichols, M.D., Chief Medical Officer, The Leukemia & Lymphoma Society. "For too long, progress for children with cancer has lagged behind; this collaboration with Kura is a major step in the right direction."

Under the terms of the agreement, LLS and the Princess Máxima Center will sponsor the Phase 1 study of ziftomenib in pediatric patients with acute leukemias. Kura will supply LLS and the Princess Máxima Center with ziftomenib for the study.

About Ziftomenib

Ziftomenib is a novel, once-daily, oral investigational drug candidate targeting the menin-KMT2A/MLL protein-protein interaction for treatment of genetically defined AML patients with high unmet need. In the KOMET-001 Phase 1 study, ziftomenib demonstrated an encouraging safety profile and tolerability with reported events most often consistent with features and manifestations of underlying disease. Clinical activity of ziftomenib as a monotherapy was optimal at the 600 mg daily dose and a 35% complete remission rate was observed in 20 patients with NPM1-mutant AML treated at the recommended Phase 2 dose (600 mg). Ziftomenib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML. Additional information about clinical trials for ziftomenib can be found at kuraoncology.com/clinical-trials/#ziftomenib.

On December 8, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported that it will focus its resources in two strategic areas: (i) treating colorectal cancer using IgM death receptor 5 (DR5) agonist antibodies, and (ii) treating autoimmune diseases using IgM T cell engager antibodies (Press release, IGM Biosciences, DEC 8, 2023, View Source [SID1234638326]). As an expansion of its autoimmune efforts, the Company also announced today that it plans to file an Investigational New Drug (IND) application to begin the clinical development of IGM-2644, its CD38 x CD3 T cell engager antibody, for the treatment of autoimmune diseases. As part of its strategic refocus, the Company is halting all hematologic oncology clinical development as well as the clinical development of its targeted cytokine product candidate. The Company will continue to focus on the development of oncology and immunology and inflammation product candidates under its collaboration with Sanofi. In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent. As a result of these actions, IGM expects to extend its cash runway into the second quarter of 2026.

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"IGM continues to have a tremendous opportunity to transform a variety of disease areas using an entirely new class of antibody medicines," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Although we are very encouraged by the clinical and preclinical data that we have generated for the programs we are halting, given the difficult conditions in the capital markets for our industry, we have decided to focus our capital resources on those opportunities that we believe have the most potential to produce significant near-term value. We are very sorry that some of our dedicated and talented employees will be leaving IGM as part of this strategic refocusing, and we wish to extend our sincere thanks and assistance to them in this difficult transition."

Pipeline Update:

Aplitabart (DR5 agonist)

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Clinical development of aplitabart in colorectal cancer prioritized.
o
Enrollment continues in randomized colorectal cancer clinical trial. The Company continues to enroll patients in a randomized clinical trial of aplitabart, a death receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer, with a goal of enrolling approximately 110 patients by the end of the first quarter of 2024. In addition to clinical trial sites in the United States, this trial includes multiple clinical trial sites in Asia and Europe.
o
Treatment at 10 mg/kg ongoing in the single arm colorectal cancer clinical trial continues. The Company also continues to treat later line colorectal cancer patients in its single arm combination clinical trial of 10 mg/kg of aplitabart and FOLFIRI. The Company expects to complete enrollment of patients in this 10 mg/kg single arm combination study in the first half of 2024.

Imvotamab (CD20 x CD3)

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Clinical development of imvotamab in autoimmune diseases prioritized. The Company is prioritizing the clinical development of imvotamab, an IgM-based CD20 x CD3 bispecific T cell engaging antibody in autoimmune diseases. The Company currently has two Phase 1b clinical trials underway, one in severe systemic lupus erythematosus (SLE) and one in severe rheumatoid arthritis (RA). These clinical trials are being expanded to include multiple U.S. and international clinical trial sites. The Company also recently received clearance from the FDA of its IND application for the use of imvotamab in treating idiopathic inflammatory myopathies (myositis), and preparations are underway to move this clinical trial forward.

IGM-2644 (CD38 x CD3)

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Clinical development of IGM-2644 in autoimmune diseases prioritized. The Company is prioritizing the clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases, and it plans to file an IND for these purposes in 2024.

As a part of this strategic refocusing, the Company will halt the following clinical development activities:

•
Aplitabart in acute myeloid leukemia and in combination with birinapant
•
IGM-2644 (CD38 x CD3) in multiple myeloma
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IGM-2537 (CD123 x CD3)
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IGM-7354 (IL-15 x PD-L1)

On December 8, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that on December 05, 2023, the compensation committee of BridgeBio’s board of directors granted thirty new employees restricted stock units for an aggregate of 147,373 shares of the Company’s common stock (Press release, BridgeBio, DEC 8, 2023, View Source [SID1234638320]). One-fourth of the shares underlying each employee’s restricted stock units will vest on November 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

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The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019 and amended and restated on February 10, 2023.