On March 7, 2023 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, reported the closing of its previously announced concurrent but separate underwritten public offerings of 11,086,000 shares of its common stock, including the exercise in full by the underwriter of its option to purchase an additional 1,446,000 shares of common stock, and 286,000 shares of its Series X Convertible Preferred Stock (each share of which is initially convertible into 10 shares of common stock), for aggregate gross proceeds of approximately $19.5 million, before deducting underwriting discounts and commissions and estimated offering expenses (Press release, Cidara Therapeutics, MAR 7, 2023, View Source [SID1234636989]).

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Cantor Fitzgerald & Co. acted as the sole book-running manager for each offering.

The securities described above were offered by Cidara pursuant to a shelf registration statement, which has been declared effective by the Securities and Exchange Commission (SEC). The offering was made only by means of a prospectus and prospectus supplements. Final prospectus supplements and the accompanying prospectus relating to the offerings have been filed with the SEC and are available for free on the SEC’s website at View Source Copies of the final prospectus supplements and the accompanying prospectus relating to these offerings may be obtained from: Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 7, 2023 Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, presented preclinical data on a CD73-targeting drug-Fc conjugate (DFC) candidate, CBO-212, from the Company’s Cloudbreak platform, at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress (ESMO TAT) in Paris, March 6-8, 2023 (Press release, Cidara Therapeutics, MAR 7, 2023, View Source [SID1234636988]).

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"The preclinical data presented at ESMO (Free ESMO Whitepaper) TAT represent important progress for Cidara in oncology, as these nonclinical results are the first supporting the anti-tumor potential of a Cloudbreak product candidate," said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. "We are initially focused on CD73 due to its documented contribution to immune evasion through the production of immune-suppressive adenosine in the tumor microenvironment. We believe that a CD73-targeted DFC, which combines positive attributes of small molecule and monoclonal antibody inhibitors, has the potential to ultimately provide a meaningful solution for patients."

The presented preclinical studies evaluated the functional activity, internalization and inhibition of CD73 by CBO-212 in both cell-free and cell-based assays. Key highlights include:

CBO-212 inhibited cell-anchored and soluble forms of CD73, both of which can contribute to immune-suppressive adenosine production in the tumor microenvironment, whereas positive control CD73 inhibitor monoclonal antibodies (mAbs) currently in clinical development acted primarily on cell-anchored CD73.
CBO-212 restored activation of human peripheral blood mononuclear cells suppressed with adenosine monophosphate to a greater extent than the mAb comparators, and similar to the small molecule inhibitors tested.
Unlike tested small molecule inhibitors currently in development, the multivalent presentation of CD73 inhibitors on CBO-212 induced receptor internalization and subsequent reduction of CD73 receptors expressed on a human breast cancer cell line.
These attributes, coupled with the long half-life mediated by the DFC Fc domain, led to significant tumor reduction in a mouse syngeneic tumor model after a single dose of CBO-212.
Cidara is currently advancing its lead CD73-targeting product candidate, CD421, which is an enhanced version of CBO-212 that confers reduced immunogenic properties.

About Cloudbreak DFCs
Cidara is developing a new generation of immunotherapeutic agents from its Cloudbreak platform that couple targeted small molecule and peptide drugs to a human antibody fragment (Fc). These highly potent, long-acting drug-Fc conjugates (DFCs) are designed to inhibit specific disease targets while simultaneously engaging the immune system. In addition to multiple oncology programs, Cidara is advancing its antiviral DFC CD388 through Phase 1 and Phase 2a clinical trials in partnership with Janssen for the universal prevention and treatment of influenza. Cidara is also advancing DFC programs to target other life-threatening viruses, such as SARS-CoV-2.

On March 7, 2023 Ampersand Biomedicines reported the company designed to tackle a key drug development challenge: on-target, off-tissue toxicity (Press release, Ampersand Biomedicines, MAR 7, 2023, View Source [SID1234636604]). By creating drugs that only act at the diseased tissue, regardless of whether a target is expressed elsewhere, the biotech aims to provide powerful punches without the side effects.

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Today, drug developers largely rely on differences in the levels of target expression to achieve a balance between safety and efficacy. Ideally, a receptor will only be found in the target tissue, limiting safety issues to off-target toxicity. But in reality some promising targets are found at high levels in healthy tissues, meaning safety concerns can torpedo the program.

The situation has resulted in a pool of targets that have validated roles in disease pathways but are found at too high levels in healthy tissues to be viable therapeutic opportunities. Biotech builder Flagship has spent the past two years trying to find a solution for that problem.

Now, the VC fund is ready to lift the lid on its work, albeit only by a fraction, and introduce Ampersand Biomedicines to the wider world. The biotech starts life with $50 million from Flagship and a platform for making molecules that target the site of disease without affecting healthy cells and tissues.

As is typical for early-stage biotechs, full details of exactly how Ampersand will pull off that trick are yet to emerge. The approach relies on the multiomics characterization of human biology, spanning healthy and diseased states. Using the data, Ampersand aims to identify localizers that ensure the drug only acts on particular organs or cells.

The biotech says the platform is applicable to a range of modalities—including proteins, small molecules, lipid nanoparticles and nucleic acids—and therapeutic areas. Ampersand is yet to share details of its first areas of focus.

Flagship has put together the initial leadership team for the startup, with its partner Avak Kahvejian, Ph.D., taking the founding CEO role and Raffi Afeyan, Ph.D., heading up innovation and strategy.

On March 7, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that it has entered into a collaboration with the Australian and New Zealand Children’s Haematology / Oncology Group (ANZCHOG) for a phase II clinical study examining paxalisib in children with advanced solid tumours, including brain tumours (Press release, Kazia Therapeutics, MAR 7, 2023, View Source [SID1234628376]).

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The study, named OPTIMISE, will combine paxalisib with chemotherapy for children with specific genetic mutations in their tumours. The study will harness expertise and insights gained from the Zero Childhood Cancer Program, which aims to match childhood cancer patients with targeted therapies suited to the unique characteristics of their tumour.

Key Points

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New collaboration is the first Australian-led clinical trial of paxalisib.

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Zero Childhood Cancer Program, led out of the Children’s Cancer Institute and the Kids Cancer Centre at Sydney Children’s Hospital, has already enrolled more than 900 children with high-risk malignancies. Patients with PI3K pathway alterations may now be eligible to receive paxalisib.

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OPTIMISE will explore paxalisib in combination with existing chemotherapy agents for the treatment of children with high-risk malignancies, including (but not confined to) brain tumours. It will first seek to establish the optimal dosing for children in combination with chemotherapy and will then determine the efficacy and safety in biomarker-defined populations.

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Up to 18 children are anticipated to be enrolled into an initial dose escalation cohort, and up to 100 patients in a dose expansion cohort.

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The study is funded by the Australian Government, through a Medical Research Future Fund (MRFF) grant, with Kazia’s contribution consisting of drug supply and in-kind support.

"We are pleased to see this very exciting new trial move forward with paxalisib as a matched targeted therapy in a biomarker-selected paediatric population," said Dr James Garner, Chief Executive Officer of Kazia. "Our commitment to childhood cancer, especially childhood brain cancer, is already substantial. The OPTIMISE study is very complementary to the ongoing PNOC022 study in DIPG, and in addition represents a promising new opportunity to explore paxalisib in a broader range of patients. This new project speaks to the substantial ongoing interest in the drug among leading clinicians and has the potential to yield important new insights into the use of paxalisib in some new areas with very substantial unmet clinical need."

Zero Childhood Cancer Program

The Zero Childhood Cancer Precision Medicine Program (ZERO) is an international effort to identify targeted therapies for childhood malignancies. One of the key insights of recent decades in cancer treatment has been the understanding that tumours are typically driven by specific genetic mutations. Instead of taking a ‘one size fits all’ approach to their treatment, ZERO aims to provide tailored individual treatment regimens for children diagnosed with cancer.

ZERO is led by the Children’s Cancer Institute and the Kid’s Cancer Centre at Sydney Children’s Hospital, Randwick in Sydney, NSW. The Institute is a leading Australian Medical Research Institute dedicated to paediatric cancer. The principal investigators of the paxalisib arm of the OPTIMISE study are Dr Marion Mateos and Professor David Ziegler, senior clinicians at the Kids Cancer Centre with extensive track records in the field.

Next Steps

OPTIMISE is expected to commence enrolment in 2H CY2023. The study will initially launch in Australia but may expand in due course to other countries.

An international phase II study of paxalisib in combination with ONC-201 for the treatment of DIPG and DMGs, sponsored by the Pacific Pediatric Neuro-Oncology Consortium (PNOC), commenced recruitment in November 2021. Initial data is anticipated in 1H CY2023.

On March 7, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer, reported that a special committee of the Board of Directors adopted a limited duration stockholder rights agreement (the "Rights Agreement") to protect stockholder interests and maximize value for all stockholders (Press release, Sensei Biotherapeutics, MAR 7, 2023, View Source [SID1234628339]).

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The Rights Agreement is intended to reduce the likelihood that any entity, person or group is able to gain control of Sensei through open market accumulation without paying all stockholders an appropriate control premium or providing the Board sufficient opportunity to make informed judgments and take actions that are in the best interests of all stockholders.

Pursuant to the Rights Agreement, Sensei will issue, by means of a dividend, one preferred share purchase right for each outstanding share of Sensei common stock to stockholders of record on the close of business on March 17, 2023. Initially, these rights will not be exercisable and will trade with, and be represented by, the shares of Sensei common stock.

The Rights Agreement will expire on March 7, 2024, or earlier, as provided in the Rights Agreement.

The Rights Agreement is similar to other rights plans adopted by publicly-held companies. Under the Rights Agreement, the rights generally become exercisable only if a person, group or persons acting in concert (each, an "acquiring person") acquires beneficial ownership of 10% (or 20% in the case of certain investors filing on Schedule 13G) or more of the outstanding shares of Sensei common stock in a transaction not approved by the Company. In that situation, each holder of a right (other than the acquiring person, whose rights will become void and will not be exercisable) will be entitled to purchase, at the then-current exercise price, additional shares of Sensei common stock at a 50% discount. In addition, if Sensei is acquired in a merger or other business combination after an unapproved party acquires more than 10% (or 20% in the case of certain investors filing on Schedule 13G) of the outstanding shares of Sensei common stock, each holder of a right would then be entitled to purchase, at the then-current exercise price, shares of the acquiring company’s stock at a 50% discount. The Board, at its option, may exchange each right (other than rights owned by the acquiring person that have become null and void) in whole or in part, at an exchange ratio of one share of Sensei common stock per outstanding right, subject to adjustment. Except as provided in the Rights Agreement, the Board is entitled to redeem the rights at $0.0001 per right.

If a person or group that beneficially owns 10% (or 20% in the case of certain investors filing on Schedule 13G) or more of the outstanding shares of Sensei common stock prior to Sensei’s announcement of its adoption of the Rights Agreement, then that person’s or group’s existing ownership percentage will be grandfathered, although, with certain exceptions, the rights will become exercisable if at any time after the announcement of the adoption of the Rights Agreement such person or group increases its ownership of Sensei common stock. Additional information regarding the Rights Agreement will be contained in a current report on Form 8-K to be filed by Sensei with the U.S. Securities and Exchange Commission.

Sensei remains committed to engaging in constructive dialogue with its stockholders, and the rights plan is not intended to prevent or interfere with any action with respect to Sensei that the Board determines to be in the best interests of the Company and its stockholders. Instead, it will position the Board to fulfill its fiduciary duties on behalf of all stockholders by ensuring that the Board has sufficient time to make informed judgments about any attempts to control or significantly influence Sensei.

Jefferies is serving as financial advisor to Sensei and Sidley Austin LLP is serving as Sensei’s legal advisor.