On October 12, 2021 Theratechnologies reported that earnings call will be held on October 13, 2021 at 8:30 a.m. ET (Press release, Theratechnologies, OCT 12, 2021, View Source [SID1234596233]).

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On October 12, 2021 Kytopen reported that 2021 Cell & Gene Meeting on the Mesa, organized by the Alliance for Regenerative Medicine, was a hybrid event held in-person in Carlsbad, CA on October 12 -14th and virtually on October 19th & 20th (Press release, Kytopen, OCT 12, 2021, View Source;utm_medium=rss&utm_campaign=kytopen-presents-at-the-2021-cell-gene-meeting-on-the-mesa [SID1234594172]). Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies.

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In this year company presentation, Kytopen provided a case study of our Flowfect non-viral transfection platform for ex vivo cell therapy discovery and manufacturing. The study in CD34+ stem cells & mRNA highlights our tiered approach to optimize payload and transfection parameters while confirming the robustness of the process despite donor variability and scale up for clinical relevance. In just 6 weeks, we scaled our process to transfect 200x more CD34+ stem cells in seconds while maintaining significantly high levels of cell recovery, viability, and efficiency.

The Flowfect platform is a transformative solution that eliminates the complexity of scale up in cell engineering in one flexible scalable solution. Our goal is to reduce risk while providing maximum control and flexibility to drive higher yields, faster approvals, and better outcomes for curative cellular disease treatment.

ARM’s 2021 Meeting on the Mesa attracted more than 1,700 registrants this year, including nearly 1,200 attendees at the in-person portion of the conference in Carlsbad, CA. With an approximately 40% increase in the number of registrants from 2019 and 2020, this year’s meeting was the largest in ARM’s history. The conference featured three days of live panels and presentations, as well as additional on-demand content and nearly 3,000 virtual and in-person partnering meetings.

On October 12, 2021 Bicycle Therapeutics plc (the "Company") reported that it entered into an underwriting agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC and SVB Leerink LLC (the "Representatives"), as representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell 3,240,741 American Depositary Shares ("ADSs"), each representing one of the Company’s ordinary shares, nominal value £0.01 per share, at a public offering price of $54.00 per ADS (the "Offering") (Filing, 8-K, Bicycle Therapeutics, OCT 12, 2021, View Source [SID1234591239]). The net proceeds to the Company from the Offering are expected to be approximately $163.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company also granted the Underwriters an option to purchase 486,111 additional ADSs at the public offering price.

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The Offering is being made pursuant to the Company’s registration statement on Form S-3 (File No. 333-260179), which became effective upon filing with the Securities and Exchange Commission on October 12, 2021, a base prospectus dated October 12, 2021 and the related prospectus supplement dated October 12, 2021. The Offering is expected to close on October 15, 2021, subject to customary closing conditions.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Underwriting Agreement. The Company’s directors and executive officers have agreed, subject to certain exceptions, not to sell or transfer any ordinary shares (including ADSs representing ordinary shares) for 60 days, and the Company has agreed not to sell or transfer any ordinary shares (including ADSs representing ordinary shares) for 60 days, in each case, after October 12, 2021, without first obtaining the written consent of the Representatives.

On October 12, 2021 Inspyr Therapeutics, Inc. ("Inspyr") reported (i) a 1-for-75 reverse stock split of its common stock and (ii) a holding company restructuring whereby Rebus Holdings, Inc. ("Rebus"), a newly created entity will serve as the new holding company that will replace Inspyr as the public company trading on the OTC Markets trading under the symbol RBSH (Press release, Inspyr Therapeutics, OCT 12, 2021, View Source [SID1234591209]). The reverse stock split and holding company reorganization will occur concurrently.

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Inspyr has completed a restructuring consisting of reacquiring its rights to its now lead asset RT-AR001 and transforming into a holding company structure. Management believes that reacquiring the Adenosine assets and its new structure will lead to a more streamlined company that will increase stockholder value. A pre-IND meeting for RT-AR-001 was held with the FDA in Q1 of 2021. Following that meeting the company has moved forward with manufacturing and non-clinical studies to support the submission of an IND. The company expects to provide a further clinical update in the first half of 2022. The Company is also in the process of launching and rebranding its new corporate website at www.rebus-corp.com.

The company anticipates that subsequent to the reverse split it will be able to apply to list its Common Stock on the OTCQB tier of the OTC Markets Group, and eventually apply for a listing on a national exchange, in order to provide stockholders with more liquidity and allow the company more flexibility in accessing the capital markets.

Immediately after the 1-for-75 reverse stock split, existing shares of Inspyr common stock will be automatically converted, on a one-for-one basis, into shares of Rebus common stock having the same designation, rights, powers, and preferences and qualifications, limitations, and restrictions as a share of Inspyr common stock immediately prior to the reorganization. Outstanding Inspyr convertible debt securities and warrants will be similarly converted on the same terms into like securities of Rebus.

Accordingly, Inspyr stockholders will automatically become stockholders of Rebus with the same ownership percentage of shares as they held in Inspyr immediately prior to the reorganization. Inspyr will subsequently operate as a wholly-owned subsidiary of Rebus.

Effective at the open of the market on Tuesday, October 12, 2021, Inspyr will cease to trade under NSPX and Rebus will begin trading under the new ticker symbol RBSH with a CUSIP of 75619J 103.

The Board of Directors and the executive officers of Inspyr immediately prior to the reorganization will continue in their same roles at Rebus.

The holding company reorganization, which is intended to be a tax-free transaction for U.S. federal income tax purposes for the stockholders, will modernize the Company’s operating and legal structure, and will provide financial and administrative flexibility.

On October 12, 2021 Agilent Technologies Inc. (NYSE: A) reported its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio (abemaciclib) in combination with endocrine therapy is being considered (Press release, Agilent, OCT 12, 2021, View Source [SID1234591195]). This is the first IHC assay measuring Ki-67 expression to receive FDA approval in the context of treatment with Verzenio and was developed in collaboration with Eli Lilly and Company.

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"Agilent’s Ki-67 IHC MIB-1 pharmDx (Dako Omnis) companion diagnostic assay for the Dako Omnis advanced staining platform has been designed and tested to aid in evaluating risk of recurrence in early breast cancer (EBC)"

Understanding the risk of recurrence in EBC is vital for informing disease management, as identifying patients at high risk can provide clarity for patients as well as facilitate treatment decisions to potentially improve outcomes. Conventional methods for evaluating the risk of recurrence in EBC are based on staging and are performed according to standard clinical and pathological features of the disease. However, these standard features may not capture the full risk of recurrence for individuals with EBC.

The American Joint Committee on Cancer has identified the Ki-67 biomarker as Level of Evidence III in diagnosing EBC due to its association with cellular proliferation. Ki-67 is thus an important component of comprehensive risk assessment, but it has been inconsistently applied in the past.1

"Agilent’s Ki-67 IHC MIB-1 pharmDx (Dako Omnis) companion diagnostic assay for the Dako Omnis advanced staining platform has been designed and tested to aid in evaluating risk of recurrence in early breast cancer (EBC)," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "Its approval establishes a clinically relevant standard for recurrence risk assessment in EBC so that more high-risk patients who may experience clinical benefit from treatment with Verzenio are identified."

This approval builds on Agilent’s previous successes in expanding the clinical applicability of therapeutic biomarker analysis, further cementing the company’s position as a provider of diagnostic assays that deliver high quality and ease of implementation.