Invitae’s PCM Assay for Minimal Residual Disease Receives its First Commercial Coverage

On March 6, 2023 Invitae (NYSE: NVTA), a leading medical genetics company, reported that its Personalized Cancer Monitoring (PCM) assay, which helps detect minimal residual disease (MRD) in patients, has obtained its first commercial coverage in all solid tumors by Blue Shield of California (Press release, Invitae, MAR 6, 2023, View Source [SID1234628234]). The policy, effective as of March 1, 2023, considers the test medically necessary for patients with stage I-IV cancer after surgical intervention for adjuvant or targeted therapy and/or monitoring for relapse or progression.

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Invitae’s PCM uses a novel set of personalized assays based on a patient’s tumor to detect circulating tumor DNA (ctDNA) in blood, assisting with risk stratification, assessing response to treatment and detecting cancer recurrence.

"We are very pleased with this coverage decision because it recognizes the utility of PCM in detecting MRD, thereby improving the clinical care of cancer patients," said Robert Nussbaum, M.D., chief medical officer at Invitae. "We are continuing to generate additional clinical evidence as well as securing other reimbursement pathways. Overall, we are encouraged to see increasing access to MRD testing and view the coverage decision as a great step forward for patients."

For more information, visit invitae.com.

Entry into a Material Definitive Agreement

On March 6, 2023 F-star Therapeutics, Inc., a Delaware corporation (the "Company"), invoX Pharma Limited, a private limited company organized under the laws of England and Wales ("Parent") and Fennec Acquisition Incorporated, a Delaware corporation and a wholly owned subsidiary of Parent ("Purchaser" and together with the Company and Parent, the "Parties"), reported that it has entered into Amendment No. 8 ("Amendment No. 8") to the Agreement and Plan of Merger, dated as of June 22, 2022, and as amended, by and among the Parties and Sino Biopharmaceutical Limited, a company organized under the laws of the Cayman Islands, as "Guarantor" (the "Merger Agreement") (Filing, 8-K, F-star, MAR 6, 2023, View Source [SID1234628233]). Capitalized terms used in this Current Report on Form 8-K without being defined herein shall have the same meanings ascribed to them in the Merger Agreement.

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The purpose of Amendment No. 8 is to extend the End Date of the Merger Agreement in order to provide additional time for the Parties to finalize an agreement with the Committee on Foreign Investment in the United States ("CFIUS") and to complete the ongoing tender offer (the "Offer") whose expiration date has been extended to March 8, 2023, unless further extended, as described below.

The Parties believe they are in the final stages of the approval process for a definitive agreement necessary to remove CFIUS’s Interim Order and allow the transaction to close. However, there can be no assurances that the Parties will reach a final agreement with CFIUS.

Other than as expressly modified pursuant to Amendment No. 8, the Merger Agreement, which was previously filed as Exhibit 2.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") by the Company on June 23, 2022, remains in full force and effect as originally executed on June 22, 2022, as amended. The foregoing description of Amendment No. 8 does not purport to be complete and is subject to, and qualified in its entirety by, the full text of Amendment No. 8 attached hereto as Exhibit 2.1 to this Current Report on Form 8-K, which is incorporated herein by reference.

Item 8.01
Other Events

Extension of Tender Offer Until March 8, 2023

On March 6, 2023, Purchaser, Parent and Guarantor extended the Offer to 5:00 p.m., Eastern Time, on March 8, 2023, unless further extended. The Offer was previously set to expire at 5:00 p.m., Eastern Time, on March 3, 2023. The purpose of the extension is to provide additional time for the Parties to complete the approval process with CFIUS for a final agreement.

As of 5:00 p.m., Eastern Time, on March 3, 2023, the Depositary had advised Purchaser, Parent and Guarantor that shares of common stock of the Company representing approximately 70.65% of the outstanding shares of common stock of the Company had been validly tendered and not properly withdrawn from the Offer.

Forward-Looking Statements

This report contains forward-looking statements. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans", "will be" and similar expressions. These forward-looking statements include, without limitation, statements related to the consummation of the acquisition of the Company, the availability of mitigation measures and other statements that are not historical facts. These forward-looking statements are based on Parent’s and the Company’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the Parties’ ability to complete the transaction on the proposed terms and schedule; whether sufficient stockholders of the Company tender their shares in the transaction; whether the Parties can address the concerns raised by CFIUS

sufficiently to enable the interim order to be revoked or terminated, or to otherwise permit the closing of the transaction or the equity investment provided for in the Merger Agreement in the event of certain terminations related to the Foreign Investment Condition; whether the Parties and CFIUS will be able to agree on terms for a National Security Agreement; the possibility that some of the Offer conditions will not be satisfied or waived by Parent, to the extent waiveable, by the Expiration Date; and other risks related to the Company’s business detailed from time-to-time under the caption "Risk Factors" and elsewhere in the Company’s SEC filings and reports, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 and the Company’s Quarterly Reports on Form 10-Q for the quarters ended June 30, 2022 and September 30, 2022. The Company undertakes no duty or obligation to update any forward-looking statements contained in this report as a result of new information, future events or changes in their expectations, except as required by law.

Additional Information and Where to Find It

A tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, was filed with the SEC by invoX and Purchaser, and a Solicitation / Recommendation Statement on Schedule 14D-9 was filed with the SEC by the Company. The offer to purchase shares of Company common stock is being made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION / RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR COMMON STOCK, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER. Investors and security holders may obtain a free copy of these statements and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which is named in the tender offer statement. Investors may also obtain, at no charge, the documents filed or furnished to the SEC by the Company under the "Investors" section of the Company’s website at www.f-star.com.

Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8010, an Antibody Drug Conjugate Targeting HER2 for the Treatment of Advanced Solid Tumors

On March 6, 2023 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8010, an antibody-drug conjugate (ADC) that targets HER2 (Press release, BioThera Solutions, MAR 6, 2023, View Source [SID1234628232]). The multicenter, open-label Phase 1 clinical study in patients with local advanced or metastatic solid tumors aims to evaluate the safety and tolerability of BAT8010. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumor.

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BAT8010 is an antibody-drug conjugate (ADC) targeting HER2 designed for the treatment of solid tumors. HER2, a member of the epidermal growth factor receptor family (EGFR), is overexpressed in a variety of solid tumors, plays an important role in tumor proliferation, invasion, and metastasis, and is related to the poor prognosis of tumors. HER2 is a validated drug target with a number of approved drugs for the treatment of breast and gastric cancer and is still a target of high interest for new drug discovery.

BAT8010 was developed by using Bio-Thera’s proprietary ADC linker-payload that includes a cleavable but systemically stable linker, a small molecule topoisomerase I inhibitor and high DAR. The small molecule topoisomerase I inhibitor payload carried by BAT8010 has a strong cell membrane penetration ability, when the target cancer cells are killed, the payload has shown to be released and kill nearby cancer cells, producing a bystander effect, which has the potential to overcome the heterogeneity of the tumor. BAT8010 has demonstrated high anti-tumor activity, good stability, and safety in both in vitro and in vivo pharmacological studies. Bio-Thera Solutions is also developing additional ADCs based on its proprietary linker-payload, including ADCs targeting FRα, B7H3, Trop2, Nectin-4. All of the ADCs in Bio-Thera’s pipeline are currently in early-stage clinical studies.

In addition, Bio-Thera has developed an ADCC-enhanced anti-HER2 monoclonal antibody, BAT1006, that is also in early-stage clinical development. Different HER2 recognition sites can effectively inhibit the formation of HER2/HER3 heteromer. With different HER2 recognition sites and functional synergy, a combination therapy of BAT1006 and BAT8010 has the potential to improve the efficacy of targeting HER2. Bio-Thera intends to explore such a combination upon completion of the Phase 1 studies of each asset.

Roche receives FDA approval of label expansion for VENTANA PD-L1 (SP263) Assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

On March 6, 2023 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has approved the VENTANA PD-L1 (SP263) Assay as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients eligible for treatment with Libtayo (cemiplimab), a PD-1 inhibitor therapy developed by Regeneron (Press release, Hoffmann-La Roche, MAR 6, 2023, View Source [SID1234628231]).

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More than 60 percent of patients diagnosed with NSCLC are diagnosed at locally advanced or metastatic stage (Stage III-IV).2 With this launch, more patients may have access to an additional immunotherapy option with Libtayo, potentially improving their treatment pathway and outcomes.

"Diagnostics, like our high medical value PD-L1 assay portfolio, enable personalised medicine to help improve patient outcomes," said Jill German, Head of Pathology Lab, Roche Diagnostics. "This approval helps physicians make more confident treatment decisions by identifying patients with tumours that may respond to the immunotherapy Libtayo."

The VENTANA PD-L1 (SP263) Assay is the only FDA approved product available with NSCLC indications for four different immunotherapy drugs, offering oncologists a broad range of treatment options for patients. Treating NSCLC as early as possible may improve patient outcomes.

Lung cancer is the leading cause of cancer death worldwide. Every year, more than 2.2 million people are diagnosed with lung cancer globally and up to 85 percent of these cases are NSCLC.3,4

About the VENTANA PD-L1 (SP263) Assay

VENTANA PD-L1 (SP263) Assay is used to detect programmed death ligand-1 (PD-L1) protein in non-small cell lung carcinoma (NSCLC) patients. PD-L1 expression on tumour cells and immune cells has been shown in clinical studies to help predict the likelihood a patient may benefit from PD-L1/PD-1 immunotherapy drugs.5

VENTANA PD-L1 (SP263) Assay testing is performed on a BenchMark ULTRA instrument and is visualised using the OptiView DAB IHC Detection Kit.

Roche has developed a leading, comprehensive and differentiated lung cancer immunohistochemical portfolio, with biomarkers that support multiple guidelines for the diagnosis and stratification of lung cancers.

Hummingbird Bioscience Exercises Its Option to License the Clinical Trial Results from Cancer Research UK to Support Further Development of HMBD-001

On March 6, 2023 Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing transformative biologic medicines for hard-to-treat diseases, and Cancer Research Horizons, the innovation arm of Cancer Research UK (CRUK), reported that Hummingbird Bioscience has exercised its option to license in the first-in-human (FIH) clinical trial results of HMBD-001, a differentiated and potentially best-in-class HER3-targeting antibody (Press release, Hummingbird Bioscience, MAR 6, 2023, View Source [SID1234628230]).

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The Phase 1/2a clinical trial in the United Kingdom is being sponsored and managed by CRUK’s Centre for Drug Development and led by Chief Investigator, Professor Johann De Bono at the Royal Marsden Hospital and The Institute of Cancer Research, London. The Phase 1a stage of the trial is currently enrolling multiple solid tumor cancer patients resistant to approved therapies, and is aimed at identifying a recommended Phase 2 dose for further evaluation.

"We decided to exercise the option at this time due to our enthusiasm for the promising data emerging from the ongoing Phase 1a study. We look forward to accelerating the opening of multiple Hummingbird-sponsored Phase 1b/2 studies. Our CRUK collaboration has been pivotal for the development of HMBD-001 and brings us one step closer to providing a precision therapy for patients with HER3-expressing cancers," said Piers Ingram, Ph.D., Chief Executive Officer, Hummingbird Bioscience.

"Hummingbird Bio’s decision to exercise a licensing option for HMBD-001, early in the clinical development process, speaks to the urgency needed to bring promising therapeutic advances to patients," explained Nigel Blackburn, Director of the Cancer Research UK’s Centre for Drug Development. "We are pleased to have partnered with Hummingbird Bioscience to provide the clinical trial expertise and funding support needed to help navigate HMBD-001 through the high-risk, early-stages of therapeutic development."

Based on the FIH dose escalation data, Hummingbird Bioscience plans to initiate multiple studies in biomarker-selected populations during the second half of 2023. In parallel, CRUK will continue the ongoing Phase 1/2a study by completing the ongoing dose escalation portion, followed by a dose expansion study in metastatic castrate-resistant prostate cancer (in combination with anti-androgen therapy) later this year.