Acquisition of Surgical Innovation Associates

On December 1, 2022 Integra LifeSciences reported acquisition of Surgical Innovation Associates (SIA) Inc (Filing, 8-K, Integra LifeSciences, DEC 1, 2022, View Source [SID1234624667]).

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Guardant Health to Showcase New Data at San Antonio Breast Cancer Symposium 2022 Demonstrating Utility of Its Blood Tests for Advanced-stage Breast Cancer Patients

On December 1, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that new data from its portfolio of blood tests will be presented at the 2022 San Antonio Breast Cancer Symposium, December 6-10 in San Antonio, Texas (Press release, Guardant Health, DEC 1, 2022, View Source [SID1234624665]). The six poster presentations highlight the use of the Guardant360 blood test and the GuardantINFORM real-world evidence dataset to identify critical biomarkers and acquired co-mutations, track associated treatment patterns and clinical outcomes, and monitor molecular response to therapy based on specific breast cancer driver mutations.

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"We look forward to sharing new data at the San Antonio Breast Cancer Symposium demonstrating the utility of our blood tests to increase the understanding of potential biomarker targets and the mechanisms of molecular response in patients with advanced breast cancer," said Helmy Eltoukhy, Guardant Health co-CEO. "The presentations will show how data from comprehensive genomic profiling tests provide critical insights that can contribute to the development of more effective therapies and improved patient outcomes."

Full List of Guardant Health Presentations

Guardant360

ctDNA molecular response based on breast cancer driver mutations predicts progression in aromatase inhibitor-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2-) advanced breast cancer (Poster PD17-02)
TRK inhibitor in a patient with metastatic triple negative breast cancer and NTRK fusions identified via cell-free DNA analysis (Poster P5-02-13)
Cell-free DNA detection of GATA3 mutations in metastatic hormone receptor positive breast cancer: a multi-institutional analysis of incidence, co-mutations, and clinical outcomes (Poster P5-02-07)
Co-occurring alterations in PALB2 germline carriers identified by liquid biopsy in patients with advanced breast cancer (Poster P5-03-18)
Characterization of the genomic landscape of breast carcinoma patients with NF1 alterations using comprehensive cell-free tumor DNA next-generation sequencing (Poster P5-05-03)
Guardant360 and GuardantINFORM

Real-world second-line treatment patterns and associated clinical outcomes for 2795 patients with advanced HR+ HER2- breast cancer treated with first-line CDK4/6 inhibitors (Poster P4-01-18)
The full abstracts are available on the officialSABCS 2022website.

Lilly Completes Acquisition of Akouos Expanding Efforts to Help People with Genetic Diseases

On December 1, 2022 Eli Lilly and Company (NYSE: LLY) reported the successful completion of its acquisition of Akouos, Inc. (NASDAQ: AKUS) (Press release, Eli Lilly, DEC 1, 2022, View Source [SID1234624664]). The acquisition expands Lilly’s efforts in genetic medicines to include Akouos’s portfolio of potential first-in-class adeno-associated viral gene therapies for the treatment of inner ear conditions, including sensorineural hearing loss.

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"Akouos brings more top-tier talent and an important pipeline to Lilly’s Institute for Genetic Medicine that will further accelerate our work to advance genetic medicines for people living with difficult-to-treat diseases," said Andrew C. Adams, Ph.D., senior vice president of genetic medicine at Lilly and co-director of the Institute for Genetic Medicine. "We look forward to supporting and enabling the Akouos team to continue their ground-breaking work developing potential genetic medicines for inner ear conditions and to help fulfill the mission of making healthy hearing available to all."

The Offer and the Merger
The tender offer to purchase all of the issued and outstanding shares ("Shares") of Akouos’s common stock in exchange for (a) $12.50 per Share, net to the stockholder in cash, without interest (the "Cash Consideration") and less any applicable tax withholding, plus (b) one non-tradable contingent value right ("CVR" and, together with the Cash Consideration, the "Offer Price") per Share, which represents the contractual right to receive contingent payments of up to $3.00 per CVR, net to the stockholder in cash, without interest and less any applicable tax withholding, upon the achievement of certain specified milestones (the "Offer"), expired as scheduled at one minute past 11:59 p.m., Eastern time, on Nov. 29, 2022 and was not extended (such date and time, the "Expiration Time"). Lilly previously announced that, as of the Expiration Time, 29,992,668 Shares were validly tendered and not validly withdrawn in the Offer, representing 81.1% of the issued and outstanding Shares as of the Expiration Time. In accordance with the terms of the Offer, Lilly and its wholly owned subsidiary, Kearny Acquisition Corporation ("Purchaser"), accepted for payment shares that were validly tendered and not validly withdrawn in the Offer.

Following consummation of the Offer, on Dec. 1, 2022, Lilly completed its acquisition of Akouos through the merger of Purchaser with and into Akouos, and without a meeting of the stockholders of Akouos in accordance with Section 251(h) of the General Corporation Law of the State of Delaware (the "DGCL"), with Akouos surviving such merger as a wholly owned subsidiary of Lilly. In connection with the merger, each Share issued and outstanding immediately prior to the effective time of the merger (other than (i) Shares held in Akouos’s treasury or owned by Akouos, or owned by Lilly, Purchaser or any direct or indirect wholly-owned subsidiary of Lilly or Purchaser or (ii) Shares held by any stockholder of Akouos who was entitled to demand and properly demanded appraisal for such Shares in accordance with Section 262 of the DGCL), including each Share that was subject to vesting or forfeiture restrictions granted pursuant to an Akouos equity incentive plan, program or arrangement, was cancelled and converted into the right to receive the Offer Price, without interest, less any applicable tax withholding. Akouos’s common stock will be delisted from The Nasdaq Global Select Market and deregistered under the Securities Exchange Act of 1934, as amended.

Under the terms of the contingent value rights agreement, CVR holders would become entitled to receive contingent payments as follows: (i) $1.00 in cash, upon the fifth (5th) participant being administered with AK-OTOF in a Phase 1 or Phase 1/2 trial on or prior to Dec. 31, 2024; (ii) $1.00 in cash, upon the fifth (5th) participant being administered with an Akouos gene therapy product for a second monogenic form of sensorineural hearing loss (excluding AK-OTOF and AK-antiVEGF) on or prior to Dec. 31, 2026; and (iii) $1.00 in cash, upon (a) the first (1st) participant being administered with an Akouos gene therapy product (excluding AK-antiVEGF) for a monogenic form of sensorineural hearing loss in a Phase 3 trial, or (b) receipt of FDA approval in the U.S. for such Akouos product, whichever occurs first, on or prior to Dec. 31, 2026, or its value will be reduced by approximately 4.2 cents per month until Dec. 1, 2028 (at which point the CVR will expire). There can be no assurance that any payments will be made with respect to the CVR.

For Lilly, Kirkland & Ellis LLP is acting as legal counsel. For Akouos, Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal counsel and Centerview Partners LLC is acting as sole financial advisor.

Cellectis to Host a Live Webcast and Provide a Company Update on December 13, 2022

On December 1, 2022 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that it will host a live webcast to review the Company’s clinical data on the AMELI-01 study (evaluating UCART123) presented at the ASH (Free ASH Whitepaper) Annual Meeting, and provide a Company update, on December 13, 2022 (Press release, Cellectis, DEC 1, 2022, View Source [SID1234624662]).

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The event will feature presentations by the management team and will be followed by a Q&A.

Cellectis Live Webcast
Tuesday, December 13, 2022
7:30am ET/1:30pm CET
To register and access the live webcast: View Source

Following the live webcast, a replay will be available under the "Events and Webcasts" section on the Investor page of the Company’s website: View Source

Carrick Therapeutics Announces $35 Million Investment from Pfizer

On December 1, 2022 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, reported a $35 million investment from Pfizer to support its rapid development of samuraciclib (CT-7001) in HR+, HER2- breast cancer, which represents more than two thirds of all new female breast cancer cases (Press release, Carrick Therapeutics, DEC 1, 2022, View Source [SID1234624661]).

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Carrick and Pfizer have also entered into an agreement under which Pfizer will provide global development capabilities and expertise to support Carrick’s Phase 2 study of samuraciclib in combination with fulvestrant for CDK4/6i-resistant HR+, HER2- advanced breast cancer. Carrick will maintain full economic ownership and control of samuraciclib and its pipeline. In conjunction with the investment, Adam Schayowitz, Ph.D., Vice President and Development Head, Breast Cancer, Colorectal Cancer and Melanoma, Pfizer Global Product Development, will join Carrick’s Scientific Advisory Board.

"Given Pfizer’s deep expertise in developing treatments for breast cancer, we are delighted to welcome them as an investor and collaborator in developing samuraciclib," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. "We believe Pfizer’s investment further underscores the potential of samuraciclib to be a first- and best-in-class treatment for patients with advanced breast cancer, following CDK4/6i therapy."

"We believe samuraciclib has the potential to play a meaningful role in the treatment of HR+, HER2- breast cancer," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology & Rare Disease, Pfizer Global Product Development. "Our hope is that Pfizer’s development capabilities and expertise in breast cancer and next-generation cyclin dependent kinases, combined with the innovation represented by samuraciclib, will help accelerate the advancement of this potential breakthrough for patients."

About Samuraciclib (CT7001)
Samuraciclib is the most advanced oral CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer, as CDK7 regulates transcription of cancer-causing genes and promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. In addition to the above studies, it is currently being evaluated in prostate cancer with further potential in pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i-resistant HR+, HER2- advanced breast cancer. Carrick is also collaborating with Roche to evaluate a novel combination of samuraciclib and Roche’s oral SERD giredestrant in CDK4/6i-resistant HR+, HER2- metastatic breast cancer.