On December 16, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of NeXT Personal, a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify molecular residual disease (MRD) and recurrence in patients previously diagnosed with cancer (Press release, Personalis, DEC 16, 2021, View Source [SID1234597332]). NeXT Personal delivers industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. This enables earlier detection across a broader variety of cancers and stages, including typically challenging early stage, low mutational burden, and low-shedding cancers.

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NeXT Personal leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially-selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. The targeted panel is then used to sequence millions of unique DNA molecules from a patient’s blood sample. Aggregation of signal across these sequences using proprietary algorithms enables part-per-million sensitivity. Personalis’ innovative methods are covered by its broad range of early and subsequent intellectual property filings.

Going beyond other tumor-informed MRD assays, NeXT Personal also simultaneously detects and quantifies clinically relevant mutations in circulating tumor DNA (ctDNA) that may be used in the future to help guide therapy, when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants which can emerge and change over time, especially under therapeutic pressure.

"With this launch, Personalis is extending what an MRD product can deliver," said John West, Personalis’ Chief Executive Officer. "With its dramatic increase in sensitivity, we expect to address a range of tumors which were out of reach with earlier technologies. With its broader information content, we also go beyond detection of a tumor, to provide the additional characterization needed to understand and eventually help manage disease."

"NeXT Personal addresses the need for higher sensitivity assays, opening the door for earlier detection and more sensitive monitoring of patient response to therapy across a broader range of cancers and stages. Today’s release is targeted towards biopharma partners and clinical collaborators. In 2022, we plan to release NeXT Personal as a clinical test, which we expect will yield opportunities for earlier intervention and treatment for cancer patients," said Dr. Richard Chen, Personalis’ Chief Medical Officer and SVP of R&D.

On December 16, 2021 Histogen Inc. (NASDAQ: HSTO), a clinical-stage company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has entered into securities purchase agreements with certain institutional and accredited investors to issue, in a private placement, 8,235,297 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 8,235,297 shares of common stock, at a purchase price of $0.425 per share of common stock (or pre-funded warrant) and associated warrant, for expected gross proceeds to Histogen of approximately $3.5 million, before deducting placement agent fees and other offering expenses payable by the Company (Press release, Conatus Pharmaceuticals, DEC 16, 2021, View Source [SID1234597353]). The warrants have an exercise price of $0.425 per share of common stock, will be exercisable commencing six months and one day following the date of issuance for a period of five and one-half years from the date of issuance.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement.

The closing of the private placement is expected to occur on or about December 20, 2021, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of common stock to be issued to the investors (including the shares of common stock issuable upon the exercise of the warrants) no later than 15 days and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 75 days in the event of a "full review" by the SEC.

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 December 16, 2021 Alpine Immune Sciences and Ireland’s Horizon Therapeutics reported a licensing and collaborative research and development agreement valued at up to $1.5 billion to generate up to four preclinical candidates for autoimmune and inflammatory diseases (Press release, Biosortia Pharmaceuticals, DEC 16, 2021, View Source [SID1234607737]).

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Horizon will have exclusive rights to develop and commercialize the candidates from Seattle-based Alpine’s unique discovery platform. Overall, the collaboration and licensing agreement between the two cross-Atlantic companies includes a lead, potential first-in-class preclinical candidate, as well as a research collaboration to jointly develop the additional novel candidates.

On December 16, 2021 Invectys Inc. a clinical-stage immunotherapy company headquartered in Houston and dedicated to the development of a new generation of products for cancer patients, reported that Praveen Tyle, Ph.D., Invectys Inc. President and CEO will participate in the 2022 edition of the JP Morgan Healthcare Meeting on January 10-13, 2022 (Press release, Invectys, DEC 16, 2021, View Source [SID1234597278]).

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If you would like to set up a meeting, feel free to contact us at [email protected].

On December 16, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will hire and deploy an additional 20 salespeople, bringing the total number of oncology sales representatives to 34 (Press release, G1 Therapeutics, DEC 16, 2021, View Source [SID1234597302]). The expansion will allow G1 to target all accounts to accelerate sales activities and help maximize the adoption of COSELA (trilaciclib). G1 and Boehringer Ingelheim have mutually agreed to end the co-promotion agreement for COSELA, effective March 2022.

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"We want to thank Boehringer Ingelheim for their support in laying the early commercial groundwork during the first year of COSELA’s availability in the U.S.," said Andrew Perry, Chief Commercial Officer of G1 Therapeutics. "We are well along in the process of hiring our COSELA-focused sales force; these experienced oncology sales professionals have existing relationships at target organizations and are prioritizing prescriber access, which is the key to execution and adoption of new therapies like COSELA. Our goal is to drive as quick an impact as possible from this effort, and as such we are hiring, training, and deploying these individuals into the field as they arrive. We have already hired 13 of these field-based professionals, deployed seven, and expect to have the full team of 34 in place and deployed by mid-February 2022."

Under the terms of the termination agreement, Boehringer Ingelheim and G1 will work together on transitioning promotional activities by March 2022. After that point, Boehringer Ingelheim will receive reduced payments based on net sales of COSELA for patients with ES-SCLC in the U.S. until March 2024. There are no payments due by either party beyond March 2024. The Co-Promotion Agreement does not extend to additional indications that G1 may pursue for trilaciclib.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to discuss the expansion of the COSELA sales force. The live call may be accessed by dialing (866) 763-6020 (domestic) or (210) 874-7713 (international) and entering the conference code: 8549816. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source