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The MMRF Drives Unparalleled Advances for Multiple Myeloma Patients

On December 4, 2020 The Multiple Myeloma Research Foundation (MMRF) reported that advances resulting from its investments in immunotherapy, clinical trials, and in prevention will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Multiple Myeloma Research Foundation, DEC 4, 2020, View Source [SID1234572178]). Held virtually this year, ASH (Free ASH Whitepaper) will feature 32 presentations describing MMRF-supported programs to benefit patients.

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These programs include the development of novel non-invasive diagnostic tests, uncovering of novel biology through the development of new immune profiling pipelines, and discovery of markers of drug resistance and disease progression. Twenty-five presentations include data from the CoMMpass StudySM, one of the largest genomic datasets of any cancer and the source of more than 100 myeloma scientific publications.

"The research presented at ASH (Free ASH Whitepaper) exemplifies the MMRF’s commitment to driving discoveries that benefit the entire myeloma community," said Dr. Hearn Jay Cho, MD, PhD, Chief Medical Officer of the MMRF. "Through our research and clinical portfolios, the MMRF is accelerating breakthroughs in immune therapies, diagnostics and prevention that have the power to save lives. This investment includes developing and improving access to better and more precise therapies for those living with myeloma, as we move ever closer to achieving our mission of a cure for every patient."

MMRF ASH (Free ASH Whitepaper) highlights include:

3 abstracts describing results from Multiple Myeloma Research Consortium (MMRC) clinical studies (#1397, 2241, 3231)
The first detailed report (#1327) on the development of the next generation liquid biopsy used in the first-in-kind, at-home genomic sequencing test as part of the MMRF CureCloud patient registry effort
4 oral presentations of novel insights on genomic risk assessment and drug resistance in myeloma using the CoMMpass dataset:
The impact of MRD negativity on progression free survival of patients enrolled in Forte/CoMMpass (#491)
Novel epigenetic changes involved in disease progression and drug resistance (#59)
Defining the impact of chromosomal abnormalities to help identify markers that may enhance personalized treatments (#60)
Discovery of markers that may help predict resistance to standard Velcade-based induction therapy (#727)
4 abstracts (#1322, 1357, 2266, 3163) that describe cutting-edge analyses from the MMRF Immune Profiling Research Network, a collaborative effort with 5 leading academic medical centers (Beth Israel Deaconess, Washington University St. Louis, Mt. Sinai School of Medicine, Emory University, and Mayo Clinic). The goal is to map the immune landscape of myeloma and bring much needed standards to the field to drive more precise immunotherapy treatments, using patient samples from the CoMMpass Study (View Source)
2 oral presentations on discovery of markers found in myeloma cells (#602) and in the tumor microenvironment (#485) that may help predict progression from myeloma precursor conditions to active myeloma, work supported by the Perelman Family Foundation and the MMRF Prevention Project (View Source)
For complete data on MMRF and MMRC abstracts being presented at the 62nd ASH (Free ASH Whitepaper) Annual Meeting please contact Mary DeRome at [email protected].

About the MMRF CoMMpass StudySM
The MMRF CoMMpass Study is a longitudinal study of patients with newly diagnosed active multiple myeloma. The goal is to map the genomic profile of each patient to clinical outcomes to develop a more complete understanding of patient responses to treatments. A cornerstone of the MMRF’s Personalized Medicine Initiative, the study is collecting and analyzing tissue samples, clinical data and genetic information from 1,000 newly diagnosed multiple myeloma patients for at least eight years. The CoMMpass Study was made possible by a $40M investment by the MMRF.

The MMRF CoMMpass Study opened in July of 2011 and now includes 1,150 patients from 76 sites in the United States, Canada and European Union. Data from the MMRF CoMMpass Study is made available to researchers via the MMRF’s Researcher Gateway (View Source), an online, open-access portal designed to make key genomic and clinical data available for additional study. The MMRF CoMMpass Study is being supported through a public-private partnership of patient donors and industry partners, including Takeda Oncology, Amgen, Bristol-Myers Squibb, Janssen Pharmaceuticals, Inc. and Janssen Diagnostics. Additional collaborating research partners include the Translational Genomics Research Institute, Van Andel Research Institute and GNS Healthcare. Please visit www.themmrf.org/research-partners/the-commpass-study to learn more about the study.

Amgen and McKesson Launch Strategic Agreement to Advance Cancer Innovation in Communities

On December 4, 2020 McKesson and Amgen (NASDAQ:AMGN), one of the world’s leading biotechnology companies, reported that have signed a strategic agreement to help improve cancer care in community oncology settings (Press release, Amgen, DEC 4, 2020, View Source [SID1234572177]). Today, 1 in 5 cancer patients receives an Amgen medicine, while McKesson reaches 20% of U.S. cancer patients. This multi-year agreement bridges the power and reach of the two companies and will focus on reducing gaps in care by optimizing access to innovative precision medicine and immuno-oncology in the community setting.

Access to the latest innovations in cancer care is still very dependent on demographics, socioeconomic status, and where in the U.S. patients receive their care. Currently, the majority of new patients are first seen in the community setting,1 making community oncology practices increasingly critical to improved patient care. Community oncology providers also typically treat a more diverse patient population, providing the greatest opportunity to impact cancer care across dimensions, including rural populations.

"Community oncology practices in the United States are the backbone of oncology care for the vast majority of patients. The COVID-19 pandemic further heightens the need to help strengthen that network as it has become imperative that people be treated closer to home," said Darryl Sleep, M.D., senior vice president, Global Medical and chief medical officer, Amgen. "At Amgen, we believe that cancer patients and those who treat them deserve to have access to the latest innovations in care no matter where they live or practice. Together with McKesson, our ultimate goal is to help community oncologists and their teams have rapid access to the latest innovations and insights to provide the best care possible where patients need it most."

Kirk Kaminsky, president of U.S. Pharmaceutical, McKesson, shared, "The combined commitment of our organizations to optimize patient outcomes will change the future of cancer care. We look forward to working with Amgen and oncology providers to navigate the inherent complexity in cancer and make novel insights actionable and accessible at the exact point of need."

This partnership will be led by OntadaTM, McKesson’s new oncology technology and insights business. Ontada is focused on helping life sciences companies like Amgen improve patient outcomes for cancer care, from early clinical development to drug commercialization and post-launch activation of insights, as well as empowering oncology providers at the point of need to deliver more-informed, more-effective, more-efficient care to their patients. Through real-world data gathered with Ontada’s proprietary technology for community oncology practices, such as those that are part of The US Oncology Network, Ontada has the real-world knowledge to help push cancer care forward.

"I have been an oncologist for 30 years, and we have never seen so much innovation, yet so many challenges, as we do today," said Michael Seiden, MD, PhD, president, The US Oncology Network. "Being able to contribute to such robust thought leadership and work with stakeholders like Ontada and Amgen allow us to really move the needle and enhance cancer care for the patients we serve in the community setting."

Amgen and Ontada will launch various programs over the course of the partnership and build on projects that have already begun, such as those focusing on reducing gaps in molecular testing and understanding treatment patterns in the community setting. For example, Amgen and McKesson recently conducted real-world research to better understand patterns of molecular testing in advanced/metastatic non-small cell lung cancer with community oncologists with plans to publish the findings in early 2021. Through the strategic partnership, McKesson and Amgen hope to:

Elevate awareness on molecular testing in order to optimize care in patients that benefit from targeted therapy;
Uncover insights on unmet need and treatment outcomes by enriching data and insight capabilities;
Leverage real-world evidence to better understand and optimize the deployment of biosimilars to offer providers and their patients greater choice of therapies relative to value;
Co-develop new approaches to deliver immuno-oncology therapies in the community setting; and
Optimize therapy sequencing to improve patient outcomes including supportive care.

Castle Biosciences Announces Publication of Peer-Reviewed Publication Demonstrating the Clinical Impact of DecisionDx®-Melanoma

On December 4, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of a clinical use study demonstrating that management decisions for patients diagnosed with American Joint Committee on Cancer (AJCC) 7th edition stage I – III melanoma were impacted by the use of DecisionDx-Melanoma, Castle’s gene expression profile prognostic test for cutaneous melanoma (Press release, Castle Biosciences, DEC 4, 2020, View Source [SID1234572175]). Study authors developed a recommended melanoma patient care management pathway that incorporates DecisionDx-Melanoma to help inform frequency and duration of follow-up visits, blood work and surveillance imaging in line with predicted metastatic risk.

The article, titled "Integrating the melanoma 31-gene expression profile test to surgical oncology practice within national guideline and staging recommendations," was published in Future Oncology.

"We found that intrinsic tumor biology, as assessed with DecisionDx-Melanoma, adds prognostic information that might be missed if we solely consider traditional risk factors to predict metastatic risk for our patients with stage I – III melanoma," said the article’s first author, surgical oncologist David Hyams, M.D. "Based on these results, we propose a melanoma patient care plan that incorporates DecisionDx-Melanoma to adjust frequency and duration of clinical visits, blood work and surveillance imaging according to metastatic risk. We expect that this plan will empower physicians to focus more intensive surveillance on high-risk patients who need it most."

The study was conducted to characterize changes in clinical management resulting from use of DecisionDx-Melanoma on low (stage I–IIA) and high-risk (stage IIB–III) patient management and to develop a management pathway for melanoma patient care that incorporates DecisionDx-Melanoma test results. A total of 112 consecutive patients with cutaneous melanoma at Desert Surgical Oncology in California between 2015–2017 were included in this study, all of whom were prospectively tested with DecisionDx-Melanoma.

Patients’ DecisionDx-Melanoma test results were found to have an impact on the number and duration of follow-up and surveillance visits, and patients assessed as having a high risk of metastasis (designated by a DecisionDx-Melanoma Class 2 test result) received more intensive management than patients assessed as having a low risk (designated by a DecisionDx-Melanoma Class 1 test result). Clinicians using the test were shown to adjust patient management in a risk-appropriate direction, within recommendations of national guidelines.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through September 30, 2020, DecisionDx-Melanoma has been ordered more than 64,560 times for use in patients with cutaneous melanoma.

Cogent Biosciences Announces Closing of Upsized Public Offering of Common Stock and Full Exercise of Underwriter’s Option to Purchase Additional Shares

On December 4, 2020 Cogent Biosciences, Inc. ("Cogent") (NASDAQ: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the closing of its upsized underwritten public offering of 11,794,872 shares of its common stock at a public offering price of $9.75 per share (Press release, Cogent Biosciences, DEC 4, 2020, View Source [SID1234572174]). This includes the exercise in full by the underwriters of their 30-day option to purchase up to 1,538,461 additional shares of common stock. The aggregate proceeds to Cogent from the offering, after deducting the underwriting discounts and commissions and before estimated offering expenses, were approximately $108.1 million.

The net proceeds from the offering will be used for the continued development, regulatory and commercial preparation of PLX9486 to treat patients living with systemic mastocytosis and gastrointestinal stromal tumors (GIST).

Jefferies and Piper Sandler & Co. acted as joint book-running managers for the offering. Wedbush PacGrow, LifeSci Capital and Ladenburg Thalmann also acted as co-managers for the offering.

The shares of common stock described above were offered by Cogent Biosciences, Inc. pursuant to a registration statement previously filed with the Securities and Exchange Commission (the "SEC") that became effective on May 1, 2019. A final prospectus supplement and accompanying prospectus were filed with the SEC and available for free on the SEC’s website at View Source Registration statements relating to the securities were filed with, and declared effective by, the Securities and Exchange Commission (the "SEC") and became effective on May 1, 2019. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus supplement and accompanying base prospectus. Copies of the final prospectus relating to the offering may be obtained from the SEC’s website at www.sec.gov or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]): or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicolett Mall, J12SO3, Minneapolis Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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.

Entry into a Material Definitive Agreement

On December 4, 2020, Sorrento Therapeutics, Inc. (the "Company") reported that it entered into Amendment No. 1 (the "Amendment") to that certain Sales Agreement, dated April 27, 2020 (the "Sales Agreement"), by and between the Company and A.G.P./Alliance Global Partners (the "Agent") (Filing, 8-K, Sorrento Therapeutics, DEC 4, 2020, View Source [SID1234572173]).

The Sales Agreement provides that the Company could offer and sell, from time to time, through or to the Agent, as sales agent and/or principal, up to $250,000,000 in shares of its common stock (the "Shares"), with the Shares to be issued pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-237142) filed with the Securities and Exchange Commission (the "SEC") on March 13, 2020 and declared effective on March 20, 2020 (the "Form S-3"), the base prospectus dated March 20, 2020 included in the Form S-3 and the prospectus supplement, dated April 27, 2020. As of December 4, 2020, the Company has sold an aggregate of 29,543,092 Shares for gross proceeds of approximately $222.8 million, leaving an aggregate of approximately $27.2 million in Shares available for issuance under the Sales Agreement.

The Amendment amends the Sales Agreement to provide that the Company may offer and sell, from time to time, through or to the Agent, as sales agent and/or principal, up to an additional $450,000,000 in shares of the Company’s common stock (the "Additional Shares"), such that the Company may offer and sell up to an aggregate of $700,000,000 in shares of its common stock (the "Offering") pursuant to the Sales Agreement, as amended by the Amendment (the "Amended Sales Agreement"). Any Additional Shares offered and sold in the Offering will be issued pursuant to the Form S-3, the base prospectus dated March 20, 2020 included in the Form S-3 and the prospectus supplement, dated December 4, 2020, that will be filed with the SEC.

Subject to the terms and conditions of the Amended Sales Agreement, the Agent will use its commercially reasonable efforts to sell the shares of the Company’s common stock from time to time, based upon the Company’s instructions. Under the Amended Sales Agreement, the Agent may sell the shares of the Company’s common stock by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

The Company has no obligation to sell any shares of its common stock pursuant to the Amended Sales Agreement, and may at any time suspend offers under the Amended Sales Agreement. The Offering will terminate upon (i) the election of the Agent upon the occurrence of certain adverse events, (ii) three business days’ advance notice from one party to the other, or (iii) the sale of all $700,000,000 of shares of the Company’s common stock pursuant thereto.

Under the terms of the Amended Sales Agreement, the Agent will be entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of shares of the Company’s common stock under the Amended Sales Agreement.

The Company currently intends to use any additional net proceeds from the Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, regulatory affairs expenditures, clinical trial expenditures, acquisitions of new technologies and investments, business combinations and the repayment, refinancing, redemption or repurchase of indebtedness or capital stock. The Company may use a portion of the net proceeds to repurchase or redeem those certain senior secured notes due 2026 in an initial aggregate principal amount of $224,000,000 issued by Scilex Pharmaceuticals Inc., an indirect majority-owned subsidiary of the Company, in September 2018.

The foregoing description of the Sales Agreement and the Amendment does not purport to be complete and is qualified in its entirety by reference to: (i) the full text of the Sales Agreement, a copy of which was filed as Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on April 27, 2020, and (ii) the full text of the Amendment, which is filed as Exhibit 1.1 hereto, each of which is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of any securities in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.