On November 17, 2020 Cambrex reported that it is expanding its mid-scale and large-scale API manufacturing capacity in Charles City, Iowa. The $50+ million investment is designed to meet the continually growing demand for small molecule drug substance development and manufacturing (Press release, Cambrex, NOV 17, 2020, View Source [SID1234571206]). It will be the sixth major investment that Cambrex has made at the site in the past eight years to support customers in mid-scale, large-scale and highly potent small molecule API manufacturing.

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The expansion, which will be operational in early 2022, will add 3 large-scale manufacturing work centers and 1 mid-scale work center to the facility in Iowa, increasing the site’s capacity by 30 percent. When completed, the Charles City site will employ more than 400 people.

"Small molecule manufacturing demand has been growing consistently over recent years, and this investment will enable Cambrex to continue to capitalize on this growth, further strengthening our position as a market-leading CDMO," commented Joe Nettleton, President of Cambrex’s Drug Substance Business Unit. He added, "This expansion in the U.S. for API manufacturing capacity comes at a time when our customers increasingly require high-quality partners to ensure reliable supply chains within the pharmaceutical sector."

Cambrex’s Charles City facility is located on a 45-acre site, and as part of the company’s Drug Substance business unit, manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.

In 2019, Cambrex was acquired by funds advised by Permira, a global investment firm, to continue to build upon Cambrex’s market leading position in API development and manufacturing and support the growth of its integrated service offering across the pharmaceutical value chain.

On November 17, 2020 Five Prime Therapeutics, Inc. (Nasdaq: FPRX) reported the closing of its upsized underwritten public offering of 8,280,000 shares of its common stock, which includes 1,080,000 shares sold upon the underwriters’ full exercise of their option to purchase additional shares, resulting in aggregate gross proceeds of approximately $173.9 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Five Prime (Press release, Five Prime Therapeutics, NOV 17, 2020, View Source [SID1234571259]).

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Cowen and SVB Leerink acted as joint book-running managers for the offering. Wedbush PacGrow acted as co-manager for the offering.

The shares of common stock were offering pursuant to a "shelf" registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected], or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at [email protected].

On November 17, 2020 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced the release of 10 abstracts that will be presented at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) from Dec 8-11, 2020 (Press release, Puma Biotechnology, NOV 17, 2020, View Source [SID1234571287]). Abstracts are available to the public online on the SABCS website at www.sabcs.org.

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Spotlight poster discussions are as follows:

PD1-05

Title: Latest findings from the breast cancer cohort in SUMMIT – a phase 2 ‘basket’ trial of neratinib + trastuzumab + fulvestrant for HER2-mutant, hormone receptor-positive, metastatic breast cancer

Presenter: Komal Jhaveri, M.D., Ph.D

Wednesday, Dec. 9, 4:00 – 5:15 p.m. CT

PD3-03

Title: Continued efficacy of neratinib in patients with HER2-positive early-stage breast cancer: Final overall survival analysis from the randomized phase 3 ExteNET trial

Presenter: Frankie Ann Holmes, M.D., FACP

Wednesday, Dec. 9, 6:30 – 7:45 p.m. CT

PD13-09

Title: Impact of neratinib on outcomes in HER2-positive metastatic breast cancer patients with central nervous system disease at baseline: Findings from the phase 3 NALA trial

Presenter: Cristina Saura, M.D., Ph.D.

Friday, Dec. 11, 1:00 – 2:15 p.m. CT

Additional posters to be presented on Wednesday, Dec. 9, beginning at 8:00 a.m. CT are as follows:

PS13-20

Title: Bringing diarrhea under CONTROL: dose escalation reduces neratinib-associated diarrhea and improves tolerability in HER2-positive early-stage breast cancer

Presenter: Manuel Ruiz-Borrego, M.D.

PS9-02

Title: Neratinib + capecitabine sustains health-related quality of life (HRQoL) while improving progression-free survival (PFS) in patients with HER2+ metastatic breast cancer and ≥2 prior HER2-directed regimens

Presenter: Beverly Moy, M.D., M.P.H.

PS7-61

Title: The Neat-HER Virtual Registry: Results on HER2+ breast cancer patients receiving neratinib as extended adjuvant therapy

Presenter: Hope Rugo, M.D.

PS10-45

Title: Budget impact of introducing neratinib for third-line treatment of HER2+ metastatic breast cancer in the United States

Presenter: Seri Anderson, Ph.D.

PS9-33

Title: Cost-effectiveness of neratinib for the extended adjuvant treatment of adult patients with early-stage, HR+, HER2-overexpressed/amplified breast cancer who initiated neratinib within 1 year of completing trastuzumab in the US

Presenter: Adam Brufsky, M.D,, Ph.D.

PS9-54

Title: Healthcare costs for metastatic breast cancer patients treated with human epidermal growth factor receptor 2 targeted agents

Presenter: Reshma Mahtani, D.O.

PS10-22

Title: Breast cancer mortality in women with HER2+ disease treated in a large integrated healthcare system

Presenter: Reina Haque, Ph.D., M.P.H.

On November 17, 2020 LabCorp reported that Seven leading diagnostics companies and laboratory service providers have formed the Access to Comprehensive Genomic Profiling Coalition (ACGP) (Press release, LabCorp, NOV 17, 2020, View Source [SID1234571227]). The goal of the organization is to collectively advocate for appropriate broad U.S. health insurance coverage of comprehensive genomic profiling (CGP) for patients living with advanced cancer. The current members of ACGP are Exact Sciences (NASDAQ: EXAS), Foundation Medicine, Illumina (NASDAQ: ILMN), LabCorp (NYSE: LH), QIAGEN (NYSE: QGEN), Roche Diagnostics (SIX: RO, ROG: OTCQX: RHHBY), and Thermo Fisher Scientific (NYSE: TMO).

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CGP testing performed soon after a diagnosis of advanced cancer better informs medical management, including treatment decisions and patient care, which can improve clinical outcomes. In advocating for coverage of CGP, ACGP will educate health insurers and other healthcare stakeholders about the clinical utility and economic value of CGP.

CGP tests assess the genomic alterations within a patient’s cancer to help physicians make more informed decisions about personalized treatment approaches. Using next-generation sequencing (NGS) with a tissue biopsy or a blood sample, this testing method can detect the four main classes of alterations known to drive cancer growth: base substitutions, insertions and deletions, copy number alterations (CNAs), and rearrangements or fusions. These tests can reveal clinically relevant alterations and biomarkers in the tumor’s DNA and RNA. This helps identify patients who could respond to specific targeted therapies and immunotherapy that can be more effective and may have fewer side effects. Healthcare professionals can use CGP to help predict patient benefit across multiple targeted therapies and cancer indications, with benefits in progression-free survival for patients with non-small cell lung cancer (NSCLC) as one example.1

"Cancer is a disease of the genome, not solely the tissue. Tumor profiling has evolved tremendously in the last decade," said Jim Almas, MD, vice president and national medical director of clinical effectiveness at LabCorp, and the chairman of ACGP. "The manufacturers and laboratories forming the coalition have produced incredible assays to help identify the mutations driving advanced cancers, leading patients to better care through targeted cancer treatments."

Despite evidence of the benefits of this approach, some health insurers still use an outdated framework to evaluate coverage for CGP, creating a disparity in access across patient populations. Many commercial insurance plans do not cover this type of testing, while public or government plans like Medicare do. Limited insurance coverage options may prevent some treating physicians from ordering CGP for their patients.

"There is no question that obstacles to coverage have inhibited physicians from ordering comprehensive genomic profiling," said Almas. "Additionally, we believe some clinicians are not aware of the advantages of a comprehensive testing approach and the benefits of one CGP test to provide genomic profiling, detect microsatellite instability and tumor mutational burden, and help physicians identify clinical trials for which patients may be candidates."

On November 17, 2020 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company utilizing a proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics, with a focus on oncology and infectious diseases including COVID-19, reported third quarter 2020 financial results and recent highlights (Press release, Immunome, NOV 17, 2020, View Source [SID1234571261]).

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"The completion of our recent IPO marks a significant milestone for Immunome and positions us to further accelerate the output of new discoveries from our platform, and to rapidly advance our lead oncology and COVID-19 therapeutic antibody programs into the clinic," said Purnanand Sarma, PhD, President and CEO of Immunome. "We are on track to execute on our near-term clinical and strategic plans, including filing IND applications for two of our programs in 2021." Dr. Sarma further stated, "I am proud of the tremendous progress our team has made this year, particularly with regard to the notable effort and dedication supporting our accelerated development of antibody-based treatment targeting multiple viral antigens to treat the COVID-19 virus. As previously announced, Immunome was awarded a $13.3 million contract from the US Department of Defense to develop an antibody cocktail discovered by the interrogation of memory B cells from ‘super-responders’ to the SARS-CoV-2 virus (DoD Press Release)."

Recent Highlights

In October 2020, Immunome completed an IPO, including the full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of $44.9 million, before deducting underwriting commissions and offering expenses.
IMM-BCP-01: Unlike approaches solely directed at neutralizing the Spike protein by other companies, we aim to develop an antibody cocktail directed at multiple SARS-CoV-2 antigens. Unbiased interrogation of SARS-CoV-2 "super-responder" memory B cells using Immunome’s discovery engine has resulted in the following advances:
We discovered that more than 50% of the antibodies isolated from super-responders are directed at non-Spike antigens, suggesting non-Spike related antibodies may play a significant role in the effective immunological clearance of this virus.
We also identified multiple neutralizing antibodies with picomolar affinity directed at SARS-CoV-2 Spike protein.
We discovered that, in addition to affinity matured IgG antibodies, COVID-19 "super-responders" appear to mount robust affinity-matured IgA responses. IgA antibodies are naturally found at the surface of respiratory track and function to prevent initial viral infection.
IMM-ONC-01: Our further pre-clinical testing continues to demonstrate that IL-38 appears to be a novel immune checkpoint. In animal models, our inhibitory antibody demonstrates antitumor effects in IL-38 expressing tumors.
Third Quarter 2020 Financial Results:

Cash and cash equivalents: Cash and cash equivalents were $6.7 million as of September 30, 2020 compared to $2.5 million as of December 31, 2019.
IPO and net proceeds: On October 2, 2020 the Company’s common stock began trading on the Nasdaq Capital Market under the ticker (IMNM) and on October 6, 2020 the IPO closed with the Company receiving net proceeds of $41.7 million, after deducting underwriting discounts but before deducting other offering expenses. After deducting other offering costs of approximately $2.8 million, aggregate net IPO proceeds to the Company were $38.9 million.
Research and development (R&D) expenses: R&D expenses were $1.6 million for the quarter ended September 30, 2020 compared to $2.2 million for the quarter ended September 30, 2019 and $5.7 million for the nine month period ended September 30, 2020 compared to $6.4 million for the nine month period ended September 30, 2019.
General and administrative (G&A) expenses: G&A expenses were $1.2 million for the quarter ended September 30, 2020 compared to $0.5 million for the quarter ended September 30, 2019 and $2.5 million for the nine month period ended September 30, 2020 compared to $1.1 million for the nine month period ended September 30, 2019.
Net loss: Net loss attributable to common stockholders was $8.4 million or $7.52 per share for the quarter ended September 30, 2020 compared to $2.7 million or $2.50 per share for the quarter ended September 30, 2019 and $13.8 million or $12.44 per share for the nine month period ended September 30, 2020 compared to $7.5 million or $6.88 per share for the nine month period ended September 30, 2019.