On November 5, 2021 Race Oncology Limited ("Race") reported that congratulates Dr Joshua Brzozowski from the laboratory of Associate Professor Nikki Verrills, University of Newcastle, for winning the Best Poster Prize in the Biomarkers and Targeted Therapy section at the Hunter Cancer Research Symposium on November 4, 2021 (Press release, Race Oncology, NOV 5, 2021, View Source [SID1234594671]).

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The presentation entitled "Preclinical efficacy of bisantrene for the treatment of breast cancer" describes the use of Zantrene (bisantrene dihydrochloride) in breast cancer cells and identified two key highlights:

Drug-resistant breast cancer cells are more sensitive to treatment with Zantrene compared to other anthracyclines, such as doxorubicin or epirubicin.
Zantrene has additive or synergistic activity when used with cyclophosphamide (a widely used breast cancer drug) in human breast cancer cell lines.
This presentation expands on results previously reported from the Verrills Laboratory (ASX announcement: 9 March 2021).

On November 5, 2021 Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the third quarter ended September 30, 2021 (Press release, Novavax, NOV 5, 2021, View Source [SID1234594579]).

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"We are excited by the significant progress made over the quarter, including our landmark milestone of gaining the first regulatory approval for our COVID-19 vaccine," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "With additional regulatory submissions around the world, we are prepared to deliver our vaccine globally. We believe the highly encouraging results from our six-month booster study complement the strong efficacy demonstrated by NVX-CoV2373 to date, and we remain confident that our vaccine will serve as an important tool to fight COVID-19 in the years to come."

Third Quarter 2021 and Recent Highlights

COVID-19 Vaccine Regulatory Pathway

Received emergency use authorization (EUA) from National Agency of Drug and Food Control of the Republic of Indonesia, in partnership with Serum Institute of India Pvt. Ltd. (SII)
NVX-CoV2373 to be marketed by SII under the brand name COVOVAX
Novavax completed multiple regulatory submissions
U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for conditional marketing authorization
Australia Therapeutic Goods Administration (TGA) for provisional approval
Health Canada for authorization
New Zealand Medsafe for provisional approval
World Health Organization (WHO) for emergency use listing (EUL)
European Medicines Agency (EMA) (submitted all final data and modules)
SII, our licensee, completed multiple regulatory submissions for our COVID-19 vaccine
Drugs Controller General of India (DCGI) and the Philippines for EUA
WHO for EUL
Expect to submit the complete regulatory package to the U.S. FDA by the end of 2021
COVID-19 Vaccine Advanced Purchase Agreements

Executed advance purchase agreement with European Commission to supply a minimum of 20 million doses and up to 100 million initial doses
Option to purchase an additional 100 million doses through 2023
COVID-19 Vaccine Manufacturing and Supply

Achieved capacity of 100 million doses per month as of the end of the third quarter of 2021, on track to achieve capacity of 150 million doses per month by the end of the fourth quarter of 2021, and expect to have capacity in excess of 2 billion annual doses in 2022
Collaborated with licensed manufacturers to enable distribution of NVX-CoV2373 globally
Expanded partnership with SII through a supply agreement
Takeda Pharmaceutical Company Limited finalized agreement with government of Japan’s Ministry of Health, Labour and Welfare for purchase of 150 million doses, with anticipated distribution in 2022
COVID-19 Vaccine Clinical Development

Completed crossover arms in U.K. Phase 3, South Africa Phase 2b, PREVENT-19 Phase 3, and pediatric expansion of PREVENT-19 trials
Ongoing pediatric expansion of PREVENT-19 Phase 3 trial
Completed enrollment of 2,248 adolescents aged 12-17 years across up to 75 sites in the U.S.
Expect to have a regulatory package available for global submission in the first quarter of 2022
Advanced booster study in the Phase 2 portion of U.S. and Australia Phase 1/2 trial
Data from 6-month booster study demonstrated positive results
Wild-type neutralizing antibodies increased more than 4-fold versus primary vaccination series
Cross-reactive functional antibodies to the Delta (B.1.617.2) variant strain detected after primary vaccination series and increased more than 6-fold following boosting
Initiated twelve-month booster dose for select participants following completion of 6-month booster study
Combination Vaccine

Completed enrollment of Phase 1/2 clinical trial for COVID-NanoFlu combination vaccine in Australia across 10 sites
Enrolled 642 healthy adults aged 50 to 70 years
Evaluating the safety, tolerability and immune response of a COVID-NanoFlu combination vaccine formulated with Matrix-M adjuvant
Data is expected in the first half of 2022
Publication Highlights

Final analysis from multiple Phase 3 trials accepted by a peer-reviewed journal and posted via the preprint server on medRxiv.org
PREVENT-19 U.S. and Mexico study
U.K. influenza co-administration sub-study
Final analysis from pivotal Phase 3 clinical trial for NanoFlu published in The Lancet Infectious Diseases
Final analysis from Phase 2 Australia and U.S. dosing regimen study published in PLOS Medicine
Corporate Highlights

Strengthened corporate leadership with executive hiring and promotions
Jim Kelly as Executive Vice President, Chief Financial Officer and Treasurer
Denny Kim, M.D. as Senior Vice President, Chief Safety Officer
Marco Cacciuttolo, Ph.D. promoted to Senior Vice President, Process and Analytical Development
Raburn Mallory, M.D. promoted to Senior Vice President, Head of Clinical Development
Financial Results for the Three Months Ended September 30, 2021

Novavax reported a net loss of $322.4 million, or $4.31 per share, for the third quarter of 2021, compared to a net loss of $197.3 million, or $3.21 per share, for the third quarter of 2020.

Novavax revenue in the third quarter of 2021 was $178.8 million, compared to $157.0 million in the same period in 2020. This increase was due to increased development activities relating to NVX-CoV2373 for services performed under the U.S. government agreement and royalties under Novavax’ licensing agreements.

Research and development expenses increased to $408.2 million in the third quarter of 2021, compared to $294.1 million in the same period in 2020. The increase was primarily due to the development and manufacturing for NVX-CoV2373.

General and administrative expenses increased to $77.8 million in the third quarter of 2021, compared to $56.9 million for the same period in 2020. The increase was primarily due to costs associated supporting our NVX-CoV2373 program.

As of September 30, 2021, Novavax had $1.9 billion in cash, cash equivalents and restricted cash, compared to $0.8 billion as of December 31, 2020. The increase in cash provided was primarily due to $1.2 billion in payments under advance purchase agreements recorded as deferred revenue and $565 million net proceeds raised through utilization of At-the-market (ATM) offerings during the first quarter of 2021.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 870-4263 (Domestic) or (412) 317-0790 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on November 4, 2021 until 11:59 p.m. ET on November 11, 2021. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 10161242.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until February 4, 2022.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19.

Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.

About NanoFlu

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant.

About Matrix-M Adjuvant

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

On November 5, 2021 Bluestar Genomics, an innovative company leading the development of next-generation liquid biopsy approaches to early cancer detection, reported the presentation of new analytical performance data on its proprietary non-invasive pancreatic cancer test at the American Pancreatic Association (APA) annual meeting (Press release, Bluestar Genomics, NOV 5, 2021, View Source [SID1234594610]). Data from the study showed that the company’s test detected a pancreatic cancer signal in people across various age groups, including patients with new-onset diabetes, occurring in 25% of new pancreatic cancer cases.

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Bluestar Genomics’ pancreatic cancer test uses a standard blood draw to assess whether an individual has an abnormal DNA signal associated with pancreatic cancer. This one-of-its-kind test would allow for early diagnosis of pancreatic cancer, one of the deadliest cancers in part because there are no existing screening methods to enable early detection. When found early, accurate detection of pancreatic cancer enables more timely, potentially curative surgical and therapeutic options for patients. People with new-onset diabetes are at high-risk of pancreatic cancer. Out of an estimated 60,000 patients diagnosed each year with pancreatic cancer in the U.S. alone, nearly 25% are found to have new-onset diabetes before a pancreatic cancer diagnosis.

"Along with our test’s recent designation by the FDA as a breakthrough device, the findings from this study presented at APA underscore the opportunity we have to make a positive difference for patients by bringing this pancreatic cancer test to market," said Samuel Levy, Ph.D., chief executive and chief scientific officer at Bluestar Genomics and lead author of the study. "Based on these results, we are moving forward with completing the analytical validation in the coming months and making a CLIA laboratory developed test available next year."

Unlike other liquid biopsy cancer tests, this pancreatic cancer-focused test is performed with Bluestar Genomics’ groundbreaking epigenomics technology platform that uses state-of-the-art machine learning coupled with a DNA-based 5-hydroxymethylcytosine (5hmC) biomarker as a precise screening method for detecting cancer at earlier stages. By combining a novel 5-hydroxymethylation enrichment assay with high-throughput sequencing, it is possible to generate powerful predictive models using machine learning to enable the detection of pancreatic cancer in patients with high accuracy.

Pancreatic cancer is the third-leading cause of cancer death in the U.S., surpassing common cancers such as breast and prostate. Bluestar Genomics’ test has the potential to screen an estimated one million adults diagnosed annually with new-onset diabetes in the U.S. for the early detection and treatment of pancreatic cancer, which could enable better patient outcomes.

The study presented at APA included 917 patients, examining whole blood samples from 117 patients with pancreatic cancer and 800 non-cancer control patients, with and without new-onset diabetes. The predictive model was trained on samples using 5hmC signals from cell-free DNA. When applied to the validation set, 50% of which were early stage (stages I and II) disease, this model showed a median of 51.5% sensitivity and 98% specificity. Results from the study demonstrated pancreatic cancer signal detection in plasma-derived cell-free DNA using 5hmC profiles. Overall, these findings showed that the model performed consistently well between the training and independent validation datasets.

In addition to completing the analytical validation, Bluestar Genomics is planning a large clinical study to further validate the use of this test to detect pancreatic cancer in patients with new-onset diabetes.

With the commercialization efforts for the test focused on pancreatic cancer as well as a growing pipeline of other epigenomic assays, the company also announced that Jim Vaughn, R. Ph., has joined the company as its chief commercial officer. Vaughn brings more than 20 years of strategic leadership experience in commercializing molecular tests in oncology, including a breadth of expertise in sales, marketing, and reimbursement strategy. Most recently, Vaughn led efforts to successfully commercialize the Oncotype DX portfolio at Genomic Health/Exact Sciences, where he was the global chief commercial officer.

"Liquid biopsy continues to show great promise in improving cancer patient survival," said Vaughn. "Our epigenomics approach is to focus on the highest-risk cancers with the greatest needs, starting with pancreatic and certain women’s cancers. I look forward to leading our efforts to bring new-generation liquid biopsy tests to physicians and patients to enable curative therapies."

"The positive data at APA along with Jim’s appointment as CCO provide confidence for the company to move forward with commercial planning for our first product, with the goal of developing a pipeline of tests employing our unique type of epigenomics analysis," said Levy.

On November 5, 2021 Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, reported that it has entered into definitive collaboration agreements with DEKA Research & Development Corp., to develop a continuous infusion pump to be used in combination with dasiglucagon, an investigational agent currently in phase 3 trials in patients with congenital hyperinsulinism (Press release, Zealand Pharmaceuticals, NOV 5, 2021, View Source [SID1234594658]). The agreement covers the technical development of the pump system as well as associated manufacturing and commercialization activities.

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"As we progress toward completion of our pivotal clinical trials for dasiglucagon as a potential treatment option for CHI, we are thrilled to announce this collaboration agreement with DEKA," said Emmanuel Dulac, President and Chief Executive Officer of Zealand Pharma. "DEKA’s innovative drug infusion pump has been FDA cleared in other uses and it represents an attractive potential solution for dasiglucagon administration in CHI, taking us one step closer to achieving our goal of improving the lives of CHI patients and their families."

"We are very pleased to be working with Zealand, leveraging our long experience with infusion pumps to aid in their development of a new treatment option for CHI," said Dean Kamen, Founder of DEKA. "Our mission at DEKA is to develop technology that can solve problems and improve people’s lives – this collaboration is a great example of how we work to fulfill that mission."

Under the terms of the agreement, DEKA and Zealand will develop a medical pump system that is suitable for use in combination with dasiglucagon. DEKA and its affiliates will be responsible for pump development and pump manufacturing activities. Zealand will be solely responsible for clinical development around the drug-device combination as well as for distribution and commercialization in all territories.

About CHI

CHI is a rare pediatric disease that affects mainly newborns, infants and toddlers. Due to a genetic defect in the insulin producing cells, these children have increased insulin levels, resulting in persistent and recurrent hypoglycemia throughout childhood. Current treatment options are limited, complex and may be insufficient to adequately control hypoglycemia.

About dasiglucagon

Invented by Zealand Pharma, dasiglucagon is a glucagon analog that is stable in aqueous solution and is thus suitable for chronic pump use. In 2017, both the U.S. Food and Drug Administration (FDA) and the European Commission granted orphan drug designation for dasiglucagon for the treatment of CHI.

On November 5, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that an abstract summarizing the most recent clinical data from an ongoing clinical trial of its differentiated CD47 antibody lemzoparlimab (also known as TJC4), will be presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2021), taking place December 11 – 14, 2021 (Press release, I-Mab Biopharma, NOV 5, 2021, View Source [SID1234594580]).

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The clinical data provide updates on the safety and efficacy of lemzoparlimab in combination with rituximab (Rituxan) in relapsed or refractory non-Hodgkin’s lymphoma (NHL). The trial (NCT03934814) is continuing to enroll more patients in the U.S., and has expanded to include clinical sites in China as an international multi-center clinical trial (IMCT). The study may potentially lead to the initiation of a registrational trial in 2022 in China .

The abstract is available online on the ASH (Free ASH Whitepaper) 2021 website, and the presentation details are listed below.

Title Lemzoparlimab, a Differentiated Anti-CD47 Antibody in Combination with Rituximab in Relapsed and Refractory Non-Hodgkin’s Lymphoma: Initial Clinical Results
Session name 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Abstract number 3542
Corresponding Presenter
Amitkumar Mehta, MD

University of Alabama at Birmingham

I-Mab will also host an investor call on December 14, 2021, at 8:00 a.m. ET to discuss the data presented at the conference.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumors in the U.S. and with Rituxan for lymphoma in the U.S. and China, in addition to an on-going clinical trial in patients with AML in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab. This includes the design and conduct of further clinical trials to evaluate lemzoparlimab in multiple cancers through global and China-specific trials. AbbVie has assumed sponsorship of the U.S. study as of April 2021.