On March 2, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that members of Transgene’s management and scientific team have been invited to participate at upcoming (virtual) scientific conferences (Press release, Transgene, MAR 2, 2021, View Source [SID1234575953]):

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– ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress 2021 which will take place March 2-4:

Éric Quéméneur, Executive Vice President and Chief Scientific Officer (CSO), will be speaking in the session ‘Where next with Oncolytics’ about Antibody armed oncolytic viruses (ID 42)

Date & Time: March 3rd at 4.20pm (CET)

– Royal Society Meeting on ‘Immuno-oncology: How to get the immune system to beat cancer’ which will take place March 24-25:

This Royal Society meeting will explore immuno-oncology therapies – both current and recent technologies. Eric Quéméneur will participate in the immuno-oncology breakthroughs session.

Date & Time: March 24th at 3.50pm (GMT)

– 4th Annual European Neoantigen Summit which will take place April 20-22:

Kaidre Bendjama, Project Leader, Personalized Cancer Vaccines, will be speaking about TG4050: Viral immunotherapy meets AI technology

Date & Time: April 22nd at 1pm (CET)

On March 2, 2021 Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2020 (Press release, Novavax, MAR 2, 2021, View Source [SID1234575952]).

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"Novavax continues to make significant strides towards bringing NVX-CoV2373, our COVID-19 vaccine candidate, to market," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "With positive efficacy results, including against evolving variant strains, NVX-CoV2373 offers a highly unique profile, including the ability to ship and store the vaccine at traditional refrigerated temperatures. We believe these attributes support emergency use authorization and have initiated dialogue with regulators to pursue appropriate regulatory authorization. In addition, we have secured agreements for the delivery of approximately 300 million doses of NVX-CoV2373. In our efforts to provide fair and equitable access to our vaccine around the world, we are proud to partner with the Serum Institute of India to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi through the COVAX Facility. We continue to work tirelessly to make final commercial preparations in advance of delivering our product across the globe."

Fourth Quarter 2020 and Recent Highlights

COVID-19 Program

Commenced regulatory process for authorization for NVX-CoV2373
Rolling submission initiated with the UK Medicines and Healthcare products Regulatory Agency; potential to file for authorization in the UK by early second quarter 2021
Engaged in ongoing dialogue with US Food and Drug Administration (FDA) through submissions to our open investigational new drug application, with potential for EUA filing in the second quarter of 2021
Rolling reviews initiated with:
European Medicines Agency
Health Canada
Australian Therapeutic Goods Administration
Medsafe New Zealand
Reported positive top-line data from Phase 3 UK clinical trial
Observed 95.6% efficacy against the original strain of COVID-19 and 85.6% against the UK variant strain
Overall primary endpoint met with a vaccine efficacy of 89.3%
Generally well-tolerated with a reassuring safety profile
Trial included 15,000 participants between 18-84 years of age, including 27 percent over the age of 65

Reported successful Phase 2b South Africa efficacy study
Observed 60% efficacy for HIV-negative portion of study population (94% of study participants were HIV-negative)
Demonstrated clinically meaningful protection from South Africa escape variant, which accounted for 93% of sequenced cases
Achieved primary efficacy endpoint in overall trial population of 49.4%
Trial included 4,404 participants, including 245 medically stable, HIV-positive participants
Supported in part by a $15 million grant from Bill & Melinda Gates Foundation (BMGF)
Completed enrollment in pivotal PREVENT-19 Phase 3 efficacy trial in the US and Mexico
30,000 participants enrolled in two-to-one study design, with highly diverse population
20% Latin American, 12% African American, 6% Native American, 5% Asian American and 13% adults over the age of 65
Interim data expected in the second quarter of 2021 dependent on the overall COVID-19 attack rate
Blinded crossover protocol, ensuring all participants are provided active vaccine, submitted to the FDA
Trial design harmonized to align with other Phase 3 clinical studies supported by the U.S. government
Ongoing clinical development of NVX-CoV2373
6-month boost dose as part of Phase 1/2 clinical trial in the US and Australia
Developing variant strain vaccines as standalone and bivalent candidates
Evaluation of candidates ongoing in non-human primates
Planning clinical evaluation of variant vaccine candidates in mid-2021

Secured cumulative funding of over $2 billion to date through US government, CEPI and BMGF for development of NVX-CoV2373
US government funding through partnership formerly known as Operation Warp Speed increased up to $1.75 billion
Coalition for Epidemic Preparedness Innovations (CEPI) funding up to $400 million

Increased projected global manufacturing capacity to over 2 billion annualized doses when at full-capacity, expected to occur in mid-2021
Approximately one billion doses to be manufactured by Serum Institute of India Private Limited (SIIPL)
Completed collaborations for global manufacturing, commercialization and distribution of NVX-CoV2373
Finalized exclusive license agreement with Takeda for the development, manufacturing and commercialization of NVX-CoV2373
Takeda to manufacture over 250 million doses of NVX-CoV2373 annually
Advanced joint commitment with SIIPL for the equitable access of 1.1 billion doses of NVX-CoV2373 for distribution by the COVAX Facility
Reached Memorandum of Understanding with Canadian government for plans to produce NVX-CoV2373 at the National Research Council’s Biologics Manufacturing Centre in Montreal
Expanded existing partnership with SK bioscience to include license agreement for the manufacturing and commercialization of NVX-CoV2373
SK bioscience to supply 40 million doses to the Republic of Korea

Secured agreements for approximately 200 million doses of NVX-CoV2373
Government of Canada to be supplied 52 million doses with an option for up to an additional 24 million
UK government to be supplied 60 million doses
Commonwealth of Australia to be supplied 51 million doses with an option for up to an additional 10 million
Government of New Zealand to be supplied 11 million doses
Government of Switzerland to be supplied 6 million doses
NanoFlu Program

Continued to advance NanoFlu program, including exploration of a combined NanoFlu/NVX-CoV2373 vaccine that could be used in a post-pandemic setting
Corporate Highlights

Appointed three individuals with extensive pharmaceutical industry experience to Novavax’ Board of Directors
Gregg Alton, J.D.
Brings extensive industry experience, including more than 20 years at Gilead Pharmaceuticals, serving in an array of leadership roles including Chief Executive Officer and Chief Patient Officer
Margie McGlynn, R. Ph.
Brings extensive pharmaceutical industry, vaccine and non-profit experience, including more than two decades at Merck; held roles of increasing responsibility, including President of Merck Vaccines and Infectious Diseases and President, US Hospital and Specialty Products Division
David Mott
Brings more than three decades of global management, board and investment experience across numerous biopharmaceutical companies, including previously having served as President and Chief Executive Officer of MedImmune
Financial Results for the Three and Twelve Months Ended December 31, 2020

Novavax reported a net loss of $177.6 million, or $2.70 per share, for the fourth quarter of 2020, compared to a net loss of $31.8 million, or $1.13 per share, for the fourth quarter of 2019. For the twelve months ended December 31, 2020, the net loss was $418.3 million, or $7.27 per share, compared to a net loss of $132.7 million, or $5.51 per share, for the same period in 2019.

Novavax revenue in the fourth quarter of 2020 was $279.7 million, compared to $8.8 million in the same period in 2019. The significant increase in revenue was comprised of revenue for services performed under the CEPI agreement and participation in OWS.

Research and development expenses increased to $401.2 million in the fourth quarter of 2020, compared to $29.3 million in the same period in 2019. The increase was primarily due to increased development activities relating to NVX-CoV2373 and increased employee-related costs, including stock-based compensation expense.

General and administrative expenses increased to $61.3 million in the fourth quarter of 2020, compared to $8.2 million for the same period in 2019. The increase was primarily due to increased employee-related costs, primarily stock-based compensation expense, and increased professional fees to support of our NVX-CoV2373 program.

As of December 31, 2020, Novavax had $806.4 million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019. Net cash used in operating activities for the twelve months of 2020 was $42.5 million, compared to $136.6 million for same period in 2019.

Through utilization of At-the-market (ATM) offerings, Novavax raised net proceeds of $428 million and $874 million during the three and twelve months of 2020, respectively. In addition, in the second quarter of 2020, Novavax received gross proceeds of $200 million upon entering into an agreement to sell Series A Convertible preferred stock, convertible into 4,388,850 shares of common stock, to an investment fund affiliated with RA Capital Management (RA Capital) in a private placement. There shares were converted to common stock in the fourth quarter of 2020.

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) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 3797013. A replay of the conference call will be available starting at 7:30 p.m. ET on March 1, 2021 until 7:30 p.m. ET on March 8, 2021. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 3797013.

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 June 1, 2021.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence 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 adjuvanted with Novavax’ patented saponin-based Matrix-M 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. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of the spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated 50-60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

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

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 March 2, 2021Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported financial results and operational updates for the fourth quarter and year ended Dec. 31, 2020 (Press release, Turning Point Therapeutics, MAR 2, 2021, View Source [SID1234575951]).

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"The progress we made during the fourth quarter and in 2020 has set us up for another potentially pivotal year in 2021, with multiple anticipated milestones across our portfolio," said Athena Countouriotis, M.D., president and CEO. "Our growing team continues to execute well as we advance our pipeline of precision oncology drug candidates."

Fourth quarter 2020 and recent highlights include:

REPOTRECTINIB, ROS1/TRK Inhibitor

Progress in the Phase 2 TRIDENT-1 registrational study of lead drug candidate repotrectinib, where the company in January reported updated interim findings in patients with ROS1-positive TKI-naïve non-small cell lung cancer (NSCLC). As of the Dec. 31, 2020 data cutoff date in 15 patients enrolled in the Phase 2 portion of the TRIDENT-1 study, the preliminary efficacy analysis showed a confirmed objective response rate (ORR) by physician assessment of 93% (95% CI: 68-100), and in 22 patients pooled from the Phase 1 (dosed at or above the Phase 2 dose) and Phase 2 portions, the confirmed ORR was 91% (95% CI: 71-99). As of an Oct. 30, 2020 data cutoff date, the interim safety update in a total of 185 patients from the Phase 1 and Phase 2 portions of the study showed repotrectinib was generally well tolerated.

Strong enrollment in the TRIDENT-1 study during the fourth quarter and into 2021, with Turning Point now anticipating enrollment in cohort 1 (EXP-1) to reach 50 patients pooled from the Phase 1 and Phase 2 portions of the study in the second quarter of 2021. The company plans to discuss next steps towards registration of repotrectinib in this patient population at a Type B meeting with the Food and Drug Administration (FDA), also anticipated in the second quarter. In addition, enrollment in the other cohorts within TRIDENT-1 continues to progress, and it is the company’s goal to provide an enrollment and clinical data update for other cohorts in the study in the second half.

Breakthrough Therapy Designation (BTD) granted by the FDA for the treatment of patients with ROS1-positive metastatic NSCLC who have not been treated with a ROS1 tyrosine kinase inhibitor. BTD is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.

Plans to present additional preclinical data highlighting repotrectinib’s combination potential in KRAS-mutant disease at a medical conference in the second quarter of 2021.

Progress toward initiating the first cohort in the multi-arm Phase 1b/2 TRIDENT-2 repotrectinib combination study in KRAS-mutant solid tumors in mid-2021.
TPX-0022, MET/ SRC/CSF1R Inhibitor

Progress in the Phase 1 SHIELD-1 study of TPX-0022, Turning Point’s MET, SRC and CSF1R inhibitor, where initial data reported in October 2020 highlighted preliminary clinical activity, including objective responses across multiple tumor types and a generally well-tolerated safety profile.

The company continues to enroll patients in the Phase 1 study and is currently evaluating multiple doses and schedules to further characterize the pharmacokinetics, safety and efficacy profile before ultimately determining a recommended Phase 2 dose (RP2D), anticipated in the second quarter. Turning Point plans to proceed directly into Phase 1 dose expansion in multiple patient cohorts after determining RP2D.
Additional clinical data update from the Phase 1 dose finding portion of SHIELD-1 planned in the second half of 2021. The company also plans to discuss the ongoing study with the FDA with the goal to modify the study into a registrational Phase 1/2 design and initiate the Phase 2 portion in the second half, pending FDA feedback.

Execution of an agreement with Zai Lab in January 2021 to develop and commercialize TPX-0022 in Greater China.
TPX-0046, RET Inhibitor

Progress in the Phase 1 dose finding study of TPX-0046, a novel RET inhibitor, where the company continues to evaluate multiple doses and schedules to further characterize the pharmacokinetics, safety, and efficacy profile. Turning Point plans to provide preliminary data in the second quarter of 2021, which will focus primarily on safety and any early signals of efficacy from initial patients.
TPX-0131, ALK Inhibitor

Approval by the Australian Ethics Committee of the Phase 1/2 clinical study of TPX-0131 focused on ALK-positive TKI-pretreated advanced NSCLC patients. Study initiation is anticipated in the second quarter of 2021.

IND submission to the FDA on track for March for TPX-0131, Turning Point’s fourth drug candidate, which has a compact macrocyclic structure that has been shown in preclinical studies to potently inhibit wildtype ALK and numerous ALK mutations, and in in-vivo studies has shown significant brain tissue penetration after repeat oral dosing supporting the potential to cross the blood-brain barrier.

Presentation of additional preclinical data highlighting the profile of TPX-0131 at a medical conference in the second quarter of 2021.
Fourth Quarter and Full-Year 2020 Financial Results

Revenue: Revenue of $25 million for the year was recognized during the third quarter in connection with the upfront payment from Zai Lab under the company’s license agreement for repotrectinib in Greater China.

R&D Expenses: Research and development expenses were $34.3 million for the fourth quarter compared to $17.1 million for the fourth quarter of 2019, and $113.4 million for the year compared to $57.9 million for the year ended Dec. 31, 2019. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, TPX-0022, TPX-0046, TPX-0131, discovery efforts and personnel expenses.

G&A Expenses: General and administrative expenses were $13.7 million for the fourth quarter compared to $5.9 million for the fourth quarter of 2019, and excluding a one-time non-cash stock-based compensation charge from the first quarter, non-GAAP G&A expenses were $42 million for the year compared to $19.8 million for the year ended Dec. 31, 2019. The increase was primarily attributable to higher personnel expenses as a result of increased employee head count and professional fees for legal and accounting services.

Net Income/Loss: Net loss was $47.4 million for the fourth quarter compared to net loss of $21 million for the fourth quarter of 2019, and excluding a one-time non-cash stock-based compensation charge from the first quarter, non-GAAP net loss was $125.9 million for the year compared to a loss of $72.1 million for the year ended Dec. 31, 2019.

Cash position: Cash, cash equivalents and marketable securities at Dec. 31 totaled $1.1 billion, compared to $409.2 million as of Dec. 31, 2019, driven primarily by net proceeds from follow-on public stock offerings in May and October of $351.6 and $433.9 million, respectively, partially offset by cash used in operating activities. Net cash used in operating activities during 2020 was $82.8 million. Turning Point projects its cash position funds current operations into 2024.
Upcoming Milestones
Key milestones anticipated in 2021 include:

Repotrectinib

Reach enrollment of 50 patients pooled from the Phase 1 and Phase 2 portions of the TRIDENT-1 study in the ROS1-positive TKI-naïve NSCLC patient cohort (EXP-1) in second quarter

Discuss next steps towards registration of repotrectinib in patients with ROS1-positive TKI-naïve NSCLC at a Type B meeting with the FDA in the second quarter

Initiate the first cohort of a multi-arm Phase 1b/2 TRIDENT-2 combination study in patients with KRAS-mutant solid tumors mid-year

Provide an enrollment and clinical data update in other cohorts of the Phase 2 TRIDENT-1 study in the second half
TPX-0046

Report early interim data from initial patients enrolled in the dose finding portion of the TPX-0046 Phase 1 study in the second quarter
TPX-0022

Provide a clinical data update from the Phase 1 dose finding portion of the SHIELD-1 study in the second half

Initiate the Phase 2 portion of the SHIELD-1 study of TPX-0022, pending FDA feedback, in the second half

Initiate the Phase 1b/2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) targeted therapy in the second half
TPX-0131

Submit the IND for TPX-0131 in the first quarter

Initiate the Phase 1/2 clinical study of TPX-0131 focused on ALK-positive TKI-pretreated advanced NSCLC patients in the second quarter
Preclinical/Research

Present multiple preclinical data presentations in the second quarter

Outline research strategy in the second half, including focus and anticipated timeline to development candidates.
Webcast and Conference Call
Turning Point will webcast its Quarterly Update Conference Call today, March 1 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Countouriotis will host the call, which will be accessible through the "Investors" section of tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 5683087. A replay will be available through the "Investors" section of www.tptherapeutics.com.

On March 2, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that it has executed an agreement with the Company’s largest shareholder, John K. Scott, Jr., to purchase $5 million of newly-designated Series E Redeemable Convertible Preferred Stock (Press release, Navidea Biopharmaceuticals, MAR 2, 2021, View Source [SID1234575949]). Over the next 18 months, the Series E Preferred can be converted into approximately 2.17 million shares of Navidea’s common stock.

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"We are pleased to receive continued support from our largest shareholder. Today’s financing provides additional strength to our balance sheet and will allow our company to accelerate potential value-accretive investments, including our therapeutics pipeline," commented Jed Latkin, Chief Executive Officer of Navidea. "We look forward to providing additional updates on the progress of our ongoing studies across our portfolio on our earnings call later this month."

John K. Scott, Jr. commented, "I am pleased to be given the opportunity to continue to support Navidea as it moves some of its key assets into the next phase of development. As a stockholder in Navidea since December 2003, I believe in the Company’s drug candidates and the positive contributions they can make to individuals and the scientific community."

The securities offered and to be sold by Navidea in the private placement to Mr. Scott have not been registered under the Securities Act of 1933 (the "Securities Act"), as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the "SEC") or an applicable exemption from registration requirements. Navidea has agreed to file a registration statement with the SEC covering the resale of the shares of common stock to be issued to Mr. Scott.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of Navidea’s securities. No offer, solicitation or sale will be made in any state or other jurisdiction in which such offering, solicitation or sale would be unlawful.

On March 2, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that management will participate in the H.C. Wainwright (HCW) Global Life Sciences Conference, which is being held digitally March 9-10, 2021 (Press release, Actinium Pharmaceuticals, MAR 2, 2021, View Source [SID1234575948]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Members of Actinium’s executive team will be available for one-on-one meetings with conference attendees. Those interested in scheduling a meeting may do so contacting their representative at HCW or the Company at [email protected]. The Company’s investor presentation can be accessed on the investor relations section of its website: View Source