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First Mining Files NI 43-101 Technical Report on the Updated Mineral Resource Estimate for the Duparquet Gold Project, Quebec

First Mining Files NI 43-101 Technical Report on the Updated Mineral Resource Estimate for the Duparquet Gold Project, Quebec
PR Newswire
VANCOUVER, BC, Oct. 6, 2022

VANCOUVER, BC, Oct. 6, 2022 /PRNewswire/ – First Mining Gold Corp. (“First Mining”…

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First Mining Files NI 43-101 Technical Report on the Updated Mineral Resource Estimate for the Duparquet Gold Project, Quebec

PR Newswire

VANCOUVER, BC, Oct. 6, 2022 /PRNewswire/ - First Mining Gold Corp. ("First Mining" or the "Company") (TSX: FF) (OTCQX: FFMGF) (FRANKFURT: FMG) is pleased to announce it has filed on SEDAR a Technical Report prepared in accordance with National Instrument 43-101 Standards of Disclosure for Mineral Projects ("NI 43-101") on the Duparquet Gold Project ("Duparquet" or the "Project") titled "NI 43-101 Technical Report and Mineral Resource Estimate Update for the Duparquet Project, Quebec, Canada," dated October 6, 2022 with an effective date of September 12, 2022.

The full Mineral Resource Estimate ("MRE") Technical Report prepared by InnovExplo Inc. in Val-d'Or (Quebec), can be found on the Company's website at www.firstmininggold.com and on SEDAR under the Company's issuer profile at www.sedar.com.

The Duparquet Gold Project is a multi-million ounce advanced exploration and mining development asset located in the Abitibi region of the province of Quebec, approximately 50 km north of the city of Rouyn-Noranda. The Duparquet deposit hosts a gold Resource of 3.4 Moz in the Measured and Indicated category, and an additional 1.6 Moz Au Inferred Resource derived from the master database of drill data, which contains 904 holes totalling 270,119m and 173,831 sampled intervals.  Existing infrastructure at the Project site includes paved provincial highways from Rouyn-Noranda to the south and LaSarre to the north and direct access to Quebec's hydroelectric power grid.  In addition, the near-by communities of Duparquet, Ruoyn-Noranda and LaSarre have strong histories of sustainable mining practices.

Table 1: Duparquet Gold Project Mineral Resource Estimate

Area

Cut-off

Measured Resource

Indicated Resource

Inferred Resource

(mining
method)

(g/t)

Tonnage (t)

Au

Ounces

Tonnage (t)

Au

Ounces

Tonnage (t)

Au

Ounces



(g/t)

(g/t)

(g/t)

Open Pit

0.40

163,700

1.37

7,200

59,410,600

1.52

2,909,600

28,333,000

1.07

970,400

UG Mining

1.50

-

-

-

5,506,900

2.26

399,300

9,038,900

2.29

665,600

Tailings

0.40

19,900

2.03

1,300

4,105,200

0.93

123,200

-

-

-

Total


183,600

1.43

8,500

69,022,700

1.55

3,432,100

37,371,900

1.36

1,636,000

Notes to accompany the Mineral Resource Estimate:

  1. The independent and qualified persons for the mineral resource estimate, as defined by NI 43 101, are Marina Iund, P.Geo., Carl Pelletier, P.Geo., Simon Boudreau, P.Eng. from InnovExplo Inc. and Guy Comeau, P.Eng. from Soutex. The effective date of the estimate is September 12, 2022.
  2. These mineral resources are not mineral reserves, as they do not have demonstrated economic viability. There is currently insufficient data to define these Inferred mineral resources as Indicated or Measured mineral resources and it is uncertain if further exploration will result in upgrading them to an Indicated or Measured mineral resource category.  The mineral resource estimate follows current CIM Definition Standards.
  3. The results are presented in situ and undiluted and have reasonable prospects of economic viability.
  4. In-pit and Underground estimates encompass sixty (60) mineralized domains and one dilution envelop using the grade of the adjacent material when assayed or a value of zero when not assayed; The tailings estimate encompass four (4) zones.
  5. In-pit and Underground: High-grade capping of 25 g/t Au; Tailings: High-grade capping of 13.0 g/t Au for Zone 1, 3.5 g/t Au for Zone 2, 1.7 g/t Au for Zone 3 and 2.2 g/t Au for Zone 4. High-grade capping supported by statistical analysis was done on raw assay data before compositing.
  6. In-pit and Underground: The estimate used a sub-block model in GEOVIA SURPAC 2021 with a unit block size of 5m x 5m x 5m and a minimum block size of 1.25m x 1.25m x1.25m. Grade interpolation was obtained by ID2 using hard boundaries. Tailings: The estimate used a block model in GEOVIA GEMS with a block size of 5m x 5m x 1m. Grade interpolation was obtained by ID2 using hard boundaries.
  7. In-pit and Underground: A density value of 2.73 g/cm3 was used for the mineralized domains and the envelope. A density value of 2.00 g/cm3 was used for the overburden. A density value of 1.00 g/cm3 was used for the excavation solids (drifts and stopes) assumed to be filled with water. Tailings: A fixed density of 1.45 g/cm3 was used in zones and waste.
  8. In-pit and Underground: The mineral resource estimate is classified as Measured, Indicated and Inferred. The measured category is defined by blocks having a volume of at least 25% within an envelope built at a distance of 10 m around existing channel samples. The Indicated category is defined by blocks meeting at least one (1) of the following conditions: Blocks falling within a 15-m buffer surrounding existing stopes and/or blocks for which the average distance to composites is less than 45 m. A clipping polygon was generated to constrain Indicated resources for each of the sixty (60) mineralized domains. Only the blocks for which reasonable geological and grade continuity have been demonstrated were selected. All remaining interpolated blocks were classified as Inferred resources. Blocks interpolated in the envelope were all classified as Inferred resources. Tailings: The Measured and Indicated categories were defined based on the drill hole spacing (Measured: Zones 1 and 2 = 30m x 30m grid; Indicated: Zone 3 = 100m x 100m grid and Zone 4 = 200m x 200m grid).
  9. In-pit and Underground: The mineral resource estimate is locally pit-constrained with a bedrock slope angle of 50° and an overburden slope angle of 30°. The out-pit mineral resource met the reasonable prospect for eventual economic extraction by having constraining volumes applied to any blocks (potential underground extraction scenario) using DSO. It is reported at a rounded cut-off grade of 0.4 g/t Au (in-pit and tailings) and 1.5 g/t Au (UG). The cut-off grades were calculated using the following parameters: mining cost = CA$70.00 (UG); processing cost = CA$11.9 to 17.0; G&A = CA$8.75; refining and selling costs = CA$ 5.00; gold price = US$ 1,650/oz; USD:CAD exchange rate = 1.31; and mill recovery = 93.9%. The cut-off grades should be re-evaluated in light of future prevailing market conditions (metal prices, exchange rates, mining costs etc.).
  10. The number of metric tons and ounces was rounded to the nearest hundred, following the recommendations in NI 43 101. Any discrepancies in the totals are due to rounding effects.
  11. The authors are not aware of any known environmental, permitting, legal, title-related, taxation, socio-political, or marketing issues, or any other relevant issue not reported in the Technical Report, that could materially affect the Mineral Resource Estimate.

Table 2: Cut-off grade sensitivity for the in-pit and underground portions of the Duparquet Gold Project

Area
(Mining Method)

Cut-off

(g/t)

Measured Resource

Indicated Resource

Inferred Resource

Tonnage (t)

Au

(g/t)

Ounces

Tonnage (t)

Au

(g/t)

Ounces

Tonnage (t)

Au

(g/t)

Ounces

Open Pit

0.7

137,321

1.53

6,755

23,142,210

2.05

1,525,279

2,592,695

1.62

135,038

0.65

141,757

1.5

6,836

25,666,698

1.98

1,633,902

3,334,098

1.48

158,647

0.6

149,158

1.46

7,001

32,690,577

1.86

1,954,908

5,716,620

1.34

246,283

0.55

154,634

1.42

7,060

36,556,977

1.77

2,080,340

7,727,020

1.23

305,568

0.5

156,938

1.41

7,122

41,152,335

1.70

2,253,068

11,007,061

1.13

400,881

0.45

161,081

1.39

7,187

53,548,726

1.58

2,722,586

22,032,449

1.16

824,601

0.4

163,709

1.37

7,222

59,410,612

1.52

2,909,551

28,332,980

1.07

970,424

0.35

165,800

1.36

7,248

66,307,600

1.46

3,117,172

37,354,222

0.96

1,147,282

UG Mining

1.9

-

-

-

5,891,904

2.67

505,871

7,168,869

2.91

669,750

1.7

-

-

-

5,224,787

2.47

414,153

7,378,504

2.51

595,956

1.5

-

-

-

5,506,861

2.26

399,356

9,038,871

2.29

665,629

1.3

-

-

-

5,302,381

2.10

357,603

11,459,118

2.05

756,440

Tailings

0.6

19,000

2.10

1,284

4,104,400

0.93

123,189

-

-

-

0.5

19,400

2.07

1,290

4,104,800

0.93

123,196

-

-

-

0.45

19,600

2.06

1,295

4,105,000

0.93

123,200

-

-

-

0.4

19,900

2.03

1,297

4,105,200

0.93

123,203

-

-

-

0.35

20,000

2.02

1,299

4,105,400

0.93

123,206

-

-

-

InnovExplo Inc., the authors of the Technical Report, concluded that:

  • The database supporting the 2022 MRE is complete, valid and up to date.
  • Geological and gold-grade continuity has been demonstrated for all 72 mineralized zones.
  • The key parameters of the 2022 MRE (density, capping, compositing, interpolation, search ellipsoid, etc.) are supported by data and statistical and/or geostatistical analysis.
  • The 2022 MRE includes measured, indicated and inferred resources for a combination of two mining scenarios: open pit and selective underground. The 2022 MRE complies with CIM Definition Standards and CIM Guidelines.
  • Two cut-off grades of 0.40 and 1.50 g/t Au were used, corresponding to potential open pit and selective underground mining scenarios.
  • Cut-off grades were calculated at a gold price of US$1,650 per troy ounce and an exchange rate of 1.31 USD/CAD, using reasonable mining, processing and G&A costs.
  • In a combined pit and selective underground mining scenario, the Project contains an estimated M+I Resource of 65,081,200 t at 1.58 g/t Au for 3,316,100 oz of gold and an Inferred Resource of 37,371,900 t at 1.36 g/t Au for 1,636,000 oz of gold. The Project also contains the Beattie mine tailings with an estimated M+I Resource of 4,125,100 t at 0.94 g/t Au for 124,500 oz of gold.
  • The results of the 2022 MRE represent a 10.5% increase in the M+I Resource and a 13.4% increase in the Inferred Resource compared to the previous 2014 MRE of Poirier et al., 2014. The increase in the M+I Resource is due to a deeper optimized shell and the updated economic parameters. The same reasons combined with the addition of 55 drill holes explain the increase in Inferred resources.
  • Based on metallurgical tests, the Duparquet project appears amenable to standard gold recovery processes. A combination of flotation, pressure oxidation and cyanide leach processes has shown a gold recovery ranging from 94.7% to 96.5%.
  • Additional diamond drilling on multiple zones would likely upgrade some of the Inferred Resource to the Indicated category and/or add to the Inferred Resource since most of the mineralized zones have not been fully explored at depth or close to surface infrastructures.

Qualified Persons

The independent and qualified persons for the MRE, as defined by National Instrument 43-101 Standards of Disclosure for Mineral Projects, are Marina Iund, P.Geo., Carl Pelletier, P.Geo., Simon Boudreau, P.Eng. from InnovExplo and Guy Comeau P.Eng. from Soutex. The effective date of the estimate is September 12, 2022.

Mr. Louis Martin P.Geo., (OGQ 0364), a consultant of First Mining, is a "Qualified Person" for the purposes of National Instrument 43-101 Standards of Disclosure for Mineral Projects, and he has reviewed and approved the scientific and technical disclosure contained in this news release.

About First Mining Gold Corp. 

First Mining is a gold developer advancing two of the largest gold projects in Canada, the Springpole Gold Project in northwestern Ontario, where we have commenced a Feasibility Study and permitting activities are on-going with a draft Environmental Impact Statement ("EIS") for the project published in June 2022, and the Duparquet, Pitt and Duquesne Gold Projects in Quebec, a collection of advanced stage development assets located on the Destor-Porcupine Fault in the prolific Abitibi region.  First Mining also owns the Cameron project in Ontario and a portfolio of gold project interests including the Pickle Crow gold project (being advanced in partnership with Auteco Minerals Ltd.), the Hope Brook gold project (being advanced in partnership with Big Ridge Gold Corp.), an equity interest in Treasury Metals Inc., and a portfolio of 21 gold royalties.

First Mining was established in 2015 by Mr. Keith Neumeyer, founding President and CEO of First Majestic Silver Corp. 

ON BEHALF OF FIRST MINING GOLD CORP.

Daniel W. Wilton 
Chief Executive Officer and Director

Cautionary Note Regarding Forward-Looking Statements

This news release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date of this news release. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "plans", "projects", "intends", "estimates", "envisages", "potential", "possible", "strategy", "goals", "opportunities", "objectives", or variations thereof or stating that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved, or the negative of any of these terms and similar expressions.

Forward-looking statements in this news release relate to future events or future performance and reflect current estimates, predictions, expectations or beliefs regarding future events.  All forward-looking statements are based on First Mining's or its consultants' current beliefs as well as various assumptions made by them and information currently available to them. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates that, while considered reasonable by the respective parties, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Such factors include, without limitation the Company's business, operations and financial condition potentially being materially adversely affected by the outbreak of epidemics, pandemics or other health crises, such as COVID-19, and by reactions by government and private actors to such outbreaks; risks to employee health and safety as a result of the outbreak of epidemics, pandemics or other health crises, such as COVID-19, that may result in a slowdown or temporary suspension of operations at some or all of the Company's mineral properties as well as its head office; fluctuations in the spot and forward price of gold, silver, base metals or certain other commodities; fluctuations in the currency markets (such as the Canadian dollar versus the U.S. dollar); changes in national and local government, legislation, taxation, controls, regulations and political or economic developments; risks and hazards associated with the business of mineral exploration, development and mining (including environmental hazards, industrial accidents, unusual or unexpected formations, pressures, cave-ins and flooding); the presence of laws and regulations that may impose restrictions on mining; employee relations; relationships with and claims by local communities, indigenous populations and other stakeholders; availability and increasing costs associated with mining inputs and labour; the speculative nature of mineral exploration and development; title to properties.; and the additional risks described in the Company's Annual Information Form for the year ended December 31, 2021 filed with the Canadian securities regulatory authorities under the Company's SEDAR profile at www.sedar.com, and in the Company's Annual Report on Form 40-F filed with the SEC on EDGAR.

First Mining cautions that the foregoing list of factors that may affect future results is not exhaustive. When relying on our forward-looking statements to make decisions with respect to First Mining, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. First Mining does not undertake to update any forward-looking statement, whether written or oral, that may be made from time to time by the Company or on our behalf, except as required by law. 

Cautionary Note to United States Investors 

The Company is a "foreign private issuer" as defined in Rule 3b-4 under the United States Securities Exchange Act of 1934, as amended, and is eligible to rely upon the Canada-U.S. Multi-Jurisdictional Disclosure System, and is therefore permitted to prepare the technical information contained herein in accordance with the requirements of the securities laws in effect in Canada, which differ from the requirements of the securities laws currently in effect in the United States. Accordingly, information concerning mineral deposits set forth herein may not be comparable with information made public by companies that report in accordance with U.S. standards.

Technical disclosure contained in this news release has not been prepared in accordance with the requirements of United States securities laws and uses terms that comply with reporting standards in Canada with certain estimates prepared in accordance with NI 43-101.

NI 43-101 is a rule developed by the Canadian Securities Administrators that establishes standards for all public disclosure an issuer makes of scientific and technical information concerning the issuer's material mineral projects.

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SOURCE First Mining Gold Corp.

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Government

FDA’s drug shortages leader wants companies to start reporting increases in demand

It is no secret that drug shortages have been prevalent in 2022. Several major drug products, such as amoxicillin and Adderall, have been in short supply…

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It is no secret that drug shortages have been prevalent in 2022. Several major drug products, such as amoxicillin and Adderall, have been in short supply for several months and have led to members of Congress applying pressure on the FDA and HHS to resolve the situation.

Valerie Jensen

Speaking at a webinar hosted by the Alliance for a Stronger FDA, Valerie Jensen, the associate director of the FDA’s Drug Shortage Staff, noted both the rise in quality-related issues and increased demand for some products. She called on companies to report such demand increases, even though they are not currently required to do so.

During the Covid-19 pandemic, she said, the agency has seen new challenges mainly related to these increases in demand.

“During the pandemic as well, we had competition on manufacturing lines and that’s still occurring due to vaccine production and other Covid products,” Jensen said. “So, the same products are being made on those lines that are making the vaccines and Covid-related products, and then that creates a competition situation.”

Jensen added that an increase in demand for manufacturing commodities due to large-scale vaccine production is also leading to shortages. Items such as glass, filters and vial hoppers are in short supply. And now the increased demand is centered around the increase in drugs to counter respiratory illnesses.

She said the physical number of drug shortages currently sits at 123, which is “a little above normal,” but there have been around 100 shortages at any given time over the past seven years. Some of those can be chalked up to companies not producing the volumes required to meet market demand. She also added that there were 38 new shortages in 2021, but the FDA is still dealing with them this year.

For some temporary solutions, Jensen said that she has been coordinating with international regulatory authorities more often, to find out what is being marketed and to see if they can import a drug in short supply in the US. She is also coordinating experts to try to mitigate the situation, providing the public with widely available information as well as expediting the review of anything that manufacturers need to boost supplies.

However, Jensen said that the increase in the demand for drugs is not something that will be going away anytime soon.

“One thing that we really see going forward are these demand increases, this is something that is fairly new to us. It’s something that we’re looking at closely,” she said. “We would really want companies to inform us if they’re seeing spikes in demand because that’s currently not required.”

While producers do need to let the FDA know of supply disruption, companies do not need to let the FDA know of spikes in demand, and Jensen would like to see this changed. Also, she would like to apply different uses for supply chain data to look for signals or patterns and ultimately predict shortages.

Jensen added that in some cases it is impossible to prevent a shortage, but she stresses that better notification of when companies are seeing a spike in demand can be a key solution:

In those cases, when we can prevent (a shortage), we are using those same tools to prevent it. So, we’re expediting review, we’re looking at potential ways that we can use flexibility to allow a product to be on the market while the company fixes a problem. All of those tools are really the same for prevention and mitigation. But I think that really the key is early notification. The earlier companies let us know about an issue the earlier we can deal with it.

With the uptick in respiratory illnesses and shortages of drugs such as amoxicillin, Jensen noted that it’s a matter of reaching out and monitoring the market to see what manufacturers are contending with. Also, Jensen will look to work with pharmacy associations and other trade groups to see what is occurring at the pharmacy level and then “put all of those pieces together” to try and help end the shortage.

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nTIDE November 2022 Jobs Report: People with disabilities continue to outperform people without disabilities in labor market

East Hanover, NJ – December 2, 2022 – Job numbers rose again for people with disabilities, in contrast to people without disabilities, according to…

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East Hanover, NJ – December 2, 2022 – Job numbers rose again for people with disabilities, in contrast to people without disabilities, according to today’s National Trends in Disability Employment – Monthly Update (nTIDE), issued by Kessler Foundation and the University of New Hampshire’s Institute on Disability (UNH-IOD). People with disabilities continued to show strength in the labor market in November, as evidenced by the substantial rise in their employment-to-population ratio.

Credit: Kessler Foundation

East Hanover, NJ – December 2, 2022 – Job numbers rose again for people with disabilities, in contrast to people without disabilities, according to today’s National Trends in Disability Employment – Monthly Update (nTIDE), issued by Kessler Foundation and the University of New Hampshire’s Institute on Disability (UNH-IOD). People with disabilities continued to show strength in the labor market in November, as evidenced by the substantial rise in their employment-to-population ratio.

Month-to-Month nTIDE Numbers (comparing October 2022 to November 2022)

Based on data from the U.S. Bureau of Labor Statistics (BLS) Jobs Report released today, the employment-to-population ratio for people with disabilities (ages 16-64) increased from 35.5 percent in October to 36.5 percent in November (up 2.8 percent or 1 percentage point). For people without disabilities (ages 16-64), the employment-to-population ratio decreased from 74.6 percent in October to 74.4 percent in November (down 0.3 percent or 0.2 percentage point). The employment-to-population ratio, a key indicator, reflects the percentage of people who are working relative to the total population (the number of people working divided by the number of people in the total population multiplied by 100).

“Similar to last month, the employment-to-population ratio for people with disabilities increased and remains above historic highs. For those without disabilities, however, the ratio dropped,” said John O’Neill, PhD, director of the Center for Employment and Disability Research at Kessler Foundation. “This decline may be a sign of the Fed’s efforts to slow the labor market. This is interesting in light of this month’s strong gain for people with disabilities.”

Findings were similar for November’s labor force participation rate. For people with disabilities (ages 16-64), the labor force participation rate was increased slightly from 38.7 percent in October to 38.8 percent in November (up 0.3 percent or 0.1 percentage point). Conversely, the labor force participation rate decreased slightly for people without disabilities (ages 16-64), from 77.1 percent in October to 76.9 percent in November (down 0.3 percent or 0.2 percentage point). The labor force participation rate is the percentage of the population that is working, not working, and on temporary layoff, or not working and actively looking for work.

“While labor force participation for people with disabilities remains stable, increases in the employment to population ratio for people with disabilities suggest that more people with disabilities are succeeding in finding jobs,” remarked Debra Brucker, PhD, research associate professor at the UNH-IOD. “Keep in mind that gains in employment may in part reflect the need to boost income in the face of rising prices. Also, these data are not seasonally adjusted, so some of this increase may be due to seasonal employment.”

Why have people with disabilities been outperforming people without disabilities? Favorable changes in the workplace as employers adapted to COVID-19 restrictions may be a factor. Our new survey compares the workplaces of 2017 and 2022, revealing gains in recruiting, hiring, accommodating, and retaining employees with disabilities. Read more about the 2022 National Employment & Disability Survey: Effects of COVID-19 Pandemic Supervisor Perspectives.

Year-to-Year nTIDE Numbers (Comparing November 2021 to November 2022)

Reflecting the continued strength of the employment of people with disabilities over the course of the year, the employment-to-population ratio for working-age people with disabilities increased substantially from 34.6 percent in November 2021 to 36.5 percent in November 2022 (up 5.5 percent or 1.9 percentage points). However, the employment-to-population ratio increased slightly for working-age people without disabilities, from 73.8 percent in November 2021 to 74.4 percent in November 2022 (up 0.8 percent or 0.6 percentage points).

Similarly, for people with disabilities (16-64), the labor force participation rate increased substantially from 37.7 percent in November 2021 to 38.8 percent in November 2022 (up 2.9 percent or 1.1 percentage points). The labor force participation rate increased slightly for people without disabilities (ages 16-64), from 76.7 percent in November 2021 to 76.9 percent in November 2022 (up 0.3 percent or 0.2 percentage points).

In November, among workers ages 16-64, the 5,962,000 workers with disabilities represented 4 percent of the total 148,009,000 workers in the U.S.

Ask Questions about Disability and Employment

Each nTIDE release is followed by an nTIDE Lunch & Learn online webinar. This live broadcast, hosted via Zoom Webinar, offers attendees Q&A on the latest nTIDE findings, provides news and updates from the field, as well as invited panelists to discuss current disability-related findings and events. On December 2, 2022 at 12:00 pm Eastern, Chai Feldblum, JD, vice chair the of Ability One Commission, a federal agency devoted to the employment of people with significant disabilities, joins Drs. O’Neill and Brucker, and Denise Rozell, Policy Strategist at the Association of University Centers on Disabilities (AUCD). Join our Lunch & Learns live or visit the nTIDE archives at: ResearchonDisability.org/nTIDE.

NOTE: The statistics in the nTIDE are based on Bureau of Labor Statistics numbers but are not identical. They are customized by UNH to combine the statistics for men and women of working age (16 to 64). nTIDE is funded, in part, by grants from the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) (90RT5037) and Kessler Foundation.

About the Institute on Disability at the University of New Hampshire

The Institute on Disability (IOD) at the University of New Hampshire (UNH) was established in 1987 to provide a university-based focus for the improvement of knowledge, policies, and practices related to the lives of persons with disabilities and their families. For information on the NIDILRR-funded Research and Training Center on Disability Statistics, visit ResearchOnDisability.org.

About Kessler Foundation

Kessler Foundation, a major nonprofit organization in the field of disability, is a global leader in rehabilitation research that seeks to improve cognition, mobility, and long-term outcomes – including employment – for people with neurological disabilities caused by diseases and injuries of the brain and spinal cord. Kessler Foundation leads the nation in funding innovative programs that expand opportunities for employment for people with disabilities. For more information, visit KesslerFoundation.org.

Stay Connected with Kessler Foundation

Twitter | Facebook | YouTube | Instagram | iTunes & SoundCloud

To interview an expert, contact:

Deborah Hauss, DHauss@kesslerfoundation.org;

Carolann Murphy, CMurphy@KesslerFoundation.org.

 

 


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International

Scientists reveal encouraging findings in first-in-human clinical trial evaluating HIV vaccine approach

NEW YORK and LA JOLLA, CA—While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy being…

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NEW YORK and LA JOLLA, CA—While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy being pursued by researchers at Scripps Research, IAVI, Fred Hutchinson Cancer Center (Fred Hutch) and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) shows new promise, according to data from a first-in-human clinical trial.

Credit: CHRISTOPHER COTTRELL, CREATED WITH BIORENDER.COM

NEW YORK and LA JOLLA, CA—While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy being pursued by researchers at Scripps Research, IAVI, Fred Hutchinson Cancer Center (Fred Hutch) and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) shows new promise, according to data from a first-in-human clinical trial.

In a paper published in Science on December 2, 2022, the scientists reveal critical new insights into their novel vaccine strategy, which involves a stepwise approach to producing antibodies capable of targeting a wide range of HIV variants. 

“The data we are publishing in Science demonstrates for the first time that one can design a vaccine that elicits made-to-order antibodies in humans. We specified in advance certain molecular properties of the antibodies that we wanted to elicit, and the results of this trial show that our vaccine antigen consistently induced precisely those types of antibodies,” says co-senior author William Schief, PhD, a professor and immunologist at Scripps Research and executive director of vaccine design at IAVI’s Neutralizing Antibody Center, whose laboratory developed the vaccine antigen. “We believe this vaccine design strategy will be essential to make an HIV vaccine and may help the field create vaccines for other difficult pathogens.”

The Phase 1 trial, known as IAVI G001, tested the first stage in a multi-stage HIV vaccine regimen the researchers are developing. The trial results show that the vaccine had a favorable safety profile and induced the targeted response in 97% of people who were vaccinated. Importantly, the Science study also provides a detailed immunological analysis of the vaccine responses.

“HIV represents an area of dire unmet need across the world, which is what makes the findings from our Phase 1 clinical trial so encouraging,” says Mark Feinberg, MD, PhD, president and CEO of IAVI. “Through the close-knit collaboration of many different scientists, disciplines and institutions, we are that much closer to designing an effective vaccine that could help end the HIV pandemic.”  

Priming the Immune System

Broadly neutralizing antibodies (bnAbs) are a rare type of antibody that can fight and protect against many different variants of a virus—including HIV. This is why scientists have tried to develop an HIV vaccine that induces bnAbs, but thus far without success.   

The researchers in the study are using a strategy known as ‘germline targeting’ to eventually produce bnAbs that can protect against HIV. The first step of germline targeting involves stimulating the rare immune cells—known as bnAb-precursor B cells—that can eventually evolve into the cells that produce the bnAbs needed to block the virus. To accomplish this first step, the researchers designed a customized molecule—known as an immunogen—that would “prime” the immune system and elicit responses from these rare bnAb-precursor cells.

The overarching goal of the IAVI G001 trial was to determine if the vaccine had an acceptable safety profile and could induce responses from these bnAb-precursor B cells.

“Through extensive safety and tolerability monitoring during the trial, we showed the vaccine had a favorable safety profile, while still inducing the necessary target cells,” says study author Dagna Laufer, MD, vice president and head of clinical development at IAVI. “This represents a large step forward in developing an HIV vaccine that is both safe and effective.”

To determine if the targeted bnAb-precursor B cells were induced, the researchers carried out a sophisticated analytical process.

“The workflow of multidimensional immunological analyses has taken clinical trial evaluation to the next level,” says co-senior author Adrian B. McDermott, PhD, former chief of the Vaccine Immunology Program at the NIAID VRC. “In evaluating these important immunological factors, we helped show why the vaccine antigen was able to induce the targeted response in 97% of vaccine recipients.” 

IAVI G001 was sponsored by IAVI and took place at two sites: George Washington University (GWU) in Washington, D.C., and Fred Hutch in Seattle, enrolling 48 healthy adult volunteers. Participants received either a placebo or two doses of the vaccine antigen, eOD-GT8 60mer, along with an adjuvant developed by the pharmaceutical company GSK. Julie McElrath, MD, PhD, co-senior author, senior vice president and director of Fred Hutch’s Vaccine and Infectious Disease Division, and David Diemert, MD, professor of medicine at GWU School of Medicine and Health Sciences, were lead investigators at the trial sites.

A Deeper Immunological Dive

The study also carefully examined the properties of the antibodies and B cells induced by the vaccine antigen, in what Schief likens to “looking under the car hood” to understand how the immune system operated in response to the vaccine. One analysis showed that the vaccine antigen first stimulated an average of 30 to 65 different bnAb precursors per person vaccinated, and then caused those cells to multiply. This helped explain why the vaccine induced the desired response in almost all participants.

Other analyses delved into the specific mutations the bnAb-precursor B cells acquired over time and how tightly they bound to the vaccine antigen. These investigations showed that that after each dose of the vaccine, the bnAb-precursor B cells gained affinity and continued along favorable maturation pathways.

One concern for this type of vaccine approach is the notion of “competitors”—in other words, the B cells induced by the vaccine antigen that are not bnAb precursors. The researchers extensively studied the “competitor” responses, and the results were very encouraging. Although the majority of the B cells triggered by vaccination were, in fact, “competitors”, these undesired B cells could not match the binding strength of the desired bnAb precursors and did not seem to impede maturation of the bnAb-precursor responses.

“These findings were very encouraging, as they indicated that immunogen design principles we used could be applied to many different epitopes, whether for HIV or even other pathogens,” adds Schief.

With these promising data in hand spanning both safety and immune responses, the researchers will continue to iterate and design boosting immunogens that could eventually induce the desired bnAbs and provide protection against the virus. These findings also come shortly after two additional studies in Immunity published in September 2022, which helped validate the germline-targeting approach for vaccinating against HIV.

“Working together with IAVI, Scripps Research, the VRC, GWU, additional investigators at Fred Hutch and many others, this trial and additional analyses will help inform design of the remaining stages of a candidate HIV vaccine regimen—while also enabling others in the field to develop vaccine strategies for additional viruses,” says McElrath of Fred Hutch.

IAVI, Scripps Research, NIAID, the Bill & Melinda Gates Foundation and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID) are partnering with the biotechnology company Moderna to develop and test mRNA delivery of these HIV vaccine antigens. Two Phase I clinical trials are underway that build on IAVI G001, one (IAVI G002) at four sites in the U.S. and another (IAVI G003) at the Center for Family Health Research in Kigali, Rwanda, and The Aurum Institute in Tembisa, South Africa. Both are testing mRNA delivery of the eOD-GT8 60mer that was evaluated as recombinant protein in IAVI G001, and the U.S. trial includes a boost antigen designed by the Schief lab and delivered with Moderna mRNA technology. A third trial (HVTN302), at ten sites in the U.S., is testing mRNA delivery of three different stabilized HIV trimers designed in the Schief laboratory that are candidates for late-stage boosters in multi-stage vaccines aiming to induce bnAbs. Using mRNA technology could significantly accelerate the pace of HIV vaccine development as it allows for faster production of clinical trial material.

This work was supported by the Bill & Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery; the IAVI Neutralizing Antibody Center; NIAID; Scripps Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery and Scripps Consortium for HIV/AIDS Vaccine Development; and the Ragon Institute of MGH, MIT, and Harvard. Other collaborating organizations include Duke Human Vaccine Institute, Karolinska Institutet, and La Jolla Institute. 

Research at the IAVI Neutralizing Antibody Center that contributed to the development of the vaccine antigen eOD-GT8 60mer was also made possible by the government of the Netherlands through the Minister of Foreign Trade & Development Cooperation and through the generous support of the American people through PEPFAR through USAID. The contents are the responsibility of IAVI and Scripps Research and do not necessarily reflect the views of PEPFAR, USAID, or the United States government.

About IAVI

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more at iavi.org.

About Scripps Research

Scripps Research is an independent, nonprofit biomedical institute ranked the most influential in the world for its impact on innovation by Nature Index. We are advancing human health through profound discoveries that address pressing medical concerns around the globe. Our drug discovery and development division, Calibr, works hand-in-hand with scientists across disciplines to bring new medicines to patients as quickly and efficiently as possible, while teams at Scripps Research Translational Institute harness genomics, digital medicine and cutting-edge informatics to understand individual health and render more effective healthcare. Scripps Research also trains the next generation of leading scientists at our Skaggs Graduate School, consistently named among the top 10 US programs for chemistry and biological sciences. Learn more at www.scripps.edu.


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