Lineage Reports Fourth Case of Retinal Tissue Restoration With OpRegen®

• Four Patients With Dry Age-Related Macular Degeneration Observed to Have Areas of Geographic Atrophy Which Diminished or Remained Unchanged Relative to Baseline for a Period of at Least 12 Months
• All Four Patients Exhibited Improvements in Visual Acuity at 12 Months
• Differences in Visual Acuity Between Treated and Untreated Eyes in all Cohort 4 Patients Remained Statistically Significant At 9, 12, and 15 Months

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 30, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that restoration of retinal tissue was observed in a fourth patient enrolled in the Company’s Phase 1/2a clinical study of its lead product candidate, OpRegen. Retinal tissue restoration and improved visual acuity has now been observed in all four better vision patients treated in Cohort 4, where surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen cells. Outer retinal layer restoration, which was observed using clinical high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of retinal pigment epithelium (RPE) monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These new and additive findings continue to support the Company’s view that atrophic AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable. OpRegen is an allogeneic RPE cell transplant in development for the treatment of age-related macular degeneration (AMD) with geographic atrophy (GA), or dry (atrophic) AMD.

“After reporting three previous cases of retinal restoration over the course of the last two years, we have been carefully examining the other Cohort 4 patients. We have put significant work into reviewing images from the remaining patient who had the majority of the area of atrophy covered by the OpRegen suspension at the time of surgical implant. I am pleased to report that at the scheduled Month 12 post-operative visit for this patient, although less prominent than the 3 previously reported cases due to a smaller area of atrophy at baseline, there is clear evidence of retinal restoration in some areas, and the total area of atrophy as calculated using square root transformation, or SQRT, is smaller than the size calculated at baseline,” stated Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder, 
Barcelona Macula Foundation. “The finding of a fourth case of restoration further supports our goal of showing that atrophic age-related macular degeneration can be responsive to this type of cell therapy. Dry AMD is a progressive disease and halting or reversing an area of atrophy does not occur spontaneously, which we believe makes the durability and reproducibility of these changes unprecedented within the field. With 12 months of follow-up complete, I am eager to have these cases submitted for peer-reviewed publication.”

“We have treated 24 patients with OpRegen, 12 of which were not legally blind at baseline and represent our intended treatment population. Among these 12 patients, four received thorough coverage of OpRegen cells across the majority of the atrophic area and experienced a cessation or reversal of their areas of atrophy at 12 months and continue to be followed. These patients also experienced increases in their visual acuity in their treated eye. We believe these four patients represent the only examples of an experimental treatment for dry AMD which can reduce an area of atrophy in humans, rather than simply slow its growth,” added  Brian M. Culley, Lineage CEO. “Restoration of retinal tissue using cell therapy represents a paradigm shift compared to conventional approaches, which to date have only shown an unremarkable slowing of progression. In addition to being well tolerated to date, the durability of changes to areas of atrophy and improvements in visual acuity support the continued and rapid clinical development of OpRegen. Alongside our advisors, we currently are preparing for multiple engagements with FDA to discuss aspects of OpRegen’s designation, our manufacturing plans, and the design of a later-stage clinical trial to begin next year. We anticipate the first of these engagements will begin next month and continue in the first quarter of 2022.”

OpRegen Phase 1/2a Interim Clinical Trial Results

• Retinal restoration, reported in four patients to date, persisted from over 12 months to greater than 3 years following treatment and continues to be followed.
• Restoration was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment.
  • Reductions, or no progression for at least 1 year, was observed in the total area of GA in all four of these better vision Cohort 4 patients.

• Overall, using the Early Treatment Diabetic Retinopathy Study (EDTRS) assessment of best corrected visual acuity (BCVA), 7/12 (58%) of each of Cohort 4 patients’ treated eye were at baseline or better at 15 months or last time point, which extends beyond 3 years in some patients. In comparison, at the same time points, 8/12 (67%) were below baseline in those same patients’ fellow untreated eyes.
  • All four retinal restoration patients reported improvements in their visual acuity, which has been maintained for at least 12 months in all four of those patients.

• Across the study, in patients with previously reported structural improvements in the retina, decreases in drusen density, and a trend toward slower GA progression in treated compared to untreated eyes continue to be present.
• Evidence of durable engraftment of OpRegen RPE cells has extended to more than 5 years in the earliest treated patients, supporting the potential for OpRegen to be a one-time treatment.

Overall, OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration (FDA), or 
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immune-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date from the ongoing Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, Lineage’s plans to meet with the FDA to discuss OpRegen’s clinical development, the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen for the treatment of dry AMD with GA, and the potential for Lineage’s investigational allogeneic cell therapies to provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including the risk that treatment with OpRegen in dry AMD patients with GA may not provide the benefits anticipated, the risk that interim results from clinical trials may not be predictive of future results, including later clinical trial results, and that interim data from clinical trials may change as more patient data become available and are subject to audit and verification procedures, and risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
([email protected])
(442) 287-8963

Solebury Trout IR
Mike Biega
([email protected])
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or  David Schull
[email protected]
[email protected]
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Lineage Reports Fourth Case of Retinal Tissue Restoration With OpRegen®

• Four Patients With Dry Age-Related Macular Degeneration Observed to Have Areas of Geographic Atrophy Which Diminished or Remained Unchanged Relative to Baseline for a Period of at Least 12 Months
• All Four Patients Exhibited Improvements in Visual Acuity at 12 Months
• Differences in Visual Acuity Between Treated and Untreated Eyes in all Cohort 4 Patients Remained Statistically Significant At 9, 12, and 15 Months

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 30, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that restoration of retinal tissue was observed in a fourth patient enrolled in the Company’s Phase 1/2a clinical study of its lead product candidate, OpRegen. Retinal tissue restoration and improved visual acuity has now been observed in all four better vision patients treated in Cohort 4, where surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen cells. Outer retinal layer restoration, which was observed using clinical high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of retinal pigment epithelium (RPE) monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These new and additive findings continue to support the Company’s view that atrophic AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable. OpRegen is an allogeneic RPE cell transplant in development for the treatment of age-related macular degeneration (AMD) with geographic atrophy (GA), or dry (atrophic) AMD.

“After reporting three previous cases of retinal restoration over the course of the last two years, we have been carefully examining the other Cohort 4 patients. We have put significant work into reviewing images from the remaining patient who had the majority of the area of atrophy covered by the OpRegen suspension at the time of surgical implant. I am pleased to report that at the scheduled Month 12 post-operative visit for this patient, although less prominent than the 3 previously reported cases due to a smaller area of atrophy at baseline, there is clear evidence of retinal restoration in some areas, and the total area of atrophy as calculated using square root transformation, or SQRT, is smaller than the size calculated at baseline,” stated Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder, 
Barcelona Macula Foundation. “The finding of a fourth case of restoration further supports our goal of showing that atrophic age-related macular degeneration can be responsive to this type of cell therapy. Dry AMD is a progressive disease and halting or reversing an area of atrophy does not occur spontaneously, which we believe makes the durability and reproducibility of these changes unprecedented within the field. With 12 months of follow-up complete, I am eager to have these cases submitted for peer-reviewed publication.”

“We have treated 24 patients with OpRegen, 12 of which were not legally blind at baseline and represent our intended treatment population. Among these 12 patients, four received thorough coverage of OpRegen cells across the majority of the atrophic area and experienced a cessation or reversal of their areas of atrophy at 12 months and continue to be followed. These patients also experienced increases in their visual acuity in their treated eye. We believe these four patients represent the only examples of an experimental treatment for dry AMD which can reduce an area of atrophy in humans, rather than simply slow its growth,” added  Brian M. Culley, Lineage CEO. “Restoration of retinal tissue using cell therapy represents a paradigm shift compared to conventional approaches, which to date have only shown an unremarkable slowing of progression. In addition to being well tolerated to date, the durability of changes to areas of atrophy and improvements in visual acuity support the continued and rapid clinical development of OpRegen. Alongside our advisors, we currently are preparing for multiple engagements with FDA to discuss aspects of OpRegen’s designation, our manufacturing plans, and the design of a later-stage clinical trial to begin next year. We anticipate the first of these engagements will begin next month and continue in the first quarter of 2022.”

OpRegen Phase 1/2a Interim Clinical Trial Results

• Retinal restoration, reported in four patients to date, persisted from over 12 months to greater than 3 years following treatment and continues to be followed.
• Restoration was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment.
  • Reductions, or no progression for at least 1 year, was observed in the total area of GA in all four of these better vision Cohort 4 patients.

• Overall, using the Early Treatment Diabetic Retinopathy Study (EDTRS) assessment of best corrected visual acuity (BCVA), 7/12 (58%) of each of Cohort 4 patients’ treated eye were at baseline or better at 15 months or last time point, which extends beyond 3 years in some patients. In comparison, at the same time points, 8/12 (67%) were below baseline in those same patients’ fellow untreated eyes.
  • All four retinal restoration patients reported improvements in their visual acuity, which has been maintained for at least 12 months in all four of those patients.

• Across the study, in patients with previously reported structural improvements in the retina, decreases in drusen density, and a trend toward slower GA progression in treated compared to untreated eyes continue to be present.
• Evidence of durable engraftment of OpRegen RPE cells has extended to more than 5 years in the earliest treated patients, supporting the potential for OpRegen to be a one-time treatment.

Overall, OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration (FDA), or 
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immune-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date from the ongoing Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, Lineage’s plans to meet with the FDA to discuss OpRegen’s clinical development, the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen for the treatment of dry AMD with GA, and the potential for Lineage’s investigational allogeneic cell therapies to provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including the risk that treatment with OpRegen in dry AMD patients with GA may not provide the benefits anticipated, the risk that interim results from clinical trials may not be predictive of future results, including later clinical trial results, and that interim data from clinical trials may change as more patient data become available and are subject to audit and verification procedures, and risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
([email protected])
(442) 287-8963

Solebury Trout IR
Mike Biega
([email protected])
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or  David Schull
[email protected]
[email protected]
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

	Image Credit: Marco Verch (Flickr)

Could a Chewing Gum Reduce COVID-19’s Spread? Here’s What We Need to Know First

An experimental chewing gum could reduce the spread of Sars-CoV-2, the virus that causes COVID-19, according to a recent study published in the journal Molecular Therapy. You might already have noticed headlines calling the findings “fresh hope” in our fight against COVID-19. But how excited should we be? And could this gum work against Omicron, the newest variant of concern?

Evidence shows people infected with Sars-CoV-2 have high levels of virus in their saliva. So researchers in the US wanted to investigate whether a specially designed chewing gum could reduce the amount of virus in the mouth, and therefore potentially reduce its spread.

Chewing gum to promote oral health is not a new idea. Studies have shown that chewing gums containing certain substances such as calcium and bicarbonate can improve oral health, reducing the incidence of dental ailments and cutting the numbers of harmful bacteria. But specifically targeting a virus in this way is a novel approach.

Sars-CoV-2 gains entry into human cells by latching onto ACE2 proteins, which are found on the surfaces of certain cells in our body. The researchers produced a gum containing high levels of ACE2 proteins, produced in plants, with the idea being that the ACE2 proteins in the chewing gum could “trap” virus particles in the mouth, minimizing the opportunity they have to infect our cells and spread to other people.

To test the effectiveness of the chewing gum, the researchers took saliva samples from patients with COVID-19 and mixed these samples with a powdered form of the gum. They found the treated saliva had significantly reduced numbers of Sars-CoV-2 virus particles compared to those treated with a placebo (the same gum but without the ACE2 protein).

The researchers also demonstrated that the gum prevented a pseudotyped virus (a harmless virus with the Sars-CoV-2 spike protein on its surface) from infecting cells in the lab. As little as 5mg of the gum was associated with significantly reduced viral entry into cells, while 50mg of the gum reduced viral entry by 95%. This suggests the ACE2 gum severely hinders the ability of the Sars-CoV-2 spike protein to infect cells.

Reasons for Caution

Although these results seem promising, there are a number of reasons we can’t view this gum as a pandemic gamechanger just yet. First, this is early-stage research, meaning the experiments were conducted in a lab in controlled conditions rather than with real people.

The conditions in a lab experiment are going to be different to the conditions in a person’s mouth. While the researchers used a chewing simulator machine to show that the motion of chewing doesn’t affect the integrity of the ACE2 protein in the gum, there are other questions for which we don’t yet have answers.

For example, would the environment in a person’s mouth, such as body temperature and oral bacteria, impact the effectiveness of the gum? And how long would one piece of gum continue working for? It will be interesting to see whether the gum produces similar effects in people as it has in the lab if the research progresses to this stage.

Second, although the gum significantly reduced infection of a virus that carried the Sars-CoV-2 spike, the researchers didn’t use the full Sars-CoV-2 virus in their experiments. While the method they used, virus pseudotyping, is a tried and tested scientific method to assess virus entry into cells, it would be interesting to see how the gum affects the full Sars-CoV-2 virus.

As for whether the gum would be effective across different COVID variants, such as Omicron, the principles of virology give us reason to be optimistic. Regardless of the variant and its mutations, Sars-CoV-2 gains entry into human cells by latching on to ACE2 proteins – which is key to how the gum works. That said, this is another question we won’t know the answer to for sure until the product is tested in real-world trials.

Finally, it’s important to understand what this gum is designed for. The researchers point out that its main use is likely to be reducing viral spread from people with COVID-19 to others, particularly in clinical settings. It’s unclear how well it would work as a prophylactic to prevent uninfected people getting the virus, particularly when Sars-CoV-2 can be transmitted through multiple routes including the eyes and nose as well as the mouth.

All the same, this gum could have exciting prospects in a clinical setting – for example reducing spread in dental surgeries or COVID hospital wards. When used in combination with current methods such as mask wearing, ventilation and vaccination, it could be another weapon in our arsenal for preventing the spread of COVID-19. But further research is needed before we can expect to be chewing it.

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Scientists Now Better Understand Viral Mutations

Tracing the Origins of a Virus

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The Detrimental Impact of Fed Policy on Savers

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Ceapro Inc. Announces R&D Funding to Support PGX Technology Project

– PGX Technology further recognized as a disruptive technology

– Additional support paves the way for the manufacturing of pharmaceutical-grade yeast beta glucan (YBG)

EDMONTON, Alberta, Nov. 29, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced they are receiving advisory services and up to $480,000 in funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to support Ceapro’s project entitled, “Boosting innovation capacity of Pressurized Gas eXpanded Technology (PGX) towards pharmaceutical applications.”

This project follows previous work supported by NRC IRAP where Ceapro successfully upgraded its Edmonton-based demonstration PGX plant and developed several biopolymer blends like alginate-yeast beta glucan-CoQ10 as well as a pure powder formulation of yeast beta glucan, which is now being studied as a potential inhalable therapeutic for fibrotic lung diseases including COVID-19 conditions.

This additional support from NRC IRAP will allow Ceapro to further develop the patented PGX Technology to increase its innovation capacity by designing the first pharmaceutical PGX processing unit along with bioactive impregnation and loading units. These new units will be used to generate active pharmaceutical ingredients like yeast beta glucan needed for stability studies and clinical human trials required to confirm its immune-boosting benefits while also tackling post-COVID-19 conditions such as pain, depression, sleep disorders, anxiety, and lung fibrosis.

“We are very grateful to NRC IRAP for their unwavering support,” said Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro. “In line with our stated strategy to expand our business model towards becoming a high-end Life Science company, this support will allow Ceapro to design and initiate the construction of the first pharmaceutical-grade PGX system that we believe will produce tomorrow’s active pharmaceutical ingredients.”

About Pressurized Gas eXpanded Liquid Technology (PGX)

Ceapro’s patented Pressurized Gas eXpanded (PGX) technology is a unique and disruptive technology with several key advantages over conventional drying and purification technologies that can be used to process biopolymers into high-value, fine-structured, open-porous polymer structures and novel biocomposites. PGX is ideally suited for processing challenging high-molecular-weight, water-soluble biopolymers. It has the ability to make ultra-light, highly porous polymer structures on a continuous basis, which is not possible using today’s conventional technologies. PGX was invented by Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta (U of A) along with Dr. Bernhard Seifried, now Senior Director of Engineering Research and Technology at Ceapro. The license from U of A provides Ceapro with exclusive worldwide rights in all industrial applications.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

This press release does not express or imply that the Company claims its product has the ability to eliminate, cure or contain the SARS-2-CoV-2 (COVID-19) at this time.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

Source: Ceapro Inc.

Ceapro Inc. Announces R&D Funding to Support PGX Technology Project

– PGX Technology further recognized as a disruptive technology

– Additional support paves the way for the manufacturing of pharmaceutical-grade yeast beta glucan (YBG)

EDMONTON, Alberta, Nov. 29, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced they are receiving advisory services and up to $480,000 in funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to support Ceapro’s project entitled, “Boosting innovation capacity of Pressurized Gas eXpanded Technology (PGX) towards pharmaceutical applications.”

This project follows previous work supported by NRC IRAP where Ceapro successfully upgraded its Edmonton-based demonstration PGX plant and developed several biopolymer blends like alginate-yeast beta glucan-CoQ10 as well as a pure powder formulation of yeast beta glucan, which is now being studied as a potential inhalable therapeutic for fibrotic lung diseases including COVID-19 conditions.

This additional support from NRC IRAP will allow Ceapro to further develop the patented PGX Technology to increase its innovation capacity by designing the first pharmaceutical PGX processing unit along with bioactive impregnation and loading units. These new units will be used to generate active pharmaceutical ingredients like yeast beta glucan needed for stability studies and clinical human trials required to confirm its immune-boosting benefits while also tackling post-COVID-19 conditions such as pain, depression, sleep disorders, anxiety, and lung fibrosis.

“We are very grateful to NRC IRAP for their unwavering support,” said Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro. “In line with our stated strategy to expand our business model towards becoming a high-end Life Science company, this support will allow Ceapro to design and initiate the construction of the first pharmaceutical-grade PGX system that we believe will produce tomorrow’s active pharmaceutical ingredients.”

About Pressurized Gas eXpanded Liquid Technology (PGX)

Ceapro’s patented Pressurized Gas eXpanded (PGX) technology is a unique and disruptive technology with several key advantages over conventional drying and purification technologies that can be used to process biopolymers into high-value, fine-structured, open-porous polymer structures and novel biocomposites. PGX is ideally suited for processing challenging high-molecular-weight, water-soluble biopolymers. It has the ability to make ultra-light, highly porous polymer structures on a continuous basis, which is not possible using today’s conventional technologies. PGX was invented by Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta (U of A) along with Dr. Bernhard Seifried, now Senior Director of Engineering Research and Technology at Ceapro. The license from U of A provides Ceapro with exclusive worldwide rights in all industrial applications.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

This press release does not express or imply that the Company claims its product has the ability to eliminate, cure or contain the SARS-2-CoV-2 (COVID-19) at this time.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

Source: Ceapro Inc.

Monday, November 29, 2021

Ocugen (OCGN)
Start of COVAXIN Clinical Trial Delayed by FDA Hold

Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Clinical Hold Delays Trial.  Ocugen announced that the FDA has issued a Clinical Hold for its Investigational New Drug Application for COVAXIN, its vaccine for protection from COVID-19. The IND delays the start of a bridging study designed to verify that the immune response in the US population is comparable to the Phase 3 study population. This Phase 3 data was submitted for marketing approval.


Reason For The Hold Were Not Specified.  Ocugen announced the IND submission on October 27, and began preparing for the clinical study. An IND becomes effective unless the FDA responds with questions or rejection within 30 days. The notification to Ocugen comes at the end of this 30-day period, but no reasons were provided. Based on previous cases, we believe the FDA could be taking extra …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Tuesday, November 23, 2021

Schwazze (SHWZ)
Post Management Call Commentary and Updated Models

Medicine Man Technologies, Inc. is now operating under its new trade name, Schwazze. Schwazze is executing its strategy to become a leading vertically integrated cannabis holding company with a portfolio consisting of top-tier licensed brands spanning cultivation, extraction, infused-product manufacturing, dispensary operations, consulting, and a nutrient line. Schwazze leadership includes Colorado cannabis leaders with proven expertise in product and business development as well as top-tier executives from Fortune 500 companies. As a leading platform for vertical integration, Schwazze is strengthening the operational efficiency of the cannabis industry in Colorado and beyond, promoting sustainable growth and increased access to capital, while delivering best-quality service and products to the end consumer. The corporate entity continues to be named Medicine Man Technologies, Inc.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Call w/Management. We remain enthusiastic about Schwazze following our conversation with CEO Justin Dye and CFO Nancy Huber. Management continues to increase market share, the implementation of the operating playbook is resulting in better than overall market performance, and there remains a defined pathway to get Schwazze to the $500 million revenue level.


MCG Acquisition.  The Company is acquiring MCG, LLC for $29 million. Also known as Emerald Fields, MCG operates two dispensaries, one in Denver and one just outside of Colorado Springs, a market in which adult use dispensaries have yet to be approved. The Manitou Springs locations is reportedly one of the highest grossing locations in Colorado …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Onconova Therapeutics To Present At The Piper Sandler 33rd Annual Virtual Healthcare Conference

NEWTOWN, Pa., Nov. 22, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company will be participating in the Piper Sandler 33rd Annual Virtual Healthcare Conference taking place November 29, 2021 through December 2, 2021.

A corporate overview presented by Steven Fruchtman, M.D., President & CEO of Onconova, will be available on-demand beginning today at 10:00 a.m. ET. The presentation can be viewed via the Piper Sandler presentation library on the conference site through December 2, 2021 for all registered attendees, and on the “Corporate Events and Presentations” section of the Onconova website.

The Company will also be participating in 1×1 meetings November 30, 2021 through December 2, 2021. Meetings can be requested exclusively via Piper Sandler.

About Onconova Therapeutics

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

For more information, please visit www.onconova.com.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors
929-469-3859
[email protected]

Onconova Therapeutics To Present At The Piper Sandler 33rd Annual Virtual Healthcare Conference

NEWTOWN, Pa., Nov. 22, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company will be participating in the Piper Sandler 33rd Annual Virtual Healthcare Conference taking place November 29, 2021 through December 2, 2021.

A corporate overview presented by Steven Fruchtman, M.D., President & CEO of Onconova, will be available on-demand beginning today at 10:00 a.m. ET. The presentation can be viewed via the Piper Sandler presentation library on the conference site through December 2, 2021 for all registered attendees, and on the “Corporate Events and Presentations” section of the Onconova website.

The Company will also be participating in 1×1 meetings November 30, 2021 through December 2, 2021. Meetings can be requested exclusively via Piper Sandler.

About Onconova Therapeutics

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

For more information, please visit www.onconova.com.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors
929-469-3859
[email protected]

Ocugen Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

MALVERN, Pa., Nov. 18, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced the Compensation Committee of the Board of Directors of Ocugen approved the grant of stock options to purchase an aggregate of 93,000 shares of its common stock and restricted stock units (RSUs) covering an aggregate of 15,600 shares of common stock to six hired employees. The stock options and RSUs were granted as of November 16, 2021, as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock options have a ten-year term and have an exercise price of $8.13 per share, which is the closing price of Ocugen’s common stock on the grant date. The stock options and RSUs vest in equal annual installments over a three-year period starting on the one-year anniversary of the grant date, subject to the applicable new employee’s continued service with Ocugen through the applicable vesting dates. The stock options and RSUs were granted outside of Ocugen’s 2019 Equity Incentive Plan.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug — “one to many,” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com. 

Cautionary Note on Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release. 

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
[email protected]

Ocugen Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

MALVERN, Pa., Nov. 18, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced the Compensation Committee of the Board of Directors of Ocugen approved the grant of stock options to purchase an aggregate of 93,000 shares of its common stock and restricted stock units (RSUs) covering an aggregate of 15,600 shares of common stock to six hired employees. The stock options and RSUs were granted as of November 16, 2021, as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock options have a ten-year term and have an exercise price of $8.13 per share, which is the closing price of Ocugen’s common stock on the grant date. The stock options and RSUs vest in equal annual installments over a three-year period starting on the one-year anniversary of the grant date, subject to the applicable new employee’s continued service with Ocugen through the applicable vesting dates. The stock options and RSUs were granted outside of Ocugen’s 2019 Equity Incentive Plan.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug — “one to many,” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com. 

Cautionary Note on Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release. 

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
[email protected]