Cancer Program FDA gave three options: 1) tNBC s
Post# of 148178
(Total Views: 608)
Posted On: 02/06/2020 4:43:59 PM
Cancer Program
FDA gave three options:
1) tNBC study
2) Compassionate Use / Expanded Access
3) Emergency Patient IND
Total of 6 patients enrolled to date.
Results from 4 patients so far.
Pt 1) Injected in Sept 27. 2 weeks CTC went from 5 to 0 copy/ml. Next three months CTC remained zero.
P2 (MIL) June 27, 2019, metastasis to brain. Main tumor reduced 56% once on LERO.
Pt 3: Injected Jan 7. 2 weeks CTC from 9 to 2.
Pt 4: Jan 2. CAML reduced from 45 to 30.
Dr. Patterson:
1) Shrinking of primary tumor
2) Reduction in metastasis via reduced CTC.
3) ???
4) Metastatic lesions have shrunk, just like the primary tumors.
NP:
Patient 5 & 6 have been enrolled.
4 more pts in next couple of weeks.
BTD – filing happened on Jan 10th.
Updated the FDA with Pt 1, 2, 3, & 4
Might have to wait 60 days from today, instead of starting the clock from Jan 10th.
Update CRONOVIRUS in China & Licensing for cancer in China
Mike Klump introduced us to Dr. Patterson
Dr. P – found the three other MOAs (5 of 6 current pts didn’t have CCR5 on primary tumor cell)
Dr. P – has contacts in China.
Signed NBA, licensing cancer and coronovirus to one of largest health providers (biopharma company) in China
Dr. P met with them 3 weeks ago
Company was involved in CAR-T and T-cell therapies
T-reg cells and reprogramming of macrophages, is what could be efficacious in Coronovirus
Partner submitted safety and efficacy data to China’s FDA equivalent (“CFDA”)
Basket Trial PR
Submitted under same IND as cancer IND. It will take a few weeks to get IRB approval. Hope by the EOM, they can get people to start enrolling
Now have 70 on waiting list to enroll.
BLA
Clinical section b/c FDA wanted all MONO data
Will be delayed until the end of February
CMC
Will be delayed until the end of February
Stability data was not given by AGC
Should be done very quickly
PreP Study & more licensing
Talking and communicating with Big Pharma
Exploring HIV licensing in EU
MOA Thai Red Cross – have protocol ready to go, 1200 pts
Fundraising
CEO for 7yrs
Raised $240M over those years total
NP raised $90M without Paulson
Craig Eastwood
1) Recent Series D
a. 8k earlier this week
b. $7.6M gross proceeds
2) Debt Financing
a. Dec 17th, 2019 – Vyera licensing deal.
b. As nearer to commercialization, looking to strike balance btw debt and equity
c. Working with IB to gauge debt financing interest
3) Other financing opportunities
a. Fully retired outstanding notes
b. Warrants are being exercised
Q&A
Frank Golden, PI
Q: NASH – where are we with publishing and licensing
A: Working with a few companies re: licensing. Chairman of Board located company to do new study – more analogous to previous study.
Ye Chen, HC Wainright
Q: BLA status
A: Two remaining sections by end of Feb?
Delay related to AMAREX and gathering patient data
Q: When to sign deal with Chinese partner?
A: Will be PR when it is ready to be announced.
Q: Any pre-clinical study re: efficacy with Coronovirus
A: Dr. P, know role of CCR5 in process given T-regs and macrophages.
Chinese were impressed with Safety and MOA.
Partner owns eight tier 1 hospitals in China
Partner will be doing clinical trials in these hospitals
Virus and cancer both use the cellular function of the immune system
Fred B., PI
Q: Business Plan re: raising money. Plan to share BP to other investors.
A: Not raising funds via PIPE, RD, or similar funding right now.
Nick K., ??? Capital
Q: Shareholder equity requirements necessary to uplist? And plan to achieve it.
A: Craig didn’t answer
NP $5M SE for NYSE, 18month
Sounds like NP knows the exact details for each of the different exchanges. Sounds like they are thinking about it and watching it very closely.
JM Cohen
Q: Updated P3 data on COMBO or MONO
A:
MONO – responders rate, post 10 weeks, 96%
Mark Lieber, NewMark
Q: Why swings in SP today?
A:
NP: Double-digit stock price is not enough. Triple-digit is where it should be.
FDA gave three options:
1) tNBC study
2) Compassionate Use / Expanded Access
3) Emergency Patient IND
Total of 6 patients enrolled to date.
Results from 4 patients so far.
Pt 1) Injected in Sept 27. 2 weeks CTC went from 5 to 0 copy/ml. Next three months CTC remained zero.
P2 (MIL) June 27, 2019, metastasis to brain. Main tumor reduced 56% once on LERO.
Pt 3: Injected Jan 7. 2 weeks CTC from 9 to 2.
Pt 4: Jan 2. CAML reduced from 45 to 30.
Dr. Patterson:
1) Shrinking of primary tumor
2) Reduction in metastasis via reduced CTC.
3) ???
4) Metastatic lesions have shrunk, just like the primary tumors.
NP:
Patient 5 & 6 have been enrolled.
4 more pts in next couple of weeks.
BTD – filing happened on Jan 10th.
Updated the FDA with Pt 1, 2, 3, & 4
Might have to wait 60 days from today, instead of starting the clock from Jan 10th.
Update CRONOVIRUS in China & Licensing for cancer in China
Mike Klump introduced us to Dr. Patterson
Dr. P – found the three other MOAs (5 of 6 current pts didn’t have CCR5 on primary tumor cell)
Dr. P – has contacts in China.
Signed NBA, licensing cancer and coronovirus to one of largest health providers (biopharma company) in China
Dr. P met with them 3 weeks ago
Company was involved in CAR-T and T-cell therapies
T-reg cells and reprogramming of macrophages, is what could be efficacious in Coronovirus
Partner submitted safety and efficacy data to China’s FDA equivalent (“CFDA”)
Basket Trial PR
Submitted under same IND as cancer IND. It will take a few weeks to get IRB approval. Hope by the EOM, they can get people to start enrolling
Now have 70 on waiting list to enroll.
BLA
Clinical section b/c FDA wanted all MONO data
Will be delayed until the end of February
CMC
Will be delayed until the end of February
Stability data was not given by AGC
Should be done very quickly
PreP Study & more licensing
Talking and communicating with Big Pharma
Exploring HIV licensing in EU
MOA Thai Red Cross – have protocol ready to go, 1200 pts
Fundraising
CEO for 7yrs
Raised $240M over those years total
NP raised $90M without Paulson
Craig Eastwood
1) Recent Series D
a. 8k earlier this week
b. $7.6M gross proceeds
2) Debt Financing
a. Dec 17th, 2019 – Vyera licensing deal.
b. As nearer to commercialization, looking to strike balance btw debt and equity
c. Working with IB to gauge debt financing interest
3) Other financing opportunities
a. Fully retired outstanding notes
b. Warrants are being exercised
Q&A
Frank Golden, PI
Q: NASH – where are we with publishing and licensing
A: Working with a few companies re: licensing. Chairman of Board located company to do new study – more analogous to previous study.
Ye Chen, HC Wainright
Q: BLA status
A: Two remaining sections by end of Feb?
Delay related to AMAREX and gathering patient data
Q: When to sign deal with Chinese partner?
A: Will be PR when it is ready to be announced.
Q: Any pre-clinical study re: efficacy with Coronovirus
A: Dr. P, know role of CCR5 in process given T-regs and macrophages.
Chinese were impressed with Safety and MOA.
Partner owns eight tier 1 hospitals in China
Partner will be doing clinical trials in these hospitals
Virus and cancer both use the cellular function of the immune system
Fred B., PI
Q: Business Plan re: raising money. Plan to share BP to other investors.
A: Not raising funds via PIPE, RD, or similar funding right now.
Nick K., ??? Capital
Q: Shareholder equity requirements necessary to uplist? And plan to achieve it.
A: Craig didn’t answer
NP $5M SE for NYSE, 18month
Sounds like NP knows the exact details for each of the different exchanges. Sounds like they are thinking about it and watching it very closely.
JM Cohen
Q: Updated P3 data on COMBO or MONO
A:
MONO – responders rate, post 10 weeks, 96%
Mark Lieber, NewMark
Q: Why swings in SP today?
A:
NP: Double-digit stock price is not enough. Triple-digit is where it should be.
(7)
(0)CytoDyn Inc (CYDY) Stock Research Links
Scroll down for more posts ▼