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Updated List — Corporal Punishment Poll For PPHM
If you agree with Ronin's position on current state of Peregrine management, and the potential addition of new board members add your name to the list. Big prize for the winners. Higher stock price.
Copy and paste with your name added. Mods will delete older versions to reduce the number of these posts.
Good luck!
1. Cheynew
2. Stoneroad
3. Hayward
4. Pphmfan
5. Hawkfan1
6. RevMonster
7. Corporal
8. Internet forum user
9. BioBS2012
10. Chevalblamc47
11. El8abin0
12. Wernaaa (& Co)
13. exwannabe
14. Ku
15. Dorf1
16. Mauriziomh
17. Jimsgtx
18. JCNJ
19. ACES UP
20. Veeets
21. Bigbro1
22. The Other Guy
23. Thomas517
24. eastcoastguy
25. Tawrus
26. Joe Six Pack (sulaco)
27. Harry Crum
28. Sliken
29. djohn
30. Along4theride
31. bfiest
32. Cures For Humanity
33. Bobby1151
34. Pergri
35. Roger1
36 Realist1
37. Veradero
38. Franny b
39. denise1970
40. Tutone
41. John R
42. Vancouverbaggie
43. Nelgglen
44. Threes
45. Justmarried
46. Bigwup
47. Stephensrevenge
48. war0001
49. 034runner
50. N3m3sis
51. JB27
52. Loofman
53. CaffeinatedInNC
54. jj1223
55. Mozer
56. El Sid
57. Dr. Rocker
58. Cubflyer1946
59. Volten
60. itsaboutime
What adds up is that the BOD has been called out in a PR news wire for all to see the history of all their shenanigans.
When your using shareholders money recklessly you get these results over and over again. BOD gets paid well though rest assured. Time for a change of the guard. Lackeys need to go lived fat on our money long enough.
New puzzle piece being added changeover of the BOD.
Reasonably detailed, summation letter of what most on this board have been lamenting about for a long time. Based on train wreck past this could put the old engine back on track for shareholders. Time will tell. I believe this guy more than all of the current BOD and management.
Thanks for this information I am in a lot of bio stocks so not completely up on all of them.
PINT and CYTOVIA are in collaboration and will spin off from IMNP.
Cytovia will no longer be in the picture unless I am missing something.
How does this recent news help this consideration?
All this news. What to make of it?
Immune Pharmaceuticals Files 8K - Entry Into Definitive Agreement >IMNP
1:37 pm ET July 12, 2017 (Dow Jones) Print
Immune Pharmaceuticals Inc. (IMNP) filed a Form 8K - Entry Into a Definitive Agreement - with the U.S Securities and Exchange Commission on July 10, 2017.
On July 10, 2017, Immune Pharmaceuticals Inc.'s (the "Company") subsidiary, Cytovia Inc. ("Cytovia"), entered into an exclusive licensing agreement (the "Licensing Agreement") with Pint Pharma International S.A. ("Pint"), a specialty pharmaceutical company focused on Latin America and other markets, for the marketing, commercialization and distribution of Ceplene throughout Latin America (the "Territory", as more fully defined in the Licensing Agreement) through Pint and one or more of its affiliates. Pursuant to the Licensing Agreement, Pint will also pay Cytovia (i) 35% of net sales in the territory (ii) a milestone payment of $500,000 when net sales of Ceplene in the Territory first reach $10,000,000 in any calendar year and (iii) a milestone payment of $1,250,000 when net sales of Ceplene in the Territory first reach $25,000,000 in any calendar year. Cytovia further granted Pint and its affiliates certain sublicensing rights to Ceplene, and a right of first refusal on any new products of Cytovia within the Territory during the term of the Licensing Agreement.
With regard to any regulatory approvals and filings related to the commercialization of Ceplene within the Territory, Pint shall be the applicant, holder of such regulatory approvals and will be responsible for the content of such regulatory submissions, as well as all costs and expenses related to, among other items delineated in the Licensing Agreement, the fees, filings, compliance, registration and maintenance of such required regulatory approval matters. Cytovia shall be responsible for providing (or if in the control of a third party, to ensure such third party provides) all appropriate documentation, samples and other information in support of Pint in connection with its regulatory submissions, compliance and maintenance matters in the Territory concerning the Ceplene product(s).
Additionally, in connection with the Licensing Agreement, the parties thereto agreed that Pint Gmbh, an affiliate of Pint, will separately enter into an investment agreement, pursuant to which Pint Gmbh will make to an investment of $4 million USD at series A valuation into Cytovia in exchange for an equity interest in Cytovia. Dr. Massimo Radaelli, Executive Chairman of Pint, will also join the board of Cytovia upon completion of the investment and an effective spin off of Cytovia from the Company, if and as consummated.
The foregoing descriptions of the terms of the Licensing Agreement and the transactions contemplated thereby do not purport to be complete and, therefore, are subject to, and qualified in their entirety by such document attached hereto as Exhibits 10.1, and incorporated herein by reference. The Licensing Agreement contains certain representations and warranties that the respective parties made to, and solely for the benefit of, the other parties thereto in the context of all of the terms and conditions of that agreement and in the context of the specific relationship between the parties, and are not for the benefit of any party other than the parties to such agreements or as stated therein and are not intended as documents for investors and the public to obtain factual information about the current state of affairs of the parties to such document and agreements.
The full text of this SEC filing can be retrieved at: http://www.sec.gov/Archives/edgar/data/1208261/000114420417036526/v470683_8k.htm
Any exhibits and associated documents for this SEC filing can be retrieved at: http://www.sec.gov/Archives/edgar/data/1208261/000114420417036526/0001144204-17-036526-index.htm
Public companies must file a Form 8-K, or current report, with the SEC generally within four days of any event that could materially affect a company's financial position or the value of its shares.
(END) Dow Jones Newswires
July 12, 2017 13:37 ET (17:37 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
Sounds like a strategy worth considering
Prepare for a short haircut over next couple days with Clay's group.
Would not enter a buy at this point.
Dia provided good insight on some potential needle movers in future
AS AN INVESTOR I WONDER HOW LONG IT IS BEFORE A R/S IS REQUIRED?
The first 180 day period ends Sept.10,2017. The second 180 day period ends March 18,2018. If additional time is required they may be granted an additional 45 days(see PPHM as an example). This would take the company up until early May 2018. So IF a R/S is required it COULD COME as late as 10 MONTHS from today.
WHAT IS NEEDED TO BRING THE SHARE PRICE OVER $1 FOR TEN DAYS?
In my opinion good news is needed to raise the share price. The bears and shorters take advantage of the absence of news. What news might we expect or hope for over the next 10 months?
1. In September 2017(2 months from now) we may receive top-line data from the phase 2 fourth line NSCLC trial using HS-110 plus low dose cyclophosphamide. Low dose CP has been used in combination with several CAR-T drugs- so its synergy with HS-110 will be of great interest.
2. Top-line data from the phase 2 HS-110 plus Opdivo NSCLC trial should be available in March 2018. However as this trial is open-label we may receive interim data at any time. It could come next week, or along with HS-110 plus CP data in September.
3. There could be further milestones hit in the Pelican trials triggering more of the $15 million grant. Recent Pelican news moved the share price up 25%.
4. There could be news from the Zika trial which would trigger some of its $1 million funding grant.
5. There could be partnering news. Clearly all six checkpoint inhibitor drug manufacturers will be following the HS-110 plus Opdivo trial. This is an open-label trial and both HTBX management, and big pharmas under confidentiality agreements, are watching the maturing data. CEO Wolf mentioned Merck, BMY and AZN as being interested. IF HS-110 can double or triple the effectiveness of their checkpoint inhibitors - they will be very interested!
6. And there could be more news from Pelican or Shattuck Labs or even an overall buy-out of Heat, Pelican and Shattuck Labs. Retail investors are always the last to know.
In my opinion the science and the off-the-shelf business model are great. At the present time the bears and shorters are playing their games. I remain long...I buy on dips...and am going on an extended holiday! Good luck to all longs!
Hope this works out eventually for the longs. I have no shares so 1v7 RS has no effect on me. Decided to add on the other side of split with Q coming up next week ETC. But will wait for draw down of Share price first. GLTA
Does the phrase "snake bit" come to mind.
All clear on the SEC front nice
Accordingly, the Panel has confirmed by letter, dated June 15, 2017, that the Company has regained compliance with Nasdaq's Listing Rule 5250(c)(1) and is in compliance with other applicable requirements as set forth in the decision and required for listing on The Nasdaq Stock Market, and has closed this matter.
Immune Pharmaceuticals' Oncology Subsidiary, Cytovia, Announces Addl. Clinical Trial Results on the Efficacy of Ceplene® in Combination Low-Dose IL-2 in Patients With Acute Myeloid Leukemia, Recently Published in Leukemia, a Leading Hematology Journal
ixty-seven per cent of patients with functional natural killer (NK) cells remained disease-free at a pre-determined end point that followed two years of treatment
Cytovia, the oncology subsidiary of Immune Pharmaceuticals Inc., a clinical stage biopharmaceutical company (NASDAQ: IMNP) ("Immune" or the "Company") announced the publication of clinical trial results on the use of Ceplene (histamine dihydrochloride) for relapse prevention in patients with acute myeloid leukemia (AML). The results were published in the leading hematology journal, Leukemia, published by Springer Nature. Investigators from the Universities of Gothenburg, Sweden and Rome, Italy reported that functional NK cells are clinically relevant anti-leukemic effector cells in AML patients who received treatment with Ceplene/IL-2.
Specifically, the investigators identified that approximately 60% of the AML patients who had received treatment with Ceplene/IL-2 harbored NK cells that were potentially reactive with the patient's leukemic cells. The "Re:Mission" phase IV trial results showed that 67% of patients with functional, autoreactive NK cells remained relapse-free for a pre-scheduled follow-up of 2 years vs. 11% relapse-free survival in corresponding patients devoid of active NK cells (p=0.0002, n=39). The results were based on analyses of the "Re:Mission" phase IV trial in AML, in which adult patients received Ceplene and low-dose IL-2 to prevent life-threatening relapses. For details of the trial design, please visit https://clinicaltrials.gov/ct2/show/NCT01347996?term=ceplene&rank=1.
The full text of the article published in Leukemia may be found at: https://www.nature.com/leu/journal/vaop/naam/pdf/leu2017151a.pdf.
"These results imply that potentially a large proportion of AML patients harbor efficacious anti-leukemic NK cells that are activated during immunotherapy with Ceplene in combination with low- dose IL-2. Additionally, NK cell profiling may contribute to optimally select patients who are suitable for treatment", said Fredrik Bergh Thorén, PhD, senior author of the Leukemia paper.
Cytovia's Dr. Daniel Teper added: "We are impressed by the quality of new scientific and clinical data, which further supports the relevance of Ceplene/IL-2 treatment for AML patients post first remission in preventing potentially life-threatening relapses of leukemia. Immune/Cytovia has been granted orphan drug designation for the use of Ceplene in combination with low-dose IL-2 in AML and is eligible for protocol assistance, potential R&D grants, waived FDA fees, tax credits and seven-year market drug exclusivity following approval in the United States."
Most patients with AML achieve complete remission from leukemia after receiving chemotherapy. However, the majority of adult patients experience relapse of AML, with poor prospects of long-term survival. Ceplene used in conjunction with low-dose Proleukin (interleukin-2) has been developed to prevent relapses in the post-chemotherapy phase of AML. A previous phase III trial in 320 patients confirmed the efficacy of Ceplene/IL-2 in preventing relapse of AML.
Ceplene in combination with low-dose IL-2 has been approved in more than 30 countries in Europe and in Israel for the treatment of AML and for maintenance of remission and prevention of relapse of leukemia. Currently, there are no approved therapies to prevent relapse for the vast majority of AML patients. An international Overall Survival study, REMAIN, is planned to support approval in the United States.
NEW YORK, July 5, 2017
For further information, contact: investors@immunepharma.com
About Ceplene
Ceplene (histamine dihydrochloride) is an immunostimulant that is administered in conjunction with low-dose interleukin-2 for maintenance of first remission in patients with AML. Ceplene has been shown in an international phase III clinical study to prevent relapse of leukemia in AML patients in first remission while maintaining good quality of life during treatment. Ceplene acts by countering dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong pharmacological rationale for this combination therapy. A Phase IV study presented at the meeting of the American Association for Cancer Research in 2016 supported the safety and efficacy of Ceplene as demonstrated in the international phase III study. As previously announced, Immune, through its oncology subsidiary, Cytovia, entered into an Asset Purchase Agreement on June 15, 2017 with Meda Pharma SARL, a Mylan N.V. company, to repurchase the remaining worldwide rights to Ceplene which it did not own previously.
About AML
AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis and typically become free of detectable leukemia, achieving "complete remission". However, within 1-2 years the majority of adult patients will experience a relapse of leukemia, of which the prognosis for survival is 33% in patients' younger than 60 years of age and 15-20% in patients over 60 years of age. According to the American Cancer Society, there will be approximately 21,380 new cases of AML and 10,590 deaths from AML in the US in 2017. AML represents an orphan indication with a particularly high unmet medical need.
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) is dedicated to alleviating the burden of patients suffering from autoimmune diseases by developing novel immunotherapeutic agents. Immune's lead product candidate, bertilimumab, is in Phase 2 clinical development for bullous pemphigoid, an orphan autoimmune dermatological condition, and for ulcerative colitis. Other potential relevant indications for bertilimumab include atopic dermatitis, Crohn's disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH). Also, Immune's pipeline includes topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis and AmiKet™ and AmiKet™ Nano™ for the treatment of neuropathic pain.
Immune's oncology subsidiary, Cytovia, plans to develop and commercialize Ceplene in combination with low-dose IL-2 for maintenance remission in AML. Additional oncology pipeline products include Azixa® and crolibulin, which are clinical stage vascular disrupting agents, and bispecific antibodies and NanomAbs™, which are novel technology platforms.
Skidmore's own a lot of shares on that 13G filing with aggregate sum of 397,765.
No history of a RS for this company from what I see. Interesting.
If we gain compliance on minimum bid with news drivers in future months perhaps it will be unnecessary.
More news
Heat Biologics Appoints Damien Hallet as Vice President of CMC Development
By AccessWire, July 03, 2017, 07:00:00 AM EDT
Vote up AAA
DURHAM, NC / ACCESSWIRE / July 3, 2017 /Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), a leader in the development of novel therapies designed to activate a patient's immune system against cancer, has announced the appointment of Damien Hallet as Vice President of Chemicals, Manufacturing and Controls (CMC).
"Damien has extensive technical and development expertise and I believe he is ideally suited to lead the next phase of growth across our development and manufacturing," said Jeff Wolf, CEO. "I am pleased to add him to our leadership team and I'm confident that he will continue his track record of success."
Mr. Hallet was promoted from his previous position as Senior Director of CMC. In this new role, he will be responsible for all aspects of development and manufacturing for the company's whole cell cancer immuno-therapy materials currently in clinical trials. He will also oversee the further development of the PTX-25 antibody from Heat's Pelican Therapeutics subsidiary.
Mr. Hallet has 17 years experience working in cell therapy and antibody development for such companies as Sanofi, Gencell SAS and UCB Pharma. He received his Masters of Advanced Studies in Industrial Microbiology from Ecole Doctorale de Toulouse, and a Biochemical Engineering degree from INSA de Toulouse, Grande Ecole.
"I am excited to be leading the CMC function within a company that has the potential to change the lives of cancer patients. Our allogeneic technology makes possible the development of scalable manufacturing processes and off-the-shelf treatments that could facilitate the access to our therapies across the globe," Hallet said. "We will continue to build our manufacturing efforts, while leading the development of next-generation capabilities to ensure our therapies are of the highest quality, safety and reliability for our clinical trials and the patient community."
About Heat Biologics, Inc.
Heat Biologics, Inc. (Nasdaq:HTBX) is an immuno-oncology company developing therapies designed to activate a patient's immune system against cancer. Heat has generated highly specific T cell-stimulating therapeutic platform technologies, known as ImPACT and ComPACT. These technologies, in combination with other therapies such as checkpoint inhibitors, are designed to address three distinct but synergistic mechanisms-of-action: robust activation of CD8+ "killer" T cells (one of the immune system's most potent weapons against cancer); reversal of tumor-induced immune suppression; and T cell co-stimulation to further enhance a patient's immune response. Currently, Heat is conducting a Phase II trial with HS-110 (viagenpumatucel-L) in combination with an anti-PD-1 checkpoint inhibitor to treat patients with non-small, cell lung cancer (NSCLC).
In addition to Heat's recent portfolio expansion due to the acquisition of Pelican Therapeutics, the company's wholly-owned subsidiary, Zolovax, Inc., is developing therapeutic and preventative vaccines to treat infectious diseases based on Heat's gp96 vaccine technology Its current focus is on the development of a Zika vaccine in conjunction with the University of Miami.
For more information, please visit www.heatbio.com.
No hurry on RS if any?
Dr. Jeff Hutchins Appointed Chief Operating Officer for Heat Biologics
By AccessWire, July 03, 2017, 07:05:00 AM EDT
Vote up AAA
DURHAM, NC / ACCESSWIRE / July 3, 2017 / Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), a leader in the development of novel therapies designed to activate a patient's immune system against cancer, has named Dr. Jeff Hutchins as its Chief Scientific and Operating Officer. Dr. Hutchins was formerly Heat's Chief Scientific Officer and Senior Vice President, Pre-clinical Development. In his new role, Dr. Hutchins will lead all product development efforts for Heat and its Pelican Therapeutics subsidiary.
"Dr. Hutchins has played a critical role in Heat's evolution and has been a vital member of our executive team," said CEO, Jeff Wolf. "He is a talented scientist and accomplished biotech executive, and his vision and expertise should help us accelerate our clinical activities on the heels of the most recent encouraging clinical results in our ongoing Phase 2 clinical trial of HS-110 in combination with Bristol-Myers Squibb's anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo®), for the treatment of non-small cell lung cancer (NSCLC)."
"This is an exciting time to be at Heat Biologics and I am honored to assume the responsibility of overseeing its product development efforts," said Hutchins. "My goal in this new role is to progress our innovative product pipeline to the marketplace as rapidly and efficiently as possible. I look forward to continuing to work with a very talented team to advance our exciting Phase 2 lung cancer clinical trial in combination with nivolumab. We are encouraged by the industry response following the positive interim data we reported earlier this year, and look forward to reporting additional data later this year."
Dr. Hutchins brings more than 24 years of research and clinical development experience from both pharmaceutical and biotechnology companies. Dr. Hutchins earned his PhD in Biomedical Sciences from the University of Texas, Health Science Center at the M.D. Anderson Cancer Center. Prior to joining Heat, he served as Vice President of Pre-clinical Research for Peregrine Pharmaceuticals, Inc., and as Vice President of Pre-clinical Development at Inhibitex Inc., which was acquired by Bristol-Myers Squibb.
The Company also provided an update following the Annual Meeting of Shareholders, in which it reiterated that it has no immediate plans to conduct a reverse split. The proposal, as adopted in prior years, was a precautionary measure for corporate governance purposes and to provide the board with maximum flexibility.
"The resolutions approved provide the board with the flexibility it needs for good corporate governance," added Wolf. "Although the shareholders empowered the board to effect a reverse stock split in its discretion, we do not intend to proceed with such a split at this time, and consider this to be just one of many options available to us in the future to maintain shareholder value," added Wolf.
Yes we do
What could this be?
SEC Grants Heat Biologics Request For Confidential Treatment
BY Midnight Trader
— 3:59 PM ET 06/14/2017
03:59 PM EDT, 06/14/2017 (MT Newswires) -- Heat Biologics ( HTBX )
Made request for confidential treatment for information it excluded from a Form 10-K filed on May 3, 2017 has been granted by the Securities and Exchange Commission.
Heat Biologics
HTBX said the information qualifies as confidential commercial or financial information under the Freedom of Information Act.
According to the SEC, the excluded information will not be released to the public through May 3, 2022.
Price: 0.63, Change: -0.01, Percent Change: -1.31
MT Newswires does not provide investment advice. Unauthorized reproduction is strictly prohibited.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
June 14, 2017
ORDER GRANTING CONFIDENTIAL TREATMENT
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Heat Biologics, Inc.
File No. 1-35994 - CF#35080
_____________________
Heat Biologics, Inc. submitted an application under Rule 24b-2 requesting
confidential treatment for information it excluded from the Exhibits to a Form 8-K filed
on May 3, 2017.
Based on representations by Heat Biologics, Inc. that this information qualifies as
confidential commercial or financial information under the Freedom of Information Act,
5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly
disclose it. Accordingly, excluded information from the following exhibits will not be
released to the public for the time periods specified:
Exhibit 10.2 through May 3, 2022
Exhibit 10.3 through May 3, 2022
Exhibit 10.4 through May 3, 2022
Exhibit 10.5 through May 3, 2022
Exhibit 10.6 through May 3, 2022
Exhibit 10.7 through May 3, 2022
Exhibit 10.8 through May 3, 2022
Exhibit 10.9 through May 3, 2022
For the Commission, by the Division of Corporation Finance, pursuant to
delegated authority:
Brent J. Fields
Secretary
Thanks for information
Curious to know the possible timeline for a PR on this Zika vaccine development. To answer my own question.
Since it is a recent grant were probably looking at a year or two.
HS-110 (viagenpumatucel-L) – Non-Small Cell Lung Cancer
HS-110 (viagenpumatucel-L) is a biologic product candidate comprising a cancer cell line that has been genetically modified using our ImPACT® technology platform to secrete a wide range of cancer-associated antigens related to lung cancer bound to gp96 proteins. We believe that HS-110 has the potential to activate a T cell-mediated pan-antigen immune response that could be an effective treatment for patients with NSCLC.
We are conducting a Phase 2 clinical trial evaluating HS-110 in combination with nivolumab (Opdivo®), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, to treat patients with NSCLC. The trial is structured as a Phase 1b/Phase 2 with pre-specified thresholds in place to expand the trial to a full Phase 2. The multicenter, open-label trial is expected to initially enroll 18 patients evaluable for baseline biopsy and is designed to accommodate cohort expansion in Phase 2 up to 30 patients per arm (approximately 60 patients). The purpose of the trial is to evaluate the safety and efficacy of HS-110 in combination with nivolumab, an FDA approved anti-PD-1 checkpoint inhibitor, in patients with NSCLC whose cancers have progressed after first-line therapy. Primary and secondary trial endpoints include safety and tolerability, immune response, overall response rate and progression-free survival. Trial enrollment is currently ongoing.
On March 21, 2017, we reported positive interim results for the Phase 2 trial evaluating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo®), for the treatment of non-small cell lung cancer (NSCLC). Fifteen patients have completed the HS-110/nivolumab combination to-date and 12 of these 15 patients were evaluable for ELISPOT analysis. ELISPOT results suggest that HS-110 plays an integral role in tumor reduction and may enhance efficacy of checkpoint inhibitors in lung cancer patients. Immune responses to HS-110 were observed in all 5 patients that exhibited tumor reductions. No tumor reductions were observed in patients that did not mount an immune response to HS-110. The timing of immune response to HS-110 corresponded to the timing of observed clinical responses, and those responses appear to be sustained. Furthermore, to-date 5 patients have been enrolled in the low tumor infiltrating lymphocytes (TIL) cohort. Three of these 5 patients (60%) have experienced significant tumor reduction, which is higher than the 10% response rate of low TIL patients reported by Teng et al, Cancer Research 75(11) June 1, 2015 for existing data on nivolumab alone.
On March 13, 2017, we issued a press release announcing that we achieved the safety and efficacy endpoints for the Phase 1b trial evaluating HS-110 in combination with nivolumab (Opdivo®), for the treatment of NSCLC and that the trial met the expansion criteria to advance into a Phase 2. Five out of 15 patients treated with the HS-110/nivolumab combination had 20% or greater tumor reduction. Patients with increased levels of TIL at 10 weeks appeared to have a durable benefit, with six out of eight of these patients (75%) alive at the one-year follow-up point. The Data Monitoring Committee concluded that the positive safety profile, mechanistic evidence and encouraging signs of synergistic efficacy warranted expansion to a Phase 2 trial.
Curious to know the possible timeline for a PR on this Zika vaccine development
Heat Biologic Announces Florida Department of Health Awards Three-Year Grant to Develop gp96-based Zika Vaccine
7:15 am ET March 16, 2017 (Benzinga) Print
Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX) announced that Natasa Strbo, M.D., D.Sc., Research Assistant Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine, received a three-year $981,901 grant from the Florida Department of Health 2016-17 Zika Research Grant Initiative to further develop and test gp96-based Zika vaccine. This vaccine is being developed under a collaboration between the University of Miami and Heat's wholly-owned subsidiary, Zolovax, Inc., which has licensed the patent.
© 2017 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
no plans on attending will be outside US on those days
Think I found my answer on the trials I was looking for.
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failure of Two or Three Previous Treatment Regimens for Advanced Disease
And
Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of Viagenpumatucel-L (HS-110) in Combination With Multiple Treatment Regimens in Patients With Non-Small Cell Lung Cancer (The "DURGA" Trial)
Since this is an open label trial was the interim data analysis designed for a read out every 10TH week?
What was the timeline for a PR on results for this Phase 2 trial?
Heat is conducting a Phase 2 trial with HS-110 (viagenpumatucel-L) in combination with an anti-PD-1 checkpoint inhibitor to treat patients with non-small cell lung cancer (NSCLC).
The strategy is very clear in this presentation:
https://www.sec.gov/Archives/edgar/data/1476963/000155335017000694/htbx_ex99z1.htm
Do we have a pulse?
DIA
Everyone knows somebody touched with these diseases. This space has potential.
Dia
There is enough pipeline potential to add shares for those interested in speculating.
We should get top line results from the phase 2 NSCLC HS-110 plus low dose cyclophosphamide in June or July. Low dose CPA has been used as a priming dose in several recent CAR-T trials.
We should get the 2 year update on the phase 2 HS-410 + SOC trial in bladder cancer in the fall. Interim results show immune response effect not seen with SOC alone. Often SOC alone results fall off by as much as 40% in the second year.
We could get an update on the open label phase 2 HS-110 plus Opdivo NSCLC at any time. If it continues to turn 50-60% of cold tumours into hot tumours...it will be of great interest to international pharmas!
We could see several new drugs go into the clinic.
We could see the first ComPACT (gp96 + OX40) trial.
We could see the first PTX-25 trial(funded by Texas).
We could see some Zika preclinical results.
We could also receive partnering news at any time. We know that "an international pharmaceutical company" took part in the recent cash raise by the Shattuck Labs spinoff. The name of the company has not been revealed....but they are obviously interested. If there is partnering there could be a phase 3 by the end of this year or early next year. Or there could just be a buyout. There is plenty about Heat for Big Pharmas to like IMO!
Dia
Added to my position-although a speculative investment there are many potentially positive developments to consider in this space some of which you highlighted below.
None of us know what is happening behind the scenes. I found it very interesting that the Shattuck Labs CEO Hornblower revealed that an "international pharmaceutical company" had taken a considerable share in their latest private placement. Shattuck Labs is where Dr. Schreiber(who currently chairs Heats SAC and formerly was Heats CSO) is now the CSO. They have licensed technology from Heat just as Pelican did.
CEO Hornblower did not release the name of the company...but this is the first concrete indication of a Big Pharma taking a role in a company closely tied to Heat!
Heat has produced a lot of very positive preclinical and clinical data. What they need now is more demonstrated interest from one or more of the companies who need help in making their checkpoint inhibitors more effective. This could come in the form of a partnership or even a buyout. Only time will tell....but if there are serious negotiations they will be behind the scenes...and we will only know after all agreements have been signed!
Dia I appreciate the information. EOM
What trials are we expecting an update on?
Before March 2018 I expect some good news from trials and one of the following possibilities...
Sorry in too many BIOS to keep up on news.
check sec filings this evening EOM
Oh and we thank all of you shareholders for your support
In due time. EOM
Could think of several International Pharma companies interested financing this science.
Shattuck Labs, Inc.
What We Do (non-layperson’s version)
The technology being developed at Shattuck Labs was conceived in order to address two basic flaws in current cancer immunotherapeutics. The first (which is partially solved by technologies including bispecific antibodies, BiTEs, DARTs and engineered scFv’s) is to design biologic molecules that are endowed with multiple functionalities. The second (not solved by any of the technologies mentioned above) is to design a biologic molecule that can simultaneously block candidate checkpoint molecules in cancer while also stimulating TNF superfamily costimulatory receptors on T cells (and innate cells). The technology platform is called ARC (Agonist Redirected Checkpoints), and is adaptable to most of the checkpoint targets currently in clinical development. We are currently entering cell line development for several lead molecules, and expect to be in the clinic within the next 18 months.
There connecting the dots and they see $$ coming down the pike for there investment.