From the January work plan for 2020 regarding AE/NGIO:
In 2019, we also made significant progress in revitalizing our oncology franchise.
Generex has a long, 15-year history of developing immunotherapeutic products
including our lead immunotherapeutic product AE37, a HER2/neu peptide linked to IiKey that has shown activity in breast cancer. The value of our technology, however, has
been locked in NuGenerex Immuno-Oncology (formerly Antigen Express) under the
Generex subsidiary structure. In 2018, we announced plans to spin out NuGenerex
Immuno-Oncology (NGIO) as a separate public company, and in 2019 we explored a
number of options, including the evaluation of several acquisition targets and potential
merger partners. At the end of the year, we made the decision to bring NGIO directly to
the public markets in order to unleash the inherent value of our immune system
activating Ii-Key technology that activates T-cells against cancer antigens. Our
technology platform has been rejuvenated by the huge market success of the PD-1, PDL1, and CTLA 4/6 immune checkpoint inhibitors, six of which have been approved by FDA
in the last couple of years. This was demonstrated by our success this past year in
resurrecting the clinical development of AE37 in breast cancer, and we are currently
conducting a phase II clinical trial of AE37 in combination with pembrolizumab (Merck’s
Keytruda) for the treatment of triple-negative breast cancer. The first cohort of
patients has completed the initial safety evaluation for AE37/Keytruda combination
therapy, and we are looking forward to completing the patient enrollment this year.
In addition to the Merck research agreement, we have a licensing and development
agreement with Shenzhen Bioscien, a Chinese biopharmaceutical company for the use
of AE37 in the treatment of prostate cancer in China. Our partners at Shenzhen are
working with the Chinese regulatory authorities to obtain approval for conducting trials
in China, which includes fulfilling manufacturing and pre-clinical requirements. As per
our licensing agreement, Shenzhen is planning a global trial in China and in Europe using
one of our clinical research sites that have previous experience conducting clinical trials
with AE37. We look forward to seeing further progress with the prostate cancer clinical
program in 2020.
We expect to achieve the public spin-out of NGIO in the first quarter of calendar 2020.
Following funding of the newly-public NGIO, we have plans to conduct a Phase II clinical
trial of AE37 in combination with checkpoint inhibitor therapy for the treatment of
bladder/urothelial cancer and another Phase II trial using the Ii-Key peptides GP-100 and
TYR in combination with checkpoint inhibitors for the treatment of melanoma. Both of
Page 5 of 7
these trials are being planned with two leading oncology research institutions, and
additional announcements will be forthcoming regarding these clinical collaborations.
In 2019, we also made significant progress in revitalizing our oncology franchise.
Generex has a long, 15-year history of developing immunotherapeutic products
including our lead immunotherapeutic product AE37, a HER2/neu peptide linked to IiKey that has shown activity in breast cancer. The value of our technology, however, has
been locked in NuGenerex Immuno-Oncology (formerly Antigen Express) under the
Generex subsidiary structure. In 2018, we announced plans to spin out NuGenerex
Immuno-Oncology (NGIO) as a separate public company, and in 2019 we explored a
number of options, including the evaluation of several acquisition targets and potential
merger partners. At the end of the year, we made the decision to bring NGIO directly to
the public markets in order to unleash the inherent value of our immune system
activating Ii-Key technology that activates T-cells against cancer antigens. Our
technology platform has been rejuvenated by the huge market success of the PD-1, PDL1, and CTLA 4/6 immune checkpoint inhibitors, six of which have been approved by FDA
in the last couple of years. This was demonstrated by our success this past year in
resurrecting the clinical development of AE37 in breast cancer, and we are currently
conducting a phase II clinical trial of AE37 in combination with pembrolizumab (Merck’s
Keytruda) for the treatment of triple-negative breast cancer. The first cohort of
patients has completed the initial safety evaluation for AE37/Keytruda combination
therapy, and we are looking forward to completing the patient enrollment this year.
In addition to the Merck research agreement, we have a licensing and development
agreement with Shenzhen Bioscien, a Chinese biopharmaceutical company for the use
of AE37 in the treatment of prostate cancer in China. Our partners at Shenzhen are
working with the Chinese regulatory authorities to obtain approval for conducting trials
in China, which includes fulfilling manufacturing and pre-clinical requirements. As per
our licensing agreement, Shenzhen is planning a global trial in China and in Europe using
one of our clinical research sites that have previous experience conducting clinical trials
with AE37. We look forward to seeing further progress with the prostate cancer clinical
program in 2020.
We expect to achieve the public spin-out of NGIO in the first quarter of calendar 2020.
Following funding of the newly-public NGIO, we have plans to conduct a Phase II clinical
trial of AE37 in combination with checkpoint inhibitor therapy for the treatment of
bladder/urothelial cancer and another Phase II trial using the Ii-Key peptides GP-100 and
TYR in combination with checkpoint inhibitors for the treatment of melanoma. Both of
Page 5 of 7
these trials are being planned with two leading oncology research institutions, and
additional announcements will be forthcoming regarding these clinical collaborations.
3
