On October 5, 2018 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (View Source) reported that the Company, in conjunction with its research collaborators Merck and the NSABP Foundation, will file an IND in October to initiate A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer (Press release, Generex, OCT 5, 2018, View Source [SID1234529796]). It is anticipated that the trial will initiate sites in the fourth quarter and begin enrolling patients in the first quarter of 2019.

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Also, as previously announced, AE37 is being developed for the treatment of prostate cancer by the Company’s partner, Shenzhen Bioscien. The Company has nearly completed the non-clinical toxicology and pharmacology work required by the Chinese Food & Drug Administration (CFDA) and is preparing the necessary documentation for application to obtain authorization on the regulatory path for approval in China. Pending acceptance of that regulatory package, Shenzhen plans to initiate a Phase II clinical trial in Europe in 2019, with Generex maintaining Rest-of-World, ex-China rights to AE37 for the treatment of prostate cancer.

Further, in conjunction with the launch of the AE37/KEYTRUDA combination trial, and as part of the continuing restructuring of Generex, the Antigen Express name will be changed to NuGenerex Immuno-Oncology, remaining a wholly-owned subsidiary under the umbrella of the parent Company.

"We are excited to launch the clinical development of our HER2/neu immunotherapeutic vaccine AE37 in combination with Merck’s anti-PD-1 therapy, Keytruda, for the treatment of patients with triple-negative breast cancer," said Dr. Eric von Hofe, President of NuGenerex Immuno-Oncology. "With this trial and our partnership with Shenzhen Bioscien, NuGenerex Immuno-Oncology is positioned to realize the full potential of AE37 while advancing our proprietary Ii-Key technology platform for use in other cancers and diseases."

Generex Chief Medical and Scientific Officer, Dr. Jason Terrell, added: "NuGenerex Immuno-Oncology will be an important division within our restructured and diversified organization. This represents a successful advancement of our overall strategy to improve patient care through the development of innovative products and healthcare solutions."

Generex President & Chief Executive Officer Joe Moscato stated, "NuGenerex Immuno-Oncology is being established to not only to advance the Antigen Express core technology, but also to expand the Company’s portfolio in the field of immunotherapy and personalized medicine through partnerships and acquisitions. Generex has long demonstrated a belief and commitment to immune-therapy for the treatment of cancer through our extensive Ii-Key research & development program, and we are proud to be a leader in this emerging era of personalized, immuno-therapeutic cancer care."

On October 5, 2018 BerGenBio ASA (OSE: BGBIO) reported that the first patient has been dosed in the second stage of the phase II trial (BGBC008) evaluating the Company’s selective AXL inhibitor bemcentinib in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose disease is progressing (Press release, BerGenBio, OCT 5, 2018, View Source [SID1234529834]).

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The trial was advanced into the second stage on the basis that the first stage met its clinical efficacy endpoint (as announced on 26 June 2018). Updated results from the first stage (n=24) were presented at the 19th Annual World Conference on Lung Cancer (WCLC: 25 September 2018)*. The Company reported an overall response rate (ORR) of 40% in patients who tested positive for AXL expression (4 out of 10 pts). Efficacy was also seen in PD-L1 negative patients (ORR of 27%, 3 out of 11 pts) for whom KEYTRUDA monotherapy is currently not indicated. Treatment with the bemcentinib/KEYTRUDA combination was well tolerated.

The second stage will enrol a further 24 patients at sites in Norway, Spain, UK and the US, and aims to confirm the safety and clinical efficacy of the combination. Comprehensive exploratory studies will continue to evaluate biomarkers in tumour and blood indicative of AXL expression and immune modulation. Preliminary results from the trial are expected during 2019.

The BGBC008 trial (ClinicalTrials.gov Identifier: NCT03184571) is being sponsored by BerGenBio. MSD, a tradename of Merck & Co., Inc., Kenilworth, New Jersey, USA, will continue to supply KEYTRUDA for use in the study under a collaboration agreement signed in March 2017.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We recently reported positive data from this phase II clinical trial at WCLC. Patients that were AXL positive reported a clinical response rate of 40%. Most notably, this included PD-L1 negative patients who do not benefit from KEYTRUDA monotherapy. These data strengthen our confidence in bemcentinib’s mode of action, as well as the value of AXL inhibition to enhance patient outcomes to KEYTRUDA immunotherapy. Additional combination data in NSCLC, including bemcentinib with targeted and chemotherapy, also presented at WCLC provide further proof supporting the concept that AXL is a key player in mediating resistance to therapy and immune evasion, and that bemcentinib has the potential to become a
cornerstone therapy in this challenging indication. We look forward to reporting outcome and biomarker data at upcoming leading medical congresses."

* James Lorens et al. Ph II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Pembrolizumab in Patients with Advanced NSCLC(abstract P2.04-27)

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

– END –

About NSCLC
It is estimated that more than 230,000 new cases of lung cancer will be diagnosed in the US in 2018 and it is the leading cause of cancer deaths. 65% of NSCLCs are of adenocarcinoma pathology. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy and immune evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently required.

About the BGBC008 trial
The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy naïve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC). The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).

On October 4, 2018 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the third quarter ended September 30, 2018 before the US financial markets open on October 24, 2018 (Press release, Alexion, OCT 4, 2018, View Source [SID1234529852]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast at 8:00 a.m. Eastern Time (ET).

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To participate in this conference call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 5947065 shortly before 8:00 a.m. ET. The audio webcast can be accessed on the Investor page of View Source and an archived version will be available for a limited time following the presentation.

On October 4, 2018 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, and its Pelican Therapeutics subsidiary ("Pelican") reported on its novel PTX-35 co-stimulatory antibody. PTX-35 is designed to harness the body’s natural antigen-specific immune activation mechanisms (Press release, Heat Biologics, OCT 4, 2018, View Source [SID1234529871]). When combined with immunotherapies, including checkpoint inhibitors as well as Heat’s ImPACT and ComPACT technologies, PTX-35 has been shown to enhance antigen-specific T-cell activation to eliminate tumor cells in pre-clinical models.

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Recent PTX-35 highlights:

Completed cell line development and creation of validated master cell bank for cGMP manufacturing
Established CMC path for the production of GMP clinical material and non-clinical preliminary pharmacology / non-GLP toxicology studies
Preliminary non-GLP pharmacology demonstrates positive results, including efficient binding and activation on cells expressing the TNFRSF25 receptor, as well as increased expansion of T-cells in-vivo
2-week IND enabling dose range finding toxicology studies in primates receiving two doses show no signs or signals of clinical toxicity across wide dose range
Ongoing pre-IND discussions with FDA; expect to submit IND in Q1 2019
Rahul Jasuja, Ph.D., CEO of Pelican, commented, "We are progressing rapidly with our pre-clinical activities and expect to submit an IND for PTX-35 in the first quarter of 2019. We are strongly encouraged by the preliminary pre-clinical efficacy and safety data which shows no signs of toxicity across a wide range of doses."

Dr. Jasuja continued, "We have been efficient in our use of funds, which has allowed us to come in under budget, further extending our runway for this program. Given our operating efficiency thus far, we expect to receive the next tranche of grant funding once we fully utilize the funds that the Cancer Prevention Research Institute of Texas ("CPRIT") has previously provided. As we progress, our plan is to advance a broad clinical development program that could include combination therapy with Heat’s ImPACT and ComPACT therapies, as well as other costimulatory agonists, checkpoint inhibitors and immune modifiers to address the unmet need for patients who do not respond well to current cancer therapies."

The Company further reported that PTX-35 was featured in Nature’s Biopharma Dealmakers September 2018 edition, which is available at: View Source

To-date, Pelican has received $8.3 million in grants from CPRIT. The CPRIT award supports pre-clinical development, manufacturing and clinical development through a comprehensive 70-patient Phase 1 clinical trial for PTX-35. The Company expects to meet the qualifications to receive the third tranche of its $15.2 million CPRIT grant award, totaling $6.9 million, later this year.

On October 4, 2018 Nimbus Therapeutics, a biotechnology company applying deep computational chemistry expertise throughout drug discovery and development, reported that it has named Jeb Keiper, M.S., M.B.A., President and Chief Executive Officer, effective immediately (Press release, Nimbus Therapeutics, OCT 4, 2018, View Source [SID1234529887]). Mr. Keiper succeeds Donald Nicholson, Ph.D., and will lead the company forward as it progresses multiple programs toward clinical development.

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"After over four years of building Nimbus and this exceptional team, the company is now poised to start the next chapter of developing important medicines for patients with autoimmune disease, cancer, and metabolic diseases," said Donald Nicholson, Ph.D. "In its next phase of growth, Nimbus will be led by a CEO with intimate knowledge of the company and a track record of successful leadership. Jeb’s deep business expertise and leadership experience made him an ideal partner to me and a logical successor. I am very much looking forward to starting the next entrepreneurial chapter of my career, and I am confident that Nimbus, the science and our employees are in great hands."

Mr. Keiper joined Nimbus in 2014 and initially served as Nimbus’ Chief Business Officer, and along with Dr. Nicholson, set the strategic direction of the company. In the ensuing four years, Nimbus brought in over $775 million of partnership and financing into the company, including the Series B financing in March 2015, the sale of Nimbus’ clinical NASH program to Gilead in May 2016 for $400 million upfront, the strategic immunology alliance with Celgene announced in October 2017, and a round of private expansion capital in 2018. Mr. Keiper was also appointed Chief Financial Officer in 2017.

Prior to Nimbus, Mr. Keiper was VP of Business Development at GSK Oncology and spent a decade at GlaxoSmithKline in various BD leadership roles. He led the oncology portion of the $16 billion GSK-Novartis transaction announced in April 2014. In 20 years of industry experience, starting as a bench chemist at Pfizer R&D and working in various roles from consulting at McKinsey to business development at TransForm Pharmaceuticals, Mr. Keiper has a track record of leading teams of talented scientists and managers to achieve stretch objectives, including advancing new medicines into clinical development, filing NDAs, and constructing transformative deals and financings.

"Jeb has been a critical component of the success at Nimbus over the last four years, and we are confident that he will lead the company into the future and its continued successful development of the pipeline," said Nimbus’ Chairman and co-founder Bruce Booth, D.Phil. "We thank Don for his passion and leadership in driving the accomplishments Nimbus has achieved to date and have immense respect for him as a scientist and a leader. I look forward to working with him on future innovative opportunities."

"Nimbus has pioneered new ways of discovering and developing important medicines for patients leveraging a globally distributed, virtually-enabled operating model," said Mr. Keiper. "Our success has challenged and reformed decades-old dogma on how to develop new small molecule medicines, and has been reflected in our partnerships with Gilead, Celgene, and Genentech. As we enter the next chapter, our ambition and business strategy remain the same: to continue innovating with computational methodologies for creating and advancing new medicines, and to couple those with cutting-edge discoveries in the mechanistic underpinnings of human disease."