On April 13, 2021 NKMax, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported the expansion of its clinical trial and supply agreement with Merck KGaA, Darmstadt, Germany to conduct a Phase I/IIa open-label, single-center trial evaluating the safety and anti-tumor activity of SNK01 (autologous natural killer cells) in combination with either gemcitabine/carboplatin or gemcitabine/carboplatin plus cetuximab (ERBITUX)* in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed after prior tyrosine kinase inhibitor (TKI) therapy (Press release, NKGEN Biotech, APR 13, 2021, View Source [SID1234578708]). Preliminary in vitro data from an NKMax study suggested that EGFR-TKI resistant NSCLC cells highly express EGFR and are more efficiently killed by SNK01 in the presence of cetuximab through antibody-dependent cellular cytotoxicity (ADCC). Dr. Jae-Cheol Lee, M.D., Ph.D. from the Department of Oncology and Lung Cancer Center at Asan Medical Center, Seoul, Korea will be acting as principal investigator. This study was approved by Korea’s regulatory agency, MFDS, earlier this year as well as by the Asan Hospital IRB. The first patient will soon be enrolled.

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"We are pleased to continue studying SNK01 in combination with well-known cancer therapies," said Sangwoo Park, Chief Executive Officer of NKMax. "Our strategy is to first take our autologous, non-genetically modified NK cell therapy into the clinic for cancer, followed by our allogeneic program later in 2021."

Under the terms of this agreement, NKMax will be the study sponsor, and Merck KGaA, Darmstadt, Germany will supply cetuximab for a Phase I/IIa clinical trial in NSCLC patients for weekly dosing with 250 mg/m2 cetuximab administered by intravenous injection. The trial will include patients whose disease has progressed after prior TKI therapy for EGFR, ALK or ROS1 alterations at least once will be enrolled to receive SNK01, chemotherapy, and cetuximab. The primary objective of the trial is to assess the safety and drug tolerance of SNK01 administered in combination with cytotoxic chemotherapy or cytotoxic chemotherapy plus cetuximab. The secondary objective of the trial will be to obtain efficacy assessments on the combination treatments. Both parties will have access to the clinical trial data.

NKMax has developed its own proprietary NK cell expansion and activation technology platform which allows it to produce unprecedented commercial amounts of autologous and allogenic NK cells from numerous donors which have near total expression of activating receptors like CD16, NKG2D, NKp30, and NKp46. In addition, its unique technology raises the cytotoxicity of the expanded NK cells with little loss during cryopreservation.

* ERBITUX is not approved for any use in metastatic non-small cell lung cancer anywhere in the world.

On April 13, 2021 Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that the Company will present at the upcoming 2021 Bloom Burton Healthcare Investor Conferencetaking place April 20-21, 2021 (Press release, Zymeworks, APR 13, 2021, View Source [SID1234577982]).

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The Company’s presentation will be on Tuesday, April 20, 2021 at 11:30 a.m. ET.

Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source, which will also host a recorded replay available afterwards.

On April 13, 2021 Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported additional positive pre-clinical results in its immuno-oncology program demonstrating efficacy of its live biotherapeutic product (LBP) consortium BMC128, this time in melanoma (Press release, Biomica, APR 13, 2021, View Source [SID1234577998]). In these studies, Biomica tested BMC128, which consists of four live bacterial strains, in a mouse model of melanoma.

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Dr. Elran Haber, CEO of Biomica, stated: "We are very excited with the results of this study demonstrating the effectiveness of BMC128 in treating additional types of solid cancer tumors. These positive pre-clinical results indicate the potential of BMC128 to become best-in-class in the treatment of solid cancer tumors, and help validate Biomica’s computational-based drug design approach. We look forward to providing incremental updates as we work towards a first-in-human, proof of concept clinical trial."

Treatment with BMC128 in combination with Immune Checkpoint Inhibitors (ICI) immunotherapy significantly enhanced anti-tumor activity, resulting in an increased response of melanoma tumors to anti-PD1, as demonstrated in an improved Objective Response Rate (ORR) and Percent Tumor Growth Inhibition (%TGI). The group treated with only anti-PD1 showed no response (ORR = 0%) as measured by the Response Evaluation Criteria in Solid Tumors (RECIST), while the group treated with a combination of BMC128 and anti-PD1 demonstrated a total of 13% response (ORR = 13%). The %TGI was increased by 100% in the BMC128 and anti-PD1 combination treated group compared to the group treated by anti-PD1 alone. Response to BMC128 was correlated with a desired anti-tumor immunological profile. BMC128 changed the course of response to ICI, leading to stimulation of the immune system which shifted cold-tumors into hot-tumors.

These positive results supplement previous pre-clinical data using BMC128 in combination with ICI in a breast cancer mouse model that demonstrated pronounced anti-tumor activity as manifested in an increase of almost 50% in ORR. The current results demonstrate the potential applicability of BMC128 and its relevance to treating multiple types of solid tumors.

Biomica’s immuno-oncology program is based on the premise that the gut microbiome affects the efficacy of cancer immunotherapy, specifically that of the ICI involving the blockade of PD-1 or PD-L1 and CTLA-4 as suggested in scientific literature.[1],[2] Fecal microbial transplantation has been recently reported to increase response in patients resistant to immune-checkpoint therapy[3],[4], however the specific microbial entities driving this response are currently unknown. BMC128 is a rationally-designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene’s MicroBoost AI platform.

As previously reported, Biomica has initiated scale-up processes and Good Manufacturing Practice (GMP) production of its drug candidate in its immuno-oncology program in preparation for the first-in-human proof-of-concept clinical trial expected later this year.

Mr. Ofer Haviv, Chairman of Biomica and Evogene President & CEO, stated: "We are proud of the results that Biomica reported today. These results support the computational biology capabilities developed by Evogene and Biomica which predicted that the microbes that make up BMC128 can be utilized to improve the efficacy of ICI in solid tumors. We look forward to validating the same computational forecasting capabilities in additional successful programs led by Biomica such as IBD and IBS."

[1] Zitvogel et al. 2018, Science 359 (6382)
[2] Thompson J, et al. Microbiome & immunotherapy: Antibiotic use is associated with inferior survival for lung cancer patients receiving PD-1 inhibitors. J Thorac Oncol 12(suppl 2):S1998, 2017
[3] Baruch E, et al. 2021. Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients. Science, 371 (6529)
[4] Davar D, et al. 2021. Fecal microbiota transplant overcomes resistance to anti–PD-1 therapy in melanoma patients. Science, 371 (6529)

On April 13, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, reported that it will host an investor conference call on Thursday, April 15, 2021 at 2 p.m. Pacific Time to discuss its financial and operating results for the fourth quarter and full year 2020 as well as provide a business update (Press release, Adamis Pharmaceuticals, APR 13, 2021, View Source [SID1234578043]). The company’s press release concerning its fourth quarter 2020 financial results will be available after 1 p.m. Pacific Time on April 15, 2021, on its website at www.adamispharmaceuticals.com, and the company also expects to file its annual report on Form 10-K for year ended December 31, 2020 on that date.

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Dennis J. Carlo, Ph.D., President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during the quarter and certain target milestones and goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link – View Source, with a replay available shortly after the live event.

On April 13, 2021 BridgeBio Pharma, Inc. (NASDAQ: BBIO), and Brown University reported a formal collaboration to advance research in genetically driven neurological disorders into potential life-changing medicines for patients (Press release, BridgeBio, APR 13, 2021, View Source [SID1234577966]).

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"Brown University is a leader in critical neurology research, and we look forward to partnering with their scientists to focus on discovering and advancing new targeted treatment approaches to potentially address challenging and complex diseases of the brain," said BridgeBio founder and CEO Neil Kumar, Ph.D.

Under the partnership, BridgeBio will work with scientists at Brown to evaluate new discoveries in neurology research that have promise to advance toward clinical investigation. Select therapeutic programs may be spun out and advanced in BridgeBio affiliate companies, with an opportunity for Brown University scientists to support as company leaders and guide ongoing development.

"BridgeBio’s unique approach and support for having researchers stay involved in development made it an easy decision to partner with them in translating our discoveries into potential medicines for patients in need," said Neil Veloso, Executive Director of Brown Technology Innovations at Brown University. "We look forward to the collaboration and empowering Brown faculty to progress their research."

BridgeBio partners with stand-out academic institutions, including Brown University, to support research around genetically driven conditions and is focused on rapidly translating findings into meaningful treatments for patients. Today BridgeBio also announced formal partnerships with GlycoNet, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center, University of California, Davis and University of California, San Diego – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

As part of an ongoing effort to translate research in genetically driven conditions toward therapeutic development, BridgeBio will continue to seek long-term partnerships with similar institutions that are rooted in trust, engagement, science and respect in order to drive forward its mission of developing transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers as quickly and safely as possible.