- Asia's first company to sponsor clinical trial of combination therapy of 
anti-cancer microbiome and anti-PD1/anti-PD-L1 drug 

- Enables to initiate Phase 1/1b clinical trial on combinational therapy of 
Merck KGaA, Darmstadt, Germany/Pfizer's avelumab (BAVENCIO(R)) with Genome & 
Company's GEN-001 microbiome therapeutic 


Genome & Company (KONEX: 314130), a biotechnology company developing innovative 
therapeutics in immune-oncology, announced today that the United States (US) 
Food and Drug Administration (FDA) has accepted the Investigational New Drug 
(IND) application for GEN-001 for combination treatment with avelumab 
(BAVENCIO(R)) in patients with solid cancers. Avelumab is an anti-PD-L1 
antibody co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany 
and Pfizer Inc.

Photo - https://photos.prnasia.com/prnh/20200420/2780891-1 
Genome & Company logo  
  
With this clearance, Genome & Company will be the first Asian company to 
initiate a first-in-human trial of anti-cancer microbiome and 
anti-PD1/anti-PD-L1 combination treatment as a sole sponsor. The phase 1/1b 
clinical trial will be initiated at the US clinical sites and the first patient 
is expected to be enrolled within this year.

"IND clearance from FDA for our first anti-cancer microbiome therapeutic 
GEN-001 is a very significant milestone as it will transition Genome & Company 
into a clinical-stage biotechnology company. We hope to add meaningful value 
and advancement in the microbiome and immuno-oncology industry with our 
combinational approach to cancer patients who have progressed on prior 
anti-PD1/anti-PD-L1 therapy," said Dr. Hansoo Park, Chief Technical Officer of 
Genome & Company.

Dr. Jisoo Pae, CEO of Genome & Company further quoted, "This IND approval is a 
meaningful corporate milestone and a critical step forward to achieving new 
arrangements in strategic partnering. We are indeed looking forward to further 
investigate how our clinical data will be translated into our cancer patients. 
I thank all the members and partners of Genome & Company for dedicating 
themselves to accomplishing this milestone."

In January this year, Genome & Company had entered into a clinical trial 
collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and 
Pfizer Inc. to evaluate the safety, tolerability, biological and clinical 
activities of GEN-001 therapy in combination with avelumab in multiple cancer 
indications. The combination trial is designed to be a first-in-human study 
including dose escalation and expansion cohorts to evaluate the safety and 
preliminary efficacy. 

BAVENCIO(R) is a trademark of Merck KGaA, Darmstadt, Germany.

About GEN-001 

GEN-001 is an oral microbiome therapeutic candidate developed to have immune 
modulating activities, resulting in potential partnership with immune 
checkpoint inhibitors. GEN-001 consists a single strain bacteria isolated from 
gut of healthy human volunteers that has been shown to activate dendritic 
cells, macrophages and T cell response. In preclinical studies, GEN-001 has 
shown optimal safety margin and synergistic effects in combination with immune 
checkpoint inhibitors by enhancing the effect of suppressing the growth of both 
immune checkpoint inhibitor sensitive and resistant tumor models.

About Genome & Company

Genome & Company is a clinical stage biotechnology company based in Republic of 
Korea that focuses on discovering and developing the next waves of innovative 
therapeutics in immuno-oncology through diverse modalities of microbiome, novel 
target immune checkpoint inhibitors and fusion proteins to fulfill the unmet 
needs of cancer patients. www.genomecom.co.kr 

Avelumab Approved Indications

Avelumab (BAVENCIO(R)) in combination with axitinib is indicated in the US, EU, 
Japan and other countries for the first-line treatment of patients with 
advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for 
avelumab (BAVENCIO(R)) for the treatment of (i) adults and pediatric patients 
12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) 
patients with locally advanced or metastatic urothelial carcinoma (mUC) who 
have disease progression during or following platinum-containing chemotherapy, 
or have disease progression within 12 months of neoadjuvant or adjuvant 
treatment with platinum-containing chemotherapy. These indications are approved 
under accelerated approval based on tumor response rate and duration of 
response. Continued approval for these indications may be contingent upon 
verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with mMCC in 50 countries globally, 
with the majority of these approvals in a broad indication that is not limited 
to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO(R)) include immune-mediated 
adverse reactions (such as pneumonitis and hepatitis [including fatal cases], 
colitis, endocrinopathies, nephritis and renal dysfunction and other adverse 
reactions [which can be severe and have included fatal cases]), 
infusion-related reactions, hepatotoxicity, major adverse cardiovascular events 
(MACE) [which can be severe and have included fatal cases], and embryo-fetal 
toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients 
treated with BAVENCIO(R) monotherapy include fatigue, musculoskeletal pain, 
diarrhea, nausea, infusion-related reaction, peripheral edema, decreased 
appetite/hypophagia, urinary tract infection and rash. Common adverse reactions 
(reported in at least 20% of patients) in patients receiving 
BAVENCIO(R) in combination with axitinib include diarrhea, fatigue, 
hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar 
erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, 
hepatotoxicity, cough, dyspnea, abdominal pain and headache.  Grade 3-4 
clinical chemistry and hematology laboratory value abnormalities reported in at 
least 10% of patients treated with BAVENCIO(R)monotherapy include hyponatremia, 
lymphopenia, GGT increased; in patients receiving BAVENCIO(R) in combination 
with axitinib, grade 3-4 clinical chemistry and hematology laboratory value 
abnormalities included blood triglyceride increased and lipase increased.

For full Prescribing Information and Medication Guide for BAVENCIO(R), please 
see www.BAVENCIO.com.


SOURCE: Genome & Company

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