PR83730

SEOUL, South Korea, April 20, 2020/PRNewswire=KYODO JBN/--

- 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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