On September 28, 2020 Sosei Group Corporation ("the Company") (TSE: 4565) reported that it has been notified by Pfizer that the first subject in a clinical trial has been dosed with a new drug candidate nominated from the multi-target drug discovery collaboration between the two companies (Press release, Sosei Heptares, SEP 28, 2020, View Source [SID1234567704]). Achievement of this milestone triggers a payment of $5 million to Sosei Heptares. This candidate was nominated for advancement by Pfizer in June 2019 generating a $3 million milestone payment at that time.

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Pfizer nominated three distinct clinical candidates from the collaboration with Sosei Heptares during 2019, two of which have now subsequently entered clinical trials. The collaboration has leveraged Sosei Heptares’ unique StaR technology and Structure-based Drug Design (SBDD) capabilities to design oral small molecules that modulate different G protein-coupled receptor (GPCR) targets across multiple disease areas of interest to Pfizer.

This candidate is the eighth GPCR-targeted drug candidate to enter clinical trials originating from Sosei Heptares’ StaR technology and structure-based drug design (SBDD) platform.

Dr. Rob Cooke, Chief Technology Officer of Sosei Heptares, said: "The start of this new clinical trial is another great example of the productivity of our StaR technology and structure-based drug design approach. It also highlights our ability to work collaboratively and successfully with leading pharma companies, applying cutting-edge complementary capabilities to discover and develop completely new drug candidates with potential to treat major diseases. We are extremely pleased with the progress being made in our long-term partnership with Pfizer."

About the Agreement with Pfizer

Sosei Heptares and Pfizer entered a multi-target drug discovery collaboration in November 2015 to research and develop potential new medicines directed at up to ten GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

To address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development initially directed to the GPCR targets selected by Pfizer. Pfizer is responsible for developing and commercializing any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential resulting agents.

Sosei Heptares has delivered multiple stabilized receptors (StaR proteins), X-ray structures and biophysical data on certain programs, triggering multiple significant milestone payments from Pfizer resulting from the nomination of new clinical candidates and entry into clinical trials. Further possible milestones payments are contemplated under the agreement, with potential for royalties also payable provided the criteria under the agreement are satisfied.

Pfizer also made a $33 million equity investment in Sosei Heptares in 2015. In the future, Pfizer and Sosei Heptares anticipate publication of select research findings from their collaboration.

On September 28, 2020 Imvax Inc., an emerging oncology leader that is revolutionizing immunotherapy for patients with glioblastoma multiforme (GBM) and other solid tumors with significant unmet medical needs, reported that it has been named by Fierce Biotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Imvax, SEP 28, 2020, View Source [SID1234567702]).

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"It is an honor to be named to the 2020 Fierce 15 list, especially among this class of promising biotech companies," said John Furey, Imvax Chief Executive Officer. "2020 has been a year of rapid growth and momentum for Imvax and this award reaffirms our efforts towards improving outcomes for people living with devastating and intractable solid tumor cancer."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 18th annual Fierce 15 selection.

The 2020 Fierce 15 comes at a time when the world is focused on a pandemic, but even as coronavirus remains a threat, patients with cancer, rare diseases and other disorders still need treatment, Fierce Biotech Senior Editor Ben Adams said. "This year, we’ve chosen from a diverse range of those fighting COVID, as well as those fighting longer term plagues against our biology," Adams said.

In July, Imvax announced the completion of a $112 million Series C financing. This financing has enabled Imvax to continue clinical development of lead product candidate IGV-001 for treatment of newly diagnosed GBM through Phase 2. IGV-001 is an autologous tumor vaccine made from patients’ tumor cells combined with an antisense molecule to affect a personalized immune response. The financing will also enable Imvax to broaden the development portfolio into additional oncology therapeutic indications. The team is continuing its pre-clinical work, targeting to start additional solid tumor Phase 1 trials during 2021.

On September 28, 2020 HUYA Bioscience International (HUYABIOTM), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the Ministry of Health, Labour and Welfare (MHLW) granted HBI-8000 orphan drug designation (ODD) in Japan as monotherapy for relapsed or refractory Adult T-cell Leukemia-Lymphoma or (ATL) (Press release, HUYA Bioscience, SEP 28, 2020, View Source [SID1234567701]). HBI-8000 already has ODD in Japan for peripheral T-cell lymphoma (PTCL).

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ATL is caused by latent infection of the human t-cell leukemia virus type 1 or HTLV-1 and is endemic in Japan with up to one million carriers and a disease incidence estimated at 0.05-0.10%. There are approximately 2,000 patients and as many as 700 – 1,000 deaths reported each year. It is primarily a disease of the elderly with poor prognosis, three-year survival rate in aggressive ATL after chemotherapy is 25% and few effective treatment options other than allogenic bone marrow transplantation and high dose chemotherapy in a subset of eligible patients.

"Effective treatment options for relapsed or refractory (R/R) aggressive ATL are very limited and the designation of ODD status recognizes the need for new treatment for this difficult-to-manage disease, I hope that development of HBI-8000 could be accelerated with the ODD," said Dr. Kunihiro Tsukasaki, MD PhD, Principal Investigator of HBI-8000 clinical study & Professor, Department of Hematopoietic Tumor, Saitama Medical University, International Medical Center.

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting viral antigens. This is a novel mechanism of action and does not overlap with currently available drugs. Recent clinical studies conducted by HUYABIO in Japan suggest clinical efficacy of HBI-8000 in this rare disease setting of R/R aggressive ATL.

"The orphan drug designation of HBI-8000 recognizes the potential of this agent to meet an important unmet medical need and ATL is a critical public health issue in Japan," said Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO. "The designation is appropriate for this rare malignancy, which afflicts an elderly population with such devastating effects. We are now preparing an application to the PMDA for approval of HBI-8000 as monotherapy for the treatment for R/R ATL."

On September 28, 2020 The National Comprehensive Cancer Network (NCCN) reported the publication of new NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Pediatric Hodgkin Lymphoma (Press release, NCCN, SEP 28, 2020, View Source [SID1234567698]). Hodgkin lymphoma is one of the most curable forms of pediatric cancer, with long-term survival rates of 90% or higher1. However, treatment can result in potentially life-threatening or -altering long-term side effects. These new recommendations from NCCN synthesize the latest evidence and expert-consensus to make sure every child receives appropriate, but not excessive, treatment.

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"There has never been a more important time for these NCCN Guidelines than during this pandemic, when many patients need to be treated at their local institutions—even when a trial is available—due to travel and caregiver limitations," said Jamie Flerlage, MD, MS, St. Jude Children’s Research Hospital, Chair, NCCN Guidelines Panel for Pediatric Hodgkin Lymphoma. "There are many treatment options to choose from for pediatric Hodgkin lymphoma; some are better than others depending on the patient’s stage and risk group. These guidelines have information to help providers weigh the benefits and potential setbacks of various options for treating each individual. We’ll continue to update these guidelines regularly and incorporate any important new data from ongoing clinical trials."

"With so many treatment options available, it’s crucial to present all the evidence that can guide providers to the best choices for their patients," said Susan Hiniker, MD, Assistant Professor, Radiation Oncology, Stanford Cancer Institute, Vice-Chair, NCCN Guidelines Panel for Pediatric Hodgkin Lymphoma. "It can be a challenge for individual practitioners to follow and interpret all the clinical trial data. The NCCN multidisciplinary panel of experts deliberated and debated carefully to be sure we’re sharing optimal approaches that are firmly rooted in evidence."

Hodgkin lymphoma accounts for approximately 6% of all childhood cancer diagnoses in the United States, with just over 1,000 people diagnosed under the age of 20 every year.2 Nearly half of all people diagnosed with Hodgkin lymphoma in the U.S. are 35 or younger.3

"The treatment approaches for children with Hodgkin lymphoma are very different than for adults, so we really needed a separate set of guidelines for this population," said Kara Kelly, MD, Division Chief, Pediatric Hematology/Oncology, Chair of Pediatrics at Roswell Park Comprehensive Cancer Center, Chief of the Roswell Park Oishei Children’s Cancer and Blood Disorders Program, and Member, NCCN Guidelines Panel for Pediatric Hodgkin Lymphoma. "Pediatric patients have fewer competing health concerns and may tolerate higher doses, which lowers their risk of relapse. These guidelines really focus on how to strike the right balance for disease control while reducing long-term effects from the treatment."

NCCN has been providing gold standard recommendations for clinical direction and policy in cancer management for 25 years with a proven track record for improving outcomes while reducing costs. NCCN Guidelines are available free-of-charge for non-commercial use at NCCN.org or via the Virtual Library of NCCN Guidelines App.

The organization began providing recommendations for managing childhood cancers with the NCCN Guidelines for Pediatric Acute Lymphoblastic Leukemia (ALL), which launched in May 2019. Since then, those guidelines have been translated into multiple languages, and harmonized for lower-resource settings in sub-Saharan Africa—as part of the group Allied Against Cancer working in collaboration with the African Cancer Coalition (ACC), American Cancer Society (ACS), the Clinton Health Access Initiative (CHAI), and IBM. They have also been re-written in non-medical terms as NCCN Guidelines for Patients: Pediatric ALL in order to empower parents and guardians as well as patients.

NCCN has subsequently published NCCN Guidelines for Pediatric Aggressive Mature B-Cell Lymphomas. Additional new guidelines for children with Wilms tumors and central nervous system cancers are coming soon.

"Our mission to improve and facilitate quality, effective, efficient, and accessible cancer care so patients can live better lives is never more pressing than it is with young people who have many years ahead of them," said Robert W. Carlson, MD, Chief Executive Officer, NCCN.

On September 28, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported that Sarah Boyce, President and Chief Executive Officer, Arthur Levin, Ph.D., Chief Scientific Officer, and Mike MacLean, Chief Financial Officer, will participate in a fireside chat at the Chardan 4th Annual Genetic Medicines Conference 2020 on Monday, October 5th, 2020 at 12:45 pm PDT (Press release, Avidity Biosciences, SEP 28, 2020, View Source [SID1234567696]). In addition, Dr. Levin will participate in a featured panel entitled "Small RNA Therapies: Upcoming Advancements in Delivery and Stabilization Chemistries" on Tuesday, October 6th, 2020 at 12:00 pm PDT. The conference is being held in a virtual format.

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A live webcast of the virtual fireside chat will be available on the Company’s website at www.aviditybiosciences.com in the Investor Resources section. A replay of the fireside chat will be archived on the site for 90 days.