Shanghai Genechem Co., Ltd. (Genechem) Announces Global Collaboration on Bispecific Antibodies

On April 6, 2021 Shanghai Genechem Co., Ltd. (Genechem), a discovery company dedicated to novel drug target discovery and development of novel therapeutics, reported the execution of a global collaboration with I-Mab (Nasdaq: IMAB), a Nasdaq-listed global biopharmaceutical company, to develop and commercialize multiple bi-specific antibodies (BsAb) based on monoclonal antibody developed by Genechem and antibodies selected by I-MAB (Press release, Shanghai GeneChem, APR 6, 2021, View Source [SID1234577645]).

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"This collaboration is the first of many that will leverage Genechem’s Good Research Practice (GRP) and CHAMP antibody discovery platform, strong bioinformatic database, as well as strong development expertise of synergistic partners, to deliver globally competitive assets based on innovative targets. We are excited to collaborate with I-Mab, a global leader in Oncology and antibody development, to bring more products to address clinical unmet needs for patients in China and globally", commented Yueqiong Cao, Founder and CEO of Genechem.

I-Mab and ABL Bio Announce First Patient Dosed in Phase 1 Trial of Bispecific Antibody TJ-L14B/ABL503 in Patients with Advanced or Metastatic Solid Tumors

On April 6, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter "ABL"), a South Korean biotech specializing in bispecific antibody technology, reported that the first patient has been dosed in a phase 1 trial for bispecific antibody TJ-L14B/ABL503 (Press release, I-Mab Biopharma, APR 6, 2021, View Source [SID1234577685]). The phase 1 clinical trial is an open-label, multi-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), preliminary antitumor activity, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TJ-L14B/ABL503 in locally advanced or metastatic solid tumors (NCT04762641).

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Being developed jointly with ABL, TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s ‘Grabody-T’ bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination.

"Immune checkpoint inhibitors, such as PD-L1, have created a new paradigm for cancer treatment; however, they have limitations in their efficacy and response rates," said Dr. Joan Shen, CEO of I-Mab. "Co-targeting of PD-L1 with a bispecific antibody molecule using this particular platform is postulated to enhance antitumor activity while ensuring the safety of the patients. It may provide an alternative therapeutic approach for patients who have not responded to existing treatments."

"We are very pleased to advance the clinical development of TJ-L14B/ABL503 as planned.," said Dr. Sang Hoon Lee, CEO of ABL. "With phase 1 trial for TJ-L14B/ABL503 being the first testbed for our Grabody-T bispecific antibody platform, we look forward to validating our company’s technology in the field of cancer immunotherapy."

"We are excited to be the first center to conduct this study for TJ-L14B/ABL503," said Dr. Anthony W. Tolcher, FRCPC, FACP, CEO and director of clinical research at NEXT Oncology. "TJ-L14B/ABL503 has demonstrated potential to overcome the adverse toxicity issues of anti-4-1BB antibodies. In collaboration with I-Mab and ABL, we hope for a thorough evaluation to deliver a highly promising treatment for the benefit of cancer patients." NEXT Oncology is a phase 1 center in the U.S. dedicated to providing patients with advance cancer access to the newest cancer treatments available.

Invitae Announces $1.15 Billion Investment Supporting Ongoing Growth Initiatives

On April 5, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported that a small group of investors, led by SB Management, a subsidiary of Softbank Group Corp., will make an investment of $1.15 billion in convertible senior notes to support the Company’s future growth initiatives (Press release, Invitae, APR 5, 2021, View Source [SID1234577575]).

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"Invitae’s mission is to deliver genetic information to improve healthcare for billions of people at all stages of life. With the support of our long-term shareholders, we’re creating the platform to support the routine use of genetics in mainstream medicine to result in better healthcare for everyone," said Sean George, co-founder and chief executive officer of Invitae. "This investment will help us continue to fuel our growth, including expanding our platform, services and menu through both in-house development and the addition of complementary companies and technologies as we work to build a differentiated platform uniquely capable of driving the transition to personalized medicine."

"Invitae has a definitive head start in the rapidly expanding market for clinical genetic sequencing. Their comprehensive diagnostic products are well positioned to further grow the global understanding of how genomics predispose populations for certain diseases. These datasets will inform treatment and dramatically improve patient outcomes," said Akshay Naheta, chief executive officer of SB Management, a subsidiary of SoftBank Group Corp.

Under the terms of the investment, the participating investors, including SB Management, will purchase a total aggregate principal amount of $1.15 billion in Convertible Senior Notes due 2028 (the "Notes"). The Notes will have an initial conversion price of $43.18 per share of the Company’s common stock, subject to customary anti-dilution and other adjustments. The initial conversion price of $43.18 represents a 20% premium to the Company’s average 5-day trailing volume-weighted average price as of April 1, 2021. The Notes will mature on April 1, 2028, unless earlier converted, redeemed or repurchased. The Notes will bear 1.5% interest per year. Upon conversion, the Company will have the right to elect settlement in cash, shares, or any combination thereof in its sole discretion.

Additional information regarding this announcement may be found in a Current Report on Form 8-K that the Company intends to file today with the U.S. Securities and Exchange Commission.

J. Wood Capital Advisors LLC and Perella Weinberg Partners LP acted as financial advisors and J.P. Morgan acted as placement agent to Invitae on the transaction.

Astellas and TOA EIYO Announce Termination of Distribution Agreement

On April 5, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) and TOA EIYO Ltd. (President: Atsuo Takahashi, Ph.D., "TOA EIYO") reported that the both companies have agreed to terminate the distribution agreement on March 31, 2022 (Press release, Astellas, APR 5, 2021, View Source [SID1234577557]). In accordance with this agreement, after April 1, 2022, TOA EIYO will independently sell and provide information on all 18 products such as Bisono tape, a transdermal patch of β1 blocker, for treatment of hypertension and atrial fibrillation and Frandol tablets and tape for treatment of ischemic heart disease, which TOA EIYO obtained Marketing Authorization in Japan, that are currently sold on consignment by Astellas.

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Astellas and TOA EIYO has collaborated for sales and marketing for a long time. Astellas currently sells most of the products which TOA EIYO obtained Marketing Authorization in Japan, and TOA EIYO provides their product information to medical institutions. The both companies have discussed and agreed to terminate the distribution agreement on March 31, 2022.

Astellas is continuously working on optimizing the allocation of management resouces in order to maximize the value of each product, and the termination of the distribution agreement is part of this effort. As a specialty pharmaceutical company in the field of cardiovascular medicine, TOA EIYO has decided that it is necessary to establish its own sales structure of products in order to meet the diverse needs of cardiovasculartreatment.

Astellas and TOA EIYO will work closely during the sales transfer process to ensure stable supply of the relevant products and a smooth continuation of activities, including the provision/collection of product information and the promotion of their proper use.

Arvinas Announces Upcoming Presentations at the American Association for Cancer Research Annual Meeting 2021

On April 5, 2021 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported two upcoming presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be held virtually from April 10-15, 2021 and May 17-21, 2021 (Press release, Arvinas, APR 5, 2021, View Source [SID1234577576]). These presentations will describe the discovery of Arvinas’ two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures.

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Details for the presentations are as follows:

Title: Discovery of ARV-110, a first in class androgen receptor degrading PROTAC for the treatment of men with metastatic castration resistant prostate cancer
Date and Time: April 11, 2021 from 2:05 PM – 2:15 PM ET
Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

Title: The discovery of ARV-471, an orally bioavailable estrogen receptor degrading PROTAC for the treatment of patients with breast cancer
Date and Time: April 11, 2021 from 2:20 PM – 2:30 PM ET
Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

Abstracts will be available for registered attendees on the AACR (Free AACR Whitepaper) website beginning on April 9, 2021.