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.

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.

On April 6, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported it has completed the acquisition of Asuragen, Inc. The transaction included initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones (Press release, Bio-Techne, APR 6, 2021, View Source [SID1234577614]). The Asuragen acquisition adds a leading portfolio of best-in-class molecular diagnostic and research products, including genetic screening and oncology testing kits, molecular controls, a Good Manufacturing Practice (GMP)-compliant 50,000 square foot manufacturing facility and a CLIA-certified laboratory, plus a team with deep expertise navigating products through the global diagnostic regulatory environment. Bio-Techne sees multiple growth synergies as a result of this acquisition, including capabilities in productizing lab-developed tests and commercializing innovative molecular products for broader market adoption. Bio-Techne also gains an attractive pipeline of expanded carrier screening panels for various pathologies recognized by The American College of Obstetricians and Gynecologists (ACOG) as areas of concern for prospective new parents. Following this acquisition, Bio-Techne now has a global workforce of more than 2,400 team members.

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On April 6, 2021 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform oncology drug discovery and development reported that Panna Sharma, President and CEO of Lantern Pharma, will participate in the 20th Annual Needham Healthcare Conference, to be held virtually on April 12-15, 2021 (Press release, Lantern Pharma, APR 6, 2021, View Source/news/press-releases/detail/46/lantern-pharma-to-participate-in-the-virtual-20th-annual" target="_blank" title="View Source/news/press-releases/detail/46/lantern-pharma-to-participate-in-the-virtual-20th-annual" rel="nofollow">View Source [SID1234577629]).

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Mr. Sharma will participate in a fireside chat moderated by Needham & Company’s Alexander Salisbury on Thursday, April 15, at 12:45 pm ET and hold one-on-one meetings with investors throughout the four-day event.

The live event will be accessible on View Source and will be archived for 90 days. Investors interested in scheduling a meeting with Mr. Sharma should contact their Needham & Company representative or Lantern Pharma investor relations.

On April 6, 2021 Bioniz Therapeutics, Inc., ("Bioniz"), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, reported the European Commission (EC) has granted orphan designation to BNZ-1 for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer (Press release, Bioniz Therapeutics, APR 6, 2021, View Source [SID1234577646]). BNZ-1 has previously been granted orphan drug designation by the U.S. Food and Drug Administration (FDA). Bioniz recently completed a phase 2 study of BNZ-1 in CTCL in the United States and intends to initiate a phase 3 clinical trial of BNZ-1 for the treatment of patients with relapsed or refractory CTCL (rCTCL). Bioniz expects the phase 3 to begin enrolling the second half of 2021.

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"The currently approved therapies to treat CTCL are not ideal given the limited efficacy and safety concerns and are typically tolerated by patients only for a limited time due to many side effects that are associated with these treatments," said Nazli Azimi, Pharm.D., Ph.D., Founder, President, and CEO of Bioniz Therapeutics. "With our lead product candidate, BNZ-1, we have completed several significant milestones, including positive efficacy data from our phase 2 study, guidance from the FDA on our phase 3 trial design, and now orphan designation in the U.S. and EU. BNZ-1 has the potential to be a significant treatment for CTCL."

Orphan designation from the EC provides incentives for companies to develop medicines intended for the treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating and where no satisfactory treatment is currently authorized. The prevalence of the condition must not exceed more than five in 10,000 people in the European Union (EU). In addition to being eligible for a 10-year period of marketing exclusivity in the EU upon product approval, orphan designation provides fee waivers, protocol assistance, and eligibility for marketing authorization under the centralized procedure granting approval in all EU countries.

About Refractory Cutaneous T-cell Lymphoma (rCTCL)
Cutaneous T-cell lymphomas (CTCLs) are a rare, aggressive, heterogeneous group of non-Hodgkin’s lymphomas that manifest primarily in the skin. Although a wide array of therapeutic options are available for early-stage CTCL, not all patients respond, resulting in refractory CTCL (rCTCL) with limited treatment options and a poor prognosis.

About BNZ-1
The company’s lead product candidate, BNZ-1, is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in CTCL and autoimmune diseases. Bioniz is also planning a phase 2 study of BNZ-1 for the treatment of alopecia areata, which is also driven by unregulated T-cell biology.