On November 2, 2021 Moderna Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Metagenomi, Inc., a genetic medicines company with a versatile portfolio of next-generation gene editing tools, reported that the two companies have entered into a strategic research and development collaboration focused on advancing new gene editing systems for in vivo human therapeutic applications (Press release, Moderna Therapeutics, NOV 2, 2021, View Source [SID1234594164]). The collaboration will utilize Metagenomi’s novel gene editing tools and leverage Moderna’s mRNA platform, as well as lipid nanoparticle (LNP) delivery technologies, with the goal of developing curative therapies for patients with serious genetic diseases.

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"Metagenomi has demonstrated the power of its proprietary metagenomics approach that mines the Earth’s natural environment to discover next-generation gene editing tools and has developed discovery capabilities with the potential to address multiple diseases," said Eric Huang, PhD, General Manager & Chief Scientific Officer, Moderna Genomics (mGx). "Their discovery platform and expertise will expand Moderna Genomics’ ongoing efforts to develop innovative in vivo gene editing therapies to address a significant unmet medical need. This collaboration represents another milestone on our journey to create transformational genome-engineering based medicines."

"Gene editing has the potential to provide a cure for millions of patients living with genetic disease. Our partnership with Moderna is designed to accelerate the creation of genetic medicines using Metagenomi’s naturally derived, compact, modular and precise gene editing systems," said Brian C. Thomas, PhD, CEO and Co-Founder of Metagenomi. "This partnership will enhance our shared vision to forge transformative therapeutics for patients."

"Unlocking the therapeutic potential of gene editing requires a long-term commitment to develop the best technologies for both in vivo delivery and gene repair," said Jak Knowles, MD, CBO at Metagenomi. "We share Moderna’s goal to develop mRNA-based medicines, and we are thrilled to partner with them."

About the Collaboration

Under the terms of the collaboration, Metagenomi and Moderna will advance a series of in vivo gene editing therapeutics against undisclosed targets. Metagenomi will utilize its vast toolbox of gene editing systems in combination with Moderna’s mRNA and LNP technologies, to deliver next-generation therapies for genetic diseases. Metagenomi will receive an upfront cash payment and is eligible to receive certain target option exercise fees as well as development, regulatory and commercial milestone payments, plus tiered royalties on net sales of any products that are commercialized by Moderna. Moderna has also agreed to make an equity investment in Metagenomi in the form of a convertible note.

On November 2, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release third quarter 2021 financial results and provide a Company update after the market closes on Tuesday, November 9, 2021 (Press release, Cumberland Pharmaceuticals, NOV 2, 2021, View Source [SID1234594163]). A conference call and live internet webcast will be held on November 9 at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 9476299. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

On November 2, 2021 Avidity Biosciences, Inc. (Nasdaq: RNA) a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported that the Avidity management team will be participating at the following conferences (Press release, Avidity Biosciences, NOV 2, 2021, View Source [SID1234594162]):

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Credit Suisse 30th Annual Healthcare Conference
November 10th, 2021
Fireside Chat @ 2:40pm ET

4th Annual Evercore ISI HealthCONx Conference
November 30th, 2021
Fireside Chat @ 10:05am ET

Live webcasts of each event, as well as an archived replay of the webcasts following each event, will be available on the "Events and Presentations" page in the "Investors" section of Avidity’s website at View Source

AbbVie has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On November 2, 2021 Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, reported that the company has enrolled and dosed its first patient with advanced or refractory solid tumors in a clinical trial of ALK-1 antibody (GT90001) in combination with KN046 on November 2 in Taiwan, China (Press release, Suzhou Kintor Pharmaceuticals, NOV 2, 2021, View Source [SID1234594160]).

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This study (NCT04984668) is a two-stage, multicenter, open-label, phase Ib/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ALK-1 antibody in combination with KN046 in patients with advanced or refractory solid tumors, including hepatocellular carcinoma (HCC), gastric carcinoma/gastroesophageal junction adenocarcinoma (GC/GEJ), urothelial carcinoma (UC) and esophageal square cell carcinoma (ESCC).

Dr.Youzhi Tong, founder, Chairman and CEO of Kintor Pharma, commented, "We are continuously enriching the pipeline of biological drugs surrounding the ALK-1 antibody. The phase II clinical trial of ALK-1 antibody combination therapy on patients with advanced hepatocellular carcinoma ("HCC") was commenced in Taiwan, China, the preliminary data of which showed positive antitumor activity and good safety profile. Recently, the clinical trial of ALK-1 antibody combination therapy for the first-line treatment of advanced HCC has also been approved by China NMPA. In 2020, we collaborated with Alphamab to further explore the clinical strategies of ALK-1 antibody in combination with KN046. Following the first patient enrolled and dosed in this clinical trial, we hope to accelerate the clinical process and benefit more patients with advanced or refractory solid tumors."

Dr.Ting Xu, Chairman and CEO of Alphamab Oncology, commented," KN046 is a bispecific antibody that targets both PD-L1 and CTLA-4 immune checkpoints, with a unique anti-tumor mechanism. Data from clinical studies of KN046 in PD-(L)1 refractory NSCLC, thymic cancer, pancreatic cancer and liver cancer have demonstrated impressive survival benefits. We are also advancing the clinical research of KN046 in combination with other therapies to fully explore its clinical value. We look forward to exploring new mechanisms of tumor immunotherapy through the combination of KN046 with Kintor Pharma’s ALK-1 antibody, and bringing new treatment options for patients."

About ALK-1 antibody

ALK-1 antibody is a fully humanized monoclonal, potential first-in-class antibody that inhibits ALK-1/TGF-β signal transduction and tumor angiogenesis.

Kintor Pharma obtained an exclusive global license for ALK-1 antibody from Pfizer, Inc., in February 2018. The preliminary data of the ongoing Taiwan phase II clinical trial was released at the ASCO (Free ASCO Whitepaper) GI 2021 and showed positive efficacy and safety results. The overall response rate ("ORR") was 40 percent.

In February 2021, the U.S. Food & Drug Administration (FDA) granted Kintor Pharma an investigational new drug ("IND") application of ALK-1 antibody for a multi-regional phase II clinical trial for the combination treatment for the second-line treatment of HCC. On 9 October 2021, the clinical trial of combination therapy of ALK-1 antibody for the first-line treatment of advanced HCC was approved by the National Medical Products Administration of China.

About KN046

KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism CTLA-4 domain fused with a PD-L1 single domain antibody; engineered to target the tumor micro-environment with high PD-L1 expression, and Treg（suppresstumor immunity）clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia and China. The results of these clinical trials have shown promising data in terms of survival for patients. Alphamab Oncology has received FDA clearance to enter later stage trials of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.