On August 5, 2021 iCo Therapeutics Inc. ("iCo" or the "Company") (TSXV: iCo) (OTCQB: iCoTF) reported that the at an annual and special meeting of the Company held on August 3, 2021, shareholder of the Company have approved, among other matters, iCo’s proposed business combination (the "Transaction") with Satellos Bioscience Inc. ("Satellos") (Press release, iCo Therapeutics, AUG 5, 2021, View Source [SID1234586216]).

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The, the Company expects trading of the shares of the combined company to begin trading on the TSX Venture Exchange as Satellos Bioscience Inc. under the symbol MSCL during the week of August 9, 2021.

William Jarosz, the CEO of iCo noted, "The Satellos transaction was approved by 98.5% of the shareholders voting at the annual and special meeting of the shareholders. The shareholders recognized the tremendous value that the Satellos assets have brought to the business combination. We are grateful for this support and will work diligently going forward to ensure that this support is warranted. We are very excited about what lies ahead for iCo."

On August 5, 2021 Sumgen Biotech reported that the Phase I clinical study of its self-developed anti-CD47/PD-L1 bispecific antibody SG12473 was launched in Guangdong Provincial People’s Hospital and successfully completed the dosing of first subject (Press release, Sumgen Biotech, AUG 5, 2021, View Source;a=nav&id=244 [SID1234625258]). This study will recruit patients with solid tumors and hematological tumors, and evaluate the safety, tolerance, PK/PD and anti-tumor efficacy of monotherapy.

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Dr. Lv Ming, Chairman of Sumgen, said that SG12473 was the first bispecific antibody project of Sumgen, which was approved by NMPA and FDA for clinical study at the end of April this year. This project can overcome the influence of COVID-19 pandemic in Guangzhou, start and advance quickly. Special thanks to Dean Wu Yilong, Dean Zhou Qing and leaders at all levels of Guangdong Provincial People’s Hospital for their strong support, and thanks to the joint efforts of the project team.

SG12473 is a bispecific antibody targeting PD-L1 and CD47, which can activate T cells by blocking PD-1/PD-L1 signaling pathway and macrophages by blocking CD47/SIRP α signaling pathway, and play a synergistic anti-tumor role. SG12473 exhibits good antitumor activity in preclinical solid tumor and hematological tumor models.

CD47/SIRP α is one of the most important targets in the field of tumor immunology in the post PD-1/PD-L1 era. Preliminary clinical studies and a large number of preclinical studies show that anti-CD47 drugs alone or in combination with other drugs show positive anti-tumor activity in hematological tumors and various solid tumors. However, due to the expression of CD47 molecules on the surface of aging red blood cells, anti-CD47 drugs cause severe anemia and other side effects. In the molecular design process, SG12473 differentiates the affinity between anti-PD-L1 antibody and CD47 inhibitor, in order to "redirect" the bispecific antibodies to the tumor area by means of the high affinity characteristics of anti-PD-L1 antibody, and reduce the influence on red blood cells while exerting synergistic anti-tumor effect.

Study on CSG-12473-101 (registration number: CTR20211029)

CSG-12473-101 is a phase I clinical study of SG12473 for injection in patients with advanced malignant tumors conducted in China. The purpose of this study is to explore the safety, tolerance and preliminary efficacy of SG12473. The lead unit of the clinical research is Guangdong Provincial People’s Hospital, and the principle investigators of the project are Dean Wu Yilong and Dean Zhou Qing.

On August 5, 2021 Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases, reported recent corporate updates and financial results for the second quarter ended June 30, 2021 (Press release, Aravive, AUG 5, 2021, View Source [SID1234594061]).

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"Aravive continued to make strong progress in advancing the development of AVB-500 in the second quarter of 2021," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "We are very encouraged by the positive preliminary pharmacokinetic/pharmacodynamic results from the patients dosed at 15 mg/kg in the first portion of the Phase 1b trial of AVB-500 in clear cell renal cell carcinoma, and we plan to initiate the Phase 2 trial in the second half of 2021. Additionally, we are on track to initiate the Phase 1b/2 trial evaluating AVB-500 as a first-line treatment for pancreatic adenocarcinoma, another area of high, unmet medical need, in the second half of 2021."

Recent Corporate Highlights

AVB-500 in Platinum Resistant Ovarian Cancer (PROC): In April 2021, Aravive announced that the first patient was dosed in its registrational Phase 3 trial of AVB-500 in PROC. The global, randomized, double-blind, placebo-controlled adaptive trial is designed to evaluate efficacy and safety of AVB-500 at a dose of 15 mg/kg in combination with paclitaxel versus paclitaxel alone. The Company expects to conduct the interim analysis in the first quarter of 2022.
AVB-500 in Clear Cell Renal Cell Carcinoma (ccRCC): In June 2021, Aravive announced positive initial safety, pharmacokinetic and pharmacodynamic results from the Phase 1b portion of its Phase 1b/2 trial in patients dosed with 15 mg/kg of AVB-500 in combination with cabozantinib who have ccRCC (advanced stage kidney cancer). The data in three evaluable patients showed that AVB-500 was well tolerated with no adverse findings. Based on the pharmacokinetics, pharmacodynamics, and safety data at 15 mg/kg of AVB-500, and approval by the Data and Safety Monitoring Board (DSMB), the Company has expanded the dosing of 15 mg/kg of AVB-500 to at least three additional patients to determine the potential of initiating the Phase 2 portion with this dose. The Company will also continue to investigate higher doses of AVB-500 in the Phase 1b trial to obtain additional safety, pharmacokinetics, and pharmacodynamics information. Aravive expects to complete enrollment in the Phase 1b portion of the Phase 1b/2 trial and initiate the Phase 2 trial in the second half of 2021.
Achieved One Development Milestone with 3D Medicines in Q2 and One Milestone in July 2021 Totaling $9 million in Milestone Payments: In July 2021, Aravive achieved a $3.0 million development milestone based on the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) approval of the Investigational New Drug (IND) application submitted by 3D Medicines Inc. to participate in Aravive’s international AVB-500 Phase 3 PROC clinical trial. The Company also received a $6.0 million milestone payment in June 2021 related to the first patient dosed by Aravive in the AVB-500 Phase 3 registrational clinical trial for PROC in the United States. Under the terms of the collaboration and license agreement with 3D Medicines, Aravive is eligible to receive up to an aggregate of $207 million in development and commercial milestone payments and royalties, including the $9 million already achieved.
Expanded and Strengthened Board of Directors: Aravive appointed three highly experienced biopharmaceutical industry executives, John A. Hohneker, M.D., Sigurd C. Kirk, and Peter T.C. Ho, M.D., Ph.D., to its Board of Directors. Dr. Hohneker serves on the Compensation Committee of the Board, and Mr. Kirk serves on the Audit Committee.
Second Quarter 2021 Financial Results
Revenue for the three and six months ended June 30, 2021 were $3.8 million and $4.0 million, respectively, compared to $0 for both periods in 2020. Revenue for the three and six months ended June 30, 2021 was derived solely from the Company’s collaboration and license agreement with 3D Medicines, and represents a portion of initial signing and milestone payments received from 3D Medicines that is recognized at the time of the receipt and a portion of the payments that is deferred and recognized over the PROC trial period.

Total operating expenses for the three and six months ended June 30, 2021 were $11.2 million and $19.5 million, respectively, compared to $5.7 million and $16.0 million for the same periods in 2020.

Total operating expenses for the three and six months ended June 30, 2021 included non-cash stock-based compensation expense of $0.5 million and $1.0 million, respectively, compared to $0.5 million and $1.2 million for the same periods in 2020. In addition, during the six months ended June 30, 2020, there were non-recurring non-cash charges for impairment of the Company’s right-of-use asset and leasehold improvements of $2.9 million.

For the three and six months ended June 30, 2021, Aravive reported a net loss of $7.1 million and $15.1 million, or $0.35 per share and $0.78 per share, respectively, compared to a net loss of $5.0 million and $15.8 million, or $0.32 per share and $1.02 per share, for the same periods in 2020.

Cash Position
As of June 30, 2021, cash and cash equivalents were $75.4 million, compared to $60.5 million as of December 31, 2020. The Company expects that its current cash and cash equivalents will be sufficient to fund its operating plans into the second half of 2022.

About AVB-500
AVB-500 is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. AVB-500 is currently being evaluated in clinical trials and has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. Analysis of all safety data to date showed that AVB-500 has been generally well tolerated with no dose-limiting toxicities or unexpected safety signals.

About the AVB-500 Phase 3 PROC Trial
The global, randomized, double-blind, placebo-controlled adaptive trial (GOG-3059/ENGOT OV-66) is designed to evaluate efficacy and safety of AVB-500 at a dose of 15 mg/kg in combination with paclitaxel. The trial is expected to enroll approximately 300-400 patients with high-grade serous ovarian cancer who have received one to four prior lines of therapy at approximately 165 sites in North America, Europe, and Asia. The primary endpoint for the trial is progression-free survival and the secondary endpoint is overall survival. Exploratory endpoints include objective response rate, duration of response, quality of life, clinical benefit rate, pharmacokinetic and pharmacodynamic profile, and AXL/GAS6 ratio. A prospectively defined interim analysis will determine whether randomization will continue with all patients, regardless of prior bevacizumab treatment, or only with patients medically ineligible to receive bevacizumab or who choose not to receive bevacizumab. This trial is being conducted in partnership with The GOG Foundation, Inc. (GOG-F), through the GOG Partners program in the USA, and in partnership with the European Network for Gynecological Oncological Trial (ENGOT) groups in Europe. The Phase 3 trial is listed on clinicaltrials.gov NCT04729608.

About the AVB-500 Phase 1b/2 ccRCC Trial
Aravive initiated its Phase 1b portion of the Phase 1b/2 trial of AVB-500 in ccRCC in March 2021. The Phase 1b portion of the clinical trial, a dose escalation study, is expected to enroll approximately 18 patients in three dosing arms (15 mg/kg, 20 mg/kg and 25 mg/kg) to evaluate tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of AVB-500 in combination with cabozantinib. The controlled, randomized, open-label Phase 2 portion of the clinical trial is expected to enroll approximately 45 patients and investigate the recommended AVB-500 dose identified during the Phase 1b portion of the clinical trial in combination with cabozantinib versus cabozantinib alone. The primary endpoint is progression-free survival. The trial will enroll patients with advanced ccRCC who have progressed on front-line treatment. The Phase 1b/2 trial is listed on clinicaltrials.gov NCT04300140.

On August 5, 2021 Bayer AG reported the acquisition of Vividion Therapeutics, Inc. (Vividion), a US-headquartered biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics (Press release, Bayer, AUG 5, 2021, View Source [SID1234585848]). Vividion’s platform is able to produce a variety of small molecule therapies across indications, with initial focus on targets relevant to oncology and immunology. Vividion’s lead programs include multiple precision oncology targets and precision immunology targets, with ongoing efforts on a transcription factor NRF2 antagonist for the potential treatment of NRF2 mutant cancers, as well as NRF2 activators for various inflammatory diseases such as irritable bowel disease – among other pre-clinical programs.

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Following closing of the acquisition, Bayer will own full rights to Vividion’s proprietary discovery platform, which comprises three integrated, synergistic components: a novel chemoproteomic screening technology, an integrated data portal, and a proprietary chemistry library. The acquisition of Vividion strengthens Bayer’s small molecule capabilities and expands Bayer’s reach into new modalities. Under the terms of the agreement, Bayer will pay an upfront consideration of USD 1.5 billion and potential success-based milestone payments of up to USD 500 million.

"This acquisition is a cornerstone of our strategy to fuel our pipeline with breakthrough innovation," said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of the Bayer’s Pharmaceuticals Division. "Vividion’s technology is the most advanced in the industry, and it has demonstrated its ability to identify drug candidates that can target challenging proteins. Together with Bayer’s existing know-how, we will be able to develop first-in-class drug candidates, increasing the value of our pipeline. We want to provide innovative therapies for patients whose medical needs are not yet met by today’s treatment options."

Identification of drug candidates for proteins that are considered undruggable is a great challenge in drug discovery. Vividion’s chemoproteomic screening platform is able to identify previously unknown binding pockets on well-validated protein targets by screening chemical probes against the entire human proteome to assess selectivity. This yields highly potent and selective compounds that provide a wide therapeutic window for a variety of areas of high-unmet medical need. Vividion’s technology has already proven its applicability pre-clinically in oncology and immune-related diseases, and has the potential to expand into additional indications.

"Despite advances in genomics, structural biology and high-throughput screening, about 90% of disease-causing proteins cannot be targeted by current therapies due to the lack of a known addressable binding site. Our proprietary chemoproteomic platform technology addresses the key limitations of conventional screening techniques and allows us to discover previously unknown, or cryptic, functional pockets on the surface of proteins and identify small molecules that selectively bind to those targets," said Jeff Hatfield, Chief Executive Officer at Vividion. "When combined with Bayer’s expertise in the development of small molecules to market and patient, an unparalleled position comes into existence to unlock undruggable targets and generate first-in-class novel compounds for the benefit of patients."

To preserve its entrepreneurial culture as an essential pillar for nurturing successful innovation, Vividion will continue to operate as an independent organization on an arm’s length basis. Vividion will remain accountable to advance its technology and portfolio while benefiting from the experience, infrastructure and reach of Bayer as a global pharmaceutical company.

Closing of the transaction is contingent on customary closing conditions, including receipt of the required regulatory approvals, and is expected to take place in Q3 2021.

Credit Suisse is serving as financial advisor to Bayer, while Baker McKenzie is serving as legal counsel. Centerview Partners is serving as financial advisor to Vividion, while Cooley LLP is serving as legal counsel

On August 5, 2021 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal third quarter ended June 30, 2021 (Press release, Arrowhead Research Corporation, AUG 5, 2021, View Source [SID1234585865]). The company is hosting a conference call today, August 5, 2021, at 4:30 p.m. ET to discuss the results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 7398304.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 7398304.

Selected Recent Events

Received Breakthrough Therapy designation from the U.S. Food and Drug Administration for ARO-AAT, also known as TAK-999, the company’s second-generation investigational RNA interference (RNAi) therapeutic being co-developed with Takeda Pharmaceutical Company Limited as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency.
Presented additional positive interim 48-week liver biopsy results from the ongoing AROAAT2002 study, an open-label Phase 2 clinical study of ARO-AAT, at The International Liver Congress – The Annual Meeting of the European Association for the Study of the Liver (EASL). The results demonstrate that investigational ARO-AAT treatment led to improvements in multiple measures of liver health, including fibrosis, with substantial and sustained reductions in the level of mutant AAT protein. In addition, ARO-AAT treatment was generally well tolerated after up to 1 year of treatment.
Presented positive interim results from AROHSD1001, an ongoing Phase 1/2 clinical study of ARO-HSD, the company’s investigational RNAi therapeutic being developed as a treatment for patients with alcohol-related and nonalcohol related liver diseases, such as nonalcoholic steatohepatitis (NASH), at EASL. The data demonstrate that ARO-HSD is the first investigational therapeutic to achieve robust reductions in messenger RNA and protein levels of hepatic HSD17B13, leading to reductions in alanine aminotransferase (ALT), a liver enzyme typically elevated in liver diseases including NASH.
Announced positive interim results from the first two cohorts of AROHIF21001, a Phase 1b dose-finding clinical study of ARO-HIF2, the company’s investigational RNAi therapeutic being developed as a treatment for patients with clear cell renal cell carcinoma. The data show clear signs of meaningful target engagement and some potentially early signs of efficacy in at least one patient.
Initiated and began dosing patients in AROANG3-2001, a Phase 2b clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed as a treatment for patients with mixed dyslipidemia.
Initiated and began dosing patients in AROAPOC3-2001, a Phase 2b clinical study of ARO-APOC3, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with severe hypertriglyceridemia (SHTG). Arrowhead also intends to initiate a Phase 2b study and a Phase 3 study of ARO-APOC3 in two additional patient populations in 2021.
Announced a global collaboration and license agreement with Horizon Therapeutics for ARO-XDH, a previously undisclosed discovery-stage RNAi therapeutic being developed by Arrowhead as a potential treatment for people with uncontrolled gout. Arrowhead received $40 million as an upfront payment from Horizon and is eligible to receive up to $660 million in potential development, regulatory and commercial milestones, and is further eligible to receive royalties in the low- to mid-teens range on net product sales.
Earned a $10 million option exercise fee from Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, for ARO-JNJ1.
Presented promising preclinical data on ARO-DUX4, Arrowhead’s first muscle-targeted program being developed as a treatment for patients with facioscapulohumeral muscular dystrophy (FSHD) at the 28th Annual FSHD Society International Research Congress. The data show that the TRiMTM muscle delivery platform achieved functional delivery to various types of skeletal muscle and achieved deep, durable, and dose-dependent knockdown of target genes. In addition, ARO-DUX4 improved multiple measures of FSHD-like muscle phenotype in relevant preclinical animal models.
Nominated ARO-C3, which is designed to reduce production of complement component 3 (C3) as a potential treatment for various complement mediated diseases, as a clinical candidate and initiated IND-enabling toxicology studies.