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Herantis Pharma: Results for the First Half Year January 1 – June 30, 2021

On August 26, 2021 Herantis Pharma Plc ("Herantis"), focusing on disease modifying therapies for debilitating neurodegenerative diseases, reported its half yearly financial report for the period January 1 – June 30, 2021 (Press release, Herantis Pharma, AUG 26, 2021, View Source;results-for-the-first-half-year-january-1—june-30–2021,c3403498 [SID1234586902]). It is available on Herantis’ website (Financial information). Investors, analysts and media are invited to a webcasted live call today at 10:30 EEST / 9:30 CEST.

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To register for Herantis’ 1H 2021 Financial Report live call

Webinar ID: 235-655-763

Questions can be submitted throughout the webcast event.

Following the webcast of the live call, a recording will be available on Herantis Pharma’s website (www.herantis.com).

Herantis transformed into a pure play CNS biotech company –

Highlights January – June 2021:

Strategic data drive decision taken to fully focus all company resources on Herantis’ CDNF and xCDNF assets, thus becoming a pure play CNS (central nervous system) biotech company.
Selected HER-096 as the xCDNF candidate to take forward into further development for the treatment of Parkinson’s Disease (PD) and other neurodegenerative diseases, an important milestone for the company. HER-096 was selected based on clear and compelling preclinical data including that it:
Effectively penetrates the Blood-Brain-Barrier (BBB)
Potently protects neurons and restores their functional phenotype
Significantly reduces aggregation of the toxic protein alpha-synuclein and the associated neuroinflammation
Restores proteostasis
A study showing CDNF’s therapeutic effects in alpha-synuclein-based animal models was published in Molecular Therapy, a leading scientific journal. This study provides new insight in how CDNF affects alpha-synuclein pathology on the molecular and cellular level.
Entered into an agreement with Nanoform Finland Plc. The collaboration provides for formulation proof-of- concept studies to combine Herantis’ CDNF therapy for Parkinson’s disease, with Nanoform nanoparticle technology.
Two presentations summarizing the results from the Phase I-II First-In-Man Clinical Trial of CDNF in PD were presented at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases, AD/PD 2021.
The clinical trial results from Phase II study investigating Herantis’ patented gene therapy Lymfactin, for the treatment of Breast Cancer Related Lymphedema (BCRL), were inconclusive. The primary purpose of the trial was to determine whether there was an additional benefit of Lymfactin treatment in combination with lymph node transfer surgery, compared to surgery alone. While both treatment groups experienced clear clinical benefits, the trial did not establish additional treatment benefit for Lymfactin in combination with surgery, compared to surgery alone. Strategic decision taken to seek out-licensing partners for the Lymfactin program.
Hilde Furberg was elected to the Board of Directors
Hilde brings 35+ years of global leadership experience both as a Board member and through her years in global sales, marketing, strategy and management in the international Pharma/Biotech industries
Former European Head of Rare Disease Europe/GM and Senior VP Rare Diseases EMEA at Genzyme/Sanofi Genzyme
Successful R&D investor day held in June. Link to the event: Herantis’ Virtual R&D Investor Day 2021
Presented novel evidence of biological and biomarker impact in humans from the CDNF Phase 1 clinical study

Summary and outlook for 2021:

The new Herantis is a pure play CNS company, and the programs are fully focused on disease modifying therapeutics to address the unmet need in Parkinson’s disease and other neurological illnesses. During the remainder of 2021 we will continue executing our roadmap as we aim to complete formulation activities for the new CDNF administrations routes, and continue strengthening the preclinical proof of concept data for HER-096 (xCDNF).

ImmuneOnco Received NMPA Authorization to Proceed with 3 Phase Ib/IIa Clinical Trials of IMM01 Combined with Azacytitin, Rituximab and Inetetamab

On August 25, 2021 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. ( hereinafter referred to as "ImmuneOnco") reported that 3 phase Ib/IIa trials of company’s lead drug candidate, IMM01, Fc fusion protein targeting CD47，the first in China, combined with Azacytitin for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with Rituximab for relapsed/refractory B-cell lymphoma and with Inetetamab (CipterbinTM) in her2-positive solid tumors have been approved by the National Drug Products Administration (NMPA) (Press release, ImmuneOnco Biopharma, AUG 25, 2021, View Source [SID1234655626]). All clinical trials will be Initiated in the near future. The clinical trial of IMM01 combined with Inetetamab (CipterbinTM) will be cooperated with Sunshine Guojian (stock code , SHA: 688336) and mainly conducted by it. So far, total five clinical trial applications for IMM01 have been approved, which further establishes ImmuneOnco leading position in the research and development of CD47 target drugs.

The ongoing Phase I study of IMM01 monotherapy for the treatment of patients with relapsed/refractory lymphoma (NHL & HL) has completed all scheduled doses of participants. No dose-limiting toxicity (DLT) is observed and no subjects developed anti-drug antibodies (ADA) except for minor infusion response in some patients. There were no drug-related serious adverse events (SAE). At the same time, some patients had an exciting indication efficacy response, especially for patients with recurrent/refractory classic Hodgkin’s lymphoma: 1 case of PR and 3 cases of SD in 5 patients with cHL, and the disease control rate reached 80%. Among them, the patient with PR was drug-resistant to PD-1 therapy. Currently, PR has lasted for 40 weeks and is still receiving treatment. In 1.5mg/kg dose group (the highest escalation dose group), four of the five patients enrolled had SD, two of them were SD with tumor shrinkage (17% and 33%, respectively). CR for 26 weeks was also observed in one patient.

"We are very pleased to see that the National Food and Drug Administration (NMPA) has approved clinical studies of IMM01 combined with Azacytitin, Rituximab and Inetetamab. The drug candidate IMM01, which is being tested in phase I clinical trials, has achieved long-lasting efficacy in some patients with advanced lymphoma at a low dose range with a good safety profile. Those clinical benefits are supported by the proprietary molecular design of IMM01. IMM01 does not bind to human red blood cells at all so as to avoid "Antigenic sink". Due to that in vivo infusion of the molecule doesn’t produce ADA and a smaller molecule (half molecular weight of regular IgG), it has higher tissue permeability and bioavailability. IMM01 has been tested in preclinical experiments in vitro in combination with various targeting and immunotherapeutic agents, efficacy appeared to be robust in tumor suppressive activity and potential to be applied to solid tumors. "We believe that IMM01 in combination with other drugs will provide significant advantages in clinical development." Dr. Tian Wenzhi, the founder of ImmuneOnco, is very confident of the IMM01 clinical trials. "We plan to expand IMM01 to apply in new indications and combination studies in the future to benefit more patients," he said.

2021 Annual Report

On August 25, 2021 Pierre Fabre reported 2021 Annual Report (Presentation, Pierre Fabre, AUG 25, 2021, View Source [SID1234639493]).

Precision BioSciences to Host In Vivo Gene Editing R&D Event on September 9, 2021

On August 25, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that it will host its first R&D event focused on in vivo gene editing at 8:00 am ET on Thursday, September 9, 2021 (Press release, Precision Biosciences, AUG 25, 2021, View Source [SID1234591429]).

Precision’s gene editing event will feature presentations from Company management as well as featured guest speakers and will outline Precision’s development strategy to advance its in vivo gene editing portfolio. The agenda will include an overview of ARCUS, Precision’s proprietary platform for in vivo gene correction, new pre-clinical data, timelines for leading in vivo gene editing programs, and updates from academic and industry collaborators.

Company Conference Call and Webcast Information

Registration for the live webcast is available under Events & Presentations in the Investors section of the Precision BioSciences website at investor.precisionbiosciences.com. The dial-in conference call numbers for domestic and international callers are (866) 970-2058 and (873) 415-0216, respectively. The conference ID number for the call is 6376435. An archived replay of the webcast will be available on the Company website for one year following the presentation.

eFFECTOR Therapeutics Debuts as Publicly Traded Next-Generation Oncology Company Advancing Mature Pipeline with New Class of Cancer Therapies

On August 25, 2021 eFFECTOR Therapeutics, Inc. (eFFECTOR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, reported thatb completed its business combination with Locust Walk Acquisition Corp. (NASDAQ: LWAC) (Press release, eFFECTOR Therapeutics, AUG 25, 2021, View Source [SID1234587034]). The resulting combined company (the Company) has been renamed "eFFECTOR Therapeutics, Inc." and expects its common stock and public warrants will commence trading on Nasdaq under the new trading symbols "EFTR" and "EFTRW", respectively, starting on August 26, 2021.

The stockholders of LWAC approved the transaction at a special meeting held on August 24, 2021, and the transaction was previously approved by eFFECTOR’s stockholders. eFFECTOR’s management team, led by president and chief executive officer, Steve Worland, Ph.D., will continue to lead the Company.

"Cancer continues to be a major global health problem because of its complexity, including multiple escape mechanisms. That is why we are advancing the development of STRIs with the potential to target a central node that drives multiple disease processes simultaneously, including cancer’s inherent escape mechanisms," commented Dr. Worland. "We believe that our unique approach to development, along with the capital raised from this transaction, could help us unlock the potential of translation regulation to bring this new class of therapies through the clinic and ultimately to patients. Importantly, we anticipate that the cash available from the transaction will see our company through key Phase 2 data readouts for both of our lead programs."

"With a strong pipeline with multiple near-term data readouts, we are excited to see eFFECTOR Therapeutics take this very important next step in its evolution," stated Chris Ehrlich, former chief executive officer and director of LWAC who will continue as a director of the Company. "eFFECTOR’s expert team, along with the strategy to accelerate the development of innovative programs that are already progressing in the clinic, makes the Company well-positioned in its efforts to transform treatments for patients with cancer."

Advisors

Credit Suisse and Stifel acted as lead placement agents for the private placement (PIPE) in connection with the business combination, and Credit Suisse also acted as capital markets advisor to eFFECTOR. Locust Walk Securities also acted as PIPE placement agent. Latham & Watkins LLP acted as legal counsel to eFFECTOR. Cantor Fitzgerald acted as the lead capital markets advisor to LWAC. JMP Securities and Mizuho Securities also acted as capital markets advisors to LWAC. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel to LWAC.