On July 8, 2021 Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotech company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, reported that results from both its Phase 1/2a trial of cancer immunotherapy EVX-01 in metastatic melanoma and interim Phase 1/2a trial of cancer immunotherapy EVX-02 in adjuvant melanoma (Press release, Evaxion Biotech, JUL 8, 2021, View Source [SID1234584697]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data from the trial of EVX-01, a novel patient-specific cancer neoepitope immunotherapy based on Evaxion’s PIONEER AI technology in combination with a PD-1 checkpoint inhibitor, showed a safety profile with only Grade 1 and 2 adverse events observed.

Combined therapy with EVX-01 demonstrated an objective response rate of 67% across all nine patients compared with historical data of 40% with anti-PD1 treatment alone1. The study also demonstrated a complete response rate of 22%, compared with a historical 7%1 with anti-PD1 treatment alone, and a partial response rate of 44%, versus 33% compared with anti-PD1 treatment alone1. Among the four patients on the highest two doses, there was an objective response rate of 75%. Three patients with Stable Disease for 10, 8 and 9 months on anti-PD1 treatment alone, achieved CR, CR and PR respectively following EVX-01 administration and subsequent activation of a neoepitope specific de novo T-cell response.

Lars Wegner, CEO of Evaxion, said: "We are very excited about the Phase 1/2a data for EVX-01, which shows encouraging results for our AI-developed immunotherapy in metastatic melanoma and appears to be well tolerated with only Grade 1 and 2 adverse events such as fatigue and fever all of which were resolved with treatment. The complete elimination of all tumors we see in the two patients stable for 8-10 months on checkpoint inhibitor treatment has further increased our belief in the benefit our neoepitope-based therapies can bring to patients. In addition, the tumor reduction in patients correlates with neoepitope specific T-cell activation and PIONEER predictions. The data demonstrate the potential of our PIONEER platform and its ability to identify patient specific cancer neoeptiopes. Importantly, the objective response rate demonstrates that EVX-01 may be able to improve the treatment landscape in melanoma and potentially other cancers. Furthermore, the first results from our Phase 1/2a trial with EVX-02 demonstrate its potential for treatment of melanoma. Based on the data from these two studies, we expect to initiate a Phase 2 trial with EVX-01 by the end of the year and a Phase 2 trial with EVX-02 in Q2 2022."

Professor Inge Marie Svane, Head of the Danish Centre for Cancer Immunotherapy and Principal Investigator of the EVX-01 study, said: "These Phase 1/2a data demonstrate the feasibility of the combination of EVX-01 with anti-PD1 therapy with substantial reduction of tumor burden in some patients. It is particularly interesting to see that two patients improved their response to anti-PD1 therapy further to complete response following addition of EVX-01. This could be good news for patients and I look forward to contributing to the further development of this novel therapy."

About the EVX-01 Phase 1/2a clinical trial in metastatic melanoma
In the Phase 1/2a trial, nine patients with metastatic melanoma were injected biweekly with EVX-01, three times intraperitoneal and three times intramuscular plus, with pembrolizumab every three weeks or nivolumab every four weeks. Patients were dosed at three different levels of EVX-01, 500 μg, 1,000 μg and 2,000 μg.

The study also revealed encouraging biomarker information supporting EVX-01’s mechanism of action. There was broad T-cell activation in all patients, with 76.2% of the administered neoepitopes inducing reactive T cells, while 84.8% of EVX-01 induced reactive T cells were de novo responses. Patient cases established a direct link between EVX-01 activated T cells and antitumor effect and duration of response. The data further demonstrated a link between neoepitopes identified by the PIONEER platform and clinical response.

The results also showed that Evaxion’s novel proprietary AI-Immunogenetic Drug Response Platform (AI-DeeP), which provides immuno-genetic profiling of individual patients based on biological rational for drug response, can predict the response to therapy with precision and sensitivity.

We believe that the data support progressing the development of EVX-01 into a subsequent randomized Phase 2b trial, which we expect to initiate in December 2021. We also intend to present the data at a upcoming medical society meeting in first half of 2022.

Phase 1/2a results with EVX-02 in adjuvant melanoma

This is an open label, multi-center study assessing the safety, tolerability, pharmacodynamics, and potential efficacy of EVX-02 in combination with checkpoint inhibitor in patients who have had a complete resection of Stage IIIB/IIIC/IIID or Stage IV melanoma and are at high risk of recurrence. The study is taking place at five clinical centers in Australia.

Data from the first patients in the trial showed T-cell activation, even in assays which had not been prestimulated. Based on this readout, Evaxion will continue to generate more data from the trial with the aim of initiating a Phase 2 trial with EVX-02 in an adjuvant setting in the second quarter of 2022.

1) Robert et al. 2015. Pembrolizumab versus Ipilimumab in Advanced Melanoma. N. Engl. J. Med. 372: 2521–32.
Webcast and Conference Call

To discuss today’s data announcement Evaxion will host a webcast and conference call today, July 8, 2021 at 8:00 a.m. EDT.

To dial-in for the conference call, please use the following details:

US: 877-407-0792

International: +1-201-689-8263

Conference ID: 13720456

Webcast: View Source

The webcast recording will be available from 8th of July 2021 at: Webcast Archive

On July 8, 2021 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), ("TransCode" or the "Company") an emerging RNA oncology company, created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, reported the pricing of its initial public offering of 6,250,000 shares of its common stock at a public offering price of $4.00 per share, for gross proceeds of $25,000,000, before deducting underwriting discounts and offering expenses (Press release, TransCode Therapeutics, JUL 8, 2021, View Source [SID1234584729]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 937,500 shares of common stock to cover over-allotments at the initial public offering price, less the underwriting discount. All of the shares of common stock are being offered by the Company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company intends to use the proceeds for testing required to file an IND for the Phase 0 trial of TTX-MC138, for further development of TTX-MC138, strategic expansion of their drug candidate portfolio, and the balance for working capital and general corporate purposes.

The shares are expected to begin trading on the Nasdaq Capital Market on July 9, 2021 under the symbol "RNAZ." The offering is expected to close on July 13, 2021, subject to satisfaction of customary closing conditions.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

A registration statement on Form S-1 (File No. 333-253599) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on July 8, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected]. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 8, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, has taken another major step towards leveraging the speed and throughput of its proprietary, plant-based FastPharming Protein Expression System by reported it is adding three anti-cancer targets to its pipeline of therapeutic candidates (Press release, iBioPharma, JUL 8, 2021, View Source [SID1234585486]). This development establishes the Company’s new drug discovery capabilities announced just a few weeks ago.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of iBio’s efforts to change the drug development paradigm with the FastPharming System by reducing the time and cost to move from initial concept to the clinic, the Company intends to partner with best-in-class technology partners to help achieve that vision. Accordingly, iBio has entered into a research services agreement with FairJourney Biologics S.A. ("FairJourney"), leaders in antibody optimization. Pursuant to the agreement, iBio will gain access to novel display technologies and proprietary antibody libraries.

"We believe combining our ‘speed-to-clinic’ advantages and Glycaneering TechnologiesTM with the antibody optimization technologies provided by FairJourney may enable us to quickly develop differentiated cancer therapeutic antibodies with improved antibody-dependent cell-mediated cytotoxicity, or ADCC," said Martin B. Brenner, DVM, Ph.D., iBio’s Chief Scientific Officer.

António Parada, CEO at FairJourney commented, "Our experience in antibody discovery for use in oncology has grown in recent years, with a number of undisclosed collaborations rapidly moving towards the clinic. We are excited to work with an innovator like iBio, which we believe has the ability to change the bioprocess paradigm, using its proprietary glycosylation technologies to enhance human anti-cancer antibody development."

On July 8, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its second quarter 2021 financial results after the close of the U.S. financial markets on July 28, 2021 (Press release, Exact Sciences, JUL 8, 2021, View Source [SID1234584698]). Following the release, company management will host a webcast and conference call at 5 p.m. EDT to discuss financial results and business progress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 3969691. The webcast, conference call and replay are open to all interested parties.

On July 7, 2021 Alector, Inc. (Nasdaq: ALEC) and GlaxoSmithKline plc (LSE/NYSE: GSK), reported a strategic global collaboration for the development and commercialization of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels (Press release, Alector, JUL 7, 2021, View Source [SID1234584646]). PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint. Enrollment is currently underway for a pivotal Phase 3 trial for AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). FTD-GRN is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis and has no approved treatments. AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a mutation in the C9orf72 gene and is planned to enter Phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021. AL101 is in a Phase 1a clinical trial and is designed to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Our focus on human genetics and the science of the immune system gives us unique insights into the potential of targets such as progranulin to help patients with a number of neurodegenerative diseases. Working with Alector’s world class scientists will allow us to investigate the potential of these immuno-neurology therapies to help patients with frontotemporal dementia, a devastating disease without any currently approved treatments, as well as explore the ability to help patients with other neurodegenerative diseases, such as ALS, Parkinson’s and Alzheimer’s."

Arnon Rosenthal, Ph.D., Chief Executive Officer, Alector, said: "This transformative collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of our progranulin franchise into large indications, while bolstering the build

For media and investors only

PRESS

RELEASE

LOGO
For media and investors only

out of our own late-stage development and commercial capabilities. Importantly, this collaboration is designed to fully support AL001 and AL101’s development and to enable Alector to continue building a fully integrated company as we strive to address the high unmet medical need in patients suffering from neurodegenerative diseases. We are confident that GSK’s extensive experience launching ground-breaking medicines at the intersection of immunology and human genetics, will ensure that AL001 and AL101 are developed to their full potential."

As part of the recent Investor Update day on 23 June 2021, GSK committed to an R&D approach focused on maximizing opportunities by leveraging an increased understanding of the science of the immune system and human genetics. The collaboration with Alector on AL001 and AL101, two antibodies designed to elevate PGRN levels and potentially slow the progression of FTD and other neurological disorders, provides GSK access to a promising clinical program in immuno-neurology.

Terms of the Collaboration

Under the terms of the collaboration agreement, Alector will receive $700 million in upfront payments. In addition, Alector will be eligible to receive up to an additional $1.5 billion in clinical development, regulatory and commercial launch-related milestone payments.

Alector will lead the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. Thereafter, Alector and GSK will share development responsibilities for all late-stage clinical studies for AL001 and AL101 and all costs for global development will be divided between the two companies.

The companies will be jointly responsible for commercialization in the U.S. and will share profits and losses. Alector will lead commercial efforts associated with AL001 in orphan indications and GSK will lead the commercialization of AL101 in Alzheimer’s and Parkinson’s disease. Outside the U.S., GSK will be responsible for commercialization of AL001 and AL101 and Alector will be eligible for tiered royalties.

The collaboration agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

About the Progranulin-Elevating Monoclonal Antibodies – AL001 and AL101

Decreased levels of PGRN, a key regulator of immune response, lysosomal function, and neuronal survival in the brain, are genetically linked to many neurodegenerative disorders. AL001 and AL101 are novel human monoclonal antibodies that elevate levels of progranulin by blocking the sortilin receptor responsible for progranulin degradation. AL001 is currently in a pivotal Phase 3 clinical study in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a C9orf72 mutation, with another Phase 2 study in patients with ALS planned to begin in the second half of 2021. AL101, is designed to treat people suffering from more prevalent neurodegenerative diseases and is currently in a Phase 1a study in healthy volunteers. AL101 is intended to be developed for treatment of Parkinson’s disease and Alzheimer’s disease.

About Frontotemporal Dementia (FTD)

Frontotemporal dementia is a rapidly progressing and severe form of dementia. It affects 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union, with potentially higher prevalence in Asia and Latin America. There are currently no FDA-approved treatment options for FTD.

There are multiple heritable forms of FTD. In one form, FTD-GRN, people have a mutation in the progranulin gene. This population represents 5% to 10% of all people with FTD. Mutations in a single copy of a progranulin gene leads to a 50% or greater decrease in the level of progranulin protein and invariably leads to development of FTD. In another form, people with mutations in the chromosome 9 open reading frame 72 (C9orf72) gene can develop FTD. FTD-C9orf72 is associated with abnormal accumulation of the protein TDP-43, which is also a hallmark in FTD-GRN. To date researchers have identified more than 120 inherited loss of function mutations in the progranulin gene that lead to FTD.

Alector Conference Call Information

Alector management will host a conference call to discuss the collaboration today at 8:30 a.m. ET. Analysts and investors are invited to participate in the conference call by dialling (888) 705-0365 from the U.S. and Canada or (415) 817-9241 internationally and using the conference ID 9476664. The live webcast can be accessed on the investor page of Alector’s website at investors.alector.com. A replay of the webcast will be available on Alector’s website approximately two hours after the completion of the event and will be archived for up to 30 days.