On June 28, 2022 Pepscan, the all-in-one peptide service provider, reported that it will supply personalized peptide pools for six patients in a phase I trial led by Mayo Clinic principal investigator Yanyan Lou, M.D., Ph.D., in collaboration with Keith L. Knutson, Ph.D (Press release, Pepscan Therapeutics, JUN 28, 2022, View Source [SID1234616347]). The trial tests the safety and tolerability of an experimental personalized peptide vaccine when given in combination with pembrolizumab in treating patients with a wide range of advanced solid tumors and tumors that have spread to other places in the body (metastases). The vaccine is designed to target certain proteins (neoantigens) on individuals’ tumor cells. Combination immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer and thereby interfere with the ability of the tumor cells to grow and spread.

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"Mayo Clinic is recognized as one of the best hospital groups in the US and we are excited to provide the peptide pools for their investigational phase I study. Supplying top researchers and clinicians worldwide to turn their ideas into better treatment outcomes for patients is what we aim for at Pepscan." says Hans de Backer, CEO of Pepscan.

The primary objective of the study "Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors" is to evaluate the safety, side effects, optimal dosages and risks/benefits of a personalized neoantigen peptide vaccine in combination with pembrolizumab in advanced solid cancers. Pepscan will manufacture up to 20 unique peptides and combine them into peptide pools, making up the active pharmaceutical ingredient (API) of the vaccine. All within only 5 weeks to shipment (under quarantine). Besides the manufacturing, Pepscan also supported Mayo Clinic with the CMC (chemistry, manufacturing and control) report, which was submitted as part of Mayo’s Investigational New Drug (IND) Application and has been approved by the FDA. Manufacturing personalized peptides for neoantigen vaccines requires a very specific set of process development and manufacturing skills, facilities and analytical methods. With 25 years of experience in mastering peptides and flexible manufacturing capabilities, Pepscan reliably delivers individual or pooled peptide sets that fit its customers’ timelines.

On June 28, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical technology company focused on developing products to diagnose and treat life and organ threatening infectious diseases, reported financial results for its fiscal year ended March 31, 2022 and provided an update on recent developments (Press release, Aethlon Medical, JUN 28, 2022, View Source [SID1234616346]).

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Company Updates

Aethlon Medical is continuing the research and clinical development of the Hemopurifier, a therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. This action has potential applications in cancer, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.

As disclosed previously, the Aethlon Hemopurifier has demonstrated binding of the SARS-CoV-2 spike protein and, as reported in a peer reviewed publication, the binding and removal from circulation of SARS-CoV-2 virus from a human patient. That publication also noted that the Hemopurifier has demonstrated the removal of exosomes and exosomal microRNAs associated with coagulopathy and acute lung injury.

We also recently published a pre-print manuscript demonstrating that Aethlon’s proprietary GNA affinity resin was able to bind seven clinically relevant SARS-CoV-2 variants in vitro, including the Delta and Omicron variants. Viral capture efficiency with the GNA affinity resin ranged from 53% to 89% for all variants tested. The GNA affinity resin is a key component of our Hemopurifier. The manuscript is titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus nivalis Agglutinin" and was published in bioRxiv.

We continued to advance our severe COVID-19 clinical trial for the Hemopurifier under our open Investigational Device Exemption (IDE) for life-threatening viral infections. In June 2022, the first patient in this study was enrolled and has completed the Hemopurifier treatment phase of the protocol. We now have nine fully activated hospitals that are actively screening patients for the trial, including Louisiana State University (LSU) Shreveport, Valley Baptist Medical Center in Texas, Loma Linda Medical Center, Hoag Irvine and Newport Beach in Southern California, University of California Davis, University of Miami Medical Center, Cooper Medical and Thomas Jefferson Medical Center. We are in the site activation process with additional U.S. medical centers. Our contract research organization (CRO) for this trial is Pharmaceutical Product Development, also known as PPD.

We also obtained ethics review board approval and entered into an agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, to initiate a COVID-19 clinical trial. We have completed all site initiation activities and this site is now open for enrollment and is actively screening patients. One patient recently completed participation in the study.

In addition to our work with COVID-19, we continue to screen patients for our IDE clinical trial in head and neck cancer. We are working to increase the number of trial sites to accelerate patient recruitment and we are also considering initiating additional trials, both domestically and abroad, to investigate the Hemopurifier as a treatment for other forms of cancer.

Aethlon also recently announced the appointment of Angela Rossetti to the Aethlon Board of Directors, effective April 1, 2022. Ms. Rossetti is a senior biopharmaceutical executive who brings more than 20 years of industry experience.

Financial Results for the Fiscal Year Ended March 31, 2022

At March 31, 2022, Aethlon Medical had a cash balance of approximately $17.1 million.

Aethlon recorded approximately $294,000 of revenue related to our government contracts with the NIH in the fiscal year ended March 31, 2022, compared to approximately $659,000 in the fiscal year ended March 31, 2021. At March 31, 2022, the Company had approximately $345,000 of deferred revenue related to those contracts as a result of not achieving certain milestones in those contracts.

Consolidated operating expenses for the fiscal year ended March 31, 2022 were approximately $10.72 million, compared to approximately $8.55 million for the fiscal year ended March 31, 2021, an increase of approximately $2.17 million in fiscal year ended March 31, 2022. The $2.17 million increase in the 2022 period was due to increases in payroll and related expenses of approximately $1.17 million and in general and administrative expense of $1.0 million, which were partially offset by a decrease of approximately $4,000 in professional fees.

The $1.17 million increase in the fiscal year ended March 31, 2022 in payroll and related expenses was due to an increase in cash-based compensation of approximately $1.2 million, which was partially offset by a decrease in stock-based compensation of approximately $29,000. The $1.2 million increase in cash-based compensation was primarily due to increases of approximately $826,000 and $721,000 in general and administrative payroll and in research and development payroll, respectively, due to headcount increases, and approximately $203,000 in relocation-related compensation to two senior executives that relocated to San Diego, California as a condition of their employment. Those increases were partially offset by the combination of a $452,000 accrual in the 2021 period related to the separation agreement with the former CEO, with no comparable expense in the 2022 period, and a net decrease of approximately $135,000 in cash bonuses.

The $1.0 million increase in the fiscal year ended March 31, 2022 in general and administrative expenses primarily arose from increases of $453,000 in clinical trial expenses, $209,000 in rent expense and $195,000 in insurance expense

As a result of the changes in revenues and expenses noted above, Aethlon’s net loss before noncontrolling interests increased to approximately $10.4 million for the fiscal year ended March 31, 2022, from approximately $7.9 million for the fiscal year ended March 31, 2021.

The unaudited condensed consolidated balance sheet for March 31, 2022 and the unaudited condensed consolidated statements of operations for the fiscal years ended March 31, 2022 and 2021 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Tuesday, June 28, 2022 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through July 28, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 4234353.

On June 28, 2022 Calliditas Therapeutics AB (publ) (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas" or "the Company") reported that it has filed with the U.S. Securities and Exchange Commission (the "SEC") a registration statement including a prospectus ("Prospectus") relating to a U.S. At-the-Market framework of up to an aggregate amount of $75,000,000, pursuant to which the Company may, at its option, sell American Depositary Shares ("ADSs") in the United States at market price, from time to time, in "at the market" transactions on The Nasdaq Global Select Market (the "ATM Program") (Press release, Calliditas Therapeutics, JUN 28, 2022, View Source [SID1234616345]). If the Company chooses to use the ATM Program, the ADSs will be sold pursuant to an Open Market Sale Agreement (the "Sale Agreement") with Jefferies LLC ("Jefferies"). The timing of any potential sales under the ATM Program will depend on a variety of factors and Calliditas is not under any obligation to utilize the ATM Program in a specified amount or at all.

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The ADSs intended to be sold under the Sale Agreement, if any, will be issued and sold by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, pursuant to a shelf registration statement on Form F-3 (the "Registration Statement"), once declared effective by the SEC. The number of ADSs sold pursuant to the Sale Agreement will be limited to the number of underlying common shares approved for transfer pursuant to the shareholder authorization obtained at the annual general meeting held on May 19, 2022 in respect of maximum 5,908,019 shares being valid up until the annual general meeting 2023. Such transfers, if any, may be made effective at a price in cash which corresponds to the market price at the time of the transfer of the Calliditas shares transferred as the Board of Directors finds appropriate. No assurance can be made that sales under the ATM Program will take place. No transactions under the ATM Program will take place on Nasdaq Stockholm. As of today, Calliditas does not hold any of its own shares, but has issued 5,908,018 class C shares to Aktieinvest which the Company intends to repurchase. All C shares are pending conversion into ordinary shares before they are transferred under the ATM Program.

To the extent that ADSs are sold pursuant to the ATM Program, the Company expects to use the net proceeds primarily to fund the development of candidates from the Company’s NOX inhibitor platform, including setanaxib, in indications for which they may have therapeutic potential, including PBC and squamous carcinoma of the head and neck, or for any indications which are in early development, to fund commercial activities for TARPEYO, to fund the development of Budenofalk in AIH, and to fund the acquisition, development and commercialization of product candidates that the Company may acquire or in-license and for working capital and other general corporate purposes.

The information was sent for publication, through the agency of the contact persons set out above, on June 28, 2022 at 11:15 p.m. CEST.

The Registration Statement was filed with the SEC on June 28, 2022 and has not yet been declared effective. Any sales under the ATM Program will be made pursuant to the Prospectus relating to the ATM Program once the Registration Statement has been declared effective. Before purchasing ADSs in the offerings, prospective investors should read the Prospectus, together with the documents incorporated by reference therein. A copy of the Prospectus may be obtained on the SEC’s website at www.sec.gov. Alternatively, a copy of such Prospectus may be obtained from Jefferies LLC, Attention: Prospectus Department, 520 Madison Avenue, New York NY 10022, or by telephone at 1-877-821-7388, or by email at [email protected].

This company announcement does not and shall not constitute an offer to sell or a solicitation to buy the securities mentioned and no sale of such securities will be made in the United States, any state or province in which such offer, solicitation or sale would be unlawful until the securities are registered or their distribution is permitted under the securities laws of that state or province. In particular, no public offering of the ADSs will be made in Europe.

On June 28, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), reported that Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx, will participate in the virtual H.C. Wainwright Preclinical Cancer Drug Discover: Emerging Targets and Modalities Conference on Wednesday, June 29, 2022 (Press release, Ambrx, JUN 28, 2022, View Source [SID1234616344]).

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Dr. Tian will participate in a virtual presentation that will be available on demand starting on Wednesday, June 29, 2022 at 7:00 AM Pacific Time / 10:00 AM Eastern Time.

Dr. Tian will participate in a live panel discussion moderated by Robert Burns on the treatment landscape of HER2 on Wednesday, June 29, 2022 at 9:00 AM Pacific Time / 12:00 PM Eastern Time.

Interested parties can access the live and pre-recorded webcasts for these conferences from the Investor Relations section of the company’s website at www.Ambrx.com. The webcast replays will be available after the conclusion of the respective presentations for approximately 90 days.

On June 28, 2022 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule cancer therapeutics, reported that data from the ongoing Phase 1b clinical trial studying RGX-202-01 in combination with FOLFIRI and bevacizumab (FOLFIRI/BEV) in second-line advanced colorectal cancer (CRC) at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer being held June 29 through July 2, 2022 in Barcelona, Spain (Press release, Inspirna, JUN 28, 2022, View Source [SID1234616343]).

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"These clinical data continue to demonstrate the clear potential of RGX-202-01 to improve on the standard of care for patients with advanced or metastatic colorectal cancer, especially for those whose tumors harbor KRAS mutations," said Andrew Hendifar, M.D., Assistant Professor at Cedars-Sinai Medical Center and Principal Investigator on the study. "RGX-202-01 employs a novel mechanism by inhibiting the creatine transporter SLC6a8, which enables cells to generate ATP as well as other nucleotides by importing phospho-creatine (p-creatine). These results also show that KRAS mutant tumors are highly sensitive to the effects of SLC6a8 inhibition by RGX-202-01. The drug is also very well-tolerated, enabling a safe and effective combination therapy with FOLFIRI/BEV to provide further optionality for patients."

RGX-202-01 is an oral, potential first-in-class small molecule inhibitor of SLC6a8, a creatine transporter that drives colorectal cancer and certain other cancers’ progression. It is currently being evaluated in a Phase 1b dose escalation and expansion study in combination with FOLFIRI/BEV in second-line, advanced or metastatic CRC. The primary endpoint of the study is to determine maximum tolerated dose (MTD), overall response rate (ORR), and treatment-emergent adverse events (TEAEs). In the dose escalation stage of the study, two dose levels of RGX-202-01 with FOLFIRI/BEV have been evaluated in patients with advanced or metastatic CRC who have progressed on available oxaliplatin based first line therapy. In the ongoing expansion stage, additional patients with CRC are being treated at the dose of 3000mg PO BID to provide further characterization of the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the treatment.

Key findings to be presented at ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer:

Previously reported data from the study (at ASCO (Free ASCO Whitepaper) 2022) as of a data cutoff of April 28, 2022 included 19 patients who were enrolled in the study, including eight total patients in the dose escalation stage treated with either 2400mg twice daily (BID) of RGX-202-01 plus FOLFIRI/BEV (n = 4) or 3000mg BID RGX-202-01 plus FOLFIRI/BEV (n = 4), and 11 patients treated in the expansion stage with 3000mg BID RGX-202-01 plus FOLFIRI/BEV.
17 patients were evaluable for response per RECIST v1.1 at data cutoff, of which 10 patients had KRAS mutant tumors and seven patients had KRAS wild-type tumors.
In the KRAS mutant population, five patients (50%) had confirmed partial responses (PR) and five patients (50%) had stable disease (SD).
In the KRAS wild-type population, one patient (14%) had an unconfirmed PR, five patients (71%) had SD, and one patient (14%) had progressive disease (PD).
Preliminary median progression-free survival (mPFS) was 11.8 months in the enrolled patients with KRAS mutant tumors.
Tumor regression was observed to deepen over time in patients with KRAS mutant tumors, with first radiographic achievement of PR appearing as late as 40 weeks post-treatment induction.
Updates since April 28, 2022 (data cutoff date) through June 10, 2022:
Two patients with KRAS mutant tumors had follow up imaging: patient 102-3112 remains in PR status and patient 102-2407 now has SD.
Two patients with KRAS WT tumors had follow up imaging: patient 102-3121 remains in SD status and patient 103-3127 maintained SD radiographically but was declared clinical PD as per the Investigator.
The ORR remains unchanged (50% in KRAS mutant group, 14% in the KRAS WT group).
Two grade 3 TEAEs (neutropenia, pulmonary embolus) deemed unrelated to RGX-202-01.
No grade 4 or 5 TEAEs reported.
The poster is available at the Annals of Oncology website and View Source

Poster Presentation Details

Title: Phase 1b study of RGX-202-01, a first-in-class oral inhibitor of the SLC6a8/CKB pathway, in combination with FOLFIRI and bevacizumab (BEV) in second-line advanced colorectal cancer (CRC)