Investor Presentation

On February 6, 2023 Aim Immunotech presented its investor presentation (Presentation, AIM ImmunoTech, FEB 6, 2023, View Source [SID1234626854]).

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!


Immutep Reaches Enrolment Target for INSIGHT-003 Trial in 1st Line NSCLC

On February 6, 2023 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, reported the investigator-initiated INSIGHT-003 trial has reached its enrolment target of 20 patients with 1L NSCLC (Press release, Immutep, FEB 6, 2023, View Source [SID1234626839]). INSIGHT-003 is the first trial evaluating Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") as part of a triple combination therapy with standard-of-care anti-PD-1 therapy and chemotherapy.

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!

Immutep’s CSO & CMO Dr Frederic Triebel said, "The promising initial efficacy and favourable safety results reported in November 2022 from this first triple combination approach instils more confidence in the flexibility of our novel immunotherapy, efti to be combined with various therapeutics and safely drive superior patient outcomes. We are pleased to have reached our enrolment target and look forward to reporting as the results mature further. Additional data from INSIGHT-003 will help further inform our next steps in 1 st line NSCLC."

In a poster presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2022, initial results in 1L NSCLC patients show the triple combination therapy is well-tolerated and provides promising early signals of therapeutic activity with an Objective Response Rate (ORR) of 72.7% (8/11) and a Disease Control Rate (DCR) of 90.9% (10/11). Nine patients had a PD-L1 Tumour Proportion Score (TPS) of <50% and this group reported an encouraging ORR of 66.7% and DCR of 88.9%. Patients with a PD-L1 of <50% represent approximately two-thirds of the 1L NSCLC patient population and are less responsive to anti-PD-1 therapy compared to patients with a PD-L1 TPS of ≥50%.

Additional data from INSIGHT-003 is expected to be presented throughout calendar year 2023. For more information on the study, please see the poster titled ‘Feasibility of eftilagimod alpha (soluble LAG-3 protein) combined with standard-of-care-therapy in advanced non-small-cell lung cancer (NSCLC). Initial results from INSIGHT 003’ in the Posters & Publications section of Immutep’s website.

About INSIGHT-003

INSIGHT-003 is an investigator-initiated study conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy in front line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination.

Rs Research Announces Poster Presentation at the ESMO TAT 2023 Congress

On February 5, 2023 RS Research, a clinical-stage biotechnology start-up developing smart nanomedicines for targeted chemotherapy, reported the acceptance of a poster presentation at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) 2023 Congress on 6-8 March in Paris – France, being known as "The Home of Phase I in Oncology" (Press release, RS Research, FEB 5, 2023, View Source [SID1234627468]).

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!

RS Research’s platform technology allows designing targeted drug candidates for different indications, which yields into development of the company’s own portfolio consisting of 5 drug candidates, as well as an important co-development potential. The nanocarriers introduce a versatile targeting capability and are suitable for loading a single or a combination of chemotherapeutic agents, with superior pharmacokinetic profiles while the targeting enables the drugs to accumulate in the tumor ensuring an enhanced therapeutic index and thus offering reduced toxicity profile.

RS-0139 is the lead candidate in Phase I clinical trial, aiming to deliver docetaxel specifically into integrin receptor expressing tumors such as NSCLC, breast, ovarian, prostate and pancreatic as well as head & neck carcinoma. RS Research Co-Founder and CSO Prof. Dr. Rana Sanyal and Medical Director Gülşah Nomak, MD will present the candidates’ promising preclinical data at ESMO (Free ESMO Whitepaper) TAT 2023

Poster Title: RS-0139, a novel tumor-targeted delivery of docetaxel, with potent anti-tumor activity in a broad spectrum of tumor cell lines and xenograft models

Date: 6 March 2023

Location: Hall Bordeaux

Poster No: 100P

Presenter: Prof. Rana Sanyal, PhD; Co-Founder & CSO, RS Research | Gülşah Nomak, MD; Medical Director, RS Research

The poster abstract will be available online at the ESMO (Free ESMO Whitepaper) TAT 2023 website on 8th March 2023.

RS Research

RS Research was founded by Prof. Rana Sanyal and Sena Nomak to take the necessary steps for bringing innovative therapies to patients, carrying out the research to clinic based on the proprietary drug delivery platforms SagittaTM Bir and SagittaTM Dui, patents covering 58 countries. Thanks to this technology, RS Research can increase effectiveness of chemotherapy and reduce side effects. The nanomedicine taken into the cell thanks to the targeting module that recognizes the receptors on the tumor surface, releases the active substance here, showing its full effect only to the tumor. The nanomedicine is released only when it is in the tumor after the targeting moiety recognizes the cell surface receptors. RS Research raised 2 million Euros seed funding in 2017, followed by a 12 million USD Series-A investment round in 2021. The company developed 5 drug candidates designed based on SagittaTM platform technology addressing multiple indications in its pipeline. RS-0139’s ongoing Phase I clinical trial has advanced to the next dose level following the positive review of the safety data by the Independent Data Monitoring Committee (IDMC). Further details regarding the clinical trial are available at clinicaltrials.gov with the trial identifier NCT04261413. RS Research is manufacturing its clinical research products at its own GMP-licensed production facility with both synthesis and filling capability drugs.

For detailed information:

[email protected]

www.rsresearch.net

Entry into a Material Definitive Agreement

On February 3, 2023, Madrigal Pharmaceuticals, Inc., a Delaware corporation (the "Company") and its subsidiary, Canticle Pharmaceuticals, Inc., a Delaware corporation ("Canticle" and, together with the Company, the "Borrowers"), entered into a First Amendment (the "Amendment") to the Loan and Security Agreement, dated May 9, 2022 (the "Loan Agreement" and as amended by the Amendment, the "Amended Loan Agreement"), with the several banks and other financial institutions or entities party thereto (each, a "Lender" and collectively referred to as the "Lenders"), and Hercules Capital, Inc., a Maryland corporation ("Hercules"), as Lender and in its capacity as administrative agent and collateral agent for the Lenders (in such capacity, "Agent") (Filing, 8-K, Madrigal Pharmaceuticals, FEB 3, 2023, View Source [SID1234627008]).

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 Amendment amended certain terms of the Loan Agreement as described below. The original terms of the Loan Agreement were previously disclosed in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 9, 2022, which Current Report on Form 8-K is incorporated herein by reference.

Interest Rate. The interest rate formula for the Company under the Amended Loan Agreement was adjusted by the Amendment such that the borrowings bear interest at a variable per annum rate determined based on the greater of (i) the prime rate as reported in The Wall Street Journal plus 2.45% and (ii) 8.25%. This has resulted in a reduction of the Company’s borrowing costs by 150 basis points after giving effect to the Amendment to 10.2% as of February 3, 2023.

Amount. The Amended Loan Agreement continues to provide for an aggregate of $250.0 million in term loans (collectively, the "Term Loans"), but the terms of certain tranches of Term Loans were revised as part of the Amendment. The second tranche of Loan Agreement ("Tranche 2") was amended to increase the committed amount available by $15.0 million, to $65.0 million. As previously announced, the Company achieved the Phase 3 clinical development milestone under Tranche 2 (the "Clinical Milestone"). In connection with the Amendment, on February 3, 2023, the Borrowers drew $35.0 million under Tranche 2 and have the ability to draw an additional $15.0 million under Tranche 2 by June 19, 2023 and an additional $15.0 million under Tranche 2 by September 30, 2023 (for a total of $30.0 million in additional committed Tranche 2 capacity). The third tranche ("Tranche 3") of $75.0 million remains unchanged by the Amendment, and such borrowings are available subject to the Company obtaining certain FDA approval for resmetirom (the "Approval Milestone") until the earlier of June 30, 2024 and 90 days following achievement of the Approval Milestone. Coincident with the expansion of Tranche 2 borrowing capacity by $15 million, the Amendment reduced the fourth tranche ("Tranche 4") by $15.0 million to $60.0 million , which amount is available subject to Hercules’ sole discretion.

Borrowings. The Borrowers have $85.0 million in outstanding borrowings under the Amended Loan Agreement, consisting of $35.0 million drawn under Tranche 2 Term Loans on February 3, 2023 and $50.0 million drawn under Tranche 1 Term Loans on May 9, 2022.

Term and Repayment. As previously disclosed, the Term Loans have a scheduled maturity date of May 1, 2026, which may be extended for an additional year upon the Company achieving the Approval Milestone (the "Scheduled Maturity Date"). Due to the Company’s satisfaction of the Clinical Milestone, the interest-only period of the Term Loans extends through May 1, 2025. This interest-only period may be extended to (i) May 1, 2026 if the Company achieves the Approval Milestone and (ii) May 3, 2027 if the Company achieves a certain revenue milestone as set forth in the Amended Loan Agreement and maintains compliance with the financial covenants previously disclosed. The terms of the Approval Milestone and such financial covenants are as set forth in the Amended Loan Agreement. After the conclusion of the interest-only period, monthly installments of principal and interest will be paid through the Scheduled Maturity Date.

Termination of Warrant Rights; Amendment of Warrant Terms For Advances Under Tranches 2, 3 and 4 of the Amended Loan Agreement. In connection with the Amendment, the rights and obligations under all previously unvested warrants (to purchase 59,545 shares of Common Stock at an exercise price of $67.12 per share) were terminated, and the Company agreed to issue warrants in connection with borrowings made under Tranche 2, 3 and 4 ("Warrants") on and after the date of the Amendment under the terms described below

Under the Amendment, the number of shares of the Company’s common stock subject to exercisable Warrants associated with Tranche 2 Term Loans funded ("Tranche 2 Warrants") equals 2.0% times the principal amount of such advances that are funded, divided by $285.31 (the "Tranche 2 Coverage Ratio"). On February 3, 2023, in connection with the $35.0 million Tranche 2 Term Loan funding, the Company issued Tranche 2 Warrants to purchase 2,543 shares of Common Stock at an exercise price of $285.31 per share. In the event future Tranche 2 Term Loan borrowings are made, the Company will issue additional Tranche 2 Warrants in accordance with the Tranche 2 Coverage Ratio at an exercise price of $285.31 per share.

Under the Amendment, the number of shares of the Company’s common stock subject to exercisable Warrants associated with (i) Tranche 3 Term Loans funded in the future will equal (1) 2.0% times the principal amount of such advances that are funded, divided by (2) the volume-weighted average price for Company Common Stock for the three full trading days immediately before written confirmation from the Agent of satisfaction of the Approval Milestone under Tranche 3 of the Loan Agreement (or the Tranche 3 Warrant Exercise Price); and (ii) Tranche 4 Term Loans funded funded in the future will equal 2.0% times the principal amount of advances that are funded, divided by volume-weighted average price for Company Common Stock for the three full trading days immediately before execution and delivery of written agreement concerning the commitments made available under Tranche 4 of the Loan Agreement (or the Tranche 4 Warrant Exercise Price).

The Warrants described above will terminate at the earlier of (i) the seventh anniversary of the date of the Amendment and (ii) the consummation of certain acquisition transactions involving the Company, as set forth in the Warrants. The number of shares for which each Warrant is exercisable and the associated exercise price are subject to certain customary proportional adjustments for fundamental events, including stock splits and reverse stock splits, as set forth in the Warrants.

The Company issued warrants to the Lenders to acquire to purchase 14,899 shares of the Company’s common stock at an exercise price of $67.12 per share, which vested based on Tranche 1 Term Loan advances on May 9, 2022; the exercise price and number of shares that may be purchased via these warrants were not affected by the Amendment.

The foregoing descriptions of the Amendment, the Amended Loan Agreement and the Tranche 2 Warrants contained herein do not purport to be complete and are qualified in their entirety by reference to the complete text of the Amendment (which includes the Amended Loan Agreement as Annex A thereto) and the form of Tranche 2 Warrant Agreement, copies which are attached hereto as exhibits and are incorporated herein by reference.

Personalis and Moderna Sign New Agreement to Leverage NeXT Platform™ in Personalized mRNA Cancer Vaccine Clinical Trials

On February 3, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, and Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported the companies have signed a new agreement to continue using the Personalis NeXT Platform as part of upcoming clinical studies evaluating mRNA-4157/V940, an investigational personalized cancer vaccine, jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada (Press release, Personalis, FEB 3, 2023, View Source [SID1234626836]). The platform, which was also utilized in the vaccine candidate’s Phase 2b clinical study, will be used to sequence genomic information from a patient’s tumor sample to identify the unique genetic mutations that are most likely to generate a tailored antitumor response.

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!

"For years, we have been at the forefront of working with pharmaceutical partners, including Moderna, to apply our NeXT Platform to the sequencing of personalized cancer vaccines," said Chris Hall, President of Personalis. "We are thrilled to enter a new agreement with Moderna and support the next stage of clinical development for this program."

"We are looking forward to continuing our partnership with Personalis on our personalized cancer vaccine program, with the goal of helping to bring truly individualized cancer treatment to patients," said Melanie Ivarsson, Moderna’s Chief Development Officer.

About Personalis

Personalis, Inc. is a leader in advanced cancer genomics, enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single sample. To enable cancer sequencing, Personalis’ Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited. For more information, visit the Personalis website and follow Personalis on LinkedIn and Twitter.

Personalis Forward-Looking Statements

All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the NeXT Platform, expected benefits of the company’s collaboration with Moderna, Personalis’ business opportunities, leadership, plans or expectations, or other future events. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis’ filings with the U.S. Securities and Exchange Commission, including Personalis’ most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.