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CStone received China NMPA IND approval for CS2006/NM21-1480, a PD-L1/4-1BB/HSA multi-specific antibody-based molecule, marking further expansion of its Pipeline 2.0

On September 15, 2021 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the investigational new drug (IND) application of multi-specific antibody CS2006/NM21-1480 has been approved by the National Medical Products Administration (NMPA) of China (Press release, CStone Pharmaceauticals, SEP 15, 2021, View Source [SID1234587864]). CS2006/NM21-1480 represents a leading class of next-generation anti-PD-1/PD-L1 cancer immunotherapies and a new backbone molecule for combinations.

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CS2006/NM21-1480 is a monovalent, tri-specific antibody-based molecule targeting PD-L1, 4-1BB, and human serum albumin (HSA).CS2006/NM21-1480 is designed to bind to the immune co-stimulation receptor 4-1BB and conditionally activate T cells only when engaging the checkpoint receptor ligand PD-L1 on the surface of tumor cells, potentially preventing the liver toxicities observed with previous anti-4-1BB agonistic antibodies. As a potential best-in-class drug, CS2006/NM21-1480 could be used as monotherapy or in combination with multiple treatments. The upcoming clinical study is designed to evaluate the safety, pharmacokinetics, and anti-tumor efficacy of CS2006/NM21-1480 in Chinese patients with various advanced solid tumors.

Compared to other PD-L1/4-1BB bispecific antibody candidates, CS2006/NM21-1480’s unique monovalent structure and ultra-high-affinity PD-L1-binding is designed to fully exploit the synergistic potential of tumor-localized modulation of PD-L1 and 4-1BB, to provide broader and more sustained treatment response and at the meantime, to avoid systemic toxicities. Furthermore, half-life extension via the HSA-binding motif enables convenient dosing schedules for patients. CS2006/NM21-1480 is anticipated to be effective against tumors with a wide range of PD-L1 expression levels and may overcome primary and/or acquired resistance to anti-PD-1/PD-L1 therapies.

Dr. Archie Tse, Chief Scientific Officer of CStone, said, "We are very glad that the IND application of CS2006/NM21-1480 in China has been approved by the NMPA, with the clinical trial starting soon, it marks a significant milestone in CStone’s Pipeline 2.0 strategy which focused on assets with first-in-class or best-in-class potential. Since April 2020, the first-in-human study of CS2006/NM21-1480 has been well underway in the US. Moving forward, we will step up our efforts to drive the research and development of CS2006/NM21-1480, and other pipeline assets to provide potentially more effective treatments for Chinese and global patients."

CS2006/NM21-1480 was discovered and engineered by Numab Therapeutics ("Numab"), CStone’s partner, using its proprietary λcap technology and MATCH platform. CStone and Numab signed an exclusive regional licensing agreement for the development and commercialization of the drug candidate. Pursuant to the terms of the licensing agreement, CStone will fund the research and development of CS2006/NM21-1480 up to completion of an initial Phase Ib clinical trial. In exchange, CStone obtains exclusive rights from Numab to develop and commercialize CS2006/NM21-1480 in Greater China (including Mainland China, Hong Kong, Macau and Taiwan), South Korea and Singapore. Numab retains all CS2006/NM21-1480 rights for the rest of the world. Upon completion of CStone’s funding period, no further financial obligations will be owed by either party.

Francis Medical Announces Close of $55 Million Series B Equity Financing

On September 15, 2021 Francis Medical, Inc., a privately-held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, reported the completion of the company’s $55.0 million Series B equity financing (Press release, Francis Medical, SEP 15, 2021, View Source [SID1234587863]).

Solas BioVentures led the Series B round with other previous investors, including Arboretum Ventures, Coloplast A/S, H2Oey Ventures and Tonkawa. The company plans to use the Series B proceeds to fund the development of its proprietary prostate cancer treatment through FDA 510(k) approval, which includes a pivotal clinical study (VAPOR 2) for the management of prostate cancer, scheduled to begin enrollment in August 2022.

"We are thrilled to be leading the Series B round of financing for Francis Medical," said Dr. David Adair, managing director of Solas BioVentures. "At Solas, we focus our investments on technologies that have the potential to transform the standard of care and directly impact patient outcomes. We strongly believe that Francis Medical’s water vapor technology will become the preferred first-line therapy for treating prostate cancer. If we achieve our goals, men facing prostate cancer will have a less invasive option that not only aggressively treats their cancer, but also helps preserve their quality of life."

The funding comes on the heels of strong results from VAPOR 1, a prospective, multicenter, single-arm study that treated 15 patients with intermediate-risk, localized prostate cancer at four U.S. clinical centers. The VAPOR 1 study reported no serious adverse events, no device-related adverse events, and no unanticipated adverse device effects as its primary endpoint. In 87% of patients treated, six-month biopsy results indicated no remaining Gleason Grade Group 2 or greater clinically significant disease in the targeted treatment areas.

As the second most common cancer in U.S. men, the American Cancer Society estimates one in eight American men will be diagnosed with prostate cancer during their lifetime. Prostate cancer is a serious disease often treated with therapies that cause complications, such as urinary incontinence and erectile dysfunction. Francis Medical’s water vapor technology applies the thermal energy stored in a few drops of sterile water to deliver targeted treatments to the cancerous tissue through a simple transurethral procedure. The therapy is designed to ablate cancer cells while protecting surrounding structures, lessening the likelihood of life-altering side effects common with other prostate cancer treatments.

"Our Founder and Chief Technology Officer, Michael Hoey, and I would like to thank our investors, employees, and physician partners for achieving this important milestone," said Michael Kujak, president and CEO of Francis Medical. "This financing is a real testament to the significant accomplishments of the entire team. At Francis Medical, our shared vision from the beginning has been to bring this breakthrough technology to market to improve the lives of prostate cancer patients worldwide. We look forward to deploying these proceeds toward making this vision a reality."

Allarity Therapeutics Receives Approximately SEK 23.3 Million (US $2.7 Million) from Subscription to Warrants of Series ALLR TO 2 and TO 3

On September 15, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the outcome of the exercise of the warrants of series ALLR TO 3 that were issued in connection with the Company’s issue of units in June 2021 (Press release, Allarity Therapeutics, SEP 15, 2021, View Source [SID1234587827]). In total, 13,719,266 warrants of series TO 3 were exercised, corresponding to approximately 9.5 percent of the total number of outstanding warrants, for subscription of 13,719,266 shares at a subscription price of SEK 1.7 per share. Through the exercise of the warrants, Allarity will receive approximately SEK 23.3 million (U.S. $2.7 million) before issuing costs amounting to approximately SEK 1.4 million.

UPDATE on the outcome of the exercise of the warrants of series ALLR TO 2 that were issued in connection with the Company’s issue of units in December 2019. In total, 8,820 warrants of series TO 2 were exercised, corresponding to approximately 0.02 percent of the total number of outstanding warrants, for subscription of 8,820 shares at a subscription price of SEK 6.0 per share. Through the exercise of the TO 2 warrants, Allarity will receive approximately SEK 53,000 before issuing costs. The final exercise period for the warrants of series TO 2 took place from September 1 up to and including September 15, 2021.

Chairman of Allarity’s Board of Directors Duncan Moore (who exercised 283,407 warrants) and the Company’s largest shareholder, Sass & Larsen ApS, were among the subscribers.

The exercise period for the warrants of series TO 3 took place from August 30 up to and including September 13, 2021. The accelerated exercise period was established, as previously announced, due to the Board of Directors’ determination that it was in the best interest of all shareholders as part of the Company’s plan to move to the U.S. Nasdaq stock market and to meet the requirements of the previously announced U.S. $20 Million recapitalization investment with 3i LP (New York).

Exercised warrants will be replaced with interim shares, pending registration with the Danish Business Authority. The interim shares are expected to be converted to shares within approximately two (2) weeks. Through the exercise, the number of shares in the Company increase from 390,063,114 shares to 403,791,200 shares, and the share capital increase by DKK 686.404,30, from DKK 19.503.155,70 to DKK 20,189,560,00.

Biodesix Announces Abstracts Presented During the IASLC 2021 World Conference on Lung Cancer

On September 15, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that two abstracts highlighting proteomic and genomic data based on their diagnostic tests were presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) (Press release, Biodesix, SEP 15, 2021, View Source [SID1234587810]).

The Role of Serum Proteomic Signature in Predicting Survival by PD-L1 Status in Patients with Non-Small Cell Lung Cancer Receiving Immunotherapy
Session P57 – Predictive Tumor Based Assays/ Biomarkers/ Pathology – ICI Biomarkers
An independent study presented by Leeseul Kim, MD of AMITA Health Saint Francis Hospital Evanston, IL, demonstrated that blood-based proteomic testing (Biodesix, Inc.) predicts survival outcomes in patients with non-small cell lung cancer (NSCLC) receiving an immune checkpoint inhibitor (ICI)-based regimen. The authors point out that while immunotherapy is very effective treating many patients with lung cancer, not all patients with lung cancer benefit.

Turnaround Time and Variant Prevalence of a Blood-based KRAS Test in Patients With NSCLC
Session P24 – Liquid Biopsy and Other Non-invasive Diagnostic Modalities – Targeted Therapy
A study presented by Edgardo Santos, MD, Florida Precision Oncology, Aventura, FL, demonstrated that the blood-based GeneStrat test, focusing specifically on the KRAS G12C/V/D+ testing for this analysis, delivered results to ordering clinicians in under 30 hours on average in two large patient cohorts representing a real-world clinical setting, enabling rapid detection of 3 common KRAS mutations across all stages of NSCLC. Expedited time-to-treatment for patients with actionable driver mutations, now including people with NSCLC that have the KRAS G12C mutation (drug Lumakras (sotorasib), Amgen, Inc.) will improve patient access and overall outcomes to the ever-evolving targeted therapies for eligible patients.

"Our mission is to Improve overall patient outcomes and lower healthcare costs by developing diagnostic solutions that reduce ineffective and unnecessary treatments", said Scott Hutton, CEO, Biodesix. "Additionally, it is always our goal to expedite treatment and remain the leader in turn-around times. These abstracts highlight the effectiveness of our approach in utilizing multiple technologies to determine the best treatment plans as rapidly as possible for patients with lung cancer."

Entry into a Material Definitive Agreement

On September 15, 2021, Vaxart, Inc. ("Vaxart" or the "Company") reported that entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor") and B. Riley Securities Inc. ("B. Riley") and, together with Jefferies, the "Sales Agents"), pursuant to which Vaxart may offer and sell, from time to time through the Sales Agents, shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $100.0 million (the "Shares") (Filing, 8-K, Vaxart, SEP 15, 2021, View Source [SID1234587809]). The Shares will be sold pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-239751), as previously filed with the U.S. Securities and Exchange Commission (the "Commission"). The Company filed a prospectus supplement, dated September 16, 2021, with the Commission in connection with the offer and sale of the Shares.

Under the Sales Agreement, the Sales Agents may sell the Shares by any method permitted by law and deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Common Stock. In addition, under the Sales Agreement, the Sales Agents may sell the Shares in privately negotiated transactions with the Company’s consent and in block transactions. Under certain circumstances, Vaxart may instruct the Sales Agents not to sell the Shares if the sales cannot be effected at or above the price designated by the Company from time to time

Vaxart is not obligated to make any sales of the Shares under the Sales Agreement. The Sales Agreement may be terminated by either party at any time upon ten days’ notice to the other party, or by Cantor or B. Riley at any time under certain circumstances.

The Sales Agreement contains customary representations, warranties and agreements by Vaxart, and customary indemnification and contribution rights and obligations of the parties. Vaxart will pay the Sales Agents an aggregate commission rate equal to up to 3% of the aggregate gross proceeds from each sale of the Shares. Vaxart will also reimburse the Sales Agents for certain specified expenses in connection with entering into the Sales Agreement.

The Sales Agreement is filed as Exhibit 1.1 to this Current Report on Form 8-K, and the description of the terms of the Sales Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of Thompson Hine LLP relating to the legality of the issuance and sale of the Shares is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.