On November 11, 2021 HanX Biopharmaceuticals reported PCT patent "Method for improving the binding affinity of IgG antibodies to FcRn and prolonging their serum half-life" has been officially authorized by the Japan Patent Office (Press release, HanX Biopharmaceuticals, NOV 11, 2021, View Source [SID1234647314]).

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The present invention discloses a platform technology for improving the binding affinity of IgG antibodies to FcRn and prolonging their serum half-life. This technology can effectively improve the binding affinity of IgG antibodies to FcRn and prolong their serum half-life. Moreover, the binding affinity of the modified IgG antibodies to the corresponding antigen will not be reduced. Based on this patented technology, Hans Bio has independently developed a number of long-acting monoclonal antibody and bispecific antibody projects, including the long-acting anti-human PD-1 monoclonal antibody HX008.

HX008 (also known as "Putelimab") is a humanized anti-PD-1 monoclonal antibody developed by Hans Biotech and its former subsidiary Taizhou Hanzhong Biotech. It uses FcRn modification technology for differentiated design, and transforms the Fc of IgG4 to extend the half-life, reduce the number of dosing, reduce treatment costs, and improve patient drug compliance. The results of Phase I clinical trials show that the half-life of the product is 17-23 days for a single dose, and the half-life can reach 18-38 days after stabilization. Hans Biotech led the pharmaceutical evaluation, preclinical research and development, and early clinical research of the HX008 project. In 2018, Lepu Biotech acquired the controlling stake of Taizhou Hanzhong and obtained the right to market and sell the product.

So far, HX008 has conducted multiple Phase II and Phase III clinical trials. Two of the registration clinical trials: advanced melanoma and multiple advanced solid tumors with MSI-H/dMMR, have been submitted to the NMPA for marketing.

On November 11, 2021 PharmaMar S.A. (MSE:PHM) reported a licensing agreement with Lotus Pharmaceutical CO., LTD. (TWSE:1795) to commercialize the anticancer drug lurbinectedin in Taiwan (Press release, PharmaMar, NOV 11, 2021, View Source [SID1234596675]).

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Under the terms of the license and commercialization agreement, PharmaMar will receive a non-disclosed upfront payment and will be eligible for additional remunerations, including regulatory and sales milestone payments. PharmaMar will retain production rights and will sell the product to Lotus for its clinical and commercial use.

Lotus will pursue the marketing approval in Taiwan and have the right to market the product exclusively upon approval.

Lurbinectedin was granted accelerated approval by FDA (Food and Drug Administration) for the treatment of metastatic Small Cell Lung Cancer in 2020. In addition, in 2021, lurbinectedin has received marketing approval in the United Arab Emirates, Canada, Australia and Singapore.

According to Luis Mora, General Manager of PharmaMar’s Oncology and Virology Business Units:

"We are very pleased to sign this new agreement with Lotus, which will allow, if approved, to bring lurbinectedin to all appropriate patients in Taiwan."

Petar Vazharov, Chief Executive Officer of Lotus, said:

"Lung cancer has been among the top cause of death in Taiwan for decades. We are very honored to have this opportunity partnering with PharmaMar to offer the patients in Taiwan access to innovative drug, which is aligned with our key focused therapeutic area."

On November 11, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present in a fireside chat at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum being held virtually November 18, 2021 (Press release, Biodesix, NOV 11, 2021, View Source [SID1234595884]).

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Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum
Date: Thursday, November 18, 2021
Time: 4:30 PM ET

The fireside chat will be webcast live and available for replay under "News & Events" in the Investors section of the Company’s website at www.biodesix.com.

On November 11, 2021 A2 Biotherapeutics, Inc., "A2 Bio", is a biotechnology company focused on the development of a first-in-class Tmod T cell therapy platform to tackle the fundamental challenge in solid tumor treatment—the ability of cancer medicines to distinguish between tumor and normal cells (Press release, A2 Biotherapeutics, NOV 11, 2021, View Source [SID1234595471]).

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A2 Bio reported the first presentation of its Tmod platform; a powerful, precise targeting system controlled by tumor deletions which transforms CEA and MSLN CAR T cells into tumor-selective agents. Preclinical results demonstrate how Tmod primary T cells selectively kill tumor cells mixed with normal cells in vitro, and display robust activity in vivo. CEA Tmod cells selectively kill tumor cells within the same mouse implanted with established "normal" and tumor xenografts. MSLN Tmod constructs show similar selectivity, illustrating the breadth and modularity of the Tmod platform. Data are being featured on Nov. 13 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting at the Walter E. Washington Convention Center in Washington, D.C.

"These data demonstrate some of the impressive properties of the Tmod system, and its potential to address a key obstacle to more effective cancer treatments: tumor vs. normal tissue selectivity," said Alexander Kamb, Founder and Chief Scientific Officer of A2 Bio.

A2 Bio is also presenting a clinical trials poster on Nov 12, BASECAMP-1 (NCT04981119): An observational study to identify relapsed solid tumor patients with human leukocyte antigen (HLA) loss of heterozygosity (LOH). The study will use the Tempus xT-Onco Next Generation Sequencing diagnostic to identify patients with loss of HLA-A*02 heterozygosity. If eligible, these patients will be leukapheresed to bank T cells for subsequent autologous Tmod CAR T cell therapy at the time of relapse. BASECAMP-1 is currently recruiting patients with colorectal, pancreatic or non-small cell lung cancer at NYU Langone Medical Center, and will soon open at other cell therapy centers of excellence, including Mayo Clinic Rochester, UCLA Medical Center, UCSD Medical Center, and MD Anderson Cancer Center.

Diane Simeone, MD, Perlmutter Professor of Surgery at NYU who is a Principal Investigator stated, "BASECAMP-1 is an exciting study that is a potential game changer for relapsed patients after surgical resection with little viable treatment options. I am completely committed to helping to identify and enroll patients in this unique logic-gated CAR T immunotherapy."

A2 Bio’s posters presented at SITC (Free SITC Whitepaper) can be viewed on the company’s website at www.a2bio.com/science/abstracts-and-publications.

On November 11, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported financial results for its first fiscal quarter ended September 30, 2021 (Press release, Beyond Air, NOV 11, 2021, View Source [SID1234595437]).

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Steve Lisi, Chairman and Chief Executive Officer of Beyond Air commented, "This has been an exciting quarter for Beyond Air, as the team continues to deliver both operationally and strategically. On the strategic front, the launch of Beyond Cancer under the new leadership of CEO Selena Chaisson, M.D. is a special achievement. The separation of the UNO franchise to an independently managed affiliate was made possible through the support of investors in a $23.9 million ongoing private financing. We believe that the spin-off will accelerate UNO’s path to the clinic and create long-term value for shareholders. Beyond Cancer will leverage our NO expertise, IP portfolio, preclinical oncology team, regulatory progress, and initially use existing Company infrastructure. The separation enables Beyond Air to focus on its core business of advancing its LungFit platform for the treatment of respiratory diseases."

Mr. Lisi continued, "Consistent with our global regulatory update from September, our PMA for LungFit PH continues to be under review at FDA. We successfully completed our Stage 1 Assessment Audit for a CE Mark in Europe and anticipate approval during the first half of calendar year 2022, after which we plan to partner the program internationally. In the United States, we continue to guide a commercial launch in the fourth quarter of this calendar year. Our commercial team has grown considerably and is ready to bring the first-ever integrated generator and delivery system that produces NO to hospitals across the country. The Beyond Air team also continues to execute on the R&D front with the release of interim data from our NTM pilot study using LungFit GO to deliver up to 250 ppm NO in a home setting. Despite the COVID-19 related lockdowns in Australia, as of September 6th we had 8 patients successfully enrolled and titrated up to 250 ppm NO, with no study discontinuations and no treatment-related serious adverse events. The pilot study continues enrolling patients, and we expect to report complete safety and efficacy results in 2022."

Recent Highlights and Upcoming Milestones

LungFit PH
Commercial launch in the United States on track for the fourth quarter of calendar year 2021, pending FDA PMA approval
Successfully completed Stage 1 Assessment Audit in the CE Mark process; expect to receive CE Mark in 1H CY2022 followed by international commercial partnership

LungFit PRO
Acute Viral Pneumonia Data
Ongoing pilot study for acute viral pneumonia in adults, including COVID-19 patients, in Israel using LungFit PRO at 150 ppm NO
Upcoming Study (pending discussion with FDA)
Plan on initiating a pivotal trial for patients hospitalized with viral lung infections in the fourth quarter of calendar year 2022

LungFit GO
Reported positive interim data for at-home pilot study in Australia using LungFit GO for self-administration of up to 250 ppm NO for the treatment of refractory NTM lung disease in adult patients
Interim results showed that 250 ppm NO was well-tolerated with no study discontinuations or treatment-related serious adverse events observed in 8 patients, with methemoglobin and NO2 concentrations remaining within acceptable safety ranges in all subjects
Expect to report full efficacy and safety data for the at-home NTM lung infection pilot study at a medical or scientific conference in calendar year 2022
Published a compassionate use case study called "Non-tuberculous mycobacteria infection treated with intermittently inhaled high-dose nitric oxide" using high concentration NO treatment to treat the Mycobacterium abscessus strain of NTM in The BMJ1

Beyond Cancer’s Solid Tumor Program
Secured commitments of $23.9 million in a concurrent private placement of common shares, not to exceed $30 million, to form Beyond Cancer that will leverage Beyond Air’s NO experience and accelerate and enhance the solid tumor pipeline
After this financing, Beyond Air will retain at least 80% equity ownership in Beyond Cancer
Anticipate beginning enrollment of patients in the first half of calendar year 2022
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1 Goldbart A, Gatt D, Golan Tripto I. BMJ Case Rep 2021;14:e243979. doi:10.1136/bcr-2021-243979

Financial results for the fiscal quarter ended September 30, 2021

Revenue for the fiscal quarter ended September 30, 2021 was $0 as compared to $350,000 for the fiscal quarter ended September 30, 2020, all of which was licensing revenue.

Research and development expenses for the fiscal quarter ended September 30, 2021 were $2.8 million, compared to $3.1 million for the fiscal quarter ended September 30, 2020.

General and administrative expenses for the fiscal quarter ended September 30, 2021 were $3.4 million, compared to $2.2 million for the fiscal quarter ended September 30, 2020.

Other income and expense for the fiscal quarter ended September 30, 2021 was a loss of $2.5 million, compared to a loss of $0.2 million for the fiscal quarter ended September 30, 2020.

For the fiscal quarter ended September 30, 2021, the Company had a net loss of $8.7 million, or ($0.36) per share, compared to a net loss of $5.1 million, or ($0.30) per share for the fiscal quarter ended September 30, 2020.

As of September 30, 2021, the Company had cash, cash equivalents and restricted cash of $48.7 million.