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iBio to Participate in the H.C. Wainwright Global Investment Conference

On May 18, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported that it will participate virtually in the H.C. Wainwright Global Investment Conference (Press release, iBioPharma, MAY 18, 2022, View Source [SID1234614787]). The hybrid conference will take place May 23-26, 2022.

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iBio’s pre-recorded presentation will be available on demand during the event for all registered attendees. Beginning on Tuesday, May 24, 2022, the presentation will also be available on the Company’s website at www.ibioinc.com under "News & Events" in the Investors section.

Bicara Therapeutics to Present Clinical Data from Lead Bifunctional Antibody Program, BCA101, at ASCO 2022 Annual Meeting

On May 18, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that it will present updated data from the dose escalation phase of its ongoing Phase 1 trial of BCA101, a bifunctional antibody designed to target the TGF-β trap to EGFR+ tumors, in an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Bicara Therapeutics, MAY 18, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-clinical-data-from-lead-bifunctional-antibody-program-bca101-at-asco-2022-annual-meeting [SID1234614785]). The meeting is being held in Chicago, Illinois and virtually from June 3-7, 2022.

Details of the presentation are as follows:

Title: A phase 1 trial of the bifunctional EGFR/TGFb fusion protein BCA101 alone and in combination with pembrolizumab in patients with advanced solid tumors

Lead Authors: Philippe L. Bedard, MD, FRCPC & Glenn J. Hanna, MD

Presentation Type: Poster Discussion Session
Session Category: Developmental Therapeutics – Immunotherapy
Date/Time: Sunday, June 5, 2022, 11:30 AM-1:00 PM CDT

Location: Hall D2

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/1b dose-escalation clinical trial of BCA101 was initiated in July 2020 and has enrolled patients with various advanced solid tumors both as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor. A recommended dose for expansion has been declared and the expansion phase of the study is currently enrolling. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.

Interim Report Q1, 2022

On May 18, 2022 Calliditas reported that launched its first commercial product, TARPEYO, in the US, supported by 40 experienced specialty sales executives who were trained and in the field in late January (Press release, Calliditas Therapeutics, MAY 18, 2022, View Source [SID1234614779]). Our commercial product was already available to ship to patients at the end of January, reflecting the great collaboration between our CMC group and our commercial team in the US.

Our transformation from a primarily R&D based company to a commercial stage, fully integrated business has been a journey, which first started 3 years ago when we brought onboard our first employee in the US. Under the guidance of a small but highly experienced senior team, we started to build our medical affairs and market access teams in preparation for a future regulatory approval.

With a fully integrated operation and a streamlined supply and distribution chain in place, the US organization had grown significantly and was by mid-2021 ready for the final step, onboarding of the sales force. When accelerated approval of TARPEYO was granted by the FDA, the entire organization was well prepared and ready. TARPEYO TouchpointsTM was available within hours and prescribers were able to access details regarding the product, the indication and could write prescriptions for appropriate patients. There was hope at last for IgAN patients in the US, as an approved product became available for the first time.

This is obviously just the very beginning of the journey, but we are very encouraged by the strong interest and early successes we have experienced, which have resulted in net product revenues of $1.9M (SEK 18.0M) for the first couple of months of commercial availability, and we remain fully committed to continuing to build the TARPEYO franchise."

CEO Renée Aguiar-Lucander

Summary of Q1 2022
January 1 – March 31, 2022
Net sales amounted to SEK 49.7 million, whereof TARPEYO net sales amounted to SEK 18.0 million, for the three months ended March 31, 2022. No net sales were recorded for the three months ended March 31, 2021.
Operating loss amounted to SEK 208.4 million and SEK 150.8 million for the three months ended March 31, 2022 and 2021, respectively.
Loss per share before and after dilution amounted to SEK 3.95 and SEK 2.62 for the three months ended March 31, 2022 and 2021, respectively.
Cash amounted to SEK 825.4 million and SEK 867.3 million as of March 31, 2022 and 2021, respectively.
Significant events during Q1 2022, in summary
In January 2022, Calliditas announced commercial availability and initial sales of TARPEYO (budesonide) delayed release capsules, the first and only FDA approved treatment for IgA nephropathy, indicated for reduction of proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression, generally considered a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g.
In February 2022, Calliditas announced that the first patient had been randomized in the company’s pivotal phase 2b/3 TRANSFORM study in patients with primary biliary cholangitis (PBC).
In March 2022, Calliditas expanded its licensing agreement with Everest to extend the territory covered to include South Korea.
Significant events after the reporting period
In May 2022, Calliditas announced that the first patient had been randomized in the company’s proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor setanaxib.
Investor Presentation May 18, 2022 14:30 CET

The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on May 18, 2022 at 7:00 a.m. CET.

The Phase Ib/II clinical study of IMM01 combined with PD-1 antibody in the treatment of relapsed and refractory malignant tumors completed the first patient enrollment and administration

On May 17, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") reported the FPI in the Phase Ib/II clinical study of first domestic SIRPα-Fc fusion protein targeting human CD47 (project number: IMM01) combined with PD-1 antibody for relapsed and refractory malignant tumors (clinical research project number: IMM01-04) (Press release, ImmuneOnco Biopharma, MAY 17, 2022, View Source [SID1234655652]). The first subject was enrolled and dosed successfully. The patient was a 56-year-old male with squamous cell esophagus carcinoma and the first infusion was completed without any adverse events reported.

The preliminary data from phase I of IMM01 is promising and encouraging. At the lower doses, it has benefited some patients with advanced lymphoma with a good safety profile. These clinical manifestations benefit from our differentiated design of the IMM01 molecule. IMM01 does not bind to human erythrocytes at all so as to avoid the "antigen sink effect", and it demonstrates low antigenicity without ADA. Its smaller molecule weight (only half of IgG molecule) guarantees better tissue permeability and bioavailability. In preclinical in vivo efficacy experiments, IMM01 was tested in combination with other targeting and immunotherapy drugs showing strong tumor suppressive activity and combined drug potential against solid tumors.

PD-1 antibody demonstrated superior curative effect on a variety of tumors. The PD-1 immunotherapy was limited by the content of T cells in tumor tissue (such as "cold tumor"), most patients do not have a good response on PD-1 antibody therapy. Macrophages are innate immune cells and born to be antigen-presenting cells. After activation, they can improve the efficacy of PD-1 antibody and maintain the durability of the efficacy through the following ways:

1) Directly phagocytose tumor cells, and present the processed tumor antigens to T cells to induce tumor antigen-specific T cell responses;

2) Release of chemokines (such as CXCL9/CXCL10) to chemotaxis T cells to the tumor tissue, thereby transforming "cold tumors" into "hot tumors" .

Dr. Tian, Wenzhi, founder, chairman and CEO of ImmuneOnco, said: "I am very pleased to see that the clinical study of our IMM01 project combined with PD-1 antibody in the treatment of relapsed and refractory malignant tumors has completed the first patient enrollment and administration. Preclinical studies have shown that IMM01 combined with PD-1 antibody has a strong synergistic effect. We have reason to believe that IMM01 combined with PD-1 antibody will have superior clinical performance and it will bring good news to the majority of cancer patients."

LifeArc co-founded company RQ Bio signs licensing agreement with AstraZeneca worth up to $157m plus royalties for monoclonal antibodies against SARS-CoV-2

On May 17, 2022 LifeArc reported that RQ Biotechnology Ltd (RQ Bio), a company it co-founded, reported that has signed a licensing agreement with AstraZeneca PLC (AZN) (Press release, LifeArc, MAY 17, 2022, View Source [SID1234615989]). Under the terms of the agreement, RQ Bio has granted AstraZeneca an exclusive worldwide licence to develop, manufacture and commercialise RQ Bio’s existing early-stage mAbs against SARS-CoV-2 and a right of first refusal to take an exclusive licence in respect of any additional mAbs against SARS-CoV-2 .

RQ Bio will receive upfront and milestone payments of up to $157 million and will be eligible to receive single digit royalties on sales. The successful licensing deal was supported by Oxford University Innovation, a wholly-owned subsidiary of the University of Oxford that manages the University’s technology transfer and consulting activities, who worked efficiently and creatively with all parties on the corresponding technology licences and the filing of intellectual properties.

RQ Bio today emerges from stealth mode announcing its launch as a new UK-based biotechnology company. The company, which is headquartered in London, is dedicated to developing treatments and preventative therapies based on potent broad spectrum mAbs to provide instant and long-lasting immunity for vulnerable people at risk of severe disease or death from existing, emerging and new viral infections.

"LifeArc is committed to backing leading UK academics and scientists, and we were inspired to fund RQ Bio because of the exceptional group of founders who are so passionately dedicated to finding new treatments and preventative therapies for viral infections in areas of high unmet patient need," said Clare Terlouw, Head of LifeArc Ventures. "LifeArc provided a wide range of support to help RQ Bio execute on its business plan, including financial backing from our venture team, scientific expertise and access to its world-class laboratory facilities. We look forward to further supporting RQ Bio as it becomes a world-leading infectious disease company."

The RQ Bio executive team is composed of biotech and pharmaceutical industry leaders with proven expertise in end-to-end antibody generation. Key appointments include:

Hugo Fry, CCO at Imbria and former Sanofi Executive, appointed Chief Executive Officer
Mike Westby, co-founder of RQ Bio, CSO of Centauri Therapeutics and former Pfizer R&D Executive, remains a key Scientific Advisor
Paul Kellam, co-founder of RQ Bio, Professor of Virus Genomics at Imperial College London and Vice President of Infectious Diseases & Vaccines at Kymab UK, remains a key Scientific Advisor
Jane Osbourn OBE, co-founder of RQ Bio, CSO of Alchemab and previous Chair of the UK Bioindustry Association (BIA), remains a key Scientific Adviser.
To maximise and accelerate patient impact, the company will continue to be supported by its collaborations with its scientific co-founders, the University of Oxford and leading UK medical research charity LifeArc. Professor Gavin Screaton, Head of the Medical Sciences Division at the University of Oxford, will continue to advise in his capacity as scientific and medical co-founder, as will Clare Terlouw, Head of LifeArc Ventures and UK BIA board member, as a member of the Board of Directors.

"Our vision is to build on our successful debut with neutralising antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases," said Hugo Fry, CEO of RQ Bio. "By combining our expertise and innovative excellence in core areas we have created a smarter approach to antibody generation making us uniquely positioned to deliver fast patient impact."