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Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, May 9, 2024
FDA, CMS, Risk, SARS-CoV-2, Food, Webcast, U.S. FDA, Administration, Research and development, Pre-exposure prophylaxis, COVID-19, Patient, Immunodeficiency, Medicine, Medicare, Clinical trial, HCPCS, Vaccine

“The recent months have been incredibly productive for Invivyd.

Key Points: 
  • “The recent months have been incredibly productive for Invivyd.
  • At the beginning of April, Invivyd announced that PEMGARDA is available for purchase in the U.S. through a network of authorized specialty distributors.
  • The company will begin reporting PEMGARDA net product revenue with its second quarter 2024 financial results.
  • First Quarter 2024 Financial Results:
    Cash Position: Cash and cash equivalents were $189.4 million as of March 31, 2024.

Anaptys Announces First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Thursday, May 9, 2024
American Academy, Ulcerative colitis, BDCA2, American Association of Immunologists, CDAI, American Academy of Dermatology, PD-1, IND, Week, AAI, Therapy, Patient, Graft-versus-host disease, Rheumatoid arthritis, AAD, Atopic dermatitis, BTLA, SAN, UC, Pharmaceutical industry

“This quarter, we continued to enroll patients globally across three Phase 2 trials for our two best-in-class checkpoint agonists: ANB032, our BTLA agonist, and rosnilimab, our PD-1 agonist.

Key Points: 
  • “This quarter, we continued to enroll patients globally across three Phase 2 trials for our two best-in-class checkpoint agonists: ANB032, our BTLA agonist, and rosnilimab, our PD-1 agonist.
  • Collaboration revenue was $7.2 million for the three months ended March 31, 2024, compared to $1.4 million for the three months ended March 31, 2023.
  • Research and development expenses were $37.0 million for the three months ended March 31, 2024, compared to $35.0 million for the three months ended March 31, 2023.
  • General and administrative expenses were $12.3 million for the three months ended March 31, 2024, compared to $10.8 million for the three months ended March 31, 2023.

Curia and Carterra Partner on Biologics Symposium to Further Biotechnology Research in the Pacific Northwest

Retrieved on: 
Thursday, May 9, 2024
Antibody, Biopharmaceutical, Residence Inn by Marriott, Nature, Surface plasmon resonance, LSA, SPR, Marketing, Partnership, Cell, NGS, Therapy, Drug discovery, Pharmaceutical industry

The purpose of the collaboration is to promote the rising biotech focus within the Pacific Northwest region of the U.S and Canada.

Key Points: 
  • The purpose of the collaboration is to promote the rising biotech focus within the Pacific Northwest region of the U.S and Canada.
  • The symposium will bring together all levels of scientific leadership from the biotech and pharma communities.
  • "We are thrilled to be partnering with Carterra to organize this antibody discovery symposium, bringing the Pacific Northwest biotech community together and sharing the latest advances in antibody discovery," said Steve Lavezoli, Vice President of Biologics at Curia.
  • Coming to the Pacific Northwest is an opportunity to create a deeper understanding of the technology in pharma and biotechs in this region.”

Alector Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, May 8, 2024
Alzheimer's disease, FDA, Brain, Total, Traffic barrier, ABC, Investment, Safety, AbbVie, Central nervous system disease, Alector, Arnon Rosenthal, ALEC, TREM2, Poster, Partnership, Microglia, CNS, Disease, Exercise, Therapy, Frontotemporal dementia, GSK, Patient, PROGRESS, BBB, Central nervous system, Drug development, PD, SAN, Strategic planning, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today reported first quarter 2024 financial results and recent portfolio and business updates. As of March 31, 2024, Alector’s cash, cash equivalents and investments totaled $562.1 million.

Key Points: 
  • We are excited to recognize the addition of Neil Berkley to our executive team as our Chief Business Officer.
  • Neil has over 20 years of corporate development, business development and strategic planning experience, spanning large pharma to small biotechs.
  • Alector will host a virtual research and development event on June 18, 2024, to discuss the company’s ABC technology platform.
  • Total research and development expenses for the quarter ended March 31, 2024, were $45.2 million, compared to $51.9 million for the quarter ended March 31, 2023.

Invivyd to Pursue Rapid Immunobridging Pathway to Potential EUA for Treatment of COVID-19 in Moderately to Severely Immunocompromised People, Based on U.S. FDA Feedback

Retrieved on: 
Tuesday, May 7, 2024
FDA, Immunoglobulin G, COVID-19, Risk, SARS-CoV-2, Pharmacokinetics, RBD, Food, Virology, Chronic lymphocytic leukemia, SVP, CLL, MDCM, Pre-exposure prophylaxis, Patient, Immunodeficiency, Medicine, Infection, Vaccine

This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA.

Key Points: 
  • This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA.
  • The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S. who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible.
  • Subsequent to the anticipated submission of an EUA request, Invivyd plans to initiate a compact clinical trial focused on confirmatory safety, pharmacokinetics (PK), and clinical virology.
  • “We are glad to once again align with the FDA on a rapid pathway towards addressing a critical unmet medical need among immunocompromised people who may benefit from alternative approaches to treating their symptomatic COVID-19.

Inmagene Announces Completion of Enrollment in Phase 2a Trial of IMG-007, a Nondepleting and Half-life Extended Anti-OX40 Monoclonal Antibody, in Patients with Alopecia Areata

Retrieved on: 
Tuesday, May 7, 2024
Safety, Doctor of Philosophy, Half-life, OX40, ADCC, Patient, Inflammation, Clinical trial, SAN, Pharmaceutical industry

The enrollment of the Phase 2a study in AA patients has been completed.

Key Points: 
  • The enrollment of the Phase 2a study in AA patients has been completed.
  • SAN DIEGO, May 07, 2024 (GLOBE NEWSWIRE) -- Inmagene Biopharmaceuticals (“Inmagene” or the “Company”), a clinical-stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory diseases, today announced that the Company completed target enrollment in its Phase 2a trial evaluating IMG-007 in adult patients with AA.
  • The Phase 2a open label trial ( NCT06060977 ) enrolled 29 AA patients with 50% or greater scalp hair loss from 11 sites in the U.S. and Canada.
  • IMG-007 is the first OX40/OX40L antagonist being evaluated in a clinical trial in AA patients,” said Yufang Lu, MD, PhD, Chief Medical Officer of Inmagene.

Memo Therapeutics increases Series C financing to CHF 45 million

Retrieved on: 
Tuesday, May 7, 2024
FDA, Phase, Cancer, Venture round, BK, Kidney, Risk, MTX, BK virus, Viremia, Memo, Disease, Patient, Kidney transplantation, BKV, CHF, Infection, Therapy, Viral, Pharmaceutical industry

Schlieren / Zurich, Switzerland, 7 May, 2024 – Memo Therapeutics AG (or “MTx”), a late-stage biotech company developing a best-in-class BKV-neutralizing antibody for BKV infection in kidney transplantation, today announces that it has successfully raised CHF 20 million as part of an extension of its Series C financing, bringing the total amount raised in the funding round to CHF 45 million.

Key Points: 
  • Schlieren / Zurich, Switzerland, 7 May, 2024 – Memo Therapeutics AG (or “MTx”), a late-stage biotech company developing a best-in-class BKV-neutralizing antibody for BKV infection in kidney transplantation, today announces that it has successfully raised CHF 20 million as part of an extension of its Series C financing, bringing the total amount raised in the funding round to CHF 45 million.
  • Erik van den Berg, CEO of Memo Therapeutics, commented: “This financing provides further external endorsement of the potential of our highly potent anti-BK virus mAb and our clinical strategy to bring it to patients as quickly as possible.
  • Thomas Harth, Principal at Ysios Capital stated: “We believe Memo Therapeutics has developed a very powerful antibody that can address the growing concern of BKV infections in kidney transplant recipients.
  • Alongside AntiBKV, Memo Therapeutics is developing a panel of pre-clinical assets in cancer and viral infections.

Memo Therapeutics increases Series C financing to CHF 45 million

Retrieved on: 
Tuesday, May 7, 2024
FDA, Phase, Cancer, Venture round, BK, Kidney, Risk, MTX, BK virus, Viremia, Memo, Disease, Patient, Kidney transplantation, BKV, CHF, Infection, Therapy, Viral, Pharmaceutical industry

Schlieren / Zurich, Switzerland, 7 May, 2024 – Memo Therapeutics AG (or “MTx”), a late-stage biotech company developing a best-in-class BKV-neutralizing antibody for BKV infection in kidney transplantation, today announces that it has successfully raised CHF 20 million as part of an extension of its Series C financing, bringing the total amount raised in the funding round to CHF 45 million.

Key Points: 
  • Schlieren / Zurich, Switzerland, 7 May, 2024 – Memo Therapeutics AG (or “MTx”), a late-stage biotech company developing a best-in-class BKV-neutralizing antibody for BKV infection in kidney transplantation, today announces that it has successfully raised CHF 20 million as part of an extension of its Series C financing, bringing the total amount raised in the funding round to CHF 45 million.
  • Erik van den Berg, CEO of Memo Therapeutics, commented: “This financing provides further external endorsement of the potential of our highly potent anti-BK virus mAb and our clinical strategy to bring it to patients as quickly as possible.
  • Thomas Harth, Principal at Ysios Capital stated: “We believe Memo Therapeutics has developed a very powerful antibody that can address the growing concern of BKV infections in kidney transplant recipients.
  • Alongside AntiBKV, Memo Therapeutics is developing a panel of pre-clinical assets in cancer and viral infections.

FibroGen Reports First Quarter 2024 Financial Results

Retrieved on: 
Monday, May 6, 2024
Pamrevlumab, Sale, Investment, Peripheral neuropathy, Pancreatic cancer, Neutropenia, RECIST, LAPC, CD46, Weight loss, MD, PSA, Webcast, Growth, IND, ASCO, CKD, Patient, Fatigue, Neoplasm, SAN, AstraZeneca, Anemia, CIA, Interest, Pharmaceutical industry

Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024.

Key Points: 
  • Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024.
  • Total revenue for the first quarter of 2024 was $55.9 million, as compared to $36.2 million for the first quarter of 2023, an increase of 55% year over year.
  • At March 31, 2024, FibroGen reported $214.7 million in cash - defined as cash, cash equivalents, investments, and accounts receivable.
  • FibroGen will host a conference call and webcast today, Monday, May 6, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update.

Inmagene Reports Positive Interim Results from Phase 2a Trial of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-life, for the Treatment of Atopic Dermatitis

Retrieved on: 
Monday, May 6, 2024
Șaeș, Patient, Outline of health sciences, Safety, Pharmacokinetics, BSA, Half-life, OX40, Disease, ADCC, Week, Aes, Chills, AA, Atopic dermatitis, I&I, SAN

Treatment with IMG-007, the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb), led to rapid, marked, and durable improvement of skin signs in patients with atopic dermatitis (AD).

Key Points: 
  • Treatment with IMG-007, the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb), led to rapid, marked, and durable improvement of skin signs in patients with atopic dermatitis (AD).
  • IMG-007 is a nondepleting anti-OX40 mAb, bioengineered to have a silenced antibody-dependent cellular cytotoxicity (ADCC) function and a prolonged half-life.
  • The Phase 2a trial ( NCT05984784 ) evaluates the safety, pharmacokinetics, and efficacy of IMG-007 in adult patients with moderate-to-severe AD who had inadequate response to and/or intolerant of topical therapies.
  • There were no serious adverse events (SAEs), and no adverse events (AEs) leading to treatment discontinuation, and no treatment-related AEs.