On August 16, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the initiation of patient dosing in the company’s Phase 1 trial of XMT-1660, the company’s Dolasynthen ADC targeting B7-H4 (Press release, Mersana Therapeutics, AUG 16, 2022, View Source [SID1234618415]).

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"The initiation of this Phase 1 trial represents an important milestone for Mersana as we continue to build our pipeline across three ADC platforms and seek to further demonstrate the potential of our Dolalock payload and Dolasynthen platform," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Based on our promising preclinical data, we believe XMT-1660 has the potential to serve as a highly impactful cancer treatment. We are excited to begin investigating how it may benefit patients in a range of cancers with high unmet needs."

XMT-1660 is a B7-H4-directed Dolasynthen antibody drug conjugate with a precise, target-optimized drug-to-antibody ratio (DAR 6) and Mersana’s clinically validated DolaLock microtubule inhibitor payload with controlled bystander effect. B7-H4 is overexpressed in a range of cancers, including breast, endometrial and ovarian tumors. In pre-clinical studies, XMT-1660 demonstrated robust anti-tumor activity across models representing each of these three cancers, as well as in multiple patient-derived xenograft models.

The multicenter Phase 1 trial is investigating the safety, tolerability and anti-tumor activity of XMT-1660 in patients with solid tumors, including in breast, endometrial and ovarian cancers. The initial dose escalation portion of this trial will evaluate the safety and tolerability of XMT-1660 as a single agent. The dose expansion portion of the trial will evaluate the tolerability and efficacy of XMT-1660 with primary endpoints of investigator-assessed objective response rate and duration of response.

On August 16, 2022 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2022 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 16, 2022, View Source [SID1234618414]).

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"Throughout the second quarter and in recent weeks, we have made substantial operational progress as we continue to advance our DNAbilize platform of products along the clinical pathway. Toward that end, we look forward to initiating our Phase 1 studies of BP1001-A, a drug product modification of prexigebersen, for the treatment of solid tumors and of BP1002 to treat relapsed/refractory acute myeloid leukemia (AML), including venetoclax resistant patients, in the coming weeks," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "The progress we are making today is laying the foundation for Bio-Path to achieve its mission to bring safe and effective new therapies to cancer patients who have limited treatment options."

Recent Corporate Highlights

Presented BP1003 Data at 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. In April, Bio-Path presented a poster highlighting preclinical BP1003 data at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. The poster, titled "Targeting STAT3 with novel liposome-incorporated antisense oligonucleotide technology enhances the efficacy of paclitaxel (taxol) or 5-fluorouracil (5- FU) in breast and ovarian cancer cells," was presented by Dr. Maria Gagliardi, Research Scientist at Bio-Path Holdings.
Appointed Aline Sherwood to Board of Directors. In April, Bio-Path announced the appointment of Aline Sherwood to the Company’s Board of Directors. Ms. Sherwood is Principal of Scienta Communications, an independent communications consultancy providing strategic public relations and corporate communications counsel to life sciences companies.
Financial Results for the Second Quarter Ended June 30, 2022

The Company reported a net loss of $3.0 million, or $0.42 per share, for the three months ended June 30, 2022, compared to a net loss of $1.8 million, or $0.26 per share, for the three months ended June 30, 2021.
Research and development expense for the three months ended June 30, 2022 increased to $1.9 million, compared to $0.8 million for the three months ended June 30, 2021, primarily due to manufacturing expenses related to drug product releases in the second quarter of 2022 and increased patient enrollment related to our Phase 2 clinical trial for prexigebersen in AML.
General and administrative expense for the three months ended June 30, 2022 was $1.2 million, an increase of $0.1 million compared to the three months ended June 30, 2021, primarily due to increased legal fees.
As of June 30, 2022, the Company had cash of $17.0 million, compared to $23.8 million at December 31, 2021. Net cash used in operating activities for the six months ended June 30, 2022, was $6.7 million compared to $4.2 million for the comparable period in 2021.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these second quarter 2022 financial results and to provide a general update on the Company. To access the conference call please dial (833) 630-1956 (domestic) or (412) 317-1837 (international). A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On August 16, 2022 GSK plc (LSE/NYSE: GSK) reported it has completed the acquisition of Affinivax, Inc (Affinivax), a clinical-stage biopharmaceutical company based in Cambridge (Boston, Massachusetts) (Press release, GlaxoSmithKline, AUG 16, 2022, View Source [SID1234618406]). Affinivax has pioneered the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines.

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As previously announced, the acquisition of Affinivax aligns with GSK’s strategy of building a strong portfolio of specialty medicines and vaccines. It includes a next-generation 24-valent pneumococcal vaccine candidate (AFX3772), currently in phase II development, which is based on the highly innovative Multiple Antigen Presenting System (MAPSTM) platform technology. A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development.

The MAPSTM technology supports higher valency than conventional conjugation technologies, potentially enabling broader coverage against prevalent pneumococcal serotypes and generating higher antibody responses against many individual serotypes than current pneumococcal vaccines.

Tony Wood, Chief Scientific Officer, GSK, said: "Affinivax’s exciting pneumococcal vaccine candidates, the potentially disruptive MAPs technology and their fantastic scientific talent, further strengthen our pipeline of novel vaccines and presence in the Boston area".

In the adult phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. In July 2021, the US Food and Drug Administration granted Breakthrough Therapy designation for AFX3772 to prevent S. pneumoniae invasive disease and pneumonia in adults 50 years and above. Preparations for the start of the phase III program are underway. Phase II clinical trials started in June 2022 to assess the use of the vaccine in the paediatric population.

Financial considerations

Under the terms of the agreement, GSK has acquired 100% of the outstanding shares of Affinivax. The acquisition comprised an upfront payment of $2.1 billion paid upon closing and two potential milestone payments of $0.6 billion to be paid upon the achievement of certain paediatric clinical development milestones. The transaction was subject to customary closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott- Rodino Anti-Trust Improvements Act of 1976. GSK will account for the transaction as a business combination.

Pneumococcal disease

Pneumococcal disease is an umbrella term used to describe any infection caused by the bacteria Streptococcus pneumoniae, a leading cause of acute bacterial infections worldwide. It has a broad clinical spectrum including bloodstream infections (sepsis), pneumonia, meningitis, and other milder diseases such as sinusitis and otitis media. A broadly recognized unmet medical need remains despite the availability of current vaccines. Pneumococcal pneumonia causes an estimated 150,000 hospitalisations each year in the United States; pneumococcal meningitis and bacteremia killed approximately 3,250 people in the United States in 2019[1].

MAPSTM technology platform

Multiple Antigen Presenting System (MAPS) is a novel and highly efficient vaccine technology platform that enables the precise, high-affinity binding of pathogen-derived polysaccharides and proteins of immune-relevance into a single vaccine. Immunisation with the resulting polysaccharide-protein complexes induces a broad and potentially protective B-cell (antibody) response to the polysaccharides and a separate B-cell and T-cell immune response to the proteins. The distinctive plug-and-play nature of MAPSTM enables the targeting of a broad range of infectious diseases.

The initial use of the technology has been directed primarily toward preventing pneumococcal disease. Applicability of the technology has also been demonstrated for additional infectious disease pathogens, including those that cause hospital-acquired infections.

On August 15, 2022 CytoDyn reported its annual report for the fiscal year ended May 31, 2022 (Filing, 3 mnth, JUN 30, CytoDyn, 2022, AUG 15, 2022, View Source [SID1234619117]).

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On August 15, 2022 Fusion Antibodies reported that it is delighted to be attending Discovery on Target 2022 (Press release, Fusion Antibodies, AUG 15, 2022, View Source [SID1234618450]).

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This event will be delivered in Boston from 17-20th October 2022.

Discovery on Target (DOT) highlights advances in current and emerging "hot" targets and technologies, as well as target validation strategies for the discovery and development of novel therapeutic agents ranging from biologics to small molecules.

Get in touch below to organise a meeting with one of the Fusion Antibodies team.