On March 15, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported that it is scheduled to participate in a fireside chat at the Oppenheimer 32nd Annual Virtual Healthcare Conference on Wednesday, March 16, 2022 at 7:00am Pacific Time (Press release, Biomea Fusion, MAR 15, 2022, View Source [SID1234610119]). Thomas Butler, Biomea’s CEO and Chairman of the Board, will participate in the fireside chat.

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An audio webcast for this conference will be available on the Company’s website at www.biomeafusion.com in the Investor Relations section.

On March 15, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly-targeted cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported that the National Cancer Institute (NCI) has achieved the intended enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the NCI-Led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune+HPV16mix) in combination with two investigational immune-modulating agents in advanced HPV-associated cancers (Press release, PDS Biotechnology, MAR 15, 2022, View Source [SID1234610118]). Currently, the study has enrolled 45 patients and will continue to enroll both CPI refractory and CPI naïve patients until the total enrollment of 56 is achieved.

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The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers in patients who have not been treated with CPIs (CPI naïve) and have failed at least one standard of care therapy. Secondly, in third-line treatment of the above-listed recurrent or metastatic HPV-positive cancers in patients who have failed at least two standard of care therapies including CPI treatment (CPI refractory).

The NCI, part of the National Institutes of Health, presented highly promising preliminary efficacy and safety data from the trial at the June 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Conference. The NCI plans to present an update in the near future. It was reported earlier this year that median survival of these patients now exceeds 12 months.

"We are pleased the NCI has achieved this important milestone as CPI refractory patients with various HPV-associated cancers have very few effective treatment options and the study data have shown the potential to extend the lives of these patients," commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "All of us at PDS Biotech would like to thank the NCI for all of their efforts in the achievement of this enrollment objective."

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: View Source

On March 15, 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 that it will present an analysis based on the June 10th, 2021 data cut from the expansion cohort of the Company’s Phase 1 trial of upifitamab rilsodotin (UpRi) at the upcoming Society of Gynecologic Oncology Annual Meeting on Women’s Cancer being held from March 18-21, 2022 in Phoenix, Arizona (Press release, Mersana Therapeutics, MAR 15, 2022, View Source [SID1234610117]).

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UpRi is a Dolaflexin ADC targeting NaPi2b and is being studied in UPLIFT, a single-arm registrational trial in patients with platinum-resistant ovarian cancer, as well as in UPGRADE, a Phase 1/2 umbrella trial evaluating UpRi in combinations starting with carboplatin. The Company plans to initiate UP-NEXT, a Phase 3 trial of UpRi monotherapy maintenance in platinum-sensitive recurrent ovarian cancer with a design informed by FDA and CHMP feedback, in the second quarter of 2022.

"The upcoming presentation at SGO will include analysis from the nearly 100 patients with ovarian cancer treated in the expansion cohort of our UpRi Phase 1 trial based on the June 10th, 2021 data cut which supported the decision to select 36 mg/m2 as the recommended Phase 2 dose for UPLIFT. The data highlight UpRi’s robust clinical activity and differentiated safety profile which further support the design of the ongoing UPLIFT registrational trial in platinum-resistant ovarian cancer," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics.

Details of the presentation and posters are as follows:

Oral Plenary Session Title: Updated Results from the Phase 1 Expansion Study of Upifitamab Rilsodotin (UpRi; XMT-1536), a NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC) in Ovarian Cancer
Abstract #: 76
Date/Time: Saturday, March 19, 2022 at 11:46 am MST
Oral Presenter: Debra L. Richardson, MD

Poster Title: Optimizing the Dose of Upifitamab Rilsodotin (UpRi; XMT-1536), a NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC): Updated Analysis of a Phase 1b Expansion Study in Ovarian Cancer
Abstract #: 319
Poster Lead Author: Bradley J. Monk, MD

Poster Title: UPGRADE: Phase 1 Combination Trial of the NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC) Upifitamab Rilsodotin (UpRi; XMT-1536) in ​Patients With Ovarian Cancer
Abstract #: 588
Poster Lead Author: Nehal Lakhani, MD, PhD

Poster Title: UPLIFT (ENGOT-ov67/GOG-3048): A Pivotal Cohort of Upifitamab Rilsodotin (XMT-1536; UpRi), a NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC) in Platinum-Resistant Ovarian Cancer
Abstract #: 585
Poster Lead Author: Debra L. Richardson, MD

Additional information can be found on the SGO website.

On March 15, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that Jeff Baxter, VBI’s President and CEO, will participate in an analyst-led fireside chat at the 32nd Annual Oppenheimer Healthcare Conference on Wednesday, March 16, 2022 (Press release, VBI Vaccines, MAR 15, 2022, View Source [SID1234610116]).

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Presentation Details

Event: 32nd Annual Oppenheimer Healthcare Conference
Date: Wednesday, March 16, 2022
Time: 10:00-10:30 AM ET
Webcast Link: View Source
A live webcast of the presentation will also be available on the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the Company’s website following the presentation.

On March 15, 2022 Coherus BioSciences, Inc. (Nasdaq: "CHRS", "the Company", "Coherus") reported Rosh Dias, MD, MRCP, has been appointed Chief Medical Officer. Dr. Dias will serve as a member of the Company’s executive leadership team and oversee a number of clinical functions including medical affairs, clinical operations, pharmacovigilance and clinical development (Press release, Coherus Biosciences, MAR 15, 2022, View Source [SID1234610115]).

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"Rosh is a terrific addition to Coherus at a time when we are sharply focused on successful execution of new product launches and on the advancement of our immuno-oncology development pipeline," said Denny Lanfear, CEO of Coherus. "A seasoned pharmaceutical executive with a demonstrated record of success leading medical affairs across multiple therapeutic areas, including oncology, he brings important experience and expertise as we prepare for the launch of up to four new products over the next 18 months."

"I am excited to join Coherus at this pivotal moment when the Company is preparing for the launch of multiple new products in immuno-oncology, immunology and ophthalmology," said Dr. Dias. "With toripalimab and its clinical and pre-clinical pipeline of PD-1 combination candidates, Coherus is well positioned to become a leader in innovative immuno-oncology drug development and commercialization. I am very excited about Coherus’ work advancing these novel treatments and about the possibilities to impact and help patients with cancer across multiple tumor types."

Dr. Dias brings more than 20 years of pharmaceutical and biotechnology industry experience leading United States and global teams in clinical development and medical affairs across multiple disease areas including oncology, cardiometabolic health and rare diseases. Dr. Dias joins Coherus most recently from Spruce Biosciences, Inc., where he was the Chief Medical Officer overseeing global clinical development and strategy. Prior to Spruce, he served as Chief Medical Officer at Indivior PLC, a global commercial pharmaceutical company focused on substance abuse and other serious mental disorders. From 2014 to 2018, Dr. Dias held senior leadership positions at Amgen, Inc., most recently as Vice President, Global Scientific Affairs, and at Amgen’s subsidiary, Onxy Pharmaceuticals, Inc., as Head of Global Medical and Scientific Affairs. Prior to Onyx, Dr. Dias worked for 10 years at Novartis Oncology in roles of increasing responsibility, including leadership roles in the global organization, the United States and in Australia, where he directed clinical development and medical affairs efforts with a focus on oncology, hematology and rare diseases.

Dr. Dias holds a Medical Doctor degree from Charing Cross and Westminster Medical School in the UK, and is a Member of the Royal College of Physicians through postgraduate qualification in Internal Medicine.