Pharmaceutical

ARV-471 continues to show activity in heavily pre-treated patients with locally advanced or metastatic ER+/HER2- breast cancer

Median progression free survival of 3.7 months in all patients and 5.7 months in patients with ESR1 mutant tumors support the initiation of two Phase 3 registrational trials

Arvinas, Inc. (Nasdaq: ARVN) today announced initial results from the Phase 2 cohort expansion portion (VERITAC) of a phase 12 study with ARV-471, a novel PROTAC® estrogen receptor (ER) protein degrader. ARV-471 is being co-developed with Pfizer Inc. (NYSE: PFE) for the treatment of patients with locally advanced or metastatic ER positive human epidermal growth factor receptor 2 (HER2) negative (ER+HER2-) breast cancer.

This disclosure was originally planned for December 8, 2022. However, on November 21, 2022, the 2022 San Antonio Breast Cancer Symposium (SABCS) incorrectly published the abstract, omitting a key safety data table, and inadvertently released the corresponding full data presentation on the SABCS website. These full data are scheduled to be presented on December 8, 2022 at 9:00 a.m. CT in an oral presentation titled "ARV-471, a PROTAC® estrogen receptor (ER) degrader in advanced ER-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer: phase 2 expansion (VERITAC) of a phase 1/2 study."

As a result of the early release of the full data presentation, Arvinas will host a conference call and webcast today, November 22, 2022, at 4:30 p.m. ET to discuss these data. Those wishing to examine the data in more detail are welcome to access our 8K filed last evening located here .

In the VERITAC trial, ARV-471 shows a favorable tolerability profile and demonstrates a clinical benefit rate of 38% (total n=71) (CBR: rate of confirmed complete response, confirmed partial response, or stable disease > 24 weeks), the primary endpoint in the trial. These results are consistent with the Phase 1 portion of this trial.

Patients in VERITAC had a median of four lines of prior therapies, in a population where 100% of patients were treated with prior cyclin-dependent kinase (CDK4/6) inhibitors, 79% with prior fulvestrant, and 73% with prior chemotherapy.

At the time of data cutoff (June 6, 2022), ARV-471 administered at 200 mg (n=35) and 500 mg (n=36) demonstrated:

  • Antitumor activity in 100% CDK4/6 inhibitor-pretreated patients, as measured by a CBR of 38% (total n=71) in all patients and 51.2% in patients with mutant ESR1 tumors (n=41).
  • Preliminary median progression-free survival (mPFS) of 3.7 months, a key secondary endpoint, in all evaluable patients and 5.7 months in patients with mutant ESR1 tumors (n=41).
  • A favorable tolerability profile, with the majority of treatment-related adverse events (TRAEs) reported as Grade 1 or 2.

"I'm gratified to see the continued differentiated profile of ARV-471 and its potential to become an important new standard of care for patients with ER+/HER2- breast cancer," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "The positive VERITAC results, in a heavily pre-treated population in which 100% of the patients received at least one prior CDK4/6 inhibitor and many who had progressed on or after chemotherapy, and fulvestrant, reinforce our confidence in ARV-471 as we prepare to initiate two pivotal trials, with the goal of working to give patients and physicians a potential new option in the fight against breast cancer."

"These data validate the early data which led us to enter into the collaboration with Arvinas and give us the confidence needed to initiate two Phase 3 registrational trials," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.

ARV-471 Clinical Update

Study Design

VERITAC is the Phase 2 cohort expansion portion of a Phase 1/2 single-arm trial of ARV-471 alone and in combination with palbociclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC) (NCT04072952). In VERITAC, patients were treated with either 200 mg or 500 mg ARV-471 with a primary endpoint of CBR (CR, PR or SD > 24 weeks). Secondary endpoints include ORR, DOR, PFS and OS as well as safety (AEs) and pharmacokinetics.

Enrollment

As of the data cut-off date of June 6, 2022, 71 patients with locally advanced or metastatic ER+/HER2- breast cancer in the VERITAC expansion cohort were treated once-daily with oral doses of ARV-471 at 200 mg (n=35) or 500 mg (n=36).

  • 100% of patients were previously treated with CDK 4/6 inhibitors
  • 79% of patients were previously treated with fulvestrant
  • 73% of patients were previously treated with chemotherapy
    • 45% received chemotherapy in the metastatic setting

Efficacy Data

Clinical benefit rate (the primary endpoint, defined as a confirmed complete response, partial response, or stable disease ≥ 24 weeks) in all patients (n=71) and in patients with tumors harboring ESR1 mutations (n=41):

  • All patients (200 mg and 500 mg, n=71): 38%
    • Patients with tumors harboring ESR1 mutations (n=41): 51.2%
    • Patients with ESR1 wild-type tumors (n=25): 20%
  • All patients at 200 mg (n=35): 37.1%
    • Patients with tumors harboring ESR1 mutations (n=19): 47%
  • All patients at 500 mg (n=36): 39%
    • Patients with tumors harboring ESR1 mutations (n=22): 55%

Progression free survival

  • All patients receiving 200 mg or 500 mg qd ARV-471 (n=71): median 3.7 months
    • Patients with mutant ESR1 tumors (n=41): median 5.7 months
  • Patients receiving 200 mg qd ARV-471 (n=35): median 3.5 months
    • Patients with mutant ESR1 tumors (n=19): median 5.5 months
  • At the time of the data cutoff, data for 500 mg cohort were immature and therefore not included in a separate analysis

Safety Data

ARV-471 was well tolerated across both dose levels. TRAEs were primarily Grade 1 and 2, with 5 patients experiencing Grade 3/4 TRAEs:

  • 200 mg cohort:
    • Grade 1 (n=13): 37%
    • Grade 2 (n=13): 37%
    • Grade 3 or 4 (n=2): 6%
      • Grade 3/4 TRAEs in the 200 mg cohort were Grade 3 QT prolonged (n=1) and Grade 3 thrombocytopenia and Grade 4 hyperbilirubinemia (n=1).

  • 500 mg cohort:

    • Grade 1 (n=11): 31%
    • Grade 2 (n=9): 25%
    • Grade 3 or 4 (n=3): 8%
      • Grade 3/4 TRAEs in the 500 mg cohort were Grade 3 fatigue (n=1), Grade 3 decreased appetite (n=1), and Grade 3 neutropenia (n=1).

There was 1 discontinuation due to a treatment-emergent adverse event (TEAE) and no dose reductions in the 200 mg cohort. There were 2 discontinuations and 3 dose reductions in the 500 mg cohort.

Anticipated 2022/2023 Milestones

  • Initiate a Phase 3 trial (First Subject First Visit) with ARV-471 as a second-line treatment in patients with ER+/HER2- metastatic breast cancer (4Q 2022).
  • Initiate a Phase 3 trial (First Subject First Visit) with ARV-471 in combination with palbociclib as a first-line treatment in patients with ER+/HER2- metastatic breast cancer (1Q 2023).
  • Initiate the first two cohorts (First Subject First Visit) and initiate additional arms with other targeted therapies in the ongoing Phase 1b combination trial (TACTIVE-U) (2023).
  • Present data from the Phase 1b combination trial with palbociclib (Part C of the Phase 1/2 trial) at a medical conference (1H 2023).

Investor Call & Webcast Details

A conference call and webcast will be held at 4:30 p.m. ET on Tuesday, November 22, 2022, with executives from Arvinas and Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. Participants are invited to listen by going to the Events and Presentation section under the Investor page on the Arvinas website at www.arvinas.com . A replay of the webcast will be archived on the Arvinas website following the presentation.

About ARV-471

ARV-471 is an investigational, orally-bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of ARV-471; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

About Arvinas
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC ® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC ® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC ® protein degraders against validated and "undruggable" targets, the company has three investigational clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766 for the treatment of men with metastatic castration-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com .

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the potential for ARV-471 to become a new standard of care for patients with ER+/HER-2 breast cancer; the timing of our and Pfizer Inc.'s ("Pfizer") plans to initiate two Phase 3 trials with ARV-471, one in combination with palbociclib, and additional arms with other targeted therapies in the ongoing Phase 1b combination trial (TACTIVE-U); and the timing of our and Pfizer's plans to present data from the Phase 1b combination trial with palbociclib. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: our and Pfizer performance of our respective obligations with respect to our collaboration with Pfizer; whether we and Pfizer will be able to successfully conduct and complete clinical development for ARV-471; whether we obtain marketing approval for and commercialize ARV-471 on our current timelines or at all; whether our cash and cash equivalent resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

Arvinas Contacts

Investors:
Jeff Boyle
+1 (347) 247-5089
Jeff.Boyle@arvinas.com

Media:
Kirsten Owens
+1 (203) 584-0307
Kirsten.Owens@arvinas.com


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Love Pharma Initiates First Steps Towards a Strategic Alliance with Starton Therapeutics with Investment in this Biotech Leader

Love Pharma Initiates First Steps Towards a Strategic Alliance with Starton Therapeutics with Investment in this Biotech Leader

  • Starton Therapeutics is a leading clinical stage Biotechnology Company based in New Jersey led by CEO and Chairman, Mr. Pedro Lichtinger, Former President of Global Primary Care & President of Europe at Pfizer (PFE - NYSE)
  • Starton is focused on transforming standard of care therapies with proprietary continuous delivery technologies for selected approved drugs. The platform creates superiority regarding safety and side effect profiles over the original and can transform the drug into new indications for best-in-class oncology therapies allowing patients to live better longer lives
  • Through this initial investment, Love Pharma will be in position to imminently leverage Starton's advancements and clinical breakthroughs, helping to guide and accelerate the Company's current and prospective clinical pursuits
  • The investment establishes initial interest in Starton's ongoing growth and advancements and provides the framework to build a long-term strategic relationship

Love Pharma Co. ("LOVE" and or "The Company") (CSE:LUV)(FSE:G1Q0), the Company is pleased to announce that it has made a strategic investment in Starton Therapeutics Inc., a New Jersey based clinical stage biotechnology company focused on transforming standard of care therapies in oncology. This first investment in Starton establishes an initial position in the company and provides the starting point for a strategic relationship going forward whereby Love will leverage Starton's advancements and breakthroughs to guide the Company's clinical pursuits

"This investment provides our shareholders with exposure to a rapidly developing therapeutics business, which has just completed its phase 1 clinical trial for its STAR - LLD continuous delivery technology deploying lenalidomide (July 13 press release)," said Mr. Zach Stadnyk, Love Pharma President and CEO. "Starton is also entering a phase 2 trial with its STAR - OLZ transdermal five - day adhesive matrix patch deploying olanzapine, for which the FDA US Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV) (press release). With this investment in Starton we are building our relationship, forming an alliance and will look to Starton's expert management team to reduce risk in our own portfolio of clinical pursuits and focus on the addiction space."

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LYRICA (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint

Pfizer (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.

As quoted in the press release:

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Oxis Acquires Pharma Company, Appoints New CEO

Oxis International (OTCQB:OXIS) appoints new CEO and Chief Medical Officer as it completes acquisition of  Georgetown Translational Pharmaceuticals, which will add new management and a class of close-to-market Central Nervous Systems products.
As quoted in the press release:

Oxis has agreed to pay 33 percent of its outstanding shares to GTP to complete the transaction, which is expected to close on or before 90 days as per the agreement.
Dr. Clarence-Smith will become Chief Executive Officer of Oxis as part of the acquisition and will be appointed to the Oxis Board of Directors. Also joining the company’s executive management team as part of the merger will be a Chief Medical Officer (name to be disclosed upon closing), who was formerly Vice President and Chief Medical Officer and Medical Director, Oncology Clinical R&D of Pfizer, Inc. (PFE).
Anthony J. Cataldo, who has served as Chief Executive Officer of Oxis since July 2014, will become Executive Chairman of the company. Steven Weldon will continue as Chief Financial Officer.
Prior to founding GTP, Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC (AGN) in 2016.
Under the deal, Allergan agreed to pay $125 million upfront along with potential Regulatory and commercial milestones of up to $875 million to the shareholders of Chase.

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ICU Medical Completes the Acquisition of Hospira Infusion Systems from Pfizer

ICU Medical Inc. (NASDAQ:ICUI) today announced that it has completed its acquisition of the Hospira Infusion Systems business from Pfizer Inc. (NYSE:PFE). The Hospira Infusion Systems business includes IV pumps, solutions, and devices that, when combined with the company’s existing businesses, makes ICU Medical one of the world’s leading pure-play infusion therapy companies.
“We are pleased that Hospira Infusion Systems is now part of ICU Medical and welcome our new Hospira colleagues to the ICU team. We look forward to working together to continue providing quality, innovation and value to our clinical customers worldwide,” said Vivek Jain, chairman and chief executive officer at ICU Medical.The Hospira Infusion Systems acquisition complements ICU Medical’s existing business to create a company with a complete IV therapy product portfolio from solutions to pumps to non-dedicated infusion sets. In addition, the acquisition gives ICU Medical a significantly enhanced global footprint and platform for continued competitiveness and long-term growth. With an integrated product offering, the company now holds industry-leading positions in key segments and has access to the full US infusion marketplace with a compelling product portfolio.The company plans to announce full FY 2017 guidance on its Q4 Earnings call in late February.Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ”will,” ”expect,” ”believe,” ”could,” ”would,” ”estimate,” ”continue,” ”build,” ”expand” or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company’s expectations, goals or intentions regarding the future, including our full year 2016 guidance and our acquisition of the Hospira infusion systems business. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company’s products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of continued growth or improving efficiencies, unexpected changes in the Company’s arrangements with its largest customers and the Company’s ability to meet expectations regarding the timing, completion and integration of the Hospira infusion systems business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company’s filings with the Securities and Exchange Commission, which include those in the Annual Report on Form 10-K for the year ended December 31, 2015 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.ICU Medical Investor Contacts:
Scott Lamb, ICU Medical, Inc.
949-366-2183
slamb@icumed.com
John Mills, ICR, Inc
646-277-1254
John.Mills@icrinc.com
Media Contact:
Tom McCall, ICU Medical, Inc.
949-366-4368
tmccall@icumed.com

Transgene Announces Collaboration with Merck and Pfizer to Evaluate the Combination of TG4001 with Avelumab

Transgene (Paris:TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, today announced it has entered a collaboration agreement with the science and technology company Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) under which Transgene will sponsor a Phase 1/2 study evaluating the potential of the therapeutic vaccine candidate TG4001 in combination with avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, for the treatment of human papilloma virus- (HPV-) positive head and neck squamous cell carcinoma (HNSCC), after failure of standard therapy.
Philippe Archinard, Chairman and CEO of Transgene, commented: “We are
pleased to enter this collaboration with Merck KGaA, Darmstadt, Germany,
and Pfizer to evaluate our therapeutic vaccine TG4001 in association
with avelumab. In previous clinical trials, TG4001 has demonstrated
promising activity in terms of HPV viral clearance and was well
tolerated. TG4001 is one of the few drugs targeting HPV-associated
cancers that can be combined with an immune checkpoint blocker such as
avelumab. The preclinical and clinical data that have been generated
with both TG4001 and avelumab individually suggest this combination
could potentially demonstrate a synergistic effect, delivering a step up
in therapy for HPV-positive HNSCC patients
.”
The combination of TG4001 and avelumab aims to target two distinct steps
in the immune response to target cancer cells. This is an exclusive
agreement between the parties to study the combination of these two
classes of investigational agents in HPV-positive HNSCC.
Prof. Christophe Le Tourneau, M.D., Head of the Early Phase Program at
Institut Curie, and a world expert in ENT cancers, will be the Principal
Investigator of the Phase 1/2 study. This trial is expected to begin in
France, with the first patient expected to be recruited in H1 2017. It
will seek to recruit patients with recurrent and/or metastatic
virus-positive oropharyngeal squamous cell carcinoma that have
progressed after definitive local treatment or chemotherapy, and cannot
be treated with surgical resection and/or re-irradiation.
Prof. Christophe Le Tourneau said: “HPV-induced head and neck cancers
are currently treated with the same regimen as non-HPV-positive HNSCC
tumors. However, their different etiology clearly suggests that
differentiated treatment approaches are needed for HPV-positive
patients. Immunotherapy, and in particular the therapeutic vaccine
TG4001 together with the PD-L1 blocker avelumab, by targeting two
distinct steps in the immune response, could deliver improved efficacy
for patients who have not responded to or have progressed after a first
line of treatment.”

TG4001 is an active immunotherapeutic designed by Transgene to express
the coding sequences of the E6 & E7 tumor-associated antigens of HPV-16
and the cytokine, IL-2. This therapeutic vaccine, which is based on a
non-propagative, attenuated vaccinia vector (MVA), has already been
administered to more than 300 patients with high grade cervical
intra-epithelial neoplasia (CIN 2/3). It has demonstrated good safety, a
significant HPV clearance rate and promising efficacy results. Its
mechanism of action and good safety profile make TG4001 a particularly
appropriate candidate for combinations with other therapies, such as
avelumab.
Avelumab is an investigational, fully human antibody specific for a
protein found on tumor cells called PD-L1, or programmed death ligand-1.
As a checkpoint inhibitor, avelumab is thought to have a dual mechanism
of action that may potentially enable the immune system to find and
attack cancer cells. By binding to PD-L1, avelumab is thought to prevent
tumor cells from using PD-L1 for protection against white blood cells
such as T-cells, exposing them to anti-tumor responses. Avelumab is also
thought to help white blood cells such as natural killer (NK) cells find
and attack tumors in a process known as ADCC, or antibody-dependent
cell-mediated cytotoxicity. In 2014, the science and technology company
Merck KGaA, Darmstadt, Germany, and Pfizer signed a strategic alliance
to co-develop and co-commercialize avelumab.
Alise Reicin, M.D., Head of Global Clinical Development in the biopharma
business of Merck KGaA, Darmstadt, Germany, which in the US and Canada
operates as EMD Serono, commented: “We believe combination regimens
show significant promise in the development of novel and efficacious
immuno-oncology treatments. Through this study, we hope to discover the
potential of avelumab as a combination therapy with TG4001 for patients
fighting this recurring cancer.”

Chris Boshoff, M.D., Ph.D., Head of Immuno-Oncology, Early Development,
and Translational Oncology at Pfizer, said: “Through this
collaboration, we hope to better understand how therapeutic vaccines may
help support the clinical development program for avelumab as our end
goal is to find the best treatment options for patients.”

About HPV-mediated Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) is a heterogeneous group
of cancers that can affect the oral cavity, pharynx, and larynx. HPV-16
infection is recognized to participate in the development of a
substantial proportion of head and neck cancers and is associated with a
subset of HNSCC, especially those arising from the oropharynx (more than
80%), which are the most frequent, and the larynx (~70%).
The incidence of HPV-16-related head and neck cancer has significantly
increased in recent years. Although there are more than 100 subtypes of
HPV, HPV-16 accounts for 90% of all HPV-related head and neck cancers.
Global spending on head and neck cancer indications amounted to
$1 billion in 2010.
Current treatments include surgical resection with radiotherapy or
chemoradiotherapy. However, better options are needed for advanced and
metastatic HPV+ HNSCC. It is thought that immunotherapy combined with
immune checkpoint inhibitors could provide a promising potential
treatment option that would address this strong medical need.
About TG4001
TG4001 is an investigational therapeutic vaccine based on a
non-propagative, highly attenuated vaccinia vector (MVA), which is
engineered to express HPV-16 antigens (E6 & E7) and an adjuvant (IL-2).
It is one of the few therapies targeting HPV+ sub population. TG4001 is
designed to have a two-pronged antiviral approach: to alert the immune
system specifically to HPV-16-infected cells that have started to
undergo precancerous transformation (cells presenting the HPV-16 E6 and
E7 antigens) and to further stimulate the infection-clearing activity of
the immune system through interleukin 2 (IL-2). TG4001 has been
administered to more than 300 patients, demonstrating good safety,
significant HPV clearance rate and promising efficacy results. Its
mechanism of action and good safety profile make TG4001 an excellent
candidate for combinations with other therapies in solid tumors.
About Avelumab
Avelumab (also known as MSB0010718C) is an investigational, fully human
antibody specific for a protein found on tumor cells called PD-L1, or
programmed death ligand-1. Avelumab is thought to have a dual mechanism
of action which may enable the immune system to find and attack cancer
cells. By binding to PD-L1, avelumab is thought to prevent tumor cells
from using PD-L1 for protection against white blood cells such as
T-cells, exposing them to anti-tumor responses. Avelumab is also thought
to help white blood cells such as natural killer (NK) cells find and
attack tumors in a process known as ADCC, or antibody-dependent
cell-mediated cytotoxicity. In November 2014, Merck KGaA, Darmstadt,
Germany, and Pfizer announced a strategic alliance to co-develop and
co-commercialize avelumab.
About Transgene
Transgene S.A. (Euronext: TNG), part of Institut Mérieux, is a publicly
traded French biopharmaceutical company focused on designing and
developing targeted immunotherapies for the treatment of cancer and
infectious diseases. Transgene’s programs utilize viral vector
technology with the goal of indirectly or directly killing infected or
cancerous cells. The Company’s two lead clinical-stage programs are:
TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The
Company has several other programs in clinical and pre-clinical
development. Transgene is based in Strasbourg, France, and has
additional operations in Lyon, as well as a JV in China with Tasly
Group. Additional information about Transgene is available at www.transgene.fr.
Disclaimer
This press release contains forward-looking statements about the
future development of TG4001. Although the Company believes its
expectations are based on reasonable assumptions, these forward-looking
statements are subject to numerous risks and uncertainties, which could
cause actual results to differ materially from those anticipated. The
occurrence of any of these risks could have a significant negative
outcome for the Company’s activities, perspectives, financial situation,
results and development. The Company’s ability to commercialize its
products depends on but is not limited to the following factors:
positive pre-clinical data may not be predictive of human clinical
results, the success of clinical studies, the ability to obtain
financing and/or partnerships for product development and
commercialization, and marketing approval by government regulatory
authorities. For a discussion of risks and uncertainties which could
cause the Company’s actual results, financial condition, performance or
achievements to differ from those contained in the forward-looking
statements, please refer to the Risk Factors (“Facteurs de Risque”)
section of the Document de Référence, which is available on the AMF
website (
http://www.amf-france.org)
or on Transgene’s website (
www.transgene.fr).

BetterLife Announces Closing of Private Placement

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB : BETRF FRA: NPAU ) is pleased to announce that it has closed a non-brokered private placement (the "Offering") by issuing 3,160,000 common shares at a price of USD$0.15 per common share for gross proceeds of USD$474,000. The common shares issued pursuant to the Offering are subject to a hold period under applicable securities laws, which hold period expires four months and a day following the date of issuance. BetterLife will use the proceeds for working capital purposes and for advancement of pre-clinical and clinical programs. Negev Capital and certain European-based investors participated in the Offering.

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U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer's Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV Disease in Older Adults

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Pfizer and Clear Creek Bio to Collaborate on a Research Program Targeting SARS-CoV-2 Papain-Like Protease

Pfizer and Clear Creek Bio to Collaborate on a Research Program Targeting SARS-CoV-2 Papain-Like Protease

  • Agreement aims to advance discovery and development of novel papain-like protease (PLpro) inhibitors and potentially introduce a new class of oral antivirals in the fight against COVID-19
  • Expands Pfizer's innovative anti-infective pipeline, complementing the company's existing portfolio of COVID-19 products

Pfizer Inc. (NYSE: PFE) and Clear Creek Bio, Inc. today announced a research collaboration and exclusive license agreement to advance the discovery and development of potential inhibitors of the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment of COVID-19. PLpro is an essential enzyme, which, along with the main protease (Mpro), plays an important role in viral replication. This program will expand Pfizer's innovative anti-infective pipeline and, if successful, will complement Pfizer's existing portfolio of COVID-19 products with direct-acting antiviral agents against different SARS-CoV-2 targets.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221206005107/en/

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BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations:) Apollo Endosurgery, Inc. , Imago BioSciences, Inc. , Opiant Pharmaceuticals Inc. , Benefitfocus, Inc.

Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ( jbrodsky@brodskysmith.com ) or Marc Ackerman ( mackerman@brodskysmith.com ) at 855-576-4847. There is no cost or financial obligation to you.

Apollo Endosurgery, Inc. (Nasdaq - APEN)

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BetterLife To Present BETR-001 Preclinical Data at the 61ST Annual Meeting of the American College of Neuropsychopharmacology in Phoenix, Arizona

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, today announced that one of its scientific collaborators, Dr. Argel Aguilar-Valles from Carleton University's Department of Neuroscience (Ottawa, Canada), will present on the anti-depressant activity of 2-bromo-LSD ("BETR-001"), the Company's lead compound, at the upcoming ACNP Conference being held December 4 to 7 at Phoenix, Arizona, USA. BETR-001 is a non-hallucinogenic Lysergic Acid Diethylamide ("LSD") derivative molecule. Dr. Aguilar-Valles will present preclinical data supporting the acute and long-term anti-depressant activity of BETR-001 monotherapy in animal models. Furthermore, the data shows that BETR-001 promotes structural neuroplasticity in brain neurons and this effect is partly mediated by the activation of 5-HT2A receptor. Dr. Ahmad Doroudian, CEO of BetterLife commented, "BETR-001 is a uniquely positioned LSD derivative with the potential to be as effective as LSD in various neuropsychiatric and neurological disorders without the burden of being hallucinogenic. Because of its non-hallucinogenic nature, BETR-001 will not have all the LSD requirements of administration in specialized clinics under special treatment protocols, the LSD controlled substance regulatory issues which impact manufacturing, distribution and patient access, and the overall associated high treatment costs for all these parameters. Additionally, BETR-001 is protected by BetterLife's composition, method-of-use, synthesis and formulation patents (issued and provisional)." He further added, "BETR-001 IND-enabling studies are being completed and we hope to file its IND and begin human trials by mid-2023."

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