- Dosing comes three weeks after the first site opened
- Full enrollment of six patients is expected to take 10 months,
conducted in up to three clinical sites
- Multiple readings for safety and efficacy are expected during
the next 6 to 18 months
Starton Therapeutics Inc. (“Starton” or “the Company”), a
clinical-stage biotechnology company focused on transforming
standard-of-care therapies with proprietary continuous delivery
technology, announced the dosing of the first patient in the
STAR-LLD Phase 1b clinical trial, which will assess the safety,
efficacy and pharmacokinetics of continuous subcutaneous
administration of low-dose lenalidomide (STAR-LLD) for the
treatment of multiple myeloma (MM).
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The study will include six second-line transplant-ineligible
patients who will receive lenalidomide by continuous administration
daily in a 28-day cycle, in combination with dexamethasone and
bortezomib (Velcade), to assess the tolerability and clinical
response of the regimen, and will evaluate safety and tolerability,
immune biomarkers, and signals of efficacy. The study is also
expected to provide signals of efficacy in assessing response
rates, duration of response, progression-free survival, and changes
in minimal residual disease.
“From its inception, Starton has been focused on execution. We
are entering the development stage, in which we expect to achieve
the safety and tolerability improvement profile as well signals of
efficacy for our proprietary continuous delivery of lenalidomide.
We will enable the patient outcomes and quality of life
improvements for which we founded Starton,” said Pedro Lichtinger,
chairman and CEO of Starton Therapeutics. “We are excited to
evaluate the potential of STAR-LLD in this trial as a critical step
towards delivering on our pipeline of transformative therapies
using our continuous delivery technology.”
Dr. Nash Gabrail, MD, the study’s principal investigator noted,
“Revlimid is an indispensable drug in treating multiple myeloma.
Unfortunately, many times patients do not tolerate the side effects
associated with oral dosing. I believe the ability to target the
precise therapeutic blood levels with continuous administration of
the drug may allow an improvement in the therapeutic index of
lenalidomide and allow patients to stay on therapy longer.”
Dr. Jamie Oliver, Starton’s Chief Medical Officer noted, “This
is a major milestone for all of the staff at Starton working to
bring new therapies to patients suffering with cancer. Lenalidomide
has been an effective immunomodulatory drug in hematologic
malignancies for years. However, adverse events have limited its
use in certain patient settings, depriving patients of the full
benefits the medicine can offer. We believe STAR-LLD may be able to
expand the use of lenalidomide where the oral form is not used
today.”
Starton has signed an agreement for a business combination with
Healthwell Acquisition Corp. I (Nasdaq: HWEL) (“Healthwell”).
Please see “Additional Information and Where to Find It” below for
additional information related to the proposed business
combination.
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide in development to
expand and replace the standard of care for the most common blood
cancers, multiple myeloma (MM) and chronic lymphocytic leukemia
(CLL). A preclinical proof-of-concept study for STAR-LLD
demonstrated that MM tumors caused by human myeloma cells grew
25-fold if untreated, five-fold when treated with daily
lenalidomide and shrank by 80% with STAR-LLD. The study also showed
100% efficacy (overall response rate ORR) at 144 mcg/day continuous
LLD and 20% of animals in this cohort were tumor free after 100
days vs. 0% ORR with active control with daily pulsatile once daily
dosing. In addition, a Phase 1 bioavailability study in healthy men
comparing STAR-LLD to Revlimid demonstrated the drug is well
tolerated and is >91% bioavailable by the subcutaneous route. It
was also observed that the Cmax is <90% lower than oral
Revlimid. These data support the safety of the planned Phase 1 dose
of 400 mcg/hr (9.6 mg a day) versus a standard 25 mg a day dose of
Revlimid.
About Starton Therapeutics
A clinical-stage biotechnology platform company focused on
transforming standard of care therapies with proprietary continuous
delivery technology, so people with cancer can receive continuous
treatment to live better, longer. Starton’s proprietary transdermal
technology is intended to increase efficacy of approved drugs, to
make them more tolerable and expand their potential use. To learn
more, visit www.startontx.com.
About Healthwell
Healthwell is a blank check company, also commonly referred to
as a special purpose acquisition company, or SPAC, formed for the
purpose of effecting a merger, share exchange, asset acquisition,
share purchase, reorganization or similar business combination with
one or more businesses or entities.
Additional Information and Where to Find It
In connection with the transactions contemplated by the business
combination agreement, dated April 27, 2023 (as amended on May 15,
2023, August 10, 2023 and September 17, 2023, and as may be further
amended or supplemented from time to time, the “Business
Combination Agreement,” and all of the transactions contemplated
thereunder, the “Transaction”), by and among Starton, Healthwell,
HWEL Holdings Corp., a Delaware corporation and wholly-owned
subsidiary of Healthwell (“Pubco”), and other parties thereto,
Pubco filed a registration statement on Form S-4 with the U.S.
Securities and Exchange Commission (the “SEC”) on May 15, 2023 (as
may be amended or supplemented from time to time, the “Registration
Statement”), which includes a proxy statement and a prospectus in
connection with the Transaction. The Registration Statement was
declared effective on September 29, 2023 and the final prospectus
(the “Prospectus”) was filed by Pubco on October 2, 2023.
STOCKHOLDERS OF HEALTHWELL ARE ADVISED TO READ THE DEFINITIVE PROXY
STATEMENT, THE PROSPECTUS AND ALL OTHER RELEVANT DOCUMENTS FILED OR
THAT WILL BE FILED WITH THE SEC IN CONNECTION WITH THE TRANSACTION,
AND ANY AMENDMENTS THERETO, AS THEY BECOME AVAILABLE BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION. THIS DOCUMENT WILL NOT CONTAIN
ALL THE INFORMATION THAT SHOULD BE CONSIDERED CONCERNING THE
TRANSACTION. IT IS ALSO NOT INTENDED TO FORM THE BASIS OF ANY
INVESTMENT DECISION OR ANY OTHER DECISION IN RESPECT OF THE
TRANSACTION. When available, the definitive proxy statement and
other relevant documents will be mailed to the stockholders of
Healthwell as of September 14, 2023, the record date established
for voting on the Transaction. Stockholders and other interested
persons will also be able to obtain copies of the definitive proxy
statement, the Prospectus and other documents filed the SEC that
will be incorporated by reference therein, without charge, at the
SEC’s website at www.sec.gov. Healthwell’s stockholders will also
be able to obtain a copy of such documents, without charge, by
directing a request to: Healthwell Acquisition Corp. I, 1001 Green
Bay Rd, #227 Winnetka, IL 60093; e-mail:
healthwell.management@healthwellspac.com.
Forward-Looking Statements
This communication contains forward-looking statements for
purposes of the “safe harbor” provisions under the United States
Private Securities Litigation Reform Act of 1995. Any statements
other than statements of historical fact contained herein are
forward-looking statements. Such forward-looking statements
include, but are not limited to, expectations, hopes, beliefs,
intentions, plans, prospects, financial results or strategies
regarding Starton and the Transaction and the future held by the
respective management teams of Healthwell or Starton, the
anticipated benefits and the anticipated timing of the Transaction,
future financial condition and performance of Starton and expected
financial impacts of the Transaction (including future revenue, pro
forma enterprise value and cash balance), the satisfaction of
closing conditions to the Transaction, financing transactions, if
any, related to the Transaction, the level of redemptions of
Healthwell’s public stockholders and the products and markets and
expected future performance and market opportunities of Starton.
These forward-looking statements generally are identified by the
words “anticipate,” “believe,” “could,” “expect,” “estimate,”
“future,” “intend,” “may,” “might,” “strategy,” “opportunity,”
“plan,” “project,” “possible,” “potential,” “project,” “predict,”
“scales,” “representative of,” “valuation,” “should,” “will,”
“would,” “will be,” “will continue,” “will likely result,” and
similar expressions, but the absence of these words does not mean
that a statement is not forward-looking. Forward-looking statements
are predictions, projections and other statements about future
events that are based on current expectations and assumptions and,
as a result, are subject to risks and uncertainties. Many factors
could cause actual future events to differ materially from the
forward-looking statements in this communication, including,
without limitation: (i) the risk that the Transaction may not be
completed in a timely manner or at all, which may adversely affect
the price of Healthwell’s securities; (ii) the risk that the
Transaction may not be completed by Healthwell’s business
combination deadline and the potential failure to obtain an
extension of the business combination deadline if sought by
Healthwell; (iii) the failure to satisfy the conditions to the
consummation of the Transaction, including, among others, the
condition that Healthwell has cash or cash equivalents of at least
$10 million, and the requirement that the Business Combination
Agreement and the transactions contemplated thereby be approved by
the stockholders of each of Healthwell and Starton; (iv) the
failure to obtain any applicable regulatory approvals required to
consummate the Transaction; (v) the occurrence of any event, change
or other circumstance that could give rise to the termination of
the Business Combination Agreement; (vi) the effect of the
announcement or pendency of the Transaction on Starton’s business
relationships, operating results, and business generally; (vii)
risks that the Transaction disrupts current plans and operations of
Starton; (viii) the risk that Pubco may not be able to raise funds
in a PIPE financing or may not be able to raise as much as
anticipated; (ix) the outcome of any legal proceedings that may be
instituted against Starton or Healthwell related to the Business
Combination Agreement or the Transaction; (x) the ability to
maintain the listing of Healthwell’s securities on a national
securities exchange or failure of Pubco to meet initial listing
standards in connection with the consummation of the Transaction;
(xi) uncertainty regarding outcomes of Starton’s ongoing clinical
trials, particularly as they relate to regulatory review and
potential approval for its product candidates; (xii) risks
associated with Starton’s efforts to commercialize a product
candidate; (xiii) Starton’s ability to negotiate and enter into
definitive agreements for supply, sales, marketing, and/or
distribution on favorable terms, if at all; (xiv) the impact of
competing product candidates on Starton’s business; (xv)
intellectual property-related claims; and (xvi) Starton’s ability
to attract and retain qualified personnel; and (xvii) Starton’s
ability to continue to source the raw materials for its product
candidates.
The foregoing list of factors is not exhaustive. You should
carefully consider such factors and the other risks and
uncertainties described and to be described in the “Risk Factors”
section of Healthwell’s initial public offering (the “IPO”)
prospectus filed with the SEC on August 4, 2021, Healthwell’s
Annual Report on Form 10-K filed for the year ended December 31,
2022 filed with the SEC on March 3, 2023 and subsequent periodic
reports filed by Healthwell with the SEC, the Prospectus and other
documents filed or to be filed by Healthwell and Pubco from time to
time with the SEC. These filings identify and address other
important risks and uncertainties that could cause actual events
and results to differ materially from those contained in the
forward-looking statements. Forward-looking statements speak only
as of the date they are made. You are cautioned not to put undue
reliance on forward-looking statements, and neither Starton,
Healthwell nor Pubco assume any obligation to, nor intend to,
update or revise these forward-looking statements, whether as a
result of new information, future events, or otherwise, except as
required by law. Neither Starton, Healthwell nor Pubco gives any
assurance that either Starton or Healthwell, or the combined
company, will achieve its expectations.
Information Sources; No Representations
The information herein does not purport to be all-inclusive. The
information herein is derived from various internal and external
sources, with all information relating to the business, past
performance, results of operations and financial condition of
Healthwell derived entirely from Healthwell and all information
relating to the business, past performance, results of operations
and financial condition of Starton derived entirely from Starton.
No representation is made as to the reasonableness of the
assumptions made with respect to the information therein, or to the
accuracy or completeness of any projections or modeling or any
other information contained therein. Any data on past performance
or modeling contained therein is not an indication as to future
performance.
No representations or warranties, express or implied, are given
in respect of the communication. To the fullest extent permitted by
law in no circumstances will Healthwell, Starton or Pubco, or any
of their respective subsidiaries, affiliates, shareholders,
representatives, partners, directors, officers, employees, advisors
or agents, be responsible or liable for any direct, indirect or
consequential loss or loss of profit arising from the use of this
communication (including without limitation any projections or
models), any omissions, reliance on information contained within
it, or on opinions communicated in relation thereto or otherwise
arising in connection therewith, which information relating in any
way to the operations of Starton has been derived, directly or
indirectly, exclusively from Starton and has not been independently
verified by Healthwell. Neither the independent auditors of
Healthwell nor the independent auditors of or Starton audited,
reviewed, compiled or performed any procedures with respect to any
projections or models for the purpose of their inclusion in the
communication and, accordingly, neither of them expressed any
opinion or provided any other form of assurances with respect
thereto for the purposes of the communication.
Prior Disclosures
Starton is aware that its CEO appeared on the television program
“Unicorn Hunters” on June 7, 2021. During that appearance, the CEO
made a number of representations as to Starton’s approach to
reformulating drug products to improve efficacy, tolerability and
patients’ quality of life. As part of these representations, the
CEO raised the specific example of Starton’s investigational
reformulation of Revlimid. While Starton believes in the value of
its product, it understands that any clinical superiority claims
cannot be made absent specific findings from rigorous clinical
studies which Starton has not undertaken. The CEO’s comments on the
television program were not intended to suggest Starton has
conducted such studies; Starton does not have data to support these
specific representations and disclaims any representations or
purported representations by its CEO which either stated or implied
the contrary.
Participants in the Solicitation
Healthwell, Starton, Pubco and their respective directors and
executive officers may be deemed participants in the solicitation
of proxies of Healthwell’s stockholders in connection with the
Transaction. Healthwell’s stockholders and other interested persons
may obtain more detailed information regarding the names,
affiliations, and interests of certain of Healthwell executive
officers and directors in the solicitation by reading Healthwell’s
final prospectus filed with the SEC on August 4, 2021 in connection
with the IPO, Healthwell’s Annual Report on Form 10-K for the year
ended December 31, 2022 filed with the SEC on March 3, 2023 and
Healthwell’s other filings with the SEC. A list of the names of
such directors and executive officers and information regarding
their interests in the Transaction, which may, in some cases, be
different from those of stockholders generally, are set forth in
the Registration Statement relating to the Transaction. These
documents can be obtained free of charge from the source indicated
above.
No Offer or Solicitation
This communication shall not constitute a solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the Transaction. This communication shall not
constitute an offer to sell or the solicitation of an offer to buy
any securities, nor shall there be any sale of securities in any
states or jurisdictions in which such offer, solicitation or sale
would be unlawful prior to registration or qualification under the
securities laws of such state or jurisdiction. No offering of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as
amended, or an exemption therefrom.
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Starton Therapeutics Investors@startontx.com
Healthwell HealthwellSPAC@edelman.com
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