- Nash Gabrail, MD of the Gabrail Cancer Center to be lead
investigator
- Start-up services are underway with patient enrollment planned
for Q4 2023
Starton Therapeutics Inc. (“Starton” or “the Company”), a
clinical-stage biotechnology company focused on transforming
standard-of-care therapies with proprietary continuous delivery
technology, today entered into a definitive agreement to conduct
its Phase 1b trial in multiple myeloma with a global Clinical
Research Organization (CRO).
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the full release here:
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This pilot, open-label study will evaluate patients treated with
continuously delivered lenalidomide for safety and tolerability,
immune biomarkers, and signals of efficacy. Transplant-ineligible
multiple myeloma patients who are to receive
lenalidomide/dexamethasone/bortezomib in their second- or
greater-line of therapy, meet all other eligibility criteria and
provide informed consent are eligible for the study. The study is
expected to accrue patients in the United States in two centers
over a period of 10 months and will provide readouts in the
tolerability of the regimen, as well as the impact of continuous
delivery on immune function by measuring biomarkers of T-cell,
NK-cell, and B-cell upregulation, along with cytokine profiles
induced by lenalidomide. It is also expected to provide signals of
efficacy in assessing response rates, duration of response,
progression-free survival, and changes in minimal residual
disease.
“With our recently announced FDA authorization to proceed with
the Phase 1b clinical trial of STAR-LLD in multiple myeloma, we are
pleased to announce a CRO partner as we actively prepare to
initiate this study,” said Pedro Lichtinger, chairman and CEO of
Starton Therapeutics. “STAR-LLD has the potential to bring
much-needed innovation to the treatment of multiple myeloma, which
under current therapeutic options presents deteriorating quality of
life for patients. We are eager 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.”
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 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 and as many 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
preliminary proxy statement and a prospectus in connection with the
Transaction. STOCKHOLDERS OF HEALTHWELL ARE ADVISED TO READ THE
PRELIMINARY PROXY STATEMENT, AND, WHEN AVAILABLE, ANY AMENDMENTS
THERETO, 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 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 a record date to be established for voting on the
Transaction. Stockholders and other interested persons will also be
able to obtain copies of the preliminary proxy statement, the
definitive proxy statement, the Registration Statement and other
documents filed the SEC that will be incorporated by reference
therein, without charge, once available, 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., 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
$15 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. Recipients
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 Registration
Statement 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. Recipients 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.
Trademarks and Tradenames
This communication includes trademarks of Starton, which are
protected under applicable intellectual property laws and are the
property of Starton or its subsidiaries. This communication also
includes other trademarks, trade names and service marks that are
the property of their respective owners. We do not intend our use
or display of other companies’ trade names, trademarks or service
marks to imply a relationship with, or endorsement or sponsorship
of us by, any other companies.
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
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