- FDA agrees to the planned Phase 1b study in second-line
transplant-ineligible patients in multiple myeloma
- Treatment regimen will include Velcade® (bortezomib) and
dexamethasone and replace oral Revlimid® with STAR-LLD
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 provided updates on its Phase 1b STAR-LLD
clinical trial of its investigational continuous delivery
lenalidomide in multiple myeloma.
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The U.S. Food and Drug Administration (“FDA”) notified the
Company that it may proceed with the U.S.-based program in
second-line transplant-ineligible patients using the combination of
STAR-LLD, Velcade, and dexamethasone. This treatment paradigm will
replace oral Revlimid with STAR-LLD. The planned study that follows
this development will evaluate six patients for tolerability,
immune biomarkers, and signals of efficacy of continuously
delivered lenalidomide at the highest planned daily dose. The study
is expected to accrue six patients in the United States in three to
four centers over a period of 10 months and will provide readouts
in the tolerability of the regimen, the impact of continuous
delivery on immune function by measuring biomarkers of T-cell,
NK-cell, and B-cell upregulation, and cytokine production induced
by lenalidomide. It will also provide signals of efficacy in
assessing response rates, duration of response, progression free
survival, and changes in minimal residual disease.
Pedro Lichtinger, chairman and CEO of Starton Therapeutics
commented, “Today’s announcement marks a significant development
for Starton and patients in need of approved drugs and improved
quality of life, and we are excited to begin this critical program
in transplant-ineligible patients with multiple myeloma. This study
will provide initial evidence of the impact of continuous delivery
of lenalidomide both in terms of safety and efficacy, as well as
provide clarity for signals of improvement in patients
outcomes.”
As part of the development plans, the FDA agreed to have a
meeting to review the initial data on safety and activity from the
study as an interim analysis, while patients continue treatment for
efficacy endpoints. This interim review is aimed at helping develop
the plans for the approval path forward with Phase 2 studies for
multiple myeloma, as well as other malignancies where lenalidomide
has shown activity but is not approved for the new indications
planned for study.
Dr. Jamie Oliver, Starton’s chief medical officer noted, “We are
very happy with the agreed protocol, which allows a quick read for
the key safety and efficacy data which we will review with the FDA.
The upcoming Phase 1b clinical study in multiple myeloma is on
track to begin enrollment in Q4 2023. Treatment of second-line
patients at our proposed optimal dose of continuous lenalidomide in
combination with the proteasome inhibitor Velcade and dexamethasone
allows us to demonstrate activity in an established standard of
care regimen by replacing Revlimid with STAR-LLD.”
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% tumor
elimination 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 >93% 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 for 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 Merger 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 HealthwellSPAC@edelman.com
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